Friday Factoids

COVID-19

Friday Factoids

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • The Federal Times says,
    • “Members of Congress are urging the Office of Personnel Management to ensure providers of its health insurance program do not exclude same-sex couples and single individuals from seeking the same artificial reproductive procedures that other federal employees do.”
  • The FEHBlog believes that this expresssed concern misunderstands OPM’s 2024 call letter and technical guidance which focus on fertility coverage and requires carriers to cover artificial insemination, which is typically used by same-sex couples and single individuals.
  • KFF tells us,
  • “A new proposal from the Centers for Medicare & Medicaid Services * * * would authorize Medicare payments to health care professionals to train informal caregivers who manage medications, assist loved ones with activities such as toileting and dressing, and oversee the use of medical equipment. * * *
  • “Several details of CMS’ proposal have yet to be finalized. Notably, CMS has asked for public comments on who should be considered a family caregiver for the purposes of training and how often training should be delivered.
  • “If you’d like to let CMS know what you think about its caregiving training proposal, you can comment on the CMS siteuntil 5 p.m. ET on Sept. 11. The expectation is that Medicare will start paying for caregiver training next year, and caregivers should start asking for it then.”

From the public health front,

  • The Centers for Disease Control announced the availability of flu shots for the 2022-23 flu season and offers flu shot finder tool.
  • Beckers Hospital Review informs us
    • “Health officials have started monitoring BA.2.86 — a highly mutated version of the COVID-19 virus. Not much is known yet about the newly detected lineage, though its large number of mutations has prompted the World Health Organization and CDC to begin tracking the strain. 
    • “The World Health Organization added BA.2.86, dubbed “Pirola” on social media by scientists closely tracking evolutionary changes in the virus, to its list of variants under monitoring Aug. 17. Shortly after, the CDC also said it has started tracking the lineage. 
    • “CDC is gathering more information and will share more about this lineage as we learn it,” the agency said on the social media platform X, formerly known as Twitter. So far, BA.2.86 has been detected in Israel, Denmark, the U.S. and the U.K. So far, only six cases of the new strain have been identified, with the single U.S. case detected in Michigan.” 
  • STAT News discusses the low rates of lung cancer screening in the U.S. notwithstanding the fact that lung cancer is the deadliest cancer in our country.
  • The National Institutes of Health informs us
    • “Past-year use of marijuana and hallucinogens by adults 35 to 50 years old continued a long-term upward trajectory to reach all-time highs in 2022, according to the Monitoring the Future (MTF) panel study, an annual survey of substance use behaviors and attitudes of adults 19 to 60 years old. Among younger adults aged 19 to 30, reports of past-year marijuana and hallucinogen use as well as marijuana and nicotine vaping significantly increased in the past five years, with marijuana use and vaping at their highest historic levels for this age group in 2022. The MTF study is funded by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, and is conducted by scientists at the University of Michigan’s Institute for Social Research, Ann Arbor.
    • “While binge drinking has generally declined for the past 10 years among younger adults, adults aged 35 to 50 in 2022 reported the highest prevalence of binge drinking ever recorded for this age group, which also represents a significant past-year, five-year, and 10-year increase.
    • “Substance use is not limited to teens and young adults, and these data help us understand how people use drugs across the lifespan,” said NIDA director, Nora Volkow, M.D. “Understanding these trends is a first step, and it is crucial that research continues to illuminate how substance use and related health impacts may change over time. We want to ensure that people from the earliest to the latest stages in adulthood are equipped with up-to-date knowledge to help inform decisions related to substance use.”

From the medical research front,

  • STAT News relates that “An innovative eye stem cell transplant could help restore vision in people with chemical injuries”
  • Medscape dives into the issue of whether artificial kidneys can replace dialysis.

From the Rx coverage front,

  • The Institute for Clincical and Economic Research reminds us
    • “ICER’s 2022 obesity management Final Evidence Report included subcutaneous semaglutide (Wegovy, Novo Nordisk), liraglutide (Saxenda, Novo Nordisk), phentermine/topiramate (Qsymia, Vivus Pharmaceuticals), and bupropion/naltrexone (Contrave, Currax Pharma). We found that semaglutide used for weight loss would achieve common thresholds for cost-effectiveness if priced between $7,500 – $9,800 per year. The current annual estimated net price is over $13,000.
    • “The Financial Times quoted ICER’s Chief Medical Officer, David Rind, MD:
      • “At current prices, ICER estimated that only 0.1 percent could be treated within five years without ‘major budget disruptions’ for the insurers. ‘The options are to move money away from other healthcare, raise premiums, or taxes if you’re the government, or manufacturers could lower the price to a cost-effective price and still make enormous amounts of money because enormous numbers of patients want this,’ Rind says.” 

From the U.S. healthcare business front

  • Forbes reports,
    • “Blue Shield of California said Thursday it will soon work with several companies to manage the prescriptions of its nearly 5 million health plan members, including Amazon Pharmacy, Cuban’s company and a fast-growing pharmacy benefit manager known as Abarca, which will “pay prescription drug claims.” Financial terms of the arrangement were not disclosed.
    • “But CVS Caremark will continue to provide specialty pharmacy services for Blue Shield “members with complex conditions, including education and high-touch patient support,” the health plan said.
    • “And it’s the specialty pharmacy business that may be a bigger deal to CVS and patients looking for a better deal on their costliest medicines.”
  • Per MedCity News,
    • “Fee-for-services payment models in the primary care ecosystem are doing a poor job of keeping Americans healthy and reducing the nation’s massive amount of healthcare spending, two CEOs of primary care companies said during a recent webinar. They argued that stakeholders in the primary care space need to come together to support more value-based care arrangements to reduce costs, advance population health and improve the patient experience.”
  • Per Healthcare Dive,
    • Rochester, Minnesota-based Mayo Clinic on Thursday reported increased operating revenue and income year over year in its second quarter earnings, driven by higher outpatient visits and surgical cases.
    • The nonprofit posted $4.5 billion in operating revenue, up 10.8% year over year, and $300 million in operating income. Operating expenses rose 7.5% compared to the prior-year period, totaling nearly $4.2 billion, though the cost of salaries and benefits increased at a slower rate this quarter compared with last year.
    • The earnings mark the second consecutive quarter of increased operating margins for Mayo, as the health system attempts to turn around after a rocky 2022 when its operating profit was cut in half.

Midweek Update

David Ermer–Congress, COVID-19, Government Contracting, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Manasvita S on Unsplash

From Washington DC,

  • Govexec informs us,
    • “The House and Senate appeared headed for a short-term spending deal when lawmakers return to Washington following the August recess, with leaders from both chambers suggesting they are pursuing that path to avoid a shutdown in October. 
    • “The continuing resolution would keep agencies funded at their current levels through early December, House Speaker Kevin McCarthy, R-Calif., told his caucus this week. Senate Majority Leader Chuck Schumer, D-N.Y., said on Wednesday he met with McCarthy a few weeks ago, and the two leaders agreed to pass a stopgap that would last “a few months.” 
    • “I thought that was a good sign,” Schumer told MSNBC. 
    • “Separately on Tuesday, Schumer said the short-term measure would allow lawmakers to come together on full-year appropriations.”
  • Federal News Network says,
    • For the second year in a row, the General Services Administration announced an increase to per diem lodging rates for federal employees.
    • Starting Oct. 1, base daily traveling allowances for feds will increase to $166 from $157 last year. That increase is thanks to an uptick in the standard per diem lodging rate for the Continental United States (CONUS), which will increase from $98 to $107. GSA did not make any changes to the per diem tiers for meals and incidental expenses. Those will remain in the range of $59 to $79, with the standard rate remaining at $59. * * *
    • GSA also offers a calculator tool to let feds search by city, state, zip code or map to figure out the exact amount of their per diem.
  • The Federal Acquisition Regulation cost principles apply these per diems to official travel by FEHB experience-rated carriers.

From the public health front,

  • The Washington Post reports,
    • Most cancers in the United States are found in people age 65 and older, but a new study shows a concerning trend: Cancer among younger Americans, particularly women, is on the rise, with gastrointestinal, endocrine and breast cancers climbing at the fastest rates.
    • A study published Wednesday in JAMA Network Open showed that while cancers among older adults have declined, cancers among people younger than 50 have increased slightly overall, with the largest increases among those aged 30 to 39.
    • “This is a population that has had less focus in cancer research, and their numbers are getting bigger, so it’s important to do more research to understand why this is happening,” said Paul Oberstein, director of the Gastrointestinal Medical Oncology Program at NYU Langone’s Perlmutter Cancer Center, who was not involved in the study.
  • STAT News points out
    • “Cancer patients, doctors, and patient advocates alike are struggling with the wide-ranging effects of the ongoing chemotherapy drug shortages. The platinum-based drugs carboplatin and cisplatin have been hard to keep in stock for months now, affecting most U.S. cancer centers: 93% have reported carboplatin shortages, and 70% have reported shortages of cisplatin.
    • “While patients with various types of cancer have been impacted by the shortages, those with ovarian cancer are among the groups most affected — both because the disease is relatively common, with women having a 1 in 78 chance of getting it in their lifetime, and because the drugs that are most effective in treating it are the ones now in short supply.
    • “While there are alternatives to the use of platinum drugs to treat ovarian cancer, none of them work quite as well. Carboplatin, in particular — in combination with the chemotherapy drug paclitaxel — has remained unchallenged as the go-to for ovarian cancer, in particular when the treatment could be curative rather than palliative.
  • Forbes relates
    • “New Covid omicron subvariant EG.5, or “Eris,” is now the dominant strain in the U.S., surpassing XBB.1.16 (or “Arcturus”), according to new data from the Centers for Disease Control and Prevention.
    • “EG.5 made up 17.3% of all cases in the two-week period from July 23 to August 5, a large jump from the 0.4% of cases it made up between April 30 and May 13.
    • “The World Health Organization classified EG.5 as a “variant of interest” Wednesday, which is a step below a variant of concern—WHO previously labeled it a “variant under monitoring” on July 19.
    • “While EG.5 may cause an increase in cases, WHO said it poses a low risk to public health in comparison to other omicron offspring because there’s no evidence it causes more severe cases.
    • “It is a recombinant strain—the result of two Covid variants combining during the replication process, which can occur if a person is infected with two variants at the same time—of the omicron family and a descendant of another strain labeled XBB.1.9.2.
    • “EG.5 has an extra mutation on its spike called mutation 465, which is present in about 35% of coronavirus sequences worldwide—a lot of the XBB variants have mutation 465, though experts don’t know what comes with the mutation.”

From the judicial front,

  • The Wall Street Journal reports,
    • “A federal appeals panel ruled that the Food and Drug Administration improperly expanded access to the widely used abortion pill mifepristone over the last seven years but left in place the drug’s original approval, teeing up the issue for review by the Supreme Court. 
    • “The ruling by a three-judge panel of the New Orleans-based Fifth U.S. Circuit Court of Appeals is the latest twist in a case that has at times threatened to pull the pill from the market nationwide.
    • “The appeals panel said pill opponents who sued the FDA had likely waited too long to challenge the drug’s original approval in 2000, and it also left in place the agency’s 2019 approval of the generic version of the pill. But the court said the FDA failed to properly scrutinize changes that eased access to mifepristone in recent years, such as allowing the drug to be administered without an in-person visit with a medical provider. * * *
    • “The appeals court decision doesn’t have immediate practical consequences because the Supreme Court in April issued an order allowing current broad levels of access to mifepristone while litigation proceeds. That is likely to ensure availability for months.”

From the U.S. healthcare business front,

  • Per Forbes
    • “Demand for nurse practitioners and primary care physicians is escalating along with their compensation as retailers from Amazon and CVS Health to Walmart and Walgreens build primary care clinics across the country.
    • “A new report from AMN Healthcare shows nurse practitioners—not doctors—topped the staffing company’s list of “most requested search engagements for the third consecutive year,” according to an annual report released Monday from AMN Healthcare’s Physician Solutions division, formerly known as Merritt Hawkins.
    • “Demand for NPs is being driven by a growing number of ‘convenient care’ providers, including retail clinics, urgent care centers and telemedicine platforms, which employ large numbers of NPs,” the report said.”
  • Beckers Hospital Review notes,
    • “Ozempic might find itself in CMS’ hands soon.
    • “Sales of the Type 2 diabetes drug in the U.S. have reached more than $3 billion so far in 2023, according to an Aug. 10 quarterly report from the drug’s maker, Novo Nordisk. CMS might try to influence the company to lower the medication’s cost, which sits at about $1,000 per month.
    • “In August 2022, President Joe Biden signed the Inflation Reduction Act, which gave Medicare Parts B and D negotiation powers for costly drugs with no generic or biosimilar competition. CMS said it will reveal by Sept. 1 which are the first 10 drugs that will see price negotiations, which are effective in 2026. This allowance will add more drugs each year. 
    • “Researchers from the Washington, D.C.-based West Health Policy Center and the University of California San Diego predicted Ozempic would be chosen for these negotiations in 2027 — when it passes 10 years on the market, one of the rules of the Inflation Reduction Act provision — according to a study published in March.”
  • Business Insurance adds,
    • “The U.S. Department of Justice has contested the Chamber of Commerce’s move to block the Medicare drug price negotiation program, stating the Chamber lacks the standing for the lawsuit and that halting the program would be detrimental to the public, The Hill reports. The Chamber had previously filed for an injunction against the program, citing potential harm to businesses and patients.”
  • Fierce Healthcare identifies “22 health systems that are charging for certain patient-provider electronic messages as of Aug. 16.” These systems are trying to squeeze the last golden egg out of the goose, in the FEHBlog’s opinion.

 

Tuesday Tidbits

David Ermer–CDC, Congress, COVID-19, FDA, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC —

  • Roll Call reports,
    • “House Republicans are planning to take up a short-term stopgap funding measure next month to avoid a partial government shutdown, Speaker Kevin McCarthy, R-Calif., told members of his conference during a Monday night call, sources familiar with the conversation said. 
    • “The continuing resolution is expected to extend current funding until early December, giving lawmakers a few extra months past the Sept. 30 deadline to complete fiscal 2024 appropriations. McCarthy said Monday that he did not want to have a continuing resolution run up to the Christmas recess, sources said. 
    • “The speaker’s announcement, which came as little surprise, served as an acknowledgment that the clock had run out for completing appropriations on time for the fiscal year that begins Oct. 1.”
  • Govexec says,
    • “Although President Biden and congressional appropriators appear to be in accord on the White House’s plan to grant federal employees their largest annual raise in more than two decades in 2024, there is still work to be done to make it a reality.
    • “Biden first proposed an average 5.2% pay increase for civilian federal workers and members of the military next year when he unveiled his fiscal 2024 budget plan. That figure marks the highest annual pay increase federal employees have seen since President Carter authorized a 9.1% raise in 1980.
    • “And although the administration and Senate Democrats have been butting heads with GOP appropriators in the House on a variety of funding issues in recent months, neither the House nor the Senate have included language in their respective spending packages to overrule the pay raise plan.”
  • The article explains the legal steps that the President must take this year to implement his pay raise plan.
  • Federal News Network informs us,
    • “In another effort to try to usher young talent into the federal workforce, the Office of Personnel Management is proposing changes to decade-old parameters for the Pathways Program.
    • “The new proposed regulations from OPM, in part, look to expand eligibility for the recent graduates’ Pathways Program, to include individuals who may not have a college degree, but who have completed different “technical education programs.” By counting experience in the Peace Corps, AmeriCorps, Job Corps and the Registered Apprenticeship Program, OPM said it hopes to make the program overall more inclusive, and help agencies attract a broader, more diverse pool of early-career applicants.”
  • Fierce Healthcare tells us,
    • “The Centers for Medicare & Medicaid Services (CMS) recently published new changes to further advance health equity and increase participation under the ACO REACH model.
    • “National Association of ACOs President and CEO Clif Gaus said the changes will “satisfy many concerns and stabilize future participation.” * * *
    • “Currently, there are 132 participants under ACO REACH, a value-based care model that began in January and replaced the Direct Contracting Model. The new model pushes providers to form accountable care organizations, or ACOs, for fee-for-service Medicare enrollees, and allows for providers to take on more financial risk. Participants are required to implement a health equity plan identifying disparities in care.”
  • A STAT News explains,
    • “The Inflation Reduction Act passed and signed into law a year ago attempts to deal with high drug prices paid by the U.S. government, allowing Medicare to negotiate the prices of some medicines after they have been on the market for years. (Industry would say it’s not negotiation but price-fixing.) But while the IRA is desperately needed — branded medicines cost 2.4 times more in the U.S. than in other developed countries, according to the RAND Corporation — there are ways in which it makes the situation worse.
    • “Here is the problem. The process of testing new experimental medicines takes a long time, sometimes a decade or more, and it is much longer for some objectives, such as preventing heart attacks, than others, like slightly extending the lives of terminal cancer patients.
    • “If one got to design a drug-pricing system from a blank slate, allowing drug prices to spike and then be cut after a few years would look less than ideal. It would be far better to set a lower price at the outset and not raise it but to allow a company to sell a drug for longer so the manufacturer has an incentive to fully study the benefits and risks of its medicines. * * *
    • “There are alternative models of how the drug pricing system can work. Take vaccines, for instance. They are not made nearly as expensive as, say, cancer drugs. But, in most cases, drug companies can trust that the market for them will be long and stable.
    • “This brings us back to the cancer drug shortage. All of the medicines in shortage are treatments that are generic, made into commodities by Hatch-Waxman. This problem could be changed if, say, hospitals were in a position to pay more to manufacturers who were seen as having a more stable supply.
    • “All of it is a reminder that the health care system in the U.S. is a Rube Goldberg machine created by past decisions that were made as much out of expediency as sober planning. The IRA, in particular, is another one of these decisions, pushed through a partisan Congress after the pharmaceutical lobby spent decades avoiding real change. It’s not surprising that a bill that has to be ushered in along partisan lines is not fully thought out or that many of the details are left to bureaucrats.
    • “At some point, we might want to actually design something sensible. Until then, we’d be better served by being more conscious of the mess we’re in.”

From the public health front —

  • Medscape points out,
    • “The newest version of the COVID-19 vaccine will be available by the end of September, according to the CDC. 
    • “The updated vaccine still needs final sign-offs from the FDA and the CDC.
    • “We anticipate that they are going to be available for most folks by the third or fourth week of September,” Director Mandy Cohen, MD, MPH, said on a podcast last week hosted by former White House COVID adviser Andy Slavitt. “We are likely to see this as a recommendation as an annual COVID shot, just as we have an annual flu shot. I think that will give folks more clarity on whether they should get one or not.”
    • “For people who are considering now whether they should get the currently available COVID vaccine or wait until the new one comes out, Cohen said that depends on a person’s individual risk. People who are 65 or older or who have multiple health conditions should go ahead and get the currently available shot if it’s been more than 6 to 8 months since their last dose. For all other people, it’s OK to wait for the new version.”
  • AHA News adds,
    • “Receiving a COVID-19 mRNA vaccine or booster during pregnancy can benefit pregnant people and their newborn infants, according to findings from a federally funded study published in Vaccine. The study looked at 167 pregnant people who received a primary or booster vaccine, which generated antibodies that crossed to the cord blood and likely conferred some protection in their newborns. Participants who received a booster dose had substantially more antibodies in their own blood and in their cord blood, suggesting that boosting increased their newborns’ immune defenses against COVID-19.
  • STAT News reports
    • “Every year, doctors get better tools to fight cancer. Engineered cancer-killing cells, immunotherapies, targeted drugs, and more are helping clinicians cure more patients. Increasingly, though, oncologists are trying to use less radiation, long one of the main pillars of cancer therapy. In some cases, they are even keeping certain patients with low-risk tumors off radiation entirely.
    • “We are in an era of radiation omission or de-escalation,” said Corey Speers, vice chair of radiation oncology at the University Hospitals Seidman Cancer Center and Case Western Reserve University. “Radiation is perhaps one of the most precise and most effective cancer therapies we have, so it will always play an important role in cancer management, but there are situations now on an individual patient basis where radiation may not be needed.”
  • MedPage Today notes that “Incident dementia was tied to exposure to fine particulate matter, especially air pollution from wildfires and agriculture, an observational study of 28,000 adults over age 50 suggested.”

From the judicial front,

  • A unanimous panel of the U.S. Court of Appeals for the 10th Circuit ruled today that ERISA and Medicare Part D preempt certain provisions of an Oklahoma PBM reform law that purport to apply to contracts between PBMs and ERISA and Part D plans. The opinion is helpful to the FEHB Program because the “relates to” clause in the ERISA state law preemption clause, 29 U.S.C. Sec. 1144, is read. analogously or “in pari materia” with the “relates to” clause in the FEHB Act’s state law preemption clause, 5 U.S.C. Sec. 8902(m)(1). Hopefully, this new precedent will pick up steam for ERISA and FEHB preemption of state laws, which do help control premiums.

From the Rx coverage front,

  • Healthcare Dive relates
    • “Amazon on Tuesday added more than 15 new manufacturer-sponsored coupons for insulin brands and diabetes care products to its online pharmacy.
    • “The additions bring Amazon’s manufacturer coupons that are automatically applied during check-out for eligible customers to 36.
    • “The new coupons include some of the most commonly prescribed products from drugmakers including Novo Nordisk, Eli Lilly and Sanofi, including insulin vials, pens and continuous glucose monitors, according to a blog post on Amazon’s website.
  • BioPharma Dive calls attention to
    • “Radiopharmaceuticals for cancer: Making radiation precise
    • “More than a dozen startups are developing drugs that deliver a dose of radiation directly to tumors. Here’s where they stand, and why their progress is worth watching.”

From the U.S. healthcare business front,

  • The International Foundation of Employee Benefit Plans informs us,
    • “U.S. corporate employers project a median healthcare cost increase of 7% for 2024, according to International Foundation of Employee Benefit Plans survey results. The 7% increase is on pace with cost trends projected last year in a similar survey conducted by the International Foundation.
    • “Plan sponsors shared their thoughts on the primary reasons contributing to a rise in medical plan costs for 2024. The top four responses are:
      • 22%—Utilization due to chronic health conditions (up from last year)
      • 19%—Catastrophic claims (same percentage as last year)
      • 16%—Specialty/costly prescription drugs/cell and gene therapy (new in the top four this year)
      • 14%—Medical provider costs (up from last year).
      • The effects of the pandemic appear to be waning as only 4% of responding employers indicated that the primary reason for cost increases is utilization due to delayed preventive/elective care during the pandemic (down from 12% last year).”
    • These factors will be largely offset by Medicare savings for those FEHB plans that are offering Medicare Part D plans for 2024, in the FEHBlog’s view.
  • Health Payer Intelligence explains,
    • “How Payers Are Reducing Prior Authorizations, Limiting Care Disruptions
    • “To limit patient care disruptions, payers have reduced prior authorization requirements for genetic testing, cataract surgeries, and physical therapy.”
  • and reports
    • “Payers prefer to utilize claims and administration platforms from vendors that are efficient, manage multiple business lines, and can meet their complex needs, according to a KLAS report.
    • “The Payer Claims & Administration Platforms 2023 report includes KLAS Decision Insights data and KLAS performance data, which reflects information about vendors and feedback from healthcare organizations.
    • “Among 28 payer organizations, 14 considered using HealthEdge’s claims and administration solutions. The vendor received an overall performance score of 76.5 on a 100-point scale. Twelve organizations considered using Cognizant, which received a score of 74.7.”
  • Healthcare Dive relates
    • “More than three years after the onset of the COVID-19 pandemic, only 1% of primary care clinicians surveyed by the Larry A. Green Center and the Primary Care Collaborative believe their practice has fully recovered from its impacts, and 61% characterize U.S. primary care as “crumbling.”
    • “Nearly 80% of respondents felt the current workforce is undersized to meet patient needs, and just 19% of clinicians report their practices are fully staffed.
    • “The results are emblematic of a “larger national crisis,” and policymakers must act to reinforce primary care, said Rebecca Etz, co-director of the Larry A. Green Center, in a statement. “ … It is not a matter of if, but when there will be another pandemic … If we don’t act soon, primary care won’t be there when it happens.”

Monday Roundup

David Ermer–COVID-19, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington DC,

  • The Department of Health and Human Services “announced two awards totaling $2 million under “the Leading Edge Acceleration Projects in Health Information Technology (LEAP in Health IT) funding opportunity. LEAP in Health IT awardees seek to create methods and tools to improve care delivery, advance research capabilities, and address emerging challenges related to interoperable health IT.”

From the public health front,

  • Medscape takes a look at the current state of Covid.
    • Cautious optimism and a call to remain vigilant seem like the consensus at the moment. While the numbers remain low so far, and the uptick in new cases and hospitalizations are relatively small compared to past scenarios, “It makes sense to boost our anti-Omicron antibody levels with immunizations before fall and winter,” Anne Liu, MD, an allergy, immunology, and infectious disease specialist at Stanford University, said.
    • “It’s just advisable for everyone — especially those who are at higher risk for hospitalization or death — to be aware,” Bernard Camins, MD, an infectious disease specialist at Mount Sinai Hospital in New York City, said, “so they can form their own decisions to participate in activities that may put them at risk for contracting COVID-19.”
  • MedPage Today says,
    • “Reassuringly, a history of oral contraceptive use had no deleterious effects on cardiovascular disease (CVD) and survival over long-term follow-up, a U.K. Biobank study showed. * * *
    • “These findings provide significant public health insights and may facilitate a shift in public perception because OC [oral contraceptive] use is common in women of reproductive age, and previously negative publicity exists about the safety of OC use,” Huijie Zhang, MD, Ph.D, of Nanfang Hospital, Southern Medical University, in Guangdong, China, and colleagues wrote in the Journal of the American Heart Association.”
  • Fierce Healthcare says,
    • “CareFirst BlueCross BlueShield is joining forces with Ryse Health, a company that specializes in providing in-person and virtual care for patients with uncontrolled Type 2 diabetes, in hopes of driving better long-term outcomes.”
    • “CareFirst officials said they believe the effort will help improve care by better pinpointing what they need most.”
    • “This partnership with Ryse is unique from our perspective because it’s one of the first ways in which we’ve been able to create a longitudinal value-based program that is complementing the broader value-based program efforts that the organization has,” Nathan Coffey, CareFirst’s manager of payment transformation, told Fierce Healthcare.
    • “But there’s been a gap, not just with us, but across the industry where you have a lot of discrete care programs for specialists, but having that longitudinal tie that amplifies the impact of those larger population health programs—that’s harder to create,” Coffey said.”

From the telehealth front —

  • mHealth Intelligence reports
    • “Despite the boom in telehealth use during the COVID-19 pandemic, Americans and healthcare workers largely agree that in-person care is higher quality, more efficient, and more affordable than virtual care, a new survey shows.
    • “Conducted by Morning Consult, the survey polled 1,006 healthcare workers from May 5 to May 18 and 2,202 United States adults from July 21 to July 23.
    • “But patient perceptions regarding telehealth may be changing. The survey shows that only 6 percent of US adults prefer virtual care versus 53 percent who prefer in-person care.
    • “This preference for in-person care was evident across all age groups. Generation Z displayed the highest preference for virtual care, with 9 percent of survey respondents in this group saying they preferred virtual care. However, 49 percent of Gen Z patients preferred in-person care. Similarly, while only 8 percent of Millennials said they preferred virtual care, 43 percent preferred in-person care. * * *
    • “On the other hand, hybrid care proved relatively popular across age groups. About 30 percent of Gen Z patients, 40 percent of Millennials, 37 percent of Gen X patients, and 31 percent of Baby Boomers said they preferred a hybrid healthcare model that includes both in-person and virtual care.”

From the U.S healthcare business front,

  • Healthcare Dive informs us,
    • Religiously affiliated hospital giant AdventHealth is suing cost management firm MultiPlan, alleging the company works with health insurers to systematically underpay for out-of-network medical claims.
    • AdventHealth alleges providers have lost at least $19 billion per year as a direct result of MultiPlan’s anticompetitive agreements with major payers, including UnitedHealth, Aetna, Elevance, Centene, Cigna, Humana and a number of Blue Cross Blue Shield insurers.
    • MultiPlan called the lawsuit, which was filed last week in the U.S. District Court for the Southern District of New York, meritless in a statement.
  • From what the FEHBlog knows about Multiplan arrangements, he agrees with Multiplan’s take.

Following up on yesterday’s lede article, the FEHBlog tracked down the American Society of Anesthesiologist’s warning about the relationship between the use of GLP-1 drugs and aspiration while under anesthesia.

“ASA’s Task Force on Preoperative Fasting suggests the following for patients taking GLP-1 agonists for type 2 diabetes or weight loss who are having elective procedures. It is also calling for further research to be done regarding GLP-1 agonist medications and anesthesia.

“Day or week prior to the procedure:

  • Hold GLP-1 agonists on the day of the procedure/surgery for patients who take the medication daily.
  • Hold GLP-1 agonists a week prior to the procedure/surgery for patients who take the medication weekly.
  • Consider consulting with an endocrinologist for guidance in patients who are taking GLP-1 agonists for diabetes management to help control their condition and prevent hyperglycemia (high blood sugar).

“Day of the procedure:

  • Consider delaying the procedure if the patient is experiencing GI symptoms such as severe nausea/vomiting/retching, abdominal bloating or abdominal pain and discuss the concerns of potential risk of regurgitation and aspiration with the proceduralist or surgeon and the patient.
  • Continue with the procedure if the patient has no GI symptoms and the GLP-1 agonist medications have been held as advised. 
  • If the patient has no GI symptoms, but the GLP-1 agonist medications were not held, use precautions based on the assumption the patient has a “full stomach” or consider using ultrasound to evaluate the stomach contents. If the stomach is empty, proceed as usual. If the stomach is full or if the gastric ultrasound is inconclusive or not possible, consider delaying the procedure or proceed using full stomach precautions. Discuss the potential risk of regurgitation and aspiration of gastric contents with the proceduralist or surgeon and the patient.

“Full stomach precautions also should be used in patients who need urgent or emergency surgery.”

https://www.asahq.org/about-asa/newsroom/news-releases/2023/06/patients-taking-popular-medications-for-diabetes-and-weight-loss-should-stop-before-elective-surgery

Midweek update

David Ermer–COVID-19 vaccine, Medicare, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From the public health and Rx coverage front —

  • Think Advisor informs us
    • “Executives from life insurance, health insurance and annuity issuers have spent their second-quarter earnings calls telling securities analysts about an open secret: The U.S. death rate is still noticeably higher than it was before 2020, when the COVID-19 pandemic began.
    • “Some executives emphasized that COVID-19 had little effect on earnings because their companies had prepared for COVID-19 to linger, not because the effects have gone away.
    • “But John Gallina, Elevance CFO, said costs related to COVID-19 and the pandemic’s impact are a headwind.
    • “When you combine COVID and non-COVID cost, the overall cost of the health care system is more expensive than if COVID had never occurred,” Gallina said. “We’ve seen it, we’ve priced for it and we’ve factored it into our expectations. But COVID is not gone. It still exists. It’s just no longer the big significant driving force that it had been for the past several years.”
  • KFF Health News says,
    • “[M]ultiple studies show that firefighters, both military and civilian, have been diagnosed with testicular cancer at higher rates than people in most other occupations, often pointing to the presence of perfluoroalkyl and polyfluoroalkyl substances, or PFAS, in the foam.
    • “But the link between PFAS and testicular cancer among service members was never directly proven — until now.
    • “A new federal study for the first time shows a direct association between PFOS, a PFAS chemical, found in the blood of thousands of military personnel and testicular cancer. * * *
    • “The Department of Veterans Affairs does not recommend blood testing for PFAS, stating on its website that “blood tests cannot be linked to current or future health conditions or guide medical treatment decisions.”
    • “But that could change soon. Rep. Dan Kildee (D-Mich.), co-chair of the congressional PFAS Task Force, in June introduced the Veterans Exposed to Toxic PFAS Act, which would require the VA to treat conditions linked to exposure and provide disability benefits for those affected, including for testicular cancer.
    • “The last thing [veterans] and their families need to go through is to fight with VA to get access to benefits we promised them when they put that uniform on,” Kildee said.”
  • Reuters reports,
    • “U.S. psychiatrists are increasingly prescribing the popular weight-loss drug Wegovy to patients who gain weight from medicines used to treat mental disorders, such as schizophrenia or bipolar disorder, according to Reuters interviews with ten prescribers across the country.
    • “Many antipsychotic drugs and mood stabilizers can cause patients to gain significant weight and contribute to diabetes and heart disease, the leading cause of death among adults with schizophrenia.”
  • The New York Times provides us with information about who should get the flu, Covid and R.S.V. vaccines, and when this fall.

From the U.S. healthcare business front,

  • The Washington Post reports,
    • “The average U.S. physician earns $350,000 a year. Top doctors pull in 10 times that.
    • “When those simple data points were first presented in 2020, a small subset of physicians came unglued on the microblogging site formerly known as Twitter, slinging personal insults and at least one deeply unflattering photo illustration of an economist.
    • “We couldn’t understand why. The figures are nigh-on unimpeachable. They come from a working paper, newly updated, that analyzes more than 10 million tax records from 965,000 physicians over 13 years. The talented economist-authors also went to extreme lengths to protect filers’ privacy, as is standard for this type of research.
    • “By accounting for all streams of income, they revealed that doctors make more than anyone thought — and more than any other occupation we’ve measured. In the prime earning years of 40 to 55, the average physician made $405,000in 2017 — almost all of it (94 percent) from wages. Doctors in the top 10 percent averaged $1.3 million. And those in the top 1 percent averaged an astounding $4 million, though most of that (85 percent) came from business income or capital gains.”
  • Fierce Healthcare relates,
    • “Hospitals nationwide charge payers more than double for healthcare services covered under commercial plans than they do for the same insurer’s Medicare Advantage (MA) plans, according to a recent Johns Hopkins analysis of hospitals’ published pricing data.
    • “The work, published this week in Health Affairs, reviewed more than 200,000 unique combinations of hospitals, insurers, settings and services for which a commercial and an MA price were available for direct comparison. In total, it included pricing data from 2,434 hospitals and 118 insurers collected in September 2022.
    • “Commercial prices were, on average, between $600 and $707 more expensive than MA prices, or 2.1 to 2.2 times more expensive.
    • “The dollar gap for prices was widest within the surgery and medicine service category where median commercial prices were nearly $800 more expensive than the charges for MA plans ($1,702 versus $928), 1.8 times higher. The median price increases were consistent across the other three reviewed service categories: imaging ($490 versus $191, 2.6 times higher), lab tests ($32 versus $12, 2.7 times higher) and ED visits ($519 versus $262, 2.0 times higher).”
  • Beckers Hospital Review points out the payer mix of largest for profit health systems based on their second-quarter earnings reports.
  • BioPharma Dive reports on the latest biotech M&A deals as the market begins to pick up.

From the miscellany department,

  • AHA News reminds us that “Health care providers must comply with the HIPAA rules with respect to telehealth effective Aug. 9 at 11:59 p.m., when the 90-day enforcement discretion period announced in April expires.” 
  • MedPage Today notes
    • “A new blood test from Quest Diagnostics has Alzheimer’s experts concerned.
    • “The Quest AD-Detect test, which consumers can now purchase from home without visiting a doctor, measures amyloid-beta 42 and amyloid-beta 40 in blood to provide an amyloid-beta 42/40 ratio. In theory, the ratio may help identify the risk of developing Alzheimer’s disease. In practice, the value of the Quest test is unknown.
    • “The test has not been cleared or approved by FDA.”

Monday Roundup

David Ermer–CDC, CMS, COVID-19, Federal employment benefits, Mental health care, No Surprises Act, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC —

  • Fedscoop reports
    • “The Office of Personnel Management is expecting to conduct a four-month trial of a new online retirement application platform for federal employees later this year, FedScoop has learned.
    • “In a letter to lawmakers, which was obtained by this publication through a Freedom of Information Act request, agency director Kiran Ahuja said OPM will conduct an approximately 120-day pilot in coordination with the National Finance Center, which is a federal agency division under the United States Department of Agriculture.
    • “Responding to questions from lawmakers, including Sen. Dick Durbin, D-Il., Ahuja wrote: “Between the electronic employee data received from the payroll center and the online retirement application, RS will receive all the information necessary to process a retirement application electronically.”
    • “She added: “The pilot will likely last 120 days, at which point RS will evaluate the results and determine the appropriate next steps to expand the program.” 
  • The Federal Times says that “Unions representing more than 900,000 federal workers are pushing back against President Joe Biden’s plan to bring back more in-person work for federal employees, citing contract terms and the benefits of a hybrid workforce.”
  • The FEHBlog had time today to redline the proposed amendments to the mental health parity rule in the existing rule, 45 C.F.R. Sec. 146.136. The FEHBlog thought that the proposed amendment would downplay the complicated non-quantitative treatment limitation (NQTL) provisions in favor of more direct requirements to improve access to, and lower costs for, mental health and substance use disorder care. Au contraire, the regulators seek to achieve these goals via the NQTL rules, which will become hyper-complicated. It’s disappointing, considering that parity could be achieved much more efficiently by covering medical/surgical and mental health/substance use disorder care under a unified set of rules.

From the public health front —

  • U.S. News and World Report informs us
    • A new coronavirus strain has taken over as the top variant circulating in the U.S.
    • EG.5 was responsible for more than 17% of new coronavirus cases over the past two weeks, according to data from the Centers for Disease Control and Prevention. That’s the highest prevalence of any strain circulating, rising above the so-called “arcturus” variant, which caused nearly 16% of infections. * * *
    • XBB.1.5, which will be the target of the updated COVID-19 vaccines coming in the fall, is decreasing in the U.S. Still, health experts say that the shot should work on other omicron subvariants as well.
    • Health officials hope that the upcoming fall booster campaign will increase protection against the coronavirus ahead of a potential fall and winter wave.
  • Reuters points out
    • “Five major U.S. health systems said they would offer Eisai and Biogen’s promising new Alzheimer’s drug Leqembi after working out payment and administrative policies, and how to assess and monitor patients, most likely in the next month or two.
    • “Leqembi, which won full U.S. regulatory approval last month, is the first treatment proven to slow progression of the mind-robbing disease for people in the earliest stages of Alzheimer’s.
    • “The disease affects an estimated 6.5 million people, most of whom are part of the U.S. government’s Medicare plan for people 65 and older.
    • “The patients are lining up. They want to be treated, but it’s difficult to rush right into it,” said Dr. James Galvin, who heads the Alzheimer’s research program at the University of Miami Miller School of Medicine.
    • “Neurologists at the Mayo Clinic in Rochester, Minnesota, Chicago’s Northwestern Memorial and Los Angeles’ Cedars-Sinai all said they plan to roll out the drug in the next few months. Cleveland Clinic and Utah’s Intermountain health system said they have not started offering it.”
  • Per Health Day,
    • “By age 75 years, approximately half the global population can expect to develop a mental disorder, according to a study published online July 30 in The Lancet Psychiatry.
    • “John J. McGrath, Ph.D., from Queensland Centre for Mental Health Research in Brisbane, Australia, and colleagues used data from 156,331 adult participants in the World Mental Health surveys (2001 to 2022; 29 countries) to estimate age-of-onset distributions, lifetime prevalence, and morbid risk for mental disorders.
    • “The researchers found that the lifetime prevalence of any mental disorder was 28.6 percent for male respondents and 29.8 percent for female respondents. By age 75 years, the morbid risk for any mental disorder was 46.4 percent for male respondents and 53.1 percent for female respondents. At 15 years, the conditional probabilities of first onset peaked, with a median age of onset of 19 years for male respondents and 20 years for female respondents. Alcohol use disorder and major depressive disorder were the two most prevalent disorders for male respondents, while major depressive disorder and specific phobia were most prevalent for female respondents.”

From the No Surprises Act front

  • According to Healthcare Dive,
    • “A Texas judge has vacated portions of the No Surprises Act dispute resolution process after the state’s medical group argued it was illegal and overly favorable to health insurers, leading the HHS to once again suspend arbitrations until further notice.
    • “Judge Jeremy Kernodle for the Eastern District of Texas on Thursday vacated regulators’ increase of the dispute resolution administrative fee to $350 and the “batching rule,” which allowed arbitration processes only on claims with the same service code.
    • “The judgment removes barriers for providers to file dispute resolution claims and will likely increase the volume of claims, especially from physician groups and hospital outpatient departments, according to a health lawyer.”
  • CMS adds
    • Effective August 7, 2023, the Departments have directed certified IDR entities to resume processing single and bundled disputes where the administrative fees have been collected (or the deadline for collecting fees expired) before August 3, 2023. Additionally, the Departments have directed certified IDR entities to resume processing batched disputes where the IDR entity determined that the batched dispute was eligible and collected administrative fees (or the deadline for collecting fees expired) before August 3, 2023. Processing of other disputes remains temporarily suspended.
  • The federal government appealed one of Judge Kernodle’s decisions in favor of the Texas Medical Association and may appeal this one too. The FEHBlog has no problem with Judge Kernodle’s batching rule. He thinks that the regulators should ladder the administrative fee based on the sum of the QPAs in dispute. The higher the sum; the higher the fee. By the way, the government’s administrative fee is on top of the independent dispute entity’s fee, which runs from $400 to $500 fee per party.

In other U.S. healthcare business news —

  • Fierce Healthcare relates
    • “Large health systems are scooping up independent hospitals, and that consolidation negatively affects employers, insurers and patients, according to a new analysis backed by Blues giant Elevance Health.
    • However, the American Hospital Association was quick to dispute the findings, with CEO Rick Pollack telling Fierce Healthcare in an email that the analysis “draws absurd conclusions about the impact of healthcare systems on access to care, cost and quality.”
  • Beckers Payer Issues ranks health insurers by commercial membership here.
  • Beckers Hospital Review names three U.S. hospitals that announced shutdown plans last week.

Friday Factoids

David Ermer–COVID-19, FDA, HSA, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC —

  • The Food and Drug Administration announced today
    • “approv[ing Sage Therapeutic’s] Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in adults. PPD is a major depressive episode that typically occurs after childbirth but can also begin during the later stages of pregnancy. Until now, treatment for PPD was only available as an IV injection given by a healthcare provider in certain healthcare facilities.
  • STAT News informs us
    • “A new White House task force on drug shortages held a rare in-person meeting last Friday with representatives from hospitals, drugmakers, pharmacies, and others in the drug supply chain to brainstorm policies for stemming shortages of cancer drugs.
    • “The meeting at the Eisenhower Executive Office Building focused on immediate steps that could help alleviate shortages, such as allowing temporary importation of drugs from other countries, according to an attendee and three others with knowledge of the discussion. It also touched on purchasing issues.”
  • HR Dive relates
    • “The National Labor Relations Board on Wednesday reversed its Trump-era stance that allowed employers to maintain certain handbook policies, such as those mandating a respectful workplace (Stericycle, Inc. and Teamsters Local 628).
    • “The shift means all policies that restrict employee speech and actions must be reviewed — “and very likely rewritten,” according to Peter Spanos, a partner at law firm Taylor English.”

From the public health front —

  • The Leapfrog Group now offers ratings on maternity care services.
  • Health Day relates,
    • “A micronutrient in human breast milk may provide significant benefit to developing newborn brains, according to new research that sheds light on the link between nutrition and brain health.
    • “Scientists looked at this sugar molecule in rodents and in human neurons. They said the micronutrient, called myo-inositol, may lead to improved infant formulas.
    • “The current research does indicate that for circumstances where breastfeeding is not possible, it may be beneficial to increase the levels of myo-inositol in infant formula,” said study co-author Thomas Biederer.
    • “Myo-inositol may also play a part in the aging brain, according to the research conducted at the Jean Mayer USDA Human Nutrition Research Center on Aging (HNRCA) at Tufts University in Boston.”
  • STAT News lets us know,
    • “Early-stage cancer diagnoses decreased by nearly 20% in the first year of the Covid-19 pandemic. A new study published in Lancet Oncology emphasizes how, because of disruptions in care, patients were more likely to get diagnosed with deadly metastatic disease — across nearly all cancer types.
    • “This study is the most comprehensive analysis of cancer diagnoses during the pandemic, using a nationwide registry that captures over 70% of all cancers in the United States. The starkest decline was observed after the initial shutdowns, with the regular 70,000 monthly cancer diagnoses (captured by the study’s inclusion criteria) being cut in half in April 2020.”
  • KFF News offers polling data on consumer interest in the new injectable weight loss drugs and their attitudes toward pharmaceutical companies and “A Look at the Latest Suicide Data and Change Over the Last Decade” in our country.

From the U.S. healthcare business front —

  • The Kaiser Foundation announced
    • “For the quarter ending June 30, 2023, Kaiser Foundation Health Plan, Inc., Kaiser Foundation Hospitals, and their respective subsidiaries (KFHP/H) reported operating revenues of $25.2 billion and operating expenses of $24.4 billion compared to operating revenues of $23.5 billion and operating expenses of $23.4 billion in the same period of the prior year. Operating income was $741 million for the second quarter of the year compared to operating income of $89 million in the second quarter of 2022.
    • “Like all health systems, Kaiser Permanente is experiencing ongoing cost headwinds and volatility driven by inflation, labor shortages, and the lingering effects of the pandemic on access to care and service.
    • “Due to favorable financial market conditions, Kaiser Permanente benefited from strong investment income with other income (net of other expenses) of $1.3 billion for the second quarter, compared to a $1.4 billion loss in the second quarter of 2022. For the second quarter, net income was $2.1 billion compared to a net loss of $1.3 billion in the same period of 2022.”
  • Healthcare Dive points out
    • “Patrick Conway is stepping up as CEO of UnitedHealth pharmacy benefit manager OptumRx effective immediately, according to a Thursday post on the executive’s LinkedIn, as part of a leadership shakeup at the healthcare giant.
    • “Conway is replacing Heather Cianfrocco, who is pivoting to president of Optum. Cianfrocco will lead the division’s pharmacy and care delivery capabilities, per UnitedHealth’s website.
    • “Cianfrocco replaces John Prince as Optum president. Prince has departed the company to serve as a senior advisor to private equity firm TPG, according to his LinkedIn.”
  • EBRI announced
    • “A new research report published today by the Employee Benefit Research Institute (EBRI) found that cost-sharing shifted from deductibles to copayments and coinsurance among enrollees in HSA-eligible health plans for a number of services impacted by IRS Notice 2019-45. The report, “The Impact of Expanding Pre-Deductible Coverage in HSA-Eligible Health Plans on Employee Choice of Health Plan and Cost Sharing,” analyzed claims data to quantify the effect of expanding pre-deductible coverage on enrollee choice of health plan and cost-sharing.
    • “In response to IRS Notice 2019-45, three-quarters of large employers and health plans offering HSA-eligible health plans expanded pre-deductible coverage for medications and services that prevent the exacerbation of chronic conditions. As a result, it is not surprising that when examining medical claims, cost-sharing shifted from deductibles to copayments and coinsurance for enrollees in HSA-eligible health plans,” explained Paul Fronstin, Ph.D., director, Health Benefits Research, EBRI. “The percentage of cost sharing paid through deductibles fell for antidepressants, insulin and other glucose-lowering agents, statins, beta blockers and inhaled corticosteroids.”
  • Health Payer Intelligence updates us on the status of provider challenges to the No Surprises Act’s arbitration rules.
    • “The legal challenges highlight the difficulties of prioritizing affordable healthcare for consumers. With payers and providers holding opposing views, federal policymakers must reach a conclusion that benefits both sides and improves costs for consumers.
    • “If federal agencies cannot establish reasonable guidelines for the IDR process, Americans may face an inflationary federal IDR process that results in higher premiums and healthcare costs, according to Georgetown University’s O’Neill Institute.
    • “There is a strong urgency to determine concrete guidelines, given the high amount of disputes that payers and providers have submitted through September 2022, a CMS report indicated.”
  • Behavioral Health Business reports
    • “The Cigna Group (NYSE: CI) has seen a historic but expected rise in behavioral health benefits utilization in recent years. 
    • “These insights, presented by the health care insurance and service conglomerate’s executives, echo others made by UnitedHealth Group (NYSE: UNH) executives on their second-quarter earnings call. 
    • “As it relates to what we’re seeing in terms of trends in terms of utilization, behavioral health has certainly been growing at a strong clip, not just this year, but for the past few years,” Brian Evanko, The Cigna Group’s CFO said Thursday on the company’s second-quarter earnings call. “Part of that is by design as we engage with our customers. And over time, that’s a good thing because the more utilization we see in behavioral health services, [the more] it helps to defray core medical costs.”

Thursday Miscellany

David Ermer–ACA, AHRQ, CDC, COVID-19, FDA, Telehealth, U.S. Healthcare–

From Washington, DC —

  • Medscape tells us
    • “The US Food and Drug Administration (FDA) [on July 31] cleared an artificial intelligence (AI)-assisted colonoscopy device called the MAGENTIQ-COLO, according to the Israeli-based manufacturer of the same name.
    • “The device helps identify lesions in real time, and is associated with a significant increase in the adenoma detection rate (ADR), according to the press release.”
  • MedPage Today lets us know,
    • “The CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously — 10 to 0 — in favor of nirsevimab (Beyfortus) for protecting a wide swath of at-risk infants from respiratory syncytial virus (RSV).
    • “At a meeting on Thursday, ACIP recommended that all infants younger than 8 months who are born during or approaching their first RSV season receive one dose of nirsevimab.
    • “The advisory committee also voted 10-0 to recommend that children 8 to 19 months who are at increased risk of severe RSV and approaching their second RSV season receive one dose of the monoclonal antibody against RSV.
    • As a result of this action, FEHB plans and health plans generally must cover the preventive service with no cost sharing when delivered in-network.
  • The Labor Departments Office of Federal Contract Compliance Programs announced
    • “a final rule titled “Pre-enforcement Notice and Conciliation Procedures.”
    • “The final rule modifies the agency’s earlier rule, “Nondiscrimination Obligations of Federal Contractors and Subcontractors: Procedures to Resolve Potential Employment Discrimination” which took effect on December 10, 2020. * * *
    • “To learn more, read Acting Director Michele Hodge’s blog about the final rule here. You can also read the Final Rule here.  
    • “The final rule will take effect on September 5, 2023.”

From the public health front —

  • UPI reports, “In examining real-world data on the long-term health of elderly patients who received the COVID-19 vaccine, researchers at Brown University and Boston-based Hebrew SeniorLife determined that the Moderna variety was the safest and most effective for older adults.”
  • The Washington University School of Medicine announced,
    • “Scientists at Washington University in St. Louis have developed a breath test that quickly identifies those who are infected with the virus that causes COVID-19. The device requires only one or two breaths and provides results in less than a minute.
    • “The study is available online in the journal ACS Sensors. The same group of researchers recently published a paper in the journal Nature Communications about an air monitor they had built to detect airborne SARS-CoV-2 — the virus that causes COVID-19 — within about five minutes in hospitals, schools and other public places.”
  • MedPage Today informs us
    • “Thymectomy carried a substantially increased risk of all-cause mortality and cancer for adults, a “landmark” study showed.
    • “Adults who had undergone thymectomy had at least double the risk of all-cause mortality and cancer at 5 years post-surgery compared with matched patients who had undergone cardiothoracic surgery without thymectomy * * *.
    • “Incidental thymectomy is common during cardiothoracic surgery due to the pyramid-shaped organ’s location in the chest in front of the heart where surgeons need to access the surgical field.
    • “While the thymus plays a critical role in normal immune system development, it was thought to be safe to remove in adulthood, “particularly since the thymus naturally involutes with age,” the researchers noted.
    • “Their conclusion from the study was that the thymus continues to be functionally important for human health in adulthood.”
  • HHS’s Agency for Healthcare Research and Quality has made available a
    • “Toolkit for Improving Perinatal Safety, a second bundle of AHRQ tools is available to improve the safety culture of labor and delivery (L&D) units. The second bundle provides resources that align the toolkit’s adaptive care processes with the clinical care processes recommended in the Alliance for Innovation on Maternal Health (AIM) program.
    • “The new tools are designed to help L&D units reduce obstetric hemorrhage and severe hypertension in pregnancy, two leading known causes of preventable maternal mortality and severe maternal morbidity in the United States.”
  • On a related note, Fierce Healthcare reports
    • “To improve maternal and infant healthcare, Health Care Service Corporation announced the launch of a program that will rely in part on the cooperation of local groups to ensure its success.”To improve maternal and infant healthcare, Health Care Service Corporation announced the launch of a program that will rely in part on the cooperation of local groups to ensure its success.
    • “HCSC said it wants to increase access to providers and reduce gaps in healthcare as well as engage and educate residents about maternal and infant well-being. The customer-owned health insurer plans to install the program in the states in which it operates: Illinois, Montana, New Mexico, Oklahoma and Texas.
    • “The initiative will first launch in the Lone Star State, HCSC said.
    • “We’re collaborating with trusted community organizations and partners, leveraging their knowledge, experience and talents on a local level,” HCSC Chief Clinical Officer Monica Berner, M.D., said in a press release. “We seek to build healthier communities by using our resources to respond to societal needs.”
  • KFF News points out that “Doctors Sound Alarm About Child Nicotine Poisoning as Vapes Flood the US Market.”

From the U.S. healthcare business front —

  • Beckers Payers Issues notes
    • “The Cigna Group raised its year-end revenue projections to $190 billion and reported a 6 percent decrease in shareholders’ net income, according to the company’s second quarter earnings published Aug. 3.
    • “Total revenues in the second quarter were $48.6 billion, up 7 percent year over year.
    • “In the second quarter, net income was nearly $1.5 billion, down 6 percent from $1.6 billion year over year. The company cited an absence of income from recently divested businesses, including the sale of businesses to Chubb in six countries and divestiture from a joint venture in Turkey.
    • “Evernorth pharmacy revenues rose 7 percent year over year to $35.2 billion. The insurance side of the business, Cigna Healthcare, reported second-quarter revenues of $12.7 billion, up 11 percent from the previous year.
    • “The company’s medical loss ratio was 81.2 percent in the second quarter, compared to 80.7 percent during the same period last year.”
  • Healthcare Dive adds
    • “Investors were concerned about medical cost trends coming into the second quarter, but health insurers have largely bucked the worst of rising expenses. Cigna, one of the last major payers to report earnings, was no different.
    • “We planned and priced for more normalized levels of utilization this year. Our year-to-date claims experience has been broadly in line with this expectation,” Cigna CFO Brian Evanko said in a Thursday morning call with investors.”
    • Cigna’s medical loss ratio, or how much of the premium dollar is spent on patient care, was 81.2% in the second quarter, according to new financial results — better than analysts expected.
  • Healthcare Dive also reports
    • “Telehealth company Amwell lowered its 2023 revenue outlook after missing analyst expectations and racking up another non-cash goodwill impairment charge in the second quarter.
    • “The company now expects to bring in revenue between $257 million and $263 million for the year, compared with earlier guidance of $275 million to $285 million, Amwell said in second-quarter results released Wednesday. 
    • “Amwell’s revenue declined 3% year over year to $62.4 million in the quarter. The telehealth vendor posted a net loss of $93.5 million, which included a $27.3 million goodwill impairment charge to make up for the “sustained decrease” in Amwell’s stock and market capitalization, according to an SEC filing.”
  • Fierce Healthcare lets us know
    • “UnitedHealthcare tapped 66 not-for-profit organizations spread over 12 states to receive grant funding to help expand access to care.
    • “The $11.1 million in grant funding, which falls under UnitedHealthcare’s Empowering Health program, aims to help improve the healthcare options of individuals living in underserved communities by addressing the social determinants of health, the insurance giant said. Specifically, it’ll target food insecurity, social isolation, behavioral health issues and health literacy efforts.
    • “Some of the organizations to receive funds include the Upstate Foundation in Syracuse, New York, CHRIS 180 in Atlanta and Trellis in Minneapolis and Saint Paul.”

Midweek update

David Ermer–Congress, COVID-19, Federal employment benefits, Generative AI, NIH, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Mount Rushmore

From Washington, DC —

  • STAT News reports
    • “Senators on the Finance Committee on Wednesday nearly unanimously passed a bill to clamp down on drug middlemen but kicked the can down the road on some of the more challenging policies.
    • “The bill would offer some more transparency into the business practices of pharmacy benefit managers, ensure PBMs aren’t skimming off of the money they send to insurers, prohibit them from overcharging insurers, and ensure certain fees in the Medicare program aren’t tied to a drug’s price.”
  • From the Senate Finance Committee, “click here for more information on the legislation, including a description of the Chairman’s Mark and a section-by-section summary.”
  • The House Ways and Means Committee relates,
    • “Congresswoman Nicole Malliotakis, a member of the House Committee on Ways and Means, today announced her legislation, the Protecting Patients from Middlemen Act, passed out of the full committee and will be included in the committee’s Health Care Price Transparency Act of 2023.
    • “Specifically, Malliotakis’ legislation, which was introduced in partnership with Rep. Brad Wenstrup (OH-02), would prohibit prescription drug plans and Pharmacy Benefit Managers (PBMs) in Medicare Part D or Medicare Advantage from charging patients more in drug cost-sharing that the net price of the drug.”
  • AHA News tells us,
    • “The House Ways and Means Committee July 26 voted 25-16 to pass the Health Care Price Transparency Act (H.R. 4822), legislation that would impose additional site-neutral payment cuts and regulatory burdens on off-campus hospital outpatient departments, impose additional Medicare sequester cuts on hospitals, and codify and make changes to hospital price transparency regulations. * * *
    • “In other action today, the committee voted 23-17 to pass the Providers and Payers COMPETE Act (H.R. 3284), AHA-opposed legislation that would impose new regulatory responsibilities on the Department of Health and Human Services regarding consolidation.”
  • Federal News Network informs us,
    • “Federal retirees, and employees looking to retire, have some new resources to help them through the often long and thorny retirement process.
    • “A new series of video tutorials from the Office of Personnel Management lays out, step by step, a couple of key items on the federal retirement to-do list.
    • “With the three new videos, OPM said it hopes to reduce the number of errors from federal retirees when trying to log in to manage their online retirement accounts. And in theory, the videos should also help reduce wait times at retirement services call centers, OPM said, now that more detailed information is readily available to feds who get caught up in some of the early steps of the process.”
  • Forbes reports
    • “The FDA has approved Octapharma’s drug Balfaxar, which is used by patients who require surgery but have seen a reduction in blood clotting factors due to being treated with the blood thinner warfarin.” 

From the public health front —

  • Employee Benefits News offers expert views on the current state of Covid.
  • The National Institutes of Health announced
    • “Researchers have found that people with obstructive sleep apnea have an increased cardiovascular risk due to reduced blood oxygen levels, largely explained by interrupted breathing. Obstructive sleep apnea has long been associated with an increased risk of cardiovascular issues, including heart attack, stroke, and death, but the findings from this study, partially supported by the National Institutes of Health and published in the American Journal of Respiratory and Critical Care Medicine, show the mechanism mostly responsible for the link.
    • “These findings will help better characterize high-risk versions of obstructive sleep apnea,” said Ali Azarbarzin, Ph.D., a study author and director of the Sleep Apnea Health Outcomes Research Group at Brigham and Women’s Hospital and Harvard Medical School, Boston. “We think that including a higher-risk version of obstructive sleep apnea in a randomized clinical trial would hopefully show that treating sleep apnea could help prevent future cardiovascular outcomes.”
  • Medscape considers where exercise boosts cognition.
  • Fierce Healthcare lets us know,
    • “One in three counties in the U.S. is considered a maternal healthcare desert.
    • “Since that statistic was dropped back in October 2022 by March of Dimes, care in corners of the country has only continued to dry up. In response to the crisis, providers are using every seed in their seed bag and looking to “multimodal” technology strategies to predict health emergencies before they happen.
    • “Those multimodal approaches combine telehealth, remote patient monitoring (RPM) and text messages to identify high-risk patients. High blood pressure monitoring and hypertension screening are currently recommended for pregnant patients by the U.S. Preventive Services Task Force, as heart disease and stroke are two of the leading causes of maternal mortality.
    • “Lucienne Ide, M.D., is the CEO of the digital health company Rimidi. She sees the country teetering on an inflection point.
      • “We’re at this fork in the road of looking at what we could do with technology, identifying high-risk women and getting them into the programs where we’re proactively and earlier identifying something dangerous and doing something about it,” Ide told Fierce Healthcare.
      • “But the alternate narrative is really, really bad, and it’s going to get worse. It’s not like, ‘Here we are today, and we could do better.’ No, here we are today, and it’s going to get worse, but we can actually do better,” she said.

From the U.S. healthcare business front —

  • Per Fierce Healthcare,
    • “As hospitals acquire ambulatory care centers, consumers are more likely to be forced to pay outpatient facility fees for routine care traditionally covered by physician offices at lower costs.
    • “These new costs, appearing seemingly out of nowhere to the average consumer through out-of-pocket spending and premium increases, can add up to hundreds or thousands of dollars in additional expenses for a patient, according to a report from Georgetown University’s Center on Health Insurance Reforms.
    • “Outpatient facility fees cover a hospital’s operational expenses. But when hospitals acquire physician practices, that usually generates another outpatient facility bill, eventually passing on the cost to the patient. Consumers are often unaware that they are now responsible for an extra cost.”
  • Healio reports that the growth of telehealth in cancer care continued after the initial surge during the COVID-19 pandemic.
  • Per Healthcare Dive, the path toward reducing physician burnout is widening.
    • “Amazon has become the latest tech giant to announce a clinical documentation service that allows providers to automatically create medical notes using generative AI.
    • “The Amazon Web Services tool announced Wednesday, called HealthScribe, allows providers to build clinical applications that use speech recognition and generative AI to create transcripts of patient visits, identify key details and create summaries that can be entered into an electronic health record.
    • “HealthScribe is being previewed for two specialties: general medicine and orthopedics. An Amazon spokesperson said AWS could expand to additional specialties based on client feedback. HealthScribe costs users a set amount per second of audio processed each month.”

Tuesday Tidbits

David Ermer–AHRQ, CDC, COVID-19, Electronic health records, FDA, Federal employment benefits, Medical / Rx research, OPM, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC —

  • The Department of Labor announced
  • STAT News adds,
    • “The new rule would force insurers to evaluate their own networks to measure not just whether they’re offering adequate mental health and addiction coverage but also whether patients are truly accessing it.
    • “This rule will ensure that we have true parity,” Neera Tanden, President Biden’s domestic policy advisor, said during a press call. “It will help ensure we finally fulfill the promise of mental health parity required under the law, to ensure that mental health is covered just like physical health.”
  • The public comment deadline will occur in late September.
  • The FEHBlog notes that health plans cannot coerce providers into their networks. The FEHBlog thought that hub and spoke tele-mental health networks would fill the gap, but that apparently hasn’t happened.
  • AHIP announced
    • “AHIP, the American Medical Association (AMA), and the National Association of ACOs (NAACOS) today announced the release of data-sharing best practices that organizations may voluntarily adopt to support a sustainable future for value-based care. The playbook, The Future of Sustainable Value-Based Care and Payment: Voluntary Best Practices to Advance Data Sharing, is intended to advance the adoption of value-based care arrangements in the private sector that could have a greater impact on the quality and equity of care and ease participation by fostering voluntary alignment of data sharing practices.”
    • Check it out.
  • The National Coordinator for Health Information Technology released on July 20, 2023,
    • “ONC Standards Bulletin 2023-2 (SB23-2) [which] describes the background of United States Core Data for Interoperability (USCDI) and the development of the USCDI Version 4 (USCDI v4) * * *. USCDI is a standard developed and adopted by ONC on behalf of the U.S. Department of Health and Human Services (HHS) that sets the technical and policy foundation for the access, exchange, and use of electronic health information to support nationwide, interoperable health information exchange. USCDI benefits a wide range of entities, individuals, and other interested parties, including federal agencies supporting health and healthcare, hospitals, research organizations, clinicians, and health IT developers. ONC publishes new versions of USCDI annually, with a draft version in January and a final version in July. This publishing cadence keeps pace with medical, technological, and policy changes. USCDI v4 includes new data elements that advance the Biden-Harris Administration’s priorities of advancing equity, diversity, and access across all healthcare settings.
    • “SB23-2 describes the ONC approach for the continued expansion of USCDI, as well as the specific priorities for adding new data elements to USCDI v4. This bulletin also includes discussion of the feedback received on the Draft USCDI v4, including recommendations received from the ONC Health IT Advisory Committee (HITAC).”
  • The U.S. Preventive Services Task Force gave a draft inconclusive grade for “screening for speech and language delay and disorders in children age 5 years or younger.” The USPSTF previously gave the same grade to the screening service in 2015. The public comment deadline is August 21, 2023.
  • FedSmith notes that the OPM final rule expanding FEDVIP eligibility will add “over 70,000 federal employees and 118,000 Postal employees” to the pool of employees eligible for FEDVIP.

From the public health front —

  • U.S. News reports
    • “Both coronavirus emergency department visits and test positivity increased, according to CDC data. The agency no longer tracks COVID-19 cases. Instead, it focuses on hospitalizations and deaths, which don’t yet show an increase.
    • “The CDC reported last week that it was the first time since January that COVID-19 metrics showed an increase. The uptick is small, but it’s a notable reversal after months of declining coronavirus numbers.
    • “Certain COVID-19 indicators continued their recent rise last week, according to data from the Centers for Disease Control and Prevention.”
  • HHS’s Agency for Healthcare Research and Quality issued a roundtable report about “Optimizing Health and Function as We Age.”
  • Yahoo News tells us,
    • “Drugmaker Pfizer Inc said over 30 drugs, including injections of painkiller fentanyl and anesthetic lidocaine, may see supply disruption after a tornado destroyed a warehouse at its Rocky Mount, North Carolina, plant last week.
    • “The company sent a letter late last week to its hospital customers saying it had identified around 64 different formulations or dosages of those more than 30 drugs produced at the plant that may experience continued or new supply disruptions.
    • “The company has placed limits on how much supply of those drugs its customers can buy.”
  • Medscape shares CDC guidance about the two new RSV vaccines for adult that the FDA and CDC recently approved.
    • “Older adults deciding whether to get the vaccines should weigh risks and their own preferences and make the decision in consultation with their clinician, say authors of a Centers for Disease Control and Prevention report published Friday.
    • “Michael Melgar, MD, with the Coronavirus and Other Respiratory Viruses Division at the CDC, was lead author on the report, published in the Morbidity and Mortality Weekly Report.“

From the U.S. healthcare business front,

  • BioPharma Dive informs us,
    • “Biogen on Tuesday said it will eliminate 1,000 jobs as part of a cost-cutting drive that it expects will save $1 billion in annual operating expenses by 2025.
    • “The company plans to invest $300 million of those savings into product launches as well as research and development, which it has spent the first half of this year reorganizing under new CEO Chris Viehbacher.
    • “There’s been a complete redesign of Biogen,” Viehbacher said on a conference call with analysts. “This is an opportunity to make sure that in this year, before we get into [new] product launches, that we are truly fit for growth.”
  • STAT News lets us know that “As Alzheimer’s drugs hit the market, the race for early detection blood tests heats up” and offers an interview with the American Medical Association’s new president Dr. Jesse Ehrenfeld.
  • Fierce Health relates,
    • “Teladoc’s second-quarter revenue jumped 10% to $652 million, boosted by strong growth in its BetterHelp direct-to-consumer mental health segment.
    • “The telehealth giant also narrowed its losses this past quarter to a net loss of $65 million, or a loss of 40 cents per share, compared to a loss of $3 billion for the second quarter of 2022. Both results beat Wall Street estimates.
    • “The Zacks Consensus Estimate for Teladoc’s second-quarter earnings per share was pegged at a loss of 44 cents and revenue of $649 million.”

In low-value care news, the National Institutes of Health tells us, “A device known as a pessary, thought promising for reducing preterm birth risk due to a short cervix, appears no more effective than usual medical care, according to a study funded by the National Institutes of Health. A pessary is a rounded silicone device that fits around a cervix that has shortened, to keep it from opening and leading to miscarriage or preterm birth. The device is typically removed before the 37th week of pregnancy.”