Tuesday Tidbits

COVID-19

Tuesday Tidbits

David Ermer–CDC, Congress, COVID-19, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The Wall Street Journal reports
    • “House Republican leaders worked to salvage a short-term spending bill that sparked angry disagreements among the party’s rank-and-file, but they remained short of the support needed to pass the measure and show the party could unite to avert a government shutdown. * * *
    • “The effort to pass a short-term deal comes as Congress is working to pass the 12 annual appropriation bills that fund the government. Leaders of both parties in the House and Senate have thrown their support behind reaching a short-term deal that would give both chambers more time to negotiate a full-year spending agreement.
    • “Both McCarthy and Senate Minority Leader Mitch McConnell (R., Ky.) have warned of the political fallout for the GOP from a shutdown.
    • “I’ve seen a few of them over the years, they never have produced a policy change, and they’ve always been a loser for Republicans politically,” said McConnell to reporters.”
  • Govexec offers federal employees a “guide to pay and benefits during a shutdown.”
  • The House Ways and Means Committee held a No Surprises Act hearing today. Here are a link to the Chairman’s opening statement and a link to the AHIP witness statements.
  • Federal News Network tells us,
    • “Enrollees in the Federal Long-Term Care Insurance Program (FLTCIP) are bracing for another big premium increase starting in 2024.
    • “The Office of Personnel Management, which runs the federal insurance program, announced plans to hike up premium rates for current enrollees. The changes will take effect on Jan. 1.
    • “Unlike the averages offered in past years, OPM declined to share an average percentage increase for FLTCIP premiums. An agency spokesperson said the percentage increases for enrollees were too variable for an average to accurately depict how much the rates are rising.
    • “But anecdotal experiences from program participants who spoke with Federal News Network and who shared their premium notification letters with the National Active and Retired Federal Employees Association (NARFE) show the increases are as large as 86%, if the enrollees choose to stick with their same coverage options. In a few other instances, enrollees received notice from OPM that their premiums will go up 77% and 49%, according to NARFE.”
  • The U.S. Preventive Services Task Force issued a revised Grade B recommendation today. “The USPSTF recommends screening for hypertensive disorders in [asymptomatic] pregnant persons with blood pressure measurements throughout pregnancy.”
  • The Wall Street Journal adds,
    • “The recommendation made Tuesday by the U.S. Preventive Services Task Force broadens 2017 guidance to screen regularly only for preeclampsia, a dangerous and increasingly common condition that can arise in pregnancy. It involves high blood pressure along with kidney or liver trouble and other problems and is believed to occur when the placenta develops abnormally because of a problem with the blood vessels that supply it.  
    • “The recommendation applies to other disorders marked by high blood pressure that, like preeclampsia, normally develop in the second half of pregnancy. They include gestational hypertension—high blood pressure without the other signs of preeclampsia—and eclampsia, which involves seizures and is life-threatening.” 
  • Per Healthcare Dive
    • “Eighty-one percent of nursing home facilities nationwide and 90% of for-profit facilities would need to hire additional registered nurses or nurse aides to meet the minimum nursing staff hours standards proposed by the CMS earlier this month, according to a KFF estimate published Monday.”

From the public health front,

  • NBC News reports,
    • “Doctors say they’re finding it increasingly difficult to distinguish Covid from allergies or the common cold, even as hospitalizations tick up.
    • “The illness’ past hallmarks, such as a dry cough or the loss of sense of taste or smell, have become less common. Instead, doctors are observing milder disease, mostly concentrated in the upper respiratory tract. 
    • “It isn’t the same typical symptoms that we were seeing before. It’s a lot of congestion, sometimes sneezing, usually a mild sore throat,” said Dr. Erick Eiting, vice chair of operations for emergency medicine at Mount Sinai Downtown in New York City.”
  • The Wall Street Journal offers “A Game Plan for Timing Your Flu, Covid, and RSV Shots This Fall.”
  • The Washington Post informs us,
    • “Doing puzzles, playing memory-boosting games, taking classes, and reading are activities that we often turn to for help keeping our brains sharp. However, research is showing that what you eat, how often you exercise, and the type of exercise you do can help lower your risk of dementia to a greater extent than previously thought.
    • “Although more studies are needed, “there’s a lot of data that suggests exercise and diet are good for the brain and can prevent or help slow down” cognitive changes, says Jeffrey Burns, co-director of the University of Kansas Alzheimer’s Disease Research Center in Fairway.
    • “And living a healthy lifestyle can produce brain benefits regardless of age.”

From the healthcare business front,

  • Fierce Health identifies the most influential minority executives in healthcare for 2023. Maazal tov to those execs.
  • Beckers Payer Issues points out,
    • “Elevance Health’s pharmacy benefit manager, CarelonRx, is launching a new integrated cost savings program to automatically offer members the lowest price for generic prescription drugs at their preferred pharmacy.
    • “We will automatically compare prices to emulate a comparative shopping experience, similar to when a member would use a discount card,” Michele Paige, vice president of product at CarelonRx, told Becker’s. “But now they don’t have to because it’s integrated within their benefits.” 
    • “The new program, EnsureRx, is set to launch in February and will automatically compare prices for more than 50 generic medications against a variety of cash discount cards, with savings automatically applied. Ms. Paige shared that the list of generic medications covered will be constantly evaluated for potential additions.” 
  • and
    • “Cigna Healthcare offers employers a supplemental benefit designed to help employees diagnosed with musculoskeletal conditions. 
    • “The payer is adding musculoskeletal conditions to its Supplemental Health Critical Illness plans, according to a Sept. 18 news release. The program provides an annual payment of $3,000 to employees to help them cover out-of-pocket hospital costs or other expenses such as rent, childcare and groceries. 
    • “Cigna offers similar benefits for cancer, heart attack and stroke.” 

Weekend update

David Ermer–Congress, COVID-19 vaccine, OPM, U.S. Healthcare–

From Washington, DC,

  • The Senate and the House of Representatives will be in session for Committee business and floor voting this week.
  • The New York Time adds,
    • “Speaker Kevin McCarthy said on Sunday that he intended to resurrect a stalled Pentagon spending measure and try to push it to the House floor this week despite pledges by members of the far-right Freedom Caucus to oppose the move unless their sweeping demands on spending were met. * * *
    • “Other House Republican leaders joined Mr. McCarthy in saying that some progress had been made in weekend talks toward resolving their internal differences over their spending strategy, and that they hoped to break the logjam this week.
    • “We are working through this, and I’m optimistic that we will continue to move the appropriations process forward,” Representative Elise Stefanik, Republican of New York and a member of the leadership team, said in a separate interview on “Fox News Sunday.”
  • Govexec tells us,
    • “The Office of Personnel Management on Friday announced that it is proposing new regulations aimed at hamstringing future administrations from reviving a controversial plan to strip tens of thousands of federal workers of their civil service protections, potentially accelerating a long-simmering battle between good government groups and conservative Republican activists. ***
    • “OPM’s newly proposed regulations, which will be published Monday in the Federal Register, seek to at least slow down a future administration from reviving Schedule F. It stipulates that when a federal employee’s job is converted from the competitive service to the excepted service, the employee retains “the status and civil service protections they had already accrued,” unless they voluntarily transfer into an excepted service position.”
    • Here’s a link to the OPM press release.

From the public health front,

  • The Washington Post reports,
    • “Women who live to age 90, 95 or even 100 experience what’s known as “exceptional longevity.” An analysis published last month found one factor linking those long lives: maintaining a stable body weight over decades.
    • “The study, published in the Journals of Gerontology: Series A, looked at data about 54,437 women from the Women’s Health Initiative, a long-term study that began in the 1990s. The women studied were born on or before Feb. 19, 1932, and the researchers looked at their weight when they began the program, in Year 3, and in Year 10 of the program, then followed up on their survival status as of Feb. 19, 2022.
    • “They found that the women whose body weight stayed stable over the years had 1.2 and 2 times the odds of surviving to 90 and beyond than those who lost weight.
    • “Women who lost 5 percent or more of their body weight over the first three years studied had 33 percent lower odds of surviving to 90, 35 percent lower odds of surviving to 95 and 38 percent lower odds of surviving to 100 than their counterparts whose weight remained stable.”
  • The new Covid shots and the flu vaccines will be available this week. The New York Times observes, and the FEHBlog agrees,
    • “Some experts believe that spreading out your shots might make sense if you can time them to just before each virus peaks. So while you may get the Covid vaccine this month, as cases rise in parts of the United States, you could consider waiting until later in the fall to get the flu shot. Flu cases typically peak between December and February; you can monitor flu activity in your state through the Centers for Disease Control and Prevention’s influenza surveillance reports for more detailed information. A doctor can also help you decide the best strategy, especially if you have a high risk of severe disease or are immunocompromised.”

From the business front,

  • The Wall Street Journal reports,
    • “Does M&A work? The latest research says it’s a tossup.
    • “Business-school students are often taught that successful mergers and acquisitions are a long shot. One influential Harvard Business Review article, dating from 2011, says a range of studies show roughly 70% to 90% of deals fail to create value for the buyer.
    • And many investors worry that takeovers are more reliably lucrative for investment banks—which LSEG says earned some $13.1 billion in M&A fees in the first half of this year—than for the acquiring companies and their shareholders.
    • But more recent research from academics and consultants puts the success rate closer to even. Companies that do frequent smaller deals, as well as making bigger bets, tend to outperform, advisers say. That is because they hone their ability to identify targets, integrate those businesses and reap the intended financial benefits. 
    • Companies should always weigh up deal making against alternative uses of funds, said Barry Weir, Citigroup’s co-head of European mergers and acquisitions. 
    • “If the risk-adjusted return from M&A is higher than the benefits from returning cash to shareholders or some other lower-risk alternative, then it makes sense,” Weir said. “If it doesn’t meet this hurdle then you shouldn’t be doing M&A.”
  • HR Dive considers the occasions on which employees subject to the Fair Labor Standards Act are entitled to be paid for commuting to the office.

Midweek update

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The Wall Street Journal reports, “House Speaker Kevin McCarthy laid out a map for passing legislation to keep the government funded past Oct. 1, but immediately ran into new roadblocks from spending hawks and fresh grumbling that he should be ousted from his post.” The FEHBlog anticipates that Congress will pass a continuing resolution before the end of the month.
  • The Centers for Medicare and Medicaid Services announced,
    • “the list of 34 prescription drugs for which Part B beneficiary coinsurances may be lower between October 1 – December 31, 2023. Some people with Medicare who take these drugs may save between $1 and $618 per average dose starting October 1, 2023, depending on their individual coverage.  * * *
    • “CMS has released information about these 34 Part B drugs and biological products in the quarterly Average Sales Price (ASP) public files, available here. A fact sheet is available here.”
  • Healthcare Dive informs us,
    • “Healthcare legislation being hashed out on the Hill is taking aim at pharmacy benefit managers, but the policies — while potentially worthwhile — are unlikely to have more than modest effects on the cost of prescription drugs in the U.S., experts say. us,
    • “Eliminating all PBM profits would only reduce total drug-related spending by “several percentage points,” since operating margins for the three biggest PBMs averaged roughly 4% of revenues last year, according to a new report from the Brookings Schaeffer Initiative on Health Policy.
    • “Lowering spending further would require “fundamental market changes” like changing drug patent protections or the way drug prices are regulated, the report says — measures sure to face heavy opposition from pharmaceutical companies.”
  • Per Becker’s Hospital Review,
    • “Cisplatin, a drug used for multiple types of cancer that’s been in a severe shortage for months, is close to returning to 100 percent of pre-shortage supply levels, the White House said Sept. 12. * * *
    • “In June and July, the FDA allowed China-based Qilu Pharmaceutical to temporarily import cisplatin. These lots have already been distributed, according to the FDA. The agency also worked with domestic drugmakers to increase their manufacturing capacity. 
    • “These actions brought the cisplatin supply back to nearly 100 percent of the pre-shortage levels and are greatly alleviating the shortages of carboplatin,” according to a post from the White House’s Office of Science and Technology Policy.”
  • The Federal Times writes about the impending premium increases in the Federal Long Term Care Insurance Program.

From the public health and research front,

  • The American Medical Association released a letter supporting the CDC’s “universal recommendation for the 2023-2024 COVID-19, XBB.1.5 containing vaccine.”
  • The National Cancer Institute informs us
    • “Testing for the presence of cancer-causing types of the human papillomavirus (HPV) is now a standard part of screening for cervical cancer, sometimes with simultaneous Pap tests (known as co-testing). But cervical cancer screening is recommended to stop at age 65 in many places and, for a variety of reasons, many older adults stop getting screened for cervical cancer well before that age. 
    • “Results from a population-based study conducted in Denmark, however, suggest that it may be worthwhile for some individuals between ages 65 and 69 to get tested for HPV: those who haven’t had cervical cancer screening for at least 5 years.
    • “In the new study, about 62% of women who were invited to undergo this “catch-up” testing for HPV (intervention group) had a test within the next year. In a comparison group of women not invited for catch-up testing, only about 2% had either a Pap test or an HPV test over the next year.”
  • The Wall Street Journal reports
    • “The first artificial womb to gestate a human baby is fast approaching reality.
    • “Food and Drug Administration regulators will weigh next week how scientists should conduct the first human tests of bag-like wombs, meant to nurture babies born so premature that modern medicine struggles to keep them healthy. * * *
    • “Philadelphia-based Vitara Biomedical has said that it is working on an artificial womb and is close to human clinical trials. A company executive said at a biotech symposium last year that the firm is commercializing the research of one of two U.S. groups known to be testing the technology on lambs. The other U.S. group says it is still a few years off from human trials.”
  • Forbes notes, “The Marcus Autism Center in Atlanta has launched its biomarker-based device that has been authorized by the FDA to aid in the diagnosis of autism in children between 16 and 30 months of age.” 

From the U.S. healthcare business front,

  • BioPharma Dive tells us,
    • “After pulling off a biomedical triumph with its COVID-19 vaccine, Moderna on Wednesday put out a roadmap for investors that promises billions of dollars from new medicines.
    • “The company aims to launch as many as 15 new products in the next five years, including four by 2025. In 2027, Moderna expects $8 billion to $15 billion in respiratory product sales. And on Wednesday, it forecast another $10 billion to $15 billion in annual sales from new treatments for cancer and rare and latent diseases it hopes to introduce by 2028.”
  • Beckers Payer Issues points out,
    • “Humana, Aetna and Molina are not renewing their contracts with senior companionship company Papa following allegations of abuse against patients or company employees, Bloomberg reported Sept. 11.
    • “In May, Bloomberg Businessweek published a report detailing allegations of abuse against seniors and Papa employees based on 1,200 complaints submitted to the company. The complaints included allegations of sexual abuse and assault, harassment, or unsafe living conditions.
    • “A spokesperson for Papa declined to provide a comment to Bloomberg about specific contracts, but said the company has grown its client base this year and is selling programs for next year.” 

Tuesday Tidbits

David Ermer–CDC, CMS, COVID-19, COVID-19 vaccine, FDA, HSA, Medical / Rx research, Rx coverage, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The American Hospital Association News tells us
    • “As authorized yesterday by the Food and Drug Administration and recommended by its vaccine advisory committee, the Centers for Disease Control and Prevention today recommended a single dose of the updated Moderna and Pfizer COVID-19 vaccines for Americans aged 12 and older, and one or two doses of the updated vaccines for previously vaccinated children aged six months through 4, at least two months after receipt of their last dose. The agency also recommended three doses of the updated Pfizer vaccine and two doses of the updated Moderna vaccine for unvaccinated children under age 5, as authorized by the FDA and recommended by the committee. CDC anticipates the updated vaccines will be available later this week.
    • “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality,” said Peter Marks, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “We very much encourage those who are eligible to consider getting vaccinated.”
  • and
    • The Food and Drug Administration’s independent Nonprescription Drugs Advisory Committee Sept. 12, by unanimous vote, declared oral phenylephrine ineffective as a decongestant. Phenylephrine is a common active ingredient in over-the-counter medications sold under the Nyquil, Tylenol, Advil, Robitussin, Sudafed and Benadryl brands, to name a few. FDA is not bound to the committee’s recommendations, but the agency’s own analysis presented prior to the panel’s meeting concluded that oral phenylephrine formulations are safe but ineffective at standard or even higher doses. The vote paves the way for products containing oral phenylephrine potentially being pulled from shelves until reformulated versions are offered.
  • FEHBlog observation — The class action lawyers should be revving up the old turbobiller.
  • The U.S. Census Bureau announced
    • “The percentage of working-age adults ages 19 to 64 with health insurance coverage increased from 2021 to 2022, primarily driven by an increase in employment-based coverage. This resulted in uninsured rates dropping from 11.6% to 10.8% according to U.S. Census Bureau data released today [September 12]. 
    • “The Health Insurance Coverage in the United States: 2022 report shows that the share of working-age adults with coverage rose across many race and ethnic groups, regions and employment status.”
  • Beckers Hospital Review informs us
    • CMS fined two more hospitals for alleged price transparency violations Sept. 5, marking the third consecutive month the agency has levied fines on noncompliant hospitals.   
    • “According to CMS’ price transparency website:
      • Washington, D.C.-based Saint Elizabeths Hospital was fined $677,440. 
      • Silver Spring, Md.-based Holy Cross Hospital was fined $325,710.
      • Additionally, CMS’ Sept. 8 update of its price transparency website included information of another hospital fined Aug. 22 that was not previously uploaded to the site. Doctors’ Center Hospital Bayamón (Puerto Rico) was fined $102,200.
    • The hospitals have 30 days from the issuance date to appeal the fines. 
    • CMS has now fined 14 hospitals for price transparency violations. To date, three hospitals have appealed their penalties and are under review, according to CMS.”  
  • ICD Monitor relates
    • “To help improve the collection of the social determinants of health (SDoH) Z codes, the Centers for Medicare & Medicaid Services (CMS) Office of Minority Health last week released a new Z code infographic. 
    • “CMS’s goal is to assist providers with understanding and using SDoH terminology in their documentation that will allow for greater alignment for ICD-10-CM Z code capture.  As discussed, CMS believes that greater Z code capture will enhance quality improvement activities and provide further insights into the existing health inequities that hospitals and their community are facing.” 

From the public health and medical research front,

  • The Wall Street Journal has updated its report on the fall vaccination season.
  • MedTech Dive lets us know,
    • A prospective study published in the journal Lancet Digital Health found that an AI tool paired with a double reading by one radiologist was as good at detecting breast cancer as a double reading by two radiologists, the current standard of care.
    • Researchers at the Capio Sankt Göran Hospital in Stockholm, Sweden, and the Karolinska Institute said the results suggest that AI “has potential for controlled implementation, which would include risk management and real-world follow-up of performance.” 
    • The study used the Insight MMG system for breast cancer detection, made by Seoul, South Korea-based Lunit. The company helped fund the research, in addition to grants from the Swedish Research Council, the Swedish Cancer Society, and Region Stockholm.
  • The American Hospital Association News reports,
    • “The U.S. infant mortality rate was essentially unchanged in 2021, but the number of deaths rose 2% to 19,928, the Centers for Disease Control and Prevention reported Sept. 12. The mortality rate increased for infants of Asian women and declined for infants of Dominican women. Infants of Black women had the highest mortality rate by race at 10.55 per 1,000 live births, while infants born before 28 weeks of gestation had the highest rate by age (353.76). The five leading causes of death were unchanged from 2020, with declines for disorders related to short gestation and low birth weight. Infant mortality rates by state ranged from a low of 2.77 in North Dakota to a high of 9.39 in Mississippi. The U.S. infant mortality rate has generally trended downward since 1995 and has declined 21% since 2005, the most recent high (6.86).”
  • STAT News is now offering a new generation weight loss drug tracker.
    • “STAT has created a new database to track the significant obesity drugs that are on the market and in development. The tracker, which will be updated with developments each quarter, gives a sense of what new mechanisms could hit the market, how they would be taken and how often, and which companies are running the most trials.
    • “A related article details the strategies and challenges of some of these companies.”
    • Roughly seventy drugs are on the tracker currently.

From the U.S. healthcare business front,

  • Fierce Healthcare tells us, “Shareholders in home health company Amedisys have approved its $3.3 billion union with Optum, even as the feds take a closer look at the deal.”
  • Per Healthcare Dive,
    • “Walgreens is partnering with startup Pearl Health to help primary care physicians manage value-based care, in a bid to expand its reach with community-based providers.
    • “The partnership announced Tuesday [September 12] marries Pearl’s provider enablement technology with Walgreens’ care delivery assets and pharmacy services in an attempt to make it easier for clinical teams to provide the personalized treatment necessary in value-based arrangements, according to the companies.
    • “Walgreens and Pearl will help doctors manage value-based care in traditional Medicare’s accountable care organization program, called ACO REACH, starting in 2024. The two plan to eventually expand to Medicare Advantage and potentially commercial payers and Medicaid down the line.”
  • Per Employee Benefits News,
    • “Saving for retirement is a life-long challenge, and one that seems to be harder for women. While they live on average five years longer than men, they’re saving less.
    • “Bank of America analyzed 565,000 health savings accounts (HSAs), looking at utilization trends across genders and generations. Women’s HSA balances are 15% lower than men’s, with women more likely to spend their HSA savings before retirement and contribute less to their accounts. Overall, men’s average net HSA savings was $128 higher in 2022, and over the years that gap begins to add up.” * * *
    • “Lisa Margeson, managing director of retirement research and insights at Bank of America,  advises employers to at the very least educate their employees on the power of HSAs and how they can use them as retirement savings vehicles. Employer HSA contributions, caregiving benefits and flexibility will also help ensure women can maintain successful careers and save for their future. 
    • “As for women, Margeson encourages them to start their HSAs early, try to put at least a little aside each month and eventually invest that money according to their bank’s capabilities. For those who are uncomfortable with a high-deductible health plan, Margeson points to emergency savings accounts or an interest-bearing savings account as a companion to their retirement plans.”
  • The Society for Human Resource Management offers a breakdown of compensation expenses over the second quarter of this year.
    • “According to the latest Employer Costs for Employee Compensation report, released September 12 by the U.S. Bureau of Labor Statistics (BLS), employers spent just 0.59 percent more on wages and benefits in June 2023 compared to March 2023.
    • “Total employer compensation costs for private-industry workers averaged $41.03 per hour worked. Wages and salaries averaged $28.97 per hour worked, accounting for 70.6 percent of employer costs, while benefits costs averaged $12.06 per hour worked, accounting for the remaining 29.4 percent, according to the report.”

Monday Roundup

David Ermer–CDC, COVID-19, COVID-19 vaccine, FDA, Federal employment benefits, Medicare, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington DC,

  • The Office of Personnel Management issued a Benefit Administration Letter providing guidance about an Enrollee Decision Period for Federal Long Term Care Insurance Program enrollees. The Enrollee Decision Period started today and ends on November 9, 2023.
  • The Food and Drug Administration announced
    • “approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc. Consistent with the totality of the evidence and input from the FDA’s expert advisors, these vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5.”
  • Roll Call adds
    • “Advisers to the Centers for Disease Control and Prevention are scheduled to discuss on Tuesday recommendations for who should receive the vaccines and when, with CDC Director Mandy Cohen expected to sign off shortly thereafter. 
    • “Drugmakers say they’re ready to begin shipping the shots immediately in accordance with the CDC’s pending guidelines.”
  • STAT News tells us, “Sen. Bernie Sanders (I-Vt.) will hold a confirmation hearing next month for Dr. Monica Bertagnolli, President Biden’s nominee to run the National Institutes of Health, he said Friday.”

From the public health front,

  • MedPage Today reports
    • “Anesthesiologists are sharply divided over how to handle the growing number of surgical patients on GLP-1 receptor agonists, given that the drugs can raise the risk of aspiration during surgery.
    • “While the leading U.S. anesthesiology society suggests that patients stop taking injectable versions of the medications for 7 days ahead of surgeryopens in a new tab or window, some anesthesiologists are turning to alternative strategies such as intubating all at-risk patients, even for minor procedures.
    • “Other anesthesiologists are calling for patients to stay off the drugs for weeks, not days, or titrate down to lower doses.
    • “This topic is being heavily discussed in the anesthesia community right now, and it’s very polarizing,” Michael Gulak, MD, a resident anesthesiologist at the University of Toronto, told MedPage Today.”

From the U.S. healthcare business front,

  • Beckers Hospital Review informs us
    • “Nonprofit hospital expenses continued to grow last year while liquidity fell to pre-pandemic levels, according to Moody’s Investor Services. 
    • “In a Sept. 7 report, Moody’s outlined 2022 fiscal year trends based on data from 218 health systems. The report noted operating margins fell to”unsustainable levels” as median operating cash flow margin was 4.9 percent and median operating margin was -0.3 percent amid labor shortages and inconsistent patient volumes.
    • “While the industry shows signs of stabilizing in 2023, the labor environment will remain challenging,” the report states.”
  • Per Benefits Pro,
    • “Hospitals in the United States faced unprecedented challenges during the COVID-19 pandemic, and those challenges have left them floundering in the face of increased costs and workforce shortages. According to the most recent Costs of Caring report from the American Hospital Association, this combination of factors has resulted in a 17.5% increase in overall hospital expenses between 2019 and 2022. “Further exacerbating the situation is the fact that the staggering expense increases have been met with woefully inadequate increases in government reimbursement,” the report states, leading to consistently negative margins and over half of hospitals ending 2022 at a financial loss.
    • “Even so, hospital expenses per inpatient day have been steadily trending upwards for years in the U.S., whether for-profit, non-profit, or state/local government. Research from KFF shows that in 1999, the average adjusted expenses per inpatient day for state/local government hospitals was $1,004. Non-profits were at $1,139, and for-profits were at $999. As of 2021, state/local government stands at $2,742—a 173% increase. Non-profits are at $3,013 (164.5%) and for-profits at $2,296 (129.8%).”
  • MedCity News points out
    • While there are fewer rural residents enrolled in Medicare Advantage plans than micropolitan or metropolitan residents, MA enrollment in rural areas is growing much more rapidly, new research shows.
    • The KFF report, published Thursday [September 7], defines rural areas as having less than 10,000 people, micropolitan areas as having 10,000 to 50,000 people and metropolitan areas as having at least 50,000 people. The findings come when Medicare Advantage growth overall is on the rise, accounting for more than half of eligible Medicare beneficiaries in 2023.
  • Healthcare Dive relates
    • Walmart is considering buying a majority stake in value-based medical chain ChenMed, according to a Bloomberg report published Friday.
    • The retail giant is in discussions with ChenMed regarding a transaction that would value the Miami-based primary care clinic operator at several billion dollars, Bloomberg reported, citing sources familiar.
    • Terms of the deal aren’t finalized, and talks could fall through or a different buyer could emerge, Bloomberg’s sources said.
    • If a deal is announced, Walmart would become the latest retail operator to bag a primary care operator, following in the footsteps of rivals including CVS, Amazon and Walgreens.
    • ChenMed operates a network of more than 125 clinics for Medicare-eligible seniors in 15 states, according to the company’s website.

Midweek Update

David Ermer–CDC, CMS, COVID-19, COVID-19 vaccine, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • The American Hospital Association informs us,
    • “Republicans on the House Energy and Commerce, Ways and Means, and Education & Workforce Committees have released a summary of draft legislation the committees could introduce as soon as this week. The Lower Costs, More Transparency Act includes provisions focused on health care price transparency, site-neutral payment cuts, and extending certain funding set to expire Sept. 30 for Community Health Centers, the National Health Service Corps and the Teaching Health Centers Graduate Medical Education Program. The bill also would delay for two years the start of Medicaid Disproportionate Share Hospital cuts scheduled to take effect on Oct. 1.”
  • CMS changed its No Surprises Act announcement to read
    • Effective September 5, 2023, the Departments have directed certified IDR entities to proceed with eligibility determinations for single and bundled disputes submitted on or before August 3, 2023.  All other aspects of Federal IDR process operations remain suspended. Disputing parties may continue to engage in open negotiation. 
  • The FEHBlog noticed on reginfo.gov that the following two No Surprises Act proposed regulations were submitted for Office of Information and Regulatory Affairs review on August 29:
    • AGENCY: HHS-CMS RIN: 0938-AV15 Status: Pending Review
    • TITLE: Independent Dispute Resolution Operations (CMS-9897)
    • STAGE: Proposed Rule SECTION 3(f)(1) SIGNIFICANT: Yes
    • RECEIVED DATE: 08/29/2023 LEGAL DEADLINE: None
    • and
    • AGENCY: HHS-CMS RIN: 0938-AV39 Status: Pending Review
    • TITLE: Federal Independent Dispute Resolution Process Fees (CMS-9890)
    • STAGE: Proposed Rule SECTION 3(f)(1) SIGNIFICANT: Yes
    • RECEIVED DATE: 08/29/2023 LEGAL DEADLINE: None
  • The first Interested party meetings with OIRA are scheduled for September 8.

From the public health front,

  • The American Hospital Association tells us
    • “The Centers for Disease Control and Prevention Sept. 5 alerted clinicians to a recent increase in respiratory syncytial virus in the Southeastern U.S., which could signal the beginning of the 2023-2024 RSV season nationally. CDC encourages clinicians to prepare to implement prevention options, including the new long-acting monoclonal antibody to protect infants and some young children at higher risk for severe disease and two new vaccines to protect older adults from severe disease.”
  • Per STAT News
    • “More older adults have been hospitalized for COVID-19 over the past several weeks, according to internal data reviewed by health insurance giant Humana.
    • “Humana, which mostly provides health insurance to those 65 and older and who are therefore more vulnerable to the worst effects of Covid, expected more Covid cases and hospitalizations this year. But it didn’t expect the uptick to come during the waning summer months.”
  • BioPharma Dive reports,
    • Moderna said that an updated COVID shot it’s developing can protect against a form of the coronavirus known as BA.2.86, or Pirola, adding to early evidence the emerging variant may not be as troublesome as scientists had feared.
    • The data, delivered in a press release on Wednesday, show that the vaccine helped spur an immune response in humans against Pirola. It follows an announcement by Moderna last month that the same vaccine appears protective against other currently circulating strains known as Eris and Formax.
    • The Food and Drug Administration is currently reviewing the booster shot, with a decision expected shortly.
  • MedPage Today explains how to navigate the fall vaccine season for COVID-19, the flu, and RSV.

From the U.S healthcare business front,

  • Health Payer Intelligence points out four essential components of chronic disease management strategies.
  • Healthcare Dive relates,
    • Salt Lake City-based Intermountain Health last week reported $184 million in operating income for the first half of 2023, a 35% decrease from the prior-year period when the health system posted an operating income of $285 million. 
    • Expenses climbed to a total of $7.4 billion, offsetting a 22% year-over-year increase in revenue. Intermountain logged nearly $8 billion of revenue for the first six months of the year. 
    • The nonprofit operator still inked nearly $1.1 billion in net gain in the first half of the year, driven by investment income of $909 million.
  • Per MedTech Dive,
    • “Abbott reached an agreement to acquire Bigfoot Biomedical, a company that makes smart insulin pen caps that can sync with continuous glucose monitors to provide dose recommendations.
    • “The companies did not disclose the price of the acquisition, but plan to close it in the third quarter, they said in a Tuesday announcement. 
    • “The planned purchase would be Abbott’s first insulin delivery technology, adding to its position as one of the top CGM makers.” 

Happy Labor Day!

David Ermer–Congress, COVID-19 testing, Federal employment benefits, Mental health care, OPM, U.S. Healthcare–

Way back in the day, OPM routinely would announce the next year’s FEHB premiums around Labor Day. The announcement was known as OPM’s Labor Day press release. Currently, the announcement is made in the last week of September.

Tammy Flanagan writes in Govexec about federal employee benefit issues confronting couples who both work for Uncle Sam, specifically

  • “Should we carry two self only plans under the Federal Employees Health Benefits program or one self plus one plan if we don’t need to cover children?
  • “Do we need to provide survivor annuities for each other?”

Check it out.

The Senate returns from its August State work break tomorrow for a shortened week of Committee business and floor voting. The House of Representatives returns to the Nation’s Capital next Tuesday.

From the public health front,

  • The Washington Post reports
    • “The Centers for Disease Control and Prevention on Friday [September 1] issued a national alert warning health-care professionals to watch out for infections of Vibrio vulnificus, a rare flesh-eating bacteria that has killed at least 13 people on the Eastern Seaboard this year.
    • “Although infections from the bacteria have been mostly reported in the Gulf Coast, infections in the eastern United States rose eightfold from 1988 to 2018, the CDC said. In the same period, the northern geographic range of infections has increased by 30 miles every year. This year’s infections came during a period of above-average coastal sea surface temperatures, the agency said.
    • “Up to 200 people in the United States every year report Vibrio vulnificus infections to the CDC. A fifth of the cases are fatal, sometimes within one or two days of the onset of illness, according to the agency.”
  • The Wall Street Journal tells us
    • “A two-decade decline in [prostate cancer] death rates has stalled. Some doctors worry deaths could rise in coming years.
    • “We’re finding them with disease not contained in the prostate but also in the bones, in the lymph nodes,” said Dr. James Porter, a urological surgeon in Seattle. “That’s a recent phenomenon.” 
    • “The pendulum swing hits at a fundamental problem in screening for all cancers: Testing too many people leads to more invasive procedures some patients don’t need. Testing too few misses opportunities to catch cases while there is a better chance treatment will work.
    • “Groups including the American Cancer Society are reviewing their own guidance for prostate-cancer screening. Many doctors want to better target the test, limiting screening for some men while encouraging high-risk groups including Black men or those with a strong family history to get testing earlier. 
    • “PSA recommendations have been ping-ponging back and forth, and what’s been lost in that is the high-risk people,” said Dr. Heather Cheng, director of the Prostate Cancer Genetics Clinic at Fred Hutchinson Cancer Center in Seattle. She is helping to review the American Cancer Society’s prostate-cancer screening guidelines. 
    • “Cheng and other doctors working to better calibrate screening said the risks of overdiagnosis have declined. More doctors now monitor low-risk tumors for growth before rushing a man into surgery or radiation. Better imaging tools have reduced biopsies.”
  • In other words, the problem is not necessarily the screening test; rather the problem may be the reaction of the medical community to screening results.  
  • NPR Shots informs us,
    • “The idea of food as medicine dates back to the ancient Greek doctor Hippocrates, and a new study adds to the evidence that a diet full of fruits and vegetables can help improve heart health. The research comes amid an epidemic of  diet-related disease, which competes with smoking as a leading cause of death.
    • “Researchers evaluated the impact of “produce prescriptions,” which provide free fruits and vegetables to people with diet related diseases including diabetes, obesity and hypertension. The study included nearly 4,000 people in 12 states who struggle to afford healthy food. They received vouchers, averaging $63 a month, for up to 10 months, which could be redeemed for produce at retail stores or farmers markets, depending on the location. 
    • “Health care providers tracked changes in weight, blood pressure and blood sugar among the participants. “We were excited to see improvements,” says study author Kurt Hager, an instructor at UMass Chan Medical School.
    • “Among adults with hypertension, we saw that systolic blood pressure decreased by 8 mm Hg and diastolic blood pressure decreased by about 5 mm Hg, which could have a meaningful impact on health outcomes,” Hager says.
    • “Among people with uncontrolled diabetes, their A1C levels, which is a 2-3 month average of their blood sugar, also declined significantly, by about .6 percent. “The reductions we saw in blood sugar were roughly half of that of commonly prescribed medications, which is really encouraging for just a simple change in diet,” Hager says.” 
  • Fortune Well explains how to deal with the uncertainty that serves as the root of anxiety.
    • “Uncertainty is life’s promise to us all. For more than twenty years, I have watched people rise from unspeakable pain to venture again into a future that withholds all certainty. I work with people who have endured shocking traumas and, predictably, our early conversations are filled with interrogative pleas for a certain safety: “How can I be absolutely sure nothing like this will ever happen again?” they ask me.
    • “The answer is: they cannot.
    • “After many years, the thing that still takes my breath away is the grace and courage of people who accept this truth and say: I rise again not because I know for sure, but because I hope anyway.”
  • The New York Times offers a reminder about how to use at home COVID tests effectively. Bear in mind that Paxlovid should be taken within five day after showing Covid symptoms.

Friday Factoids

David Ermer–CDC, COVID-19, COVID-19 vaccine, Electronic health records, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • The Wall Street Journal reports
    • “Nursing homes will have to maintain minimum staffing levels under a Biden administration proposal despite furious lobbying from the industry, which says it will be too onerous amid a continuing labor shortage.
    • “Biden administration officials said the first-ever national staffing rule would require nursing homes that participate in Medicare and Medicaid to provide a minimum of 0.55 hours of care from a registered nurse per resident a day, and 2.45 hours of care from a nurse aide per resident a day. A registered nurse would be required to be on-site at all times and nursing-home care assessments would be strengthened under the proposal.
    • “The Centers for Medicare and Medicaid Services estimates that about 75% of nursing homes would have to strengthen staffing in their facilities under the proposal. The proposed staffing standard exceeds those existing in nearly all states.”
  • and
    • “The Federal Trade Commission said Friday it had agreed to end its legal challenge of drugmaker  Amgen’s $27.8 billion deal to buy  Horizon Therapeutics, averting a trial that was to have started this month.
    • “The pact also dismisses the antitrust claims of six states that joined the FTC in May seeking to block the deal over concerns that Amgen would illegally bundle its products with Horizon’s medicines for thyroid eye disease and gout. Amgen agreed in the proposed settlement not to bundle the Horizon treatments and swore off conditional rebates or other tactics that could entrench the monopoly position of Horizon’s products.”
  • HHS Secretary Xavier Berra made a statement recognizing National Suicide Awareness Month.
    • “The Biden-Harris Administration is deeply committed to tackling the mental health crisis facing America, particularly the alarming rates of suicide. Recognizing the urgency of this issue, SAMHSA continues to support the Suicide Prevention Resource Center and consistently invests millions in suicide prevention initiatives. In fact, SAMHSA will award nearly $12 million to the Zero Suicide in Health Systems program next week. This ambitious program aims to comprehensively integrate the Zero Suicide intervention and prevention model across various health systems with the express aim of reducing suicide ideation, suicide attempts, and deaths due to suicide.
    • “But no program exemplifies our work to prevent suicide better than 988, the three-digit Suicide & Crisis Lifeline, which HHS launched in collaboration with the states in 2022. The Biden-Harris Administration has invested close to $1 billion in 988, and, thanks to 988, Americans are now connected with trained counselors who offer real support in times of crisis. Since the July 2022 launch, 988 has received more than 5.5 million calls, texts, and chats, and this July, text and chat were made available in Spanish.”
  • Per Fierce Healthcare,
    • Enforcement of information blocking penalties for health IT entities [went] into effect on Friday, opening the door to penalties of up to $1 million per violation.
    • The breakdown of how exactly the Department of Health and Human Services (HHS) Office of Inspector General (OIG) will prioritize what it expects to be a deluge of information-blocking complaints was posted by the regulator in late June.

From the public health front,

  • The Wall Street Journal discusses “Covid This Fall: What’s the Same, What’s Different and What to Know.”
  • The Hill adds
    • “COVID-19 hospitalizations have steadily increased over the past few weeks, reaching 15,067 for the week ending Aug. 19 — an 18.8 percent increase from the week prior, according to CDC data. But at this time last year, the U.S. averaged over 84,000 hospitalizations per week. More than 96 percent of U.S. counties are experiencing low COVID-19 hospitalization levels, at less than 10 new COVID-19 hospital admissions per 100,00 people.”
  • Per Beckers Hospital Review,
    • “The CDC updated its risk assessment on distant omicron relative BA.2.86 on Aug. 30, saying the strain — which has concerned experts over the large number of mutations it carries — has been detected in at least four states. 
    • “CDC continues to track the presence of the BA.2.86 [COVID-19] variant,” the update said. “Since CDC’s initial risk assessment, this variant has been identified in additional countries from both human and wastewater specimens.” 
    • “In the U.S., BA.2.86 cases have been detected in Virginia, Michigan, Ohio and New York either through human samples or wastewater samples. Separately, Houston Methodist in an Aug. 31 statement emailed to Becker’s said it has identified Texas’ first reported instance of BA.2.86 through genomic sequencing. The hospital’s COVID-19 sequencing team continues to sequence all positive specimens.” 
  • The New York Times Morning column provides an overview of Fall 2023 Covid, flu and now RSV vaccines. Of note, at least to the FEHBlog,
    • “This year’s flu vaccine shots are now available at drugstores, hospitals, doctor’s offices and elsewhere. You may want to wait until late September or October to get one, though. The heaviest parts of flu season tend to occur between December and February. If you wait, the shot’s protection against severe illness will still be near its strongest level during those months.”

From the U.S. healthcare business front,

  • Healthcare Dive relates,
    • “Walgreens chief executive Rosalind Brewer is stepping down as CEO and a member of the board effective immediately, the retail pharmacy giant announced Friday.
    • “Brewer’s departure comes less than three years after she joined the Illinois-based retailer. The parting was a mutual decision between Brewer and Walgreens’ board, according to a release. Walgreens’ lead independent director Ginger Graham will serve as interim CEO while the company looks for a permanent replacement.”
  • STAT News discusses the “curious case of J&J’s Stelara, the unluckiest drug on Medicare’s list” of ten drugs subject to CMS “price negotiation.” Bad beat.

Friday Factoids

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From the No Surprises Act front,

  • The American Hospital Association informs us,
    • “The U.S. District Court for the Eastern District of Texas, for a third time, ruled to set aside certain regulations implementing the No Surprises Act. In this case, the Texas Medical Association, joined by several air ambulance providers and supported by an amicus filed by the AHA, successfully argued that the methodology for how insurers calculate the qualifying payment amount tilts the arbitration process in insurers’ favor.” 
  • The Centers for Medicare and Medicaid Services adds,
    • “On August 24, 2023, the U.S. District Court for the Eastern District of Texas issued an opinion and order in Texas Medical Association, et al. v. United States Department of Health and Human Services, Case No. 6:22-cv-450-JDK (TMA III), vacating certain portions of 86 Fed. Reg. 36,872, 45 C.F.R. § 149.130 and 149.140 , 26 C.F.R. § 54.9816-6T and 54.9817-1T, 29 C.F.R. § 2590.716-6 and 2590.717-1, and 5 C.F.R. § 890.114(a) as well as certain portions of several guidance documents. As a result of the TMA III decision, effective immediately, the Departments have temporarily suspended all Federal IDR process operations until the Departments can provide additional instructions. Disputing parties should continue to engage in open negotiation.”
  • The FEHBlog hopes that the federal regulators move to stay this decision pending appeal to the U.S. Court of Appeals for the Fifth Circuit. That court is already reviewing Judge Kernodle’s first decision modifying the final No Surprises Act implementing rule (No. 23-40217).

From Washington, DC —

  • STAT News tells us,
    • “With last fall’s chaotic early start to the respiratory virus season still fresh in the public memory, federal health authorities are trying to move quickly to convey the impression that this year will be different.
    • “In a briefing for reporters Thursday, senior officials of the Centers for Disease Control and Prevention [CDC] and the Food and Drug Administration [FDA] detailed the various countermeasures available to combat COVID-19, RSV, and influenza, and discussed the expected timing on the rollouts of these tools. They spoke on condition that their names and titles would not be disclosed.
    • “We are in our strongest position yet to be able to fight COVID-19 as well as the other viruses that are responsible for the majority of fall and winter hospitalizations,” one CDC official said. “We also have more tools, including … for the first time ever, vaccines for all three of the major fall and winter respiratory viruses — influenza, Covid, and RSV. Our goal, our imperative, our task is to make sure we’re using those tools.”
    • “The updated Covid vaccines have not yet been cleared by the FDA, but that must be coming in the next two and a half weeks or so, because a meeting of the CDC’s expert vaccine panel, the Advisory Committee on Immunization Practices, has been slated for Sept. 12. ACIP must vote on whether to recommend the updated vaccines — and the recommendation must be endorsed by CDC Director Mandy Cohen — before they can begin to be used. The federal officials said the vaccine rollout would begin by mid-September.”
  • The CDC also updated flu vaccine information for the 2023-24 flu season.
  • Per the U.S. Department of Justice,
    • “[On Wednesday, August 23, 2023,] Deputy Attorney General Lisa O. Monaco delivered opening remarks at a roundtable meeting of senior Justice Department officials and investigative partners to announce the results of a coordinated, nationwide enforcement action to combat COVID-19 fraud, which included 718 enforcement actions – including federal criminal charges against 371 defendants – for offenses related to over $836 million in alleged COVID-19 fraud. Deputy Attorney General Monaco also announced the launch of two additional COVID-19 Fraud Enforcement Strike Forces: one at the U.S. Attorney’s Office for the District of Colorado and one at the U.S. Attorney’s Office for the District of New Jersey. These two strike forces add to the three strike forces launched in September 2022 in the Eastern and Central Districts of California, the Southern District of Florida, and the District of Maryland.”

From the medical and Rx research fronts —

  • BioPharma Dive reports,
    • “Two weeks ago, Danish drugmaker Novo Nordisk released results of a large trial showing its weight loss drug Wegovy can help prevent heart attacks and strokes in overweight people with cardiovascular disease. It followed up on those landmark data Friday with further evidence the injectable drug helps protect the heart.
    • “In people with a form of heart failure, Wegovy reduced disease symptoms and improved quality of life and exercise duration by more than placebo, according to results from the trial, codenamed “STEP-HFpEF.” The data were released at the European Society of Cardiology meeting and published in The New England Journal of Medicine.
    • “The newly released data could further help Novo persuade insurers to provide broader coverage for Wegovy, which carries a list price of more than $17,000 a year. Insurers might be more open to offering coverage if they know the shot can avert expensive hospitalizations and episodes of care.
    • “Broad coverage also could help Novo retain its lead over rival Eli Lilly, which has a similarly acting drug Mounjaro that is approved to treat diabetes but not yet weight loss.”
  • MedPage Today points out,
    • A novel 14-year risk score helped identify people from age 50 onward at risk for all-cause dementia, a large U.K. study showed.
    • The tool, called the U.K. Biobank Dementia Risk Score (UKBDRS), was developed and validated in two U.K. cohorts, reported Raihaan Patel, Ph.D., of the University of Oxford in England, and co-authors.

From the U.S. healthcare business front,

  • Beckers Payer Issues relates,
    • Employers will pay more than $15,000 on average for each employee’s healthcare in 2024, according to an analysis from consulting firm Aon. 
    • Employer-sponsored insurance costs will rise 8.5 percent in 2024, up from an average of $13,906 per employee in 2023, according to Aon’s estimates published August 22.
    • Read the full report here.
  • Fortunately, OPM’s decision to allow FEHB carriers to offer Medicare Part D EGWP arrangements in 2024 will offset the factors discussed in the Aon report.
  • Beckers Hospital Review reports,
    • “Ongoing increases in expenses were part of the drive behind lower hospital operating margins in July, according to a Syntellis report.
    • “While such margins remained positive, they contracted for the first time since rising into the black in March, the report showed. The operating margin median for July was 1.1 percent compared to 2 percent in June, but still higher than the March through May period and 2.6 percentage points higher than July 2022.
    • “While overall expenses were up 3.6 percent on the same period in 2022, labor expenses increased 2.1 percent. Supplies and drug costs were both up over 5 percent, the report said.”
  • Per Healthcare Dive,
    • “A new brief from out Wednesday from research firm KFF explores the potential of consumer cost changes and antitrust regulation when healthcare systems engage in cross-market mergers, including a body of research indicating possible healthcare price increases.
    • “Antitrust agencies have historically focused on mergers between hospitals and health systems that operate in the same geographic market, the KFF brief noted. The Federal Trade Commission has never formally challenged a cross-market merger and antitrust agencies have not developed guidelines for evaluating them.
    • “Regulating cross-market mergers, will be “on the radar” of policymakers and regulators as they become increasingly common, KFF said. Between 2010 and 2019, cross-market mergers made up 55% of hospital M&A ventures, and drove at least nine large-scale mergers since June 2021.”

Midweek update

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

From Washington, DC –

  • STAT News informs us,
    • “The Centers for Disease Control and Prevention said Wednesday it’s too early to tell whether a new version of the SARS-CoV-2 virus that has triggered some international concern will actually prove to be disruptive.
    • “In a preliminary statement about the BA.2.86 subvariant, the CDC also revealed that updated Covid-19 vaccines should be available across the country as early as mid-September, earlier than previous estimates have placed the start of the fall booster campaign.
    • “The vaccines, made by Pfizer, Moderna, and Novavax, must first be authorized by the Food and Drug Administration and recommended by the CDC’s expert vaccine panel, the Advisory Committee on Immunization Practices, and the CDC itself. The three manufacturers have said they have doses at the ready for when the FDA and CDC sign-offs come.”
  • The National Institutes of Health announced,
    • “An international research team has generated the first truly complete sequence of a human Y chromosome, the final human chromosome to be fully sequenced. The new sequence, which fills in gaps across more than 50% of the Y chromosome’s length, uncovers important genomic features with implications for fertility, such as factors in sperm production. The study, led by the Telomere-to-Telomere (T2T) Consortium, a team of researchers funded by the National Human Genome Research Institute (NHGRI), part of the National Institutes of Health, was published today in Nature.”
  • Levita Magnetics, “whose mission is to help more patients get access to better surgery,” tells us,
    • “U.S. Food and Drug Administration (FDA) gave Levita clearance for its MARS™ platform.
    • “The Levita MARS system is a first-of-its-kind minimally invasive surgical platform aimed at the high-volume abdominal surgery market. Harnessing the power of both magnets and machines, MARS reduces the number of incisions and enables surgeons to have complete control during laparoscopic procedures, all in a compact footprint designed to fit into existing operating rooms.
    • “Building on the success of its first commercial product, the Levita Magnetic Surgical System®, Levita designed MARS to deliver the same patient benefits as Magnetic Surgery®, while empowering surgeons with increased control of surgical instruments and providing an efficient way for hospitals and ambulatory surgery centers (ASCs) to incorporate this new technology.”

From the public health front,

  • Ovia Health released a white paper “externally validating Ovia’s preterm birth reduction programming.
  • STAT News discusses steps being taken to cure a “severe shortage of doctors who actually specialize in treating obesity” in the United States.
    • “To ensure that all 115 million Americans with obesity have access to care, the field should focus on empowering primary care providers to treat “simple obesity,” or uncomplicated cases, said Kimberly Gudzune, medical director of the American Board of Obesity Medicine. “That, hopefully, prevents the development of some of the complications.”
    • “And this work begins in medical school and residency. For instance, [Juliana] Simonetti [,an obesity doctor at the University of Utah,] has proposed a one-month elective course on obesity at the University of Utah School of Medicine, and Freshwater has been working with the Obesity Medicine Association to incorporate education into training programs nationwide, including the local family medicine residency in Boise.”

From the Rx coverage front,

  • BioPharma Dive points out,
    • “A closely watched, experimental Roche medicine may be helping lung cancer patients live longer, spurring renewed optimism about an emerging class of immunotherapy treatments.
    • “The data come from an interim analysis of a Phase 3 trial pairing the drug, tiragolumab, with a marketed Roche immunotherapy called Tecentriq in patients with non-small cell lung cancer. Roche completed the analysis in February, but never publicly disclosed its findings, which were inadvertently released on its website Tuesday night and discovered by Wall Street analysts. The company is expected to provide the final study results either late this year or early next.”
  • Per Fierce Healthcare,
    • “CVS Health has launched a new segment that aims to work with drugmakers to bring additional biosimilars to market.
    • “The new, wholly owned subsidiary, called Cordavis, aims to develop a biosimilar portfolio with the goal of expanding access to these drugs across the country. Increased uptake of biosimilars can drive down costs of pricey brand drugs that otherwise lack market competition, CVS said.”

From the U.S. healthcare business front,

  • Forbes delves into Amazon’s recently expanded Amazon Clinic product.
    • “With Amazon Clinic, one of the world’s biggest technology companies is looking to infuse the black box of healthcare pricing with some actual transparency. Login to the site and you’ll see that a person who tests positive for Covid-19 in Wyoming can pay $35 for a message-based conversation with a doctor, who will respond within an hour and 45 minutes. Or $40 to get a response in 30 minutes. A video visit costs $74 with a wait time of around an hour and 30 minutes.
    • “Amazon isn’t directly providing the medical services. Instead, the tech giant has contracted with four different startups to provide message and video appointments for around 30 medical conditions. The result is a dynamic marketplace where customers can see pricing, wait times and the typical number of prescription refills upfront. “If you want the lower cost provider, you can choose that. If you are actually prioritizing the speed at which someone is getting back to you, you can prioritize that as well,” Nworah Ayogu, chief medical officer and general manager of Amazon Clinic tells Forbes. “We think really being able to surface different options for different customers lets them choose what’s important to them.”
  • Per Fierce Healthcare,
    • “Most Americans support the idea of value-based care but don’t understand or resonate with the term, according to new research from United States of Care. 
    • “USofCare is a self-described nonpartisan think tank focused on building a more equitable healthcare system. Its latest research relied on (PDF) virtual focus groups with a dozen participants, a national survey that reached 1,000 respondents and a “ReMesh” session, or an AI-driven feedback collection platform that engaged 100 participants more deeply.”