Monday Roundup

COVID-19 vaccine

Monday Roundup

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, FDA, Mental health care, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • The New York Times reports,
    • “After days of warnings, [Rep. Matt] Gaetz [(R FL)] rose Monday evening [on the floor of the House of Representatives] to bring up a resolution declaring the speakership vacant. That started a process that would force a vote within days on whether to keep Mr. McCarthy in his post. * * *
    • “Under House rules, Mr. McCarthy and his leadership team will need to address the motion within two legislative days — though they could do so sooner.”
  • Roll Call adds,
    • “The Senate will adjourn earlier than planned this week, with no session on Thursday, to allow members to travel to California and pay their respects to the late Sen. Dianne Feinstein. * * *
    • “On Sunday, California Gov. Gavin Newsom appointed Laphonza Butler to fill the remainder of Feinstein’s term. Butler recently led the abortion rights campaign group EMILY’s List and spent 20 years as president of SEIU Local 2015, a home care workers union in California.
    • “Butler will serve until a replacement is elected in a still-unscheduled special election. Three House Democrats — Barbara Lee, Katie Porter and Adam B. Schiff — are running in the March primary for the full, six-year term and can also run in the special election.
    • “Butler is scheduled to be sworn in by Harris on Tuesday. She will become the first openly gay Black woman to serve in the Senate.”
  • Last Thursday, U.S. District Judge John Bates vacated a Trump-era Affordable Care Act rule permitting health plans, including FEHB plans, to use copay assistance accumulators. These accumulators prevent manufacturer assistance used to pay cost-sharing for expensive drugs from counting towards out-of-pocket maximums. While that outcome seems reasonable to the FEHBlog, Judge Bates takes the opposite view in his opinion. The federal government, which is the defendant in the case, has the right to appeal this final judgment.
  • The Institute for Clinical and Economic Research published a “Special Report on Eliquis and Xarelto Submitted to CMS as Part of Public Comment Process on Medicare Drug Price Negotiations.” The report “evaluate[es] the evidence on apixaban (Eliquis®, Bristol-Myers Squibb) and rivaroxaban (Xarelto®, Bayer) for the treatment of nonvalvular atrial fibrillation (NVAF).”
  • BioPharma Dive identifies five Food and Drug Administration to watch for in the fourth quarter of 2023. “By the end of the year, the regulator will decide on new genetic treatments for sickle cell, expanded use of Alnylam’s Onpattro and an inflammatory disease drug from Pfizer.”

From the public health front,

  • MedPage Today informs us
    • “Maternal COVID vaccination in pregnancy protected young infants against Omicron-associated hospitalization, but few women actually receive the vaccine during pregnancy, according to new data from the CDC.
    • “At least one maternal vaccine dose had an effectiveness of 54% (95% CI 32-68) against COVID-related hospitalization among infants younger than 3 months of age, and an effectiveness of 35% (95% CI 15-51) for infants younger than 6 months, reported researchers led by Regina Simeone, Ph.D., of CDC’s National Center for Immunization and Respiratory Diseases in Atlanta, in the Morbidity and Mortality Weekly Report. * * *
    • “Looking at the COVID shot specifically, women were nine times more likely to receive a bivalent booster if a provider recommended it (63.2% vs 6.8% when a provider did not).”
  • The American Medical Association offers “What doctors wish patients knew about managing anxiety disorders.”
  • STAT News points out,
    • “In a guidance document published Monday in the Federal Register, the CDC is seeking input on its proposal that health providers offer gay and bisexual men who have sex with men, as well as transgendered women, access to a common antibiotic, doxycycline, that they could take after having had unprotected sex to lower their risk of acquiring chlamydia, gonorrhea, or syphilis. Doxycycline is in the tetracycline family of antibiotics.
    • “Studies have show the so-called “doxy PEP” regime — a single, 200-milligram dose taken no later than 72 hours after unprotected sex — can reduce acquisition of chlamydia and syphilis by nearly 80%, and gonorrhea by about 50%. PEP is short for post-exposure prophylaxis.
    • “Doxy PEP is moving STI prevention efforts into the 21st century,” Jonathan Mermin, director of CDC’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention, said in a statement. “We need game-changing innovations to turn the STI epidemic around, and this is a major step in the right direction.”

From the awards front,

  • The Wall Street Journal reports
    • “Katalin Karikó and Drew Weissman won the Nobel Prize in medicine on Monday for an idea that pushed them to the fringes of the scientific establishment before it saved millions of lives during the pandemic. 
    • “Karikó, a molecular biologist, and Weissman, an immunologist, realized during a chance encounter at a University of Pennsylvania a photocopy machine in the 1990s that they could combine their work exploring messenger RNA’s potential in drugs or vaccines. 
    • “Their collaboration was met with skepticism by their colleagues and indifference in the scientific community. Karikó struggled to secure funding for her work. Penn demoted her and sent her to work in an office on the outskirts of campus. 
    • “People wondered, ‘What the hell is wrong with her,’ there must be some reason she’s not on the faculty,” Karikó has said.
    • “Years later, as drugmakers raced to develop vaccines against COVID-19, it was mRNA technology that powered widely used shots from Pfizer–BioNTech and Moderna. The Nobel committee credited Karikó’s and Weissman’s work with saving millions of lives.
    • “The laureates contributed to the unprecedented rate of vaccine development during one of the greatest threats to human health in modern times,” the committee said in awarding Karikó, 68, and Weissman, 64, the annual prize in physiology or medicine. Karikó is the 13th woman among 227 people to win the prize.”
    • Bravo.
  • Fierce Healthcare announced its Fierce 50.
    • “The Fierce 50 goes beyond surface-level accolades to delve deep into the monumental impact 50 exceptional individuals and organizations have on the lives of patients. It shines a spotlight on the visionaries and trailblazers who have pioneered groundbreaking therapies, overhauled patient care models, and spearheaded innovative approaches to address the most pressing challenges in biopharma and healthcare.”

From the U.S. healthcare business front,

  • Beckers Hospital CFO Report tells us,
    • “Hospital margins are moving in the right direction, as the median year-to-date operating margin improved in August to 1.1 percent, according to Kaufman Hall. 
    • “August’s median of 1.1 percent marked an upswing from the 0.9 percent median margin recorded in July, according to Kaufman Hall’s latest “National Hospital Flash Report” — based on data from more than 1,300 hospitals.
    • “Increased revenue offset hospitals’ increased supply and drug expenses in August. Decreased reliance on contract labor helped labor expenses decline on a volume-adjusted basis, while average lengths of stay also fell, by 4 percent month over month.”

Thursday Miscellany

David Ermer–Congress, COVID-19, COVID-19 vaccine, Medicare, Mental health care, OPM, Patient safety, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • The Wall Street Journal reports,
    • “House Speaker Kevin McCarthy (R., Calif.) embraced border security as a possible way to break a congressional impasse over funding the government, saying it could be a key ingredient in any last-ditch push to avert a partial shutdown this weekend.  * * *
    • “Speaking to reporters on Thursday morning, McCarthy said concerns among both Democrats and Republicans about the pace of migrants crossing the U.S.-Mexican border could provide enough common ground for them to work out a short-term deal to keep the government open past Sept. 30, when the fiscal year ends.
    • “He said he had spoken with some Democratic senators about border enforcement as recently as Thursday morning.“They want something on the border. They’re working on it,” he said of Democrat senators. “And so I think there’s an opportunity here. We know we have to keep the government funded. We know we have a concern about the border—both sides.” Asked directly by a reporter if he expects a shutdown, McCarthy said: “No, I’m saying we work through this and get it done.”
  • Per Fierce Healthcare,
    • Following a Senate Finance Committee markup hearing in July, where members voted 26-1 in favor of the Modernizing and Ensuring PBM Accountability (MEPA) Act, Senators Ron Wyden, D-Oregon, and Mike Crapo, R-Idaho, formally introduced the bill on Thursday.
    • Designed to curb the power of pharmacy benefit managers, the bill would prohibit PBM compensation in Medicare from being tied to the price, increase audit and enforcement measures and aid independent community pharmacies that have struggled because of PBM practices, according to a news release.
  • AHIP announced that yesterday
    • Following reports of some patients having difficulties accessing new COVID-19 boosters without cost sharing, Alliance of Community Health Plans, Association for Community Affiliated Plans, AHIP, and Blue Cross Blue Shield Association came together in a letter to Xavier Becerra, Secretary of the Department of Health & Human Services, to reiterate their commitment to providing access, swiftly addressing any challenges, and continuing to partner with HHS and others across the health care system.”
    • Good to hear.
  • STAT News offers six approaches to resolving the drug shortages confronting our country.
  • STAT News also informs us
    • “A panel of independent advisers to the Food and Drug Administration voted overwhelmingly against a polarizing potential treatment for ALS on Wednesday, concluding that the medicine’s messy supporting data did not meet the standard for approval.
    • “After a day-long meeting that included impassioned testimony from ALS patients, the agency’s expert advisers voted 17-1 with one abstention that the case for NurOwn, a treatment from BrainStorm Cell Therapeutics, was based too heavily on convoluted clinical trial results and compelling but unreliable anecdotal evidence.”
  • Per Beckers Hospital Review,
    • “The label for Novo Nordisk’s weight loss drug Ozempic now acknowledges some users’ reports of ileus or intestinal blockage. 
    • “In its update, however, the FDA said it’s difficult to confirm a causal relationship between the side effect and the drug. 
    • “Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure,” the label says. 
    • “Wegovy and Mounjaro, also GLP-1 agonist medications, already acknowledge reports of ileus on their labels. Novo Nordisk is the maker of both Ozempic and Wegovy, which both use an injection of semaglutide.” 
  • The Affordable Care Act regulators released ACA FAQ 61, which updates interested parties on transparency in coverage and RxDc reporting issues.
  • The U.S. Office of Personnel Management announced “issuing an interim final rule today to extend the eligibility date for noncompetitive appointment of military spouses married to a member of the armed forces on active duty through December 31, 2028, as called for by enactment of the Fiscal Year (FY) 2023 National Defense Authorization Act (NDAA) (P.L. 117-263).” 

From the public health front,

  • STAT News tells us
    • “[A 36-year-old woman living in San Francisco was told her kidneys would heal. But they didn’t; dialysis became a regular routine. She moved to UCSF Medical Center, seeking better care and a place that would allow her parents to visit. There, she met Chi-yuan Hsu, UCSF’s chief of nephrology, who was looking to study patients who might be successfully weaned from dialysis. He believed many patients with acute kidney injury like Lawson stayed on dialysis for longer than they needed.
    • “The results of a new study by Hsu, published Thursday in the Journal of the American Society of Nephrology, validate his suspicions. The study of nearly 8,000 patients, nearly 2,000 with acute kidney injury, found 40% of patients with acute kidney injury recovered their kidney function. But of these patients, just 18% were weaned from dialysis through having fewer sessions, and 9% by having shorter sessions.
    • “More than 70% of these patients ended up eventually stopping dialysis without any weaning — “cold turkey” as Hsu puts it — suggesting they could have been having fewer, or shorter treatments earlier. This is important, he said, because dialysis not only impacts quality of life, as it did for Lawson, it can also lead to infection and heart damage, and possibly — this is still under debate — to additional kidney injury that could inhibit recovery and lead to a need for permanent dialysis.”
  • Health Leaders Media explains how to address the relationship between patient safety and health equity.
  • Employee Benefit News points out the need for mental health benefits to cover suicide prevention.

From the U.S. healthcare business front,

  • Forbes reports that CVS, Walgreens And Rite Aid are closing nearly 1,500 stores across the U.S.
    • “All three drug chains have different reasons for closing stores, but the downsizing prescription is the same. Chain drugstores cost a lot to operate, and they don’t have sufficient differentiation to attract customers feeling the economic pinch.”
  • STAT News says,
    • Ophthalmologists who accepted payments from drug companies were less likely to prescribe a cheaper medicine to treat an eye disease that causes blindness in older people, rather than a pair of more expensive alternatives, according to a new study. This led Medicare to spend an additional $643 million during a recent six-year period.
    • Specifically, physicians who received money prescribed Avastin, an older cancer medicine, 28% of the time for combating age-related macular degeneration. And they prescribed two costlier treatments, which have approved specifically to treat the eye disease, 72% of the time. Physicians who did not accept payments prescribed Avastin 46% of the time, nearly twice as often as those who accepted payments.
    • “As a result, Medicare shelled out an estimated $642.8 million from 2013 to 2019, presumably due to the company payments, according to the study, which was published in JAMA Health Forum. The researchers examined Medicare Part B data that encompassed nearly 21,600 ophthalmologists who accepted money from Roche and Regeneron Pharmaceuticals, which sell the pricier eye treatments.”
  • Per Healthcare Dive,
    • “Satisfaction with telehealth is significantly higher among younger patients, according to a study by consumer data company JD Power. 
    • “Members of Generation Y, who were born between 1977 and 1994, and Generation Z, born between 1995 and 2004, report a satisfaction score of 714 out of 1,000. But Baby Boomers, born between 1946 and and 1964, and people born earlier had a significantly lower score of 671.
    • “The satisfaction gap between older and younger generations is widest when it comes to digital channels and appointment scheduling, which could mean older users are struggling to use telehealth providers’ digital interfaces, the study argues.” 
  • Beckers Hospital Review lets us know
    • “Medicare Advantage provides health coverage to more than half of the nation’s seniors, but a growing number of hospitals and health systems nationwide are pushing back and dropping the private plans altogether.
    • “Among the most commonly cited reasons are excessive prior authorization denial rates and slow payments from insurers. Some systems have noted that most MA carriers have faced allegations of billing fraud from the federal government and are being probed by lawmakers over their high denial rates.
    • “It’s become a game of delay, deny and not pay,” Chris Van Gorder, president and CEO of San Diego-based Scripps Health, told Becker’s. “Providers are going to have to get out of full-risk capitation because it just doesn’t work — we’re the bottom of the food chain, and the food chain is not being fed.” 
    • “In late September, Scripps began notifying patients that it is terminating Medicare Advantage contracts for its integrated medical groups, a move that will affect more than 30,000 seniors in the region. The medical groups, Scripps Clinic and Scripps Coastal, employ more than 1,000 physicians, including advanced practitioners.”
  • and
    •  interviews an Aetna executive about successful value based care.
  • The Wall Street Journal reports about employer groups that are successfully advocating for lower hospital prices in their states. The flagbearer is Gloria Sachdev, who is chief executive officer of the Employers’ Forum of Indiana. Good luck.

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.” 

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.

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.”

Thursday Miscellany

David Ermer–ACA, Congress, COVID-19, COVID-19 vaccine, Electronic health records, Medical / Rx research, NIH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC —

  • Govexec informs us
    • “The Senate continues to advance spending bills without controversy and with bipartisan support, offering hope that lawmakers will avoid a lapse in appropriations this fall. 
    • “The [Senate Appropriations Committee] has now approved eight of the 12 annual must-pass spending measures, most of which have won unanimous approval. Sen. Patty Murray, D-Wash., who chairs the appropriations committee, announced Thursday her panel would hold votes on the final four funding packages next week. Murray said ahead of Thursday’s votes that she was focusing on passing bills “that can actually be signed into law.”  * * *
    • “The House Appropriations Committee has approved 10 of the 12 spending bills, all largely along party-line votes. House Speaker Kevin McCarthy, R-Calif., said on Wednesday he planned to bring those to the House floor soon, adding his intention was to have the process complete before current funding expires on Sept. 30. Without commenting on the vast differences between the two sets of bills, McCarthy called it “a positive” that the Senate was already moving its spending measures.”
  • The Affordable Care Act regulators issued a letter encouraging employers and other plan sponsors to extend the special employer-sponsored health plan enrollment period for employees who lost Medicaid or CHIP coverage for themselves or family members beyond the sixty days required by law.  
  • The Department of Health and Human Services released guidance “to clarify the prohibition at 45 CFR § 162.412(b) that a health plan may not require a healthcare provider that has been assigned an NPI to obtain an additional NPI.” However, “it does not prohibit a health plan from requiring that a subpart that does not have a unique NPI obtain a unique NPI as a condition of enrollment with the health plan.”
  • The American Academy of Actuaries posted its annual report outlining the factors likely to drive premium changes in the individual and small group insurance markets for the next plan year, in this case, 2024. 

From the public health front —

  • MedPage Today informs us,
    • “A second booster with an mRNA bivalent vaccine offered the best protection against severe COVID-19 due to the Omicron BA.5 variant in older adults, and protection appeared to wane less than with the monovalent shot, a large retrospective study out of Italy showed.”
  • The National Institutes of Health announced
    • “Omega-3 fatty acids, which are abundant in fish and fish oil supplements, appear promising for maintaining lung health, according to new evidence from a large, multi-faceted study in healthy adults supported by the National Institutes of Health. The study provides the strongest evidence to date of this association and underscores the importance of including omega-3 fatty acids in the diet, especially given that many Americans do not meet current guidelines. Funded largely by the National Heart, Lung, and Blood Institute (NHLBI), part of NIH, the study results were published in the American Journal of Respiratory and Critical Care Medicine.” 
  • Cigna Healthcare offers five tips for healthier sleep.

From the EHR interoperability front, check out this fascinating Computer World update

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • 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.
  • Beckers Hospital Review tells us,
    • “Severe winds from an EF-3 tornado on July 19 crushed a North Carolina Pfizer manufacturing plant that made nearly 25 percent of the drugmaker’s sterile injectables used by U.S. hospitals. 
    • “The facility manufactured and stored injectable drugs, and 50,000 pallets of therapies were destroyed by wind and rain, according to local news outlets, NBC affiliate WRAL and CBS affiliate WNCN. 
    • “At 1.4 million square feet, the facility was one of the largest sterile injectable plants in the world, according to Pfizer’s website. The site made nearly 400 million products every year, including solutions of anesthesia, analgesia, therapeutics, anti-infectives and neuromuscular blockers.
    • “The tornado touched down in Rocky Mount, N.C., at 12:36 p.m., according to a tweet from the county’s government.
    • “Pfizer said there are no reports of workers with serious injuries.” 
  • The Wall Street Journal reports,
    • “A surge in heart procedures and higher demand for cold and flu medicines helped Johnson & Johnson report solid gains in revenue and profit for the second quarter.
    • “J&J’s quarterly earnings are regarded as a bellwether for healthcare because the company has large pharmaceutical, medical-device and consumer-health divisions. The overall improvement in J&J’s results suggests an easing of some of the challenges that have dogged health-product makers in recent years: supply-chain constraints, hospital staffing shortages and Covid-19 pandemic restrictions. “You now have hospital staffing much more on a routine cadence,” J&J Chief Financial Officer Joseph Wolk said in an interview Thursday.” 
  • Healthcare Dive adds,
    • “Abbott on Thursday posted a decline in second-quarter net earnings as demand for its COVID-19 testing supplies continued to wane, but the company raised the outlook for its base business on higher sales of its medical devices and nutrition products.
    • “Excluding COVID-19 tests, organic sales exceeded the company’s expectations with a nearly 12% increase in the quarter.”
  • The Society for Human Resource Management explores the limited impact that the Supreme Court’s affirmative action in education decision may have on employer affirmative action and diversity, equity, inclusion, and accessibility programs.