Thursday Miscellany

COVID-19

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.

Midweek Update

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

From Washington, DC,

  • Fedweek compares the House and Senate versions of the appropriations bill that funds OPM and the FEHBP.
  • The Federal Times reports,
    • “Reproductive health advocacy groups and Democratic lawmakers are pressing the Office of Personnel Management on why some insurers offer fewer infertility treatments than they’re required to in federal employee health plans.
    • “In a letter to OPM Director Kiran Ahuja obtained by Federal Times, Rep. Gerry Connolly (D-Va.) and Sen. Tammy Duckworth (D-Ill.) said certain providers under the Federal Employee Benefits Program — which serves 8 million beneficiaries — are denying coverage of standard fertility preservation treatments. * * *
    • “For the 2023 plan year, OPM announced it was requiring all FEHB carriers to “provide coverage for standard fertility preservation procedures for … iatrogenic infertility.” Per KFF, “Iatrogenic, or medically induced, infertility refers to when a person becomes infertile due to a medical procedure done to treat another problem, most often chemotherapy or radiation for cancer.”
  • The Federal Times article contends that FEHB plans are not fully compliant with this mandate. OPM has created a process for members to ask for OPM review of claim decisions (following internal plan reconsideration). This process can work out any compliance kinks.
  • InsiderNJ adds,
    • “Today, U.S. Senator Cory Booker (D-NJ) and U.S. Representative Rosa DeLauro (D-CT) reintroduced the bicameral Access to Infertility Treatment and Care Act, legislation that would require more health insurers to provide coverage for infertility treatment, as well as fertility preservation services for individuals who undergo medically necessary procedures that may cause infertility, such as chemotherapy. * * *
    • “The full text of the bill can be found here.”
  • AHA News informs us,
    • “The Federal Trade Commission and Department of Justice July 19 released for comment through Sept. 18 updated guidance describing how the agencies review mergers and acquisitions to determine compliance with federal antitrust laws. The agencies said the document outlines 13 principles they may use when determining whether a merger is unlawfully anticompetitive and clarifies the frameworks and tools they may use when analyzing a merger with respect to each guideline. 
    • “FTC and DOJ initiated the update with a request for public input in January 2022, and plan to use the comments to update the draft before finalizing the guidelines. For more on the draft guidelines, see the agencies’ fact sheet. AHA intends to submit comments on the proposed guidelines.”
  • Washington Technology tells us,
    • “Maximus is locked in a protest fight after the U.S. Postal Service chose Deloitte Consulting for a $175 million contract to the consulting firm to build a new health benefits system.
    • “By 2025, USPS plans to move that new system for delivering health insurance benefits to its employees. USPS tasked Deloitte Consulting to build the system that would include enrollment processing, eligibility determinations, data analytics and other features, according to solicitation documents on GovTribe.
    • “Maximus filed a protest with the Government Accountability Office on Tuesday to challenge the award. The Office of Personnel Management is managing the contract on behalf of the Postal Service. * * *
    • “A decision from GAO is due Oct. 26.”
  • Cardiovascular Business points out that “The U.S. Food and Drug Administration (FDA) has announced that Medtronic is recalling nearly 350,000 implantable cardiac devices due to continued issues with their ability to deliver high voltage therapy when necessary.”

From the public health front –

  • The Wall Street Journal reports,
    • “You might know a Covid-19 super-dodger who was infected with the virus but didn’t get sick. Their luck could be written in their genes. 
    • “A DNA variation that affects the immune system can boost a person’s odds of avoiding Covid-19 symptoms, a study found. The work, published Wednesday in the journal Nature, helps explain why some people infected with the virus that causes Covid-19 don’t fall ill. 
    • “The T cells of some people with the variation can find and kill the virus without having seen it before, researchers said. That is because the part of the virus their T cells home in on is similar enough to common coronaviruses they have already encountered.  
    • “There are people out there that have got strong prior immunity from their common coronavirus exposures,” said Danny Altmann, a professor of immunology at Imperial College London, who wasn’t involved in the study. The work could help researchers design better vaccines, Altmann said.” 
  • STAT News relates,
    • “Cancer drugs can burn through tumors like wildfire, killing off the vast majority of malignant cells. But a few stubborn cells often end up surviving, seeding a recurrence of the disease. The prevailing theory behind this drug resistance is built on natural selection: Among the vast and genetically diverse population of cancer cells in a tumor, some have random mutations that help these cells survive an onslaught.
    • “But this is not the full picture,” said Yogesh Goyal, a cancer researcher at Northwestern University. Goyal and his colleagues at the University of Pennsylvania demonstrated in a series of experiments that cancer cells can survive treatments just by having certain genes turned on, even if they were nearly genetically identical to cancer cells that died but had activated different genes.
    • “We think this work stands to really change how we think about therapy resistance,” said Arjun Raj, the study’s co-senior author and a bioengineer at the University of Pennsylvania.
    • “In other words, mutations alone cannot fully explain resistance to cancer therapy. Instead, researchers may need to look more closely at the assemblage of genes turned on or off at any given time in a cancer cell — what scientists call the cell’s transcriptional profile — to better understand whether it will respond to a certain drug, Goyal said.”

From the U.S. healthcare business front —

  • Healthcare Dive lets us know
    • “Elevance’s second-quarter earnings alleviated recent cost trend and utilization concerns, as the health insurer reported lower medical spending than analysts expected.
    • “The payer beat Wall Street expectations for the quarter with revenue of $43.7 billion, up 13% year over year, and profit of $1.9 billion, up 14% year over year. * * *
    • “Elevance reported a medical loss ratio of 86.4%, down 70 basis points year over year due to premium rate adjustments reflecting the post-pandemic cost of care, CFO John Gallina told investors on a Wednesday morning call.”
  • Fierce Healthcare informs us,
    • “Amar Desai, M.D., wrote in a post on LinkedIn Wednesday that he is “thrilled” to come back to the UnitedHealth Group subsidiary as the CEO of Optum Health. Desai previously spent several years in leadership roles at Optum before taking the role of president of healthcare delivery at rival CVS Health.
    • “Desai is also an associate clinical professor of medicine at the Keck School of Medicine at the University of Southern California. He previously served as president of HealthCare Partners, which was acquired in 2019 by UHG as part of DaVita Medical Group.”
  • The Society for Human Resource Management reports
    • “U.S. organizations are budgeting an average increase of 4 percent in 2024, according to consulting firm WTW, which surveyed more than 2,000 U.S. organizations for its Salary Budget Planning Survey. That number is down from the actual increase of 4.4 percent in 2023, and the 4.2 percent increase in 2022, but the projected 2024 figures remain higher than the 3.1 percent salary increase budget in 2021 as well as other increases in pre-pandemic years.”

Monday Roundup

David Ermer–ACA, COVID-19, FDA, Generative AI, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the public health front —

  • The Wall Street Journal reports
    • “Parents have a new tool to protect their newborns from a common but potentially deadly respiratory virus that sends tens of thousands of babies to the hospital each year.
    • “The Food and Drug Administration on Monday approved the first drug to protect all infants against respiratory syncytial virus. RSV is the leading cause of hospitalization of infants in the U.S., killing as many as 300 children under the age of 5 each year.  
    • “The FDA said it approved the drug Beyfortus from Sanofi and AstraZeneca based on studies that found it safely prevented the lower respiratory tract infections caused by the virus. * * *
    • “While Beyfortus isn’t a vaccine, it has a similar objective. The injection gives infants antibodies to neutralize the virus before their immune systems are mature enough to generate them on their own.  * * *
    • “Sanofi plans to make Beyfortus available in time for this year’s RSV season. Before the drug can become widely available, CDC advisers will need to recommend the drug’s use.”  
  • The FEHBlog’s favorite columnist on Covid, the New York Times David Leonhardt, let us know, “The United States has reached a milestone in the long struggle against Covid: The total number of Americans dying each day — from any cause — is no longer historically abnormal.” Consequently, the pandemic era is over.
  • In other Covid news, Medscape tells us,
    • “An air monitor made by researchers at Washington University in St. Louis can detect COVID-19 virus in a room with an infected person within 5 minutes. 
    • “The project was a collaboration among researchers from the university’s engineering and medical schools. Nature Communications published the results of their work in the journal’s Monday edition. * * *
    • “The team tested their device both in laboratory experiments where they released aerosolized SARS-CoV-2 into a room-sized chamber, as well as in the apartments of two people who were COVID-positive.
    • “There is nothing at the moment that tells us how safe a room is,” Washington University neurology professor John Cirrito, Ph.D., in a statement. “If you are in a room with 100 people, you don’t want to find out 5 days later whether you could be sick or not. The idea with this device is that you can know essentially in real-time, or every 5 minutes if there is a live virus in the air.”
    • “Their goal is to develop a commercially available air quality monitor, the researchers said.” 
  • Cigna discusses how to help women to stay on track with screenings for common cancers.
  • KFF explains why different BMI standards apply to older folks. For example,
    • “Epidemiologic research suggests that the ideal body mass index (BMI) might be higher for older adults than younger adults. (BMI is a measure of a person’s weight, in kilograms or pounds, divided by the square of their height, in meters or feet.)
    • “One large, well-regarded study found that older adults at either end of the BMI spectrum — those with low BMIs (under 22) and those with high BMIs (over 33) — were at greater risk of dying earlier than those with BMIs in the middle range (22 to 32.9).
    • “Older adults with the lowest risk of earlier deaths had BMIs of 27 to 27.9. According to World Health Organization standards, this falls in the “overweight” range (25 to 29.9) and above the “healthy weight” BMI range (18.5 to 24.9). Also, many older adults whom the study found to be at the highest mortality risk — those with BMIs under 22 — would be classified as having “healthy weight” by the WHO.
    • “The study’s conclusion: “The WHO healthy weight range may not be suitable for older adults.” Instead, being overweight may be beneficial for older adults, while being notably thin can be problematic, contributing to the potential for frailty.”
  • According to STAT News,
    • “At the turn of the century, nearly 18 million women in the United States were battling hot flashes, night sweats, and other symptoms of menopause with hormones. But in 2002, the therapy went into a free-fall when a landmark trial suggested treating menopause with estrogen and progesterone increased the risk of breast cancer and cardiovascular disease. The study was shut down early — and a year later, prescriptions had plummeted to nearly half what they had been in 2001.
    • “More than two decades later, menopause experts have come to think about the results of the trial very differently. Newer research points to more benefits than risks for many healthy women under 60 treating menopause symptoms with hormone therapy. But many women who are good fits still aren’t getting treatment. “The pendulum has been slowly — too slowly — swinging back,” said OB-GYN Mike Green, chief medical officer of menopause telehealth company Winona. 
    • “Winona is part of a new generation of virtual-first health care companies aiming to give that pendulum a push. In the last five years, more than a dozen telehealth companies have started up to serve women in and approaching menopause, including with hormone therapy. 
    • “Women fall through the cracks,” said internist Lisa Larkin, president-elect of The Menopause Society and founder of concierge women’s health network Ms. Medicine. “That’s why the telemedicine business is booming.” 

From the Alzheimer’s Disease front,

  • Medscape tells us,
    • “Eastern and southeastern areas of the US have the highest rates of Alzheimer’s disease (AD), new research shows.
    • “Investigators at Rush University in Chicago, Illinois, found AD prevalence was highest in Maryland, New York, Mississippi, and Florida. At the county level, Miami-Dade in Florida, Baltimore in Maryland, and the Bronx in New York were among the US counties with the highest prevalence of the disease.
    • “Such geographical variations may be due to the unique make-up of regional populations, study investigator Kumar Rajan, PhD, professor of Medicine and director of Rush Institute for Healthy Aging, Rush University Medical Center, in Chicago, told Medscape Medical News.”
  • STAT News relates,
    • Medicare on Monday proposed ending restrictions on how many PET scans patients can receive to detect amyloid plaques in their brains, which will offer physicians more options as they treat patients with a new drug to slow the progression of dementia.
    • The agency that oversees Medicare had previously restricted coverage to a single scan for patients who participated in clinical studies. Advocates had warned that it could cause issues related to a new class of Alzheimer’s drugs designed to clear those plaques.
  • BioPharma Dive calls our attention to
    • “A closely watched experimental drug for Alzheimer’s disease slowed the decline patients typically experience by about half a year in a key clinical trial, according to new results released Monday.
    • “The drug, called donanemab, is being developed by Eli Lilly and works in a similar way as two other medicines recently approved in the U.S. to treat Alzheimer’s. These therapies are designed to break up clusters of “amyloid beta,” a mutated protein that forms toxic brain plaques and has long been viewed as a root cause of the disease. * * *
    • “Along with its presentation, Lilly disclosed it had completed its approval application to the FDA and expects a verdict by the end of the year. The results were also published in the medical journal JAMA.”
  • Reuters adds,
    • “Alzheimer’s disease experts are revamping the way doctors diagnose patients with the progressive brain disorder – the most common type of dementia – by devising a seven-point rating scale based on cognitive and biological changes in the patient.
    • “The proposed guidelines, unveiled by experts on Sunday in a report issued at an Alzheimer’s Association conference in Amsterdam, embrace a numerical staging system assessing disease progression similar to the one used in cancer diagnoses. They also eliminate the use of terms like mild, moderate and severe.”

From the generative AI front, Fierce Healthcare explains how Blue Cross licensee HCSC is using AI to speed up prior authorization.

From the U.S. healthcare business front,

  • The American Hospital Association informs us,
    • “The Federal Trade Commission July 14 voted 3-0 to withdraw two antitrust policy statements related to enforcement in health care markets, calling the 1996 and 2021 statements outdated. The Department of Justice withdrew the same statements in February.  
    • “AHA is deeply disappointed that the FTC made the same mistake as the DOJ in withdrawing antitrust guidelines for hospitals and other health care providers,” said AHA General Counsel & Secretary Melinda Hatton. “Over the years, AHA has urged both federal antitrust agencies to modernize the guidelines to accommodate the need for more flexibility in enforcement actions to support hospitals’ ability to navigate a changing healthcare landscape. And AHA was instrumental in securing appropriate ACO guidance that allowed hospitals to fully participate in that important program. Withdrawing all the guidance without consultation with the field is both unnecessary and reckless.”
  • According to STAT News,
    • “Sanofi will license a new CRISPR enzyme from the startup Scribe Therapeutics in a bid to be the first to develop a safer, simpler, and more scalable cure for sickle cell disease.
    • “The French drugmaker will pay Scribe $40 million upfront and promise another $1.2 billion in potential milestones to license a DNA-cutting enzyme called CasX for use in a potential single-infusion treatment for the serious blood disorder — what’s known as in vivo therapy. CasX was discovered in CRISPR pioneer Jennifer Doudna’s lab, which subsequently spun out Scribe. * * *
    • “The company will have competition on tackling sickle cell in new ways. In 2021, Novartis started collaborating with the Gates Foundation to develop an in vivo therapy. The base editing company Beam Therapeutics has presented data on an approach that still requires cells to be edited outside the body but is much less toxic. And Sana Biotechnology has a program that hopes to target stem cells with virus-like particles. None of the companies, however, have yet begun clinical trials. 

In employment news,

  • HR Dive reports,
    • “The Occupational Safety and Health Administration published Friday its final electronic recordkeeping rule requiring employers with 100 or more employees in certain industries to submit information from the agency’s Forms 300 and 301 once per year.
    • “OSHA’s rule also updates its system for determining which industries are subject to the information submission requirement. In a departure from the proposed rule, OSHA has retained the requirement for employers with 250 or more employees to electronically submit information from Form 300A once per year. Additionally, employers with 20 to 249 employees in certain designated industries will continue to be required to electronically submit information from Form 300A once per year.
    • “Per the rule, the agency will post data gathered via these submissions on a public website, with identifying information — such as employees’ names and contact information — removed. The final rule is effective Jan. 1, 2024.”

Thursday Miscellany

David Ermer–Congress, COVID-19, COVID-19 vaccine, Generative AI, Medicare, Mental health care, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington DC —

  • The Food and Drug Administration announced
    • approve[ing] Opill (norgestrel) tablet for nonprescription use to prevent pregnancy— the first daily oral contraceptive approved for use in the U.S. without a prescription. Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online.
  • The New York Times adds,
    • The pill’s manufacturer, Perrigo Company, based in Dublin, said Opill would most likely become available from stores and online retailers in the United States in early 2024.
  • The OTC contraceptive will be available with no member cost sharing from FEHB plan network pharmacies due to the Affordable Care Act’s contraceptive mandate. Per the New York Times,
    • The company did not say how much the medication would cost — a key question that will help determine how many people will use the pill — but Frédérique Welgryn, Perrigo’s global vice president for women’s health, said in a statement that the company was committed to making the pill “accessible and affordable to women and people of all ages.”
  • The American Hospital Association informs us
    • “The Centers for Medicare & Medicaid Services July 13 issued a proposed rule that would increase Medicare hospital outpatient prospective payment system rates by a net 2.8% in calendar year 2024 compared to 2023. This includes a proposed 3.0% market basket update, offset by a 0.2% cut for productivity.”
  • and
    • “The Centers for Medicare & Medicaid Services July 13 released its calendar year 2024 proposed rule for the physician fee schedule. The rule proposes a decrease to the conversion factor by 3.34%, to $32.75 in calendar year 2024, as compared to $33.89 in CY 2023. This reflects the expiration of the 2.5% statutory payment increase for CY 2023; a 1.25% statutory payment increase for 2024; a 0.00% conversion factor update under the Medicare Access and CHIP Reauthorization Act; and a -2.17% budget-neutrality adjustment.  * * * 
      “CMS also proposes several provisions to advance access to behavioral health services. For example, it would create a new benefit category for marriage and family therapists and mental health counselors under Part B. In addition, CMS would establish new payment codes for mobile psychotherapy for crisis services.”\
  • The public comment deadline for both proposed rules is September 11, 2023.
  • STAT News reports
    • “A key Senate health care panel has developed a plan to tackle reforms to middlemen in the pharmacy drug payment system, according to bill text obtained by STAT.
    • “The draft legislation, authored by Senate Finance Chair Ron Wyden (D-Ore.) and ranking member Mike Crapo (R-Idaho), includes several measures to regulate how pharmacy benefit managers are paid by health plans to negotiate with drugmakers.
    • “The most significant measure is a bill from Sens. Bob Menendez (D-N.J.) and Marsha Blackburn (R-Tenn.) that would prohibit PBMs from getting any income outside of service fees, and prohibits those service fees from being related to drugs’ list prices.
    • “Other provisions include a bill from Sens. Catherine Cortez Masto (D-Nev.) and Thom Tillis (R-N.C.) to require PBMs to send annual reports to Medicare insurance plans about their rebate and price negotiations, a policy that would ban PBMs from charging Medicaid more than they pay for drugs (a practice called spread pricing), and a mandate for the Department of Health and Human Services to outline acceptable performance measures for pharmacies.”

From the public health front

  • The Wall Street Journal reports
    • Two different arms of the World Health Organization released separate findings on the widely used sweetener aspartame—one calling it safe and the other identifying it as a possible cancer hazard.
    • Here’s what you need to know:
    • Is it safe to drink Diet Coke?
      • Yes, in moderate amounts. Food regulators around the world agree that aspartame is safe. Aspartame has been studied for decades. The WHO reaffirmed its recommendation that people consume no more than 40 milligrams of aspartame a day for each kilogram they weigh—which would be a lot of soda.
      • With around 200 mg of aspartame per 12-ounce can of Diet Coke, that is roughly 16 cans a day for a 175-pound person. People get aspartame from some other food sources, though, and often the presence or amounts of aspartame in them aren’t disclosed. The WHO and other health experts also caution against consuming large amounts of sweetened products, including soda. They recommend drinking water instead.
      • “This is particularly important for young children” whose tastes are developing, said Dr. Francesco Branca, director of the WHO’s department of nutrition and food safety.
    • Obviously, the article continues on with other FAQs, but this is the one that caught the FEHBlog’s attention.
  • The U.S. Preventive Services Task Force finalized its research plan for chronic kidney disease screening.
  • STAT News tells us
    • “Amid ongoing controversy over the cost of medicines, a key Biden administration official told Covid-19 vaccine manufacturers that their next round of shots should be priced reasonably, a move that comes after two key suppliers were accused of price gouging.”
  • The CMS Administration informed insurers and others
    • “As we look toward efforts to provide updated COVID-19 vaccines this fall, we know you may have questions about the shift away from U.S. Government purchasing of vaccines to a more traditional commercial market. To be clear, that shift has not yet occurred, and the currently authorized and approved COVID-19 vaccines continue to be free and widely available nationwide. We also wanted to send these reminders from the Centers for Medicare & Medicaid Services (CMS) about COVID-19 vaccine coverage and encourage you to start planning now for the fall vaccination campaign.
    • “[M]ost private health insurance, like employer-sponsored plans, Marketplace plans, and other individual market coverage that is subject to the Affordable Care Act (ACA) market reforms are required to cover vaccines for COVID-19 authorized for emergency use or approved by the FDA and recommended by the ACIP and their administration, without patient cost-sharing.”
  • Fierce Healthcare relates
    • The Centers for Medicare & Medicaid Services (CMS) is recommending preexposure prophylaxis (PrEP) with oral or injectable antiretroviral therapy to people at risk of HIV without patient cost sharing. * * *
    • Currently, Medicare beneficiaries are only guaranteed access to daily oral PrEP through Part D, facing out-of-pocket costs, said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute. Injectable PrEP has not been covered traditionally.
  • Roll Call points out
    • “One year after the creation of the three-digit crisis hotline known as 988, officials say the next step is expanding awareness and local crisis care.
    • “More than 4 million people have called, texted or chatted the suicide prevention hotline in the year since its creation, according to Laurel Stine, executive vice president and chief policy officer for the American Foundation for Suicide Prevention.
    • “She estimates that number will grow in the next fiscal year to 9 million contacts.
    • “We have to be mindful that Rome was not built in a day,” she said. “We’ve had a fragmented mental health behavioral health crisis system for a number of years.”
  • Forbes reports on the “worsening” cancer drug shortage which it describes as a resolvable public health emergency.

From the generative AI front —

  • Healthcare Dive notes
    • Generative artificial intelligence could capitalize on the healthcare industry’s wealth of unstructured data, alleviating provider documentation burden and improving relationships between patients and their health plans, according to a new report by consulting firm McKinsey.
    • The report argues generative AI could help payers quickly pull benefits material for members or help call center workers aggregate information during conversations about claims denials. Providers could use AI to take conversations with patients and turn them into clinical notes, create discharge summaries or handle administrative questions from workers at health systems.
    • But healthcare leaders should start planning now if they want to use generative AI, as the risks can be high, the report said. Data fidelity and accuracy is key, so executives should begin assessing the quality of their AI tech stacks and considering potential problems like bias and privacy concerns, according to McKinsey.
  • Econtalk host Russ Roberts held an informative interview with Marc Andreessen about generative AI.

Midweek update

David Ermer–CMS, Congress, COVID-19, Rx coverage, SDOH, Telehealth, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

From Washington, DC —

  • Politico reports,
    • “The Senate Finance Committee is releasing the next in its parade of legislation targeted at pharmacy benefit managers — an industry that Democrats and Republicans on Capitol Hill argue drives up the cost of drugs.
    • “Sens. Catherine Cortez Masto (D-Nev.) and Thom Tillis (R-N.C.) — along with Chair Ron Wyden (D-Ore.) and ranking member Mike Crapo (R-Idaho) — plan to unveil legislation that would require PBMs, which manage prescription drugs for health insurers, to report a broader range of data about their business practices. The lawmakers seek comment on their proposal.
    • “The bill would require PBMs to submit annual reports to the Medicare drug plans that detail information about the treatments the plan covers, the discounts PBMs negotiate with drugmakers on medicines and the fees they collect.
    • “It’s the latest in a plan from Wyden and Crapo, who released a roadmap in April of PBM-focused legislation they want the committee to pursue.”
  • The Senate Finance Committee adds,
    • “Senate Finance Committee Chair Ron Wyden (D-Ore.) and Ranking Member Mike Crapo (R-Idaho) today announced that the committee will mark up legislative proposals to modernize and enhance federal prescription drug programs on Wednesday, July 26th at 2 p.m. The committee package will focus on addressing pharmacy benefit manager practices that have grown increasingly complex and opaque in recent years at the expense of patients and taxpayers.”
  • The American Hospital Association further informs us,
    • “The House Education & Workforce Committee July 12 voted 39-0 to pass legislation (H.R. 4509) that would require off-campus hospital outpatient departments to obtain a separate unique health identifier and include it on all claims for services billed to commercial group health plans or their enrollees. The legislation would prohibit the health plan from paying the claim and the hospital from collecting payment from the plan enrollee if the claim excludes the identifier, and impose civil monetary penalties on hospitals that violate the requirement. * * *
    • “In other action, the committee also passed bills that would strengthen price transparency requirements for commercial group health plans (H.R. 4507); require that the plans’ contracts with service providers allow the employer/plan fiduciary to access all de-identified claims and encounter data (H.R. 4527); and require the plans to further report to the employer/fiduciary their financial arrangements with pharmacy benefit managers (H.R. 4508).”

From the public health front —

  • Beckers Clinical Leadership and Infection Control tells us,
    • “After identifying a new COVID-19 omicron subvariant — EU.1.1, a descendant of XBB.1.5 — in late June, its growth has slowed, according to the CDC. 
    • “Right now, the subvariant accounts for only 1.1 percent of cases in the U.S., data shows. Nationwide, hospitalizations and deaths both continue to decline. The CDC’s most recent data shows that hospitalizations decreased by 0.8 percent as of July 1, and deaths decreased by 9.1 percent in the same one-week period.
  • CNN reports
    • Childhood cancer diagnoses in the US have been trending up for more than a decade, according to a study published Tuesday in the Journal of the National Cancer Institute.
    • There were 14,381 new childhood cancer diagnoses in the US in 2019: about 177 new cases for every 1 million children and teens up to age 19. Incidence rates have dropped since reaching a peak in 2016 but are still about 8% higher than they were in 2003, when there were about 165 new cases for every 1 million children and teens.
    • “Overall, cancer is very rare in children and adolescents, and the increases were small,” said Dr. David Siegel, a pediatric oncologist and an epidemiologist with the US Centers for Disease Control and Prevention’s cancer division who was the lead author of the study. “Past studies have also reported increased survival rates. So the combination of increases in incidence and decreases in deaths means that there are more and more cancer survivors that need long-term care and resources.”
  • The U.S. Census Bureau issued a report examining “Racial/Ethnic Disparities in Disability by Health Condition.”
    • “The data show patterns in health-related disability among adults age 40 and older and key differences by sex, race and Hispanic origin.
      • “Among findings:
      • “Women were more likely than men to have health conditions that limited their daily activities.
      • “Asian (non-Hispanic) adults reported the lowest rates (17.2%) of disability-related health conditions.
      • “Black (non-Hispanic) adults (31.8%) and those reporting Other or multiple-race non-Hispanic identity (42.9%) were among those with higher rates.
  • The All of Us Program released its July 2023 Medical Minutes.

From the Rx coverage front

  • Per Healthcare Dive,
    • Major pharmacy benefits manager CVS Caremark is partnering with drug discounter GoodRx on a joint program to bring down out-of-pocket drug costs, the companies announced Wednesday.
    • Commercially insured customers will be able to pay GoodRx’s discounted pricing when filling commonly prescribed generic prescriptions at in-network pharmacies. The payments will be automatically applied to their deductibles and out-of-pocket limits.
    • The program, called Caremark Cost Saver, will be available for tens of millions of CVS Caremark clients’ members at in-network pharmacies starting January 2024.
  • Per Beckers Payer Issues,
    • ‘About two-thirds of patients who take popular weight loss drugs end their regimen within a year, according to a Prime Therapeutics study released July 11.
    • ‘Prime, a pharmacy benefit manager owned by 19 Blue Cross Blue Shield companies, analyzed pharmacy and medical claims of 4,255 patients who took GLP-1 receptor agonists — such as Ozempic and Wegovy — for weight loss in 2021. The study found only 32 percent of patients continued their weight loss treatment after one year. 
    • “The majority of patients aren’t getting the value of the product and there’s waste, especially with an expensive therapy,” Patrick Gleason, PharmD, Prime’s assistant vice president for health outcomes and a co-author of the analysis, told Reuters. “I was a little bit surprised by the persistency rate.”
  • STAT News delves into how Medicare Advantage plans are approaching the FDA’s approval of the infused Alzheimer’s drug Leqembi. The most illuminating part of the article concerns the Mayo Clinic.
    • As a condition of coverage, Medicare rolled out a new patient registry to collect more information from physicians prescribing Leqembi. Information is supposed to be submitted every six months. Physicians who had previewed the registry said it appeared to function, though many clinics are still finalizing protocols for prescribing Leqembi.
    • “I’m not sure it’s sufficiently detailed to answer the [coverage with evidence development] questions that the [national coverage decision] put forth. We and others would need to collect more detailed information to understand the true benefits and risks of the medicine,” said Ronald Petersen, the director of the Mayo Clinic Alzheimer’s Disease Research Center.
    • Mayo Clinic isn’t prescribing Leqembi yet, as it’s planning to launch an Alzheimer’s treatment clinic in October, Petersen said. He said there has been interest from patients, but it “hasn’t been a landslide.”
    • Petersen is hoping to start a new research study at Mayo Clinic to do more detailed monitoring on patients. To start, Mayo physicians will likely only agree to treat patients in the geographic area close to the facility so they can oversee the follow-up appointments.
    • “We’d be more than happy to share our data with broader communities or merge it with data from CMS. It is incumbent upon all of us to share data to learn from each other what works,” Petersen said.

From the U.S. healthcare business front —

  • MedPage Today points out
    • “Private equity acquisitions of U.S. physician practices have risen dramatically over the last decade, driving up consumer prices in the process, according to a new report.
    • “In 2012, there were 75 private equity deals for physician practices across a range of specialties; in 2021, there were 484, marking a more than six-fold increase, Richard Scheffler, PhD, of the University of California Berkeley, and colleagues found.
    • “Over the entire period, the largest number of deals occurred in dermatology (376), ophthalmology (276), gastroenterology (120), and primary care (118), collectively accounting for 81% of the activity, Scheffler and colleagues wrote in the report, a joint effort by the American Antitrust Institute, the Nicholas C. Petris Center on Health Care Markets and Consumer Welfare at the University of California Berkeley, and the Washington Center for Equitable Growth.”

In telehealth news,

  • Fierce Healthcare tells us,
    • “While payers should cover telehealth, where these services are the most valuable still requires investigation, according to a study in Information Systems Research.
    • “The Centers for Medicare & Medicaid Services made the rules about telehealth usage more flexible during the COVID-19 pandemic, and some lawmakers want to make those changes permanent. But that should not mean giving providers carte blanche approval in using the new technology, nor should payers cover all uses of telehealth, suggests a study by researchers with the University of Texas.
    • “Telehealth should not be regarded as a one-size-fits-all solution to virtualize healthcare,” the study said.
    • “Despite that, however, the study also states that “insurance plans should expand their telehealth coverage to include more providers and close the healthcare access divide in rural locations, which can reduce subsequent hospitalizations and unnecessary costs.”
    • “The authors argue that telehealth’s benefits can be seen in treating conditions and diseases with “high virtualization potential” such as mental health, skin problems, metabolic conditions and musculoskeletal diseases. However, telehealth did not significantly reduce visits to specialists or emergency departments for circulatory, respiratory or infectious diseases.
    • “Indranil Bardhan, Ph.D., one of the authors of the study, said in a press release that “people believed that telehealth would be the next big thing, the future of healthcare. But our research shows that its impact is not as straightforward as people might think. It’s more nuanced.”

Thursday Miscellany

David Ermer–CDC, COVID-19, FDA, Federal employment benefits, Mental health care, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC —

  • The Wall Street Journal reports
  • STAT News adds
    • “Previous treatments for Alzheimer’s targeted the disease’s symptoms and not the underlying cause of worsening dementia. The debate among physicians is whether that 27% slowing seen with Leqembi is clinically meaningful enough to make the drug, which carries a list price of $26,500 per year, suitable for every patient who might want it.
    • “My general argument is that ‘clinically meaningful’ is personal and specific to a patient and their families, and it’s not something I or any provider can paternalistically determine,” said James Galvin, a neurologist who leads the Comprehensive Center for Brain Health at the University of Miami. “I can’t tell you what’s clinically meaningful to you.”
    • “Eisai’s trial enrolled patients with mild cognitive impairment or early-stage Alzheimer’s who also have evidence of amyloid buildup in the brain, confirmed by an imaging scan. The drug’s label reflects the same narrowed patient population, estimated to encompass approximately 1 million people in the U.S., or just under 20% of those currently living with Alzheimer’s.
    • “In the drug’s prescribing label, the FDA recommends doctors test for a genetic mutation, affecting about 15% of people with Alzheimer’s, that increases the risks of ARIA and reduces the efficacy of Leqembi. The agency also warns doctors to take “additional caution” when considering prescribing to people who are taking blood thinners, which could increase the risk of serious brain bleeds.”
  • Here is a link to the FDA’s press release.
  • In closing, the Wall Street Journal points out
    • Drugmakers and researchers are working on dozens of potential [Alzheimer’s Disease] drugs. Next up for approval is another amyloid-reducing antibody drug, called donanemab, from Eli Lilly. In a small, mid-stage trial, donanemab also modestly slowed the cognitive decline of study subjects compared with placebo.
    • “As of early 2022, there were 143 drugs in clinical trials for Alzheimer’s disease, including 31 drugs in Phase 3, typically the last stage of testing before a drug can be approved, according to a report in Alzheimer’s & Dementia: Translational Research and Clinical Interventions.”
  • Federal News Network reports on OPM’s diminishing yet still excessive backlog of federal retirement claims.
  • Govexec tells us
    • “The Office of Personnel Management last week reminded agencies of the array of workplace flexibilities at their disposal such as leave and telework to help federal workers who have been impacted by natural disasters.
    • “The memo, distributed by OPM Director Kiran Ahuja to heads of federal agencies, corresponds with the start of the annual hurricane season and comes shortly after Typhoon Mawar caused disruptions in Guam and the Northern Mariana Islands, both of which are under U.S. jurisdiction.”

From the public health front —

  • The Associated Press reports
    • “Drinking water from nearly half of U.S. faucets likely contains “forever chemicals” that may cause cancer and other health problems, according to a government study released Wednesday.
    • “The synthetic compounds known collectively as PFAS are contaminating drinking water to varying extents in large cities and small towns — and in private wells and public systems, the U.S. Geological Survey said.
    • “Researchers described the study as the first nationwide effort to test for PFAS in tap water from private sources in addition to regulated ones. It builds on previous scientific findings that the chemicals are widespread, showing up in consumer products as diverse as nonstick pans, food packaging and water-resistant clothing and making their way into water supplies. * * *
    • “The heaviest exposures were in cities and near potential sources of the compounds, particularly in the Eastern Seaboard; Great Lakes and Great Plains urban centers; and Central and Southern California. Many of the tests, mostly in rural areas, found no PFAS.
    • “Based on the data, researchers estimated that at least one form of PFAS could be found in about 45% of tap water samples nationwide.
    • “The study underscores that private well users should have their water tested for PFAS and consider installing filters, said Faber of the Environmental Working Group. Filters containing activated carbon or reverse osmosis membranes can remove the compounds.”
  • The Wall Street Journal informs us
    • A new longitudinal study has examined the medical records of all citizens of Denmark over the age of 16, some 6.5 million people in all, for patterns of diagnosis, hospitalization and treatment for substance use between 1995 and 2021. In the paper, published in the journal JAMA Psychiatry in May, Dr. Oskar Hougaard Jefsen of Aarhus University and colleagues showed that people who had previously been diagnosed with cannabis use disorder were almost twice as likely to be diagnosed later with clinical depression. According to the Centers for Disease Control and Prevention, cannabis use disorder is characterized by craving marijuana, using it more often than intended, spending a lot of time using it, and having it interfere with friends, family and work.
    • Even more dramatically, the paper also found that people with cannabis use disorder were up to four times as likely to be diagnosed later with bipolar disorder with psychotic symptoms. As is true of many psychological disorders, the increased risk was higher in men than in women, and the more a person consumed, the greater the risk. The study did not distinguish between different forms and concentrations of cannabis.
    • Though the association was strong, the authors note that they can’t say for certain whether chronic and heavy cannabis use induces psychosis, or whether people prone to mental illness are more likely to be heavy users. It makes sense that people who feel the symptoms of incapacitating depression or mania, or who sense apparitions or voices only they can hear, might try to self-medicate with cannabis. Without a randomized controlled trial, which would be unethical in the extreme, it’s hard to untangle these strands definitively.
    • But the study is still eye-opening due to its sheer magnitude. With so many people over so many years, there is very little statistical “noise.” And because the information was gathered from the national Danish Health Registry, there were few dropouts—often a big problem in longitudinal studies. As much as possible, the researchers confirmed that the symptoms of a person’s psychiatric disorder emerged after their chronic cannabis use and diagnosis, not before, and that they compared people who were alike in all ways except the frequency of their use.
  • Beckers Hospital Review notes that “In an effort to prevent a repeat of last winter’s “tripledemic” of respiratory illnesses, public health officials are encouraging Americans to get not only a flu shot but also a COVID-19 vaccine and a new vaccine against the respiratory syncytial virus, The New York Times reported July 5.” The FEHBlog thinks that immunity created by the tripledemic will tamp down the viruses this year. Nevertheless, the FEHB plans to get all three vaccines.

From the telehealth and artificial intelligence fronts, we learn from

  • Healthcare Dive that
    • “Nearly one-third of American adults and 40% of adults under 34 report that they would be comfortable with an artificial intelligence-led primary care appointment, according to a new survey released by Outbreaks Near Me and SurveyMonkey.
    • “But the option isn’t their preference. Although survey respondents reported believing that AI in healthcare could reduce medical bias and improve diagnostic accuracy, over 80% of respondents would prefer seeing a human medical professional for prescribing pain medications, deciding when to go to the emergency room and other services.
    • “The latest survey suggests that, while AI hype may be on the upswing, entrenched patient attitudes and preferences for care could be slow to shift.”
  • and
    • “Mental healthcare led telehealth utilization for the sixth straight month in April, representing 68.4% of telehealth claim lines among privately insured patients, according to Fair Health’s April telehealth report.
    • “Although nationwide demand for telehealth services dipped by 5.4% from March to April this year, the percentage of telehealth claims related to mental health services grew for the fourth consecutive month.
  • and
    • “Telehealth patients across most medical specialties are less likely to attend follow-up appointments 90 days after a visit compared to in-person appointments, according to new research from Epic.
    • “The analysis of follow-up visits comes after a December report from Epic found most telehealth patients did not require a follow-up appointment in the three months after an initial visit. Mental health, physical medicine, and rehabilitation and pain medicine had the highest in-person follow-up rates compared to telehealth visits, according to the latest research.
    • “The[se] new telehealth stud[ies] come as federal lawmakers debate whether to make pandemic-era virtual care flexibilities permanent before they expire in 2024.”

From the U.S. healthcare business front

  • Beckers Payer Issues relates
    • “Eli Lilly is now the largest healthcare company in the world by market value, surpassing UnitedHealth Group, Bloomberg reported July 5. 
    • “The pharmaceutical company’s market capitalization surpassed UnitedHealth Group’s July 5 — the first time Eli Lilly has closed above UnitedHealth Group since 2013, according to Bloomberg. 
    • “Eli Lilly’s success is driven by Monjauro, its drug approved for diabetes treatment and expected to receive FDA approval for weight loss, analysts told Bloomberg. The drug is expected to net between $25 and $48 billion in sales once approved.”
  • STAT News tips its cap to Lilly’s leadership David Ricks, 55, Lilly’s CEO, and Daniel Skovronsky, 50, its chief scientific officer.
  • The American Hospital Association offers its two cents on the recent Wall Street Journal article about the state of hospital finances.
  • Fierce Healthcare tells us
    • “Baylor Scott & White Health (BSW) is adding dozens of Texas urgent care clinics to its network thanks to a newly announced deal with NextCare Urgent Care.
    • “Forty-one facilities in “fast-growing areas” such as Houston, San Antonio and Abilene will give the state’s largest nonprofit health system a foothold in new markets. The deal also catapults BSW to a new role as one of Texas’ major providers of urgent care services.
    • “We are dedicated to providing customers with as much choice as possible when seeking care,” Pete McCanna, CEO of BSW, said in a Thursday release from the system. “Through this venture, the NextCare sites across the state will be integrated into our ecosystem of offerings, which already includes 24/7 virtual care available to all Texans via MyBSWHealth.com.”
  • and
    • “Hospital outpatient departments are marking up the prices for biologic medicines more than physician offices, particularly for “innovator biologics” that have clinically equivalent and lower cost alternatives on the market, according to a new analysis from the Employee Benefit Research Institute (EBRI).
    • “These higher charges for these products among hospital outpatient departments (HOPDs) are “roughly doubling costs for employers and minimizing savings that could be achieved through biosimilar competition,” the independent research group found in its review of a proprietary commercial claims database of 25 million people with private health insurance.
    • “While HOPDs tend to charge higher prices for all medicines relative to the [physician office], higher HOPD markups on biologic medicines are roughly doubling costs for employers and minimizing savings that could be achieved through biosimilar competition,” Paul Fronstin, director of health benefits research at EBRI, and M. Christopher Roebuck, CEO of health policy research firm RxEconomics, wrote in the brief.”

 

Midweek Update

David Ermer–CDC, CMS, Congress, COVID-19, Employee Wellness Programs, FDA, Federal employment benefits, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–

The FEHBlog hopes his readers enjoyed their Fourth of July weekend. The FEHBlog certainly did.

From Washington, DC —

  • FedWeek informs us
    • “The House version of the annual defense authorization bill would require DoD and OPM to conduct a “comprehensive review of the civilian workforce on FEHB to ensure that all family members and dependents who are currently receiving benefits are in fact eligible.”
    • “The language, inserted as an amendment to a bill that could come to floor voting in the upcoming weeks, would be the most concrete response to date regarding an issue that has been the subject of repeated warnings from OPM’s inspector general’s office and most recently from the GAO: ineligible persons being covered in the program as family members.”
  • FEHBlog note — The largest internal control problem with FEHB eligibility stems from the fact that OPM does not take advantage of the HIPAA 820 electronic enrollment roster, which allows health plan carriers to reconcile premium to headcount. For example, if the carrier finds via the HIPAA 820 that it is not receiving premiums on a self and family enrollee, then the outcome may be disenrolling the individual and their covered family members in a fair way. In the FEHBlog’s view, it does not make sense to move forward with a family member eligibility audit until the HIPAA 820 transaction is operational in FEHB. That is the most logical first step.
  • Federal News Network provides us with background on OPM’s new employee assistance program guidance. In the FEHBlog’s opinion, OPM should team up EAPs with FEHB plans in order to better coordinate their respective coverages.
  • Fedweek also explains for the benefit of federal and postal employees how to continue FEGLI coverage into retirement.
  • Healthcare Dive relates
    • “The CMS is proposing to cut Medicare reimbursements to home health agencies by 2.2% next year, or $375 million less than providers received in 2023, according to draft regulation released Friday. 
    • “The agency said the proposed rule includes a 2.7% payment bump that’s offset by a 5.1% cut related to the Patient-Driven Groupings Model, which aimed to better sort patients into different payment categories by clinical need and other factors.
    • “The reimbursement changes also reflect an estimated 0.2% increase due to an updated fixed-dollar loss ratio, according to regulators.”

From the public health front —

  • CBS News reports
    • “Nearly 1 in 4 U.S. adults and older teens had still not caught COVID-19 by the end of last year, according to new estimates from the Centers for Disease Control and Prevention, while 77.5% had antibodies from at least one prior infection. The figures are based on the final batch of results from the agency’s nationwide studies of antibodies in Americans ages 16 and up. * * *
    • “Virtually every American ages 16 and older — 96.7% — had antibodies either from getting vaccinated, surviving the virus or some combination of the two by December, the CDC now estimates. The study found 77.5% had at least some of their immunity from a prior infection. * * *
    • Rates were similar among men and women. Black and White people also have similar prior infection rates, between 75% and 80%. 
    • Among other racial and ethnic groups, Asian Americans had the smallest proportion of people with antibodies from a prior infection, at 66.1%, while Hispanic people had the highest, at 80.6%.

From the Rx and medical devices coverage front —

  • BioPharma Dive points out
    • “Moderna on Wednesday said it’s submitted applications to regulatory agencies around the world in a bid to win approval of a new vaccine to fight respiratory syncytial virus, or RSV, in older adults.
    • “The company filed with regulatory agencies in Europe, Switzerland and Australia and began a rolling submission to the U.S. Food and Drug Administration for the vaccine, which is currently known as mRNA-1345. Future applications are planned for other nations as well.
    • “Moderna’s submissions come two months after the FDA approved the first RSV vaccine, developed by GSK. The agency cleared a second RSV shot from Pfizer weeks later. Both products are approved for use in patients who are at least 60 years old, the same group Moderna aims to treat.”
  • Forbes reports
    • “On Wednesday, medtech giant Abbott announced that its new leadless pacemaker system, Aveir DR, has been approved by the FDA. This is the first time the FDA has given a thumbs up to a device of this type for two different chambers of the heart, which opens up this technology to nearly any patient who needs a pacemaker.
    • “From a clinical perspective, we know that leadless pacing offers a number of important advantages to patients in terms of getting away from the complications related to traditional pacemakers,” says Leonard Ganz, a cardiologist and Abbot’s chief medical officer for cardiac rhythm management. “This will expand the number of patients who can benefit from leadless pacing many, manyfold,” he tells Forbes.” * * *
    • “Although pacemakers have been life-changing for millions of people, they do carry downsides, explains Ganz, in particular, risk of infection both from the surgical procedure needed to implant them as well as the leads themselves should their insulation become compromised. Leadless pacemakers, by contrast, are much smaller, don’t require surgical implantation and have no wires connected to the heart. Instead, they are injected using a catheter in a vein and placed directly in the heart in a way that allows for removal if need be. All of these factors significantly reduce the risk of complications.
    • “The first leadless pacemaker, manufactured by Medtronic, was cleared by the FDA in 2016. Abbott’s first leadless pacemaker, the Aveir VR, was approved by the FDA in March 2022. [In contrast to the new Abbott device, b]oth of these products only work in a single chamber of the heart. About 80% of the patients that require a pacemaker need shocks in two cardiac chambers in order to keep the desired heart rhythm.”
  • The New York Times discusses “food noise,” which the new weight loss drugs dissipate.
    • “The active ingredient in Ozempic and Wegovy is semaglutide, a compound that affects the areas in the brain that regulate appetite, Dr. Gabbay said; it also prompts the stomach to empty more slowly, making people taking the medication feel fuller faster and for longer. That satiation itself could blunt food noise, he said.
    • “There’s another theoretical framework for why Ozempic might quash food noise: Semaglutide activates receptors for a hormone called GLP-1. Studies in animals have shown those receptors are found in cells in regions of the brain that are particularly important for motivation and reward, pointing to one potential way semaglutide could influence cravings and desires. It’s possible, although not proven, that the same happens in humans, Dr. Hwang said, which could explain why people taking the medication sometimes report that the food (and, in some cases, alcohol) they used to crave no longer gives them joy.”

From the U.S. healthcare business front

  • Segal Consulting delves into health plan prior authorization practices.
  • The Wall Street Journal reports that “Some hospitals that spent big on nurses during the pandemic are now short on cash; Distressed institutions are closing unprofitable services, selling assets to avoid default on debts.” Ruh-roh!
  • Forbes reports
    • “Rite Aid reported a quarterly loss of more than $306 million as the drugstore chain grapples with the loss of customers from its Elixir pharmacy benefits business as executives work to turn around the struggling drugstore chain.
    • “Rite Aid, which has closed more than 140 unprofitable stores in the last two years, reported a fiscal first-quarter loss of $306.7 million, or $5.56 per share, for the period ended June 3, 2023. That compares with a loss of $110.2 million, or $2.03 per share, in last year’s first quarter.”

From the fraud, waste, and abuse front, HealthTech explains how the Justice Department is using advanced analytics to combat healthcare fraud.

From the medical research front, the National Institutes of Health announced that “The first clinical trial of a three-month TB treatment regimen is closing enrollment because of a high rate of unfavorable outcomes with the investigational course of treatment.” The FEHBlog appreciates NIH’s transparency.

Monday Roundup

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

From Washington DC —

Photo by Sven Read on Unsplash
  • Federal News Network reports,
    • “The House and Senate armed services committees each finished their work on their versions of next year’s defense authorization bill within a day of one another, with both key committees approving overall funding levels that closely match the Biden administration’s 2024 funding request of $842 billion in discretionary DoD spending.
    • “The Senate Armed Service Committee’s bill, approved behind closed doors on Friday, would authorize $844 billion next year, while the House version, debated in a public session a day earlier, would match the administration’s request.
    • “Another area of commonality: both committees endorsed the administration’s proposed pay increase for military service members, making it highly likely that they’ll receive a 2024 increase of 5.2%, the largest military pay raise since 2002.
    • “For now, the measures do not include language that would grant the administration’s request for the same pay raise for federal civilian workers. A provision to achieve that could still be added when the bills reach the House and Senate floors; however, a large faction of House Republicans is pushing an alternative plan that would make all civil servants’ pay increases “merit-based.”
  • The Centers for Medicare and Medicaid Services issued,
    • “a proposed rule that proposes to update payment rates and policies and includes requests for information under the end-stage renal disease (ESRD) Prospective Payment System (PPS) for renal dialysis services furnished to Medicare beneficiaries on or after January 1, 2024. This rule also proposes an update to the Acute Kidney Injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities for calendar year (CY) 2024. In addition, the rule proposes to update requirements for the ESRD Quality Incentive Program (QIP).
    • “For CY 2024, CMS is proposing to increase the ESRD PPS base rate to $269.99, increasing total payments to ESRD facilities by approximately 1.6 percent. The CY 2024 ESRD PPS proposed rule also includes several proposals and requests for information related to ESRD PPS payment policies.
  • The National Institutes of Health announced,
    • “The Biden-Harris Administration awarded $50 million to launch the Persistent Poverty Initiative, an initiative to alleviate the cumulative effects of persistent poverty on cancer outcomes by building research capacity, fostering cancer prevention research, and promoting the implementation of community-based programs. The Persistent Poverty Initiative is the first major program to address the structural and institutional factors of persistent poverty in the context of cancer. It is coordinated by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). These awards create five new Centers for Cancer Control Research in Persistent Poverty Areas that will advance key priorities of the Administration’s Cancer Moonshot — to reduce inequities in the structural drivers of cancer and prevent more cancers before they start by reducing tobacco use and making sure everyone has access to healthy food.”
  • FedScoop informs us,
    • “Most federal government employees will receive between four and eight additional hours of leave time in 2023, the U.S. Office of Personnel Management said.
    • “The 2023 leave year ending Jan. 13, 2024, will have 27 pay periods, OPM said in a memo sent on Monday to human resource directors of U.S. government agencies. That means most federal employees will receive an additional pay period’s worth of leave in 2023, which could be four, six, or eight hours depending on their accrual rate, according to the memo.
    • “The change doesn’t apply to agencies whose first pay period was Jan. 8, 2023, as they will have 26 pay periods, the memo said. 
    • “While most federal workers will get more leave time, the maximum carryover amount for annual leave – 240 hours for most employees and 360 hours for overseas employees – won’t change, OPM said. It encouraged agencies to remind affected workers to use any time over that limit before the end of the leave year so they don’t lose it.”

From the public health front —

  • CBS News tells us,
    • The Centers for Disease Control and Prevention is now separately tracking several new COVID-19 variants, the agency announced Friday, adding more Omicron descendants to an increasingly complex list of new strains that are competing nationwide. 
    • Among the new variants now being tracked by the CDC is EU.1.1, a strain first designated by scientists earlier this year over its rapid ascent in some European countries. 
    • The variant is a more distant descendant of the XBB.1.5 variant that had surged earlier this year, with a handful of more mutations to its spike protein that may be driving its spread. 
    • The CDC estimates that EU.1.1 is now 1.7% of U.S. cases nationwide but may have already reached as much as 8.7% of cases in the region spanning Colorado, Montana, North Dakota, South Dakota, Utah and Wyoming.
    • It is too early to know whether EU.1.1 will lead to new or different symptoms in the U.S.
  • FEHBlog note — Reassuringly, the variants remain descendants of the late, great Omicron.
  • Helio informs us,
    • “Prenatal lifestyle interventions delivered by an allied health professional, with individual delivery formats and a moderate number of sessions, decreased gestational weight gain., according to data published in JAMA Network Open.
    • “In addition, researchers observed associations with reduced gestational weight gain among physical activity and mixed behavioral interventions. 
    • “These findings suggest that future pragmatic research should focus on testing and evaluating components to inform implementation in varied antenatal care settings, including those with limited resources, to optimize population benefits for pregnant individuals and the next generation,” the researchers wrote.”

From the obesity drug front —

  • STAT News reports,
    • “Almost half of Americans would be willing to spend up to $100 a month for new weight loss medicines such as Wegovy, and one-third say they would indefinitely pay whatever they can afford to get the drugs, according to a new survey by STAT and The Harris Poll.
    • “Although 47% say they would only spend the money up to a point — such as losing a certain amount of weight, or up until a special event — demand is so great that nearly one-quarter said they would pay up to $250 each month. And another 17% percent are willing to shell out as much as $500 each month. The survey, which polled 2,046 U.S. adults, was conducted earlier this month.”
  • and
    • An experimental pill from Eli Lilly led to 14.7% weight loss on the highest dose in a 36-week trial, heating up the growing competition among drugmakers to develop an effective oral obesity therapy.
    • The mid-stage results for orforglipron match the estimates of 14-15% weight loss that Lilly gave in an investor call late last year. The full results, published Friday in the New England Journal of Medicine, were presented here to a packed conference room at the American Diabetes Association conference.
    • Nonetheless, an overwhelming majority — 84% — believe insurance companies should cover the injectable medicines, which carry list prices ranging from $900 to $1,300 a month.
  • Meanwhile, Healthcare Dive relates,
    • “Pfizer is scrapping of one of two experimental weight-loss pills it’s been developing after spotting signs of potential safety concerns in clinical testing.  
    • “The company on Monday said the decision to stop testing of the pill, lotiglipron, was made after receiving the results from drug-drug interaction studies and observing liver enzyme elevations in early- and mid-stage tests. Patients with liver enzyme spikes, which can be signs of organ damage, didn’t have side effects or require treatment, Pfizer said.  
    • “Pfizer will now focus on its other, similar weight-loss prospect, danuglipron, which so far hasn’t had such concerns. Danuglipron is currently in Phase 2 testing in Type 2 diabetes and obesity, and could move into late-stage development by the end of the year.”  

In other Rx and medical device news

  • Biopharma Dive identifies five Food and Drug Administration (FDA) decisions to watch for in this third quarter of 2023.
  • Beckers Hospital Review points out
    • The FDA has given a fast-track designation to a drug designed to prevent infection from both influenza A and B strains created by San Diego-based Cidara Therapeutics, according to a June 22 news release.
    • The novel drug, CD388, is being developed alongside Janssen Pharmaceuticals primarily for flu prevention in adults who are high risk as well as for individuals for whom flu vaccines “are either ineffective or contraindicated,” the release states. 
    • The FDA’s decision could prove to be timely as early data from the flu season that is currently underway in the Southern Hemisphere is showing that both influenza A and B are both circulating.
  • MedTech Dive notes
    • “Dexcom next year will introduce a continuous glucose monitor aimed at the 25 million non-insulin-using Americans with Type 2 diabetes.
    • “The CGM, which is based on the Dexcom G7, will last for 15 days, include a cash-pay option and come with software designed for the needs of people who are yet to require insulin.
    • “Dexcom’s analysis shows those patients want help understanding the effect of lifestyle on blood glucose and staying off insulin, leading the company to develop a revised set of features for the new device.” 

From the U.S. healthcare business front

  • The Wall Street Journal reports
    • “UnitedHealth Group will acquire Amedisys for $101 a share, or nearly $3.29 billion, upending a prior deal for the home-health provider to combine with Option Care Health
    • “Amedisys said Monday that it has agreed to a takeover by UnitedHealth’s Optum health-services arm in which each Amedisys share will be converted into the right to $101 in cash. 
    • “Amedisys will become a wholly owned subsidiary of UnitedHealth when the transaction is completed. UnitedHealth’s UnitedHealthcare is the biggest U.S. health insurer. Its Optum business includes a sprawling network of physician groups, surgery centers and other assets.” * * *
    • “The companies didn’t provide an expected closing date on the acquisition, which still needs to be approved by regulators and Amedisys shareholders. 
    • “The combination is likely to draw close antitrust scrutiny from the Federal Trade Commission. Optum will be seeking to take over the No. 2 competitor in the home-health business after recently absorbing the No. 3 company, according to analysts. * * *
    • “When it announced its offer for Amedisys, UnitedHealth said it was confident it could secure approval for the combination, partly because of how fragmented the home-health business is.”
  • Health Payer Intelligence points out
    • “What will happen to the volume and value of mergers and acquisitions in 2023? This is a question at the forefront of payers’ minds as the healthcare industry emerges from the uncertainties of the coronavirus pandemic.
    • “The twelve months ending on May 15, 2023, witnessed strong merger and acquisition volume despite various challenges, according to a report from PwC. At the end of the report’s timeframe, the volume of deals was nearly twice as high as the period of 2018 to 2020.
    • “Still, health services deals dipped slightly, dropping by four percent from 2022. Volume dropped from 1,738 in 2022 to 1,661 as of May 15, 2023.
    • “Deal values declined significantly by 15 percent. In 2022, deal value amounted to $100 billion. In the study’s timeframe, deal value totaled $85 billion. Megadeal values, specifically, have been more than halved in the last two years since 2021, a trend which might continue due to rate hikes.”

Weekend update

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

The FEHBlog is back in DC this week.

And speaking of Washington, DC —

  • The U.S. Supreme Court has ten decisions to issue from its October 2022 term. Last week, the Supreme Court issued seven decisions. Its next decision day is Tuesday, June 27.
  • Last Friday, the President issued an Executive Order on Strengthening Access to Affordable, High Quality Contraception and Family Planning Services.
    • “Sec. 2.  Improving Access and Affordability Under the Affordable Care Act.  (a)  The Secretaries of the Treasury, Labor, and Health and Human Services (Secretaries) shall consider issuing guidance, consistent with applicable law, to further improve Americans’ ability to access contraception, without out-of-pocket expenses, under the Affordable Care Act.  In doing so, the Secretaries shall consider actions that would, to the greatest extent permitted by law:
    •           “(i)   ensure coverage of comprehensive contraceptive care, including all contraceptives approved, granted, or cleared by the Food and Drug Administration, without cost sharing for enrollees, participants, and beneficiaries; and
    •           “(ii)  streamline the process for patients and healthcare providers to request coverage, without cost sharing, of medically necessary contraception.
    •      “(b)  The Secretaries shall consider additional actions, as appropriate and consistent with applicable law, to promote increased access to affordable over-the-counter contraception, including emergency contraception.”
  • From the public health / medical research front –
  • Bloomberg Prognosis offers guidance on Covid boosters.
    • In April, a CDC advisory committee on immunization practices showed just how rapidly we can lose the protections vaccines offer, Wallace points out. A review of data from 20 states revealed the bivalent booster’s effectiveness in those 65 and older fell to 65% in the first two months. That dropped to 45% in four months and plummeted to 22% in six months.
    • Those numbers are part of the reason higher-risk people are offered second doses of the bivalent shot.
    • “If people are in these groups, I would not hesitate to take advantage of this additional protection, as well as considering taking other prevention strategies, like masking in indoor public spaces,” says Wallace.
    • If you’re unsure, a healthcare provider can explain which dosing strategy is right for you. 
  • Medscape informs us
    • Can common anti-depressants prevent COVID-19 infection? That’s the suggestion of research in BMC Medicine, based on infection trends among more than 5,600 mental health care patients in the United Kingdom from April to December 2020.
    • The report says that selective serotonin reuptake inhibitors (SSRIs) were particularly effective in blocking COVID-19 transmission.
    • “Mental health patients with a recent (previous 90 days) prescription for an SSRI had an almost 40% reduction in the likelihood of a positive COVID-19 test,” wrote the Center for Infectious Disease Research & Policy (CIDRAP) at the University of Minnesota.
    • Research showed that 27.7% of COVID-19-negative patients had taken at least one antidepressant medication within the last 90 days before they were admitted to a mental health care facility, compared to just over 16% of COVID-19 positive patients.  * * *
    • “The results of this study hint at the potential clinical benefit” of SSRIs on COVID-19 infection, said the lead author, Oleg Glebov of King’s College London, in a press release.
  • The Raleigh News Observer reports
    • “Until recently, if a heart stopped beating, it couldn’t be donated. Donor hearts typically come from patients determined to be brain dead, from which doctors can extract the beating organ and transplant it into its new owner. But a new study from Duke researchers found that using a heart that has been “reanimated” by a machine works just as well as traditional transplants. This method could expand the pool of heart donors by 30%, said Dr. Adam DeVore, a Duke researcher and author on the paper. DeVore said this method allows doctors to salvage hearts from a group of patients who previously had been unable to donate.
    • “Duke’s own heart transplant clinic has greatly benefited by drawing from this new pool of donors. DeVore said the program has doubled in size in the last year, which he credits in part to the new method.”
  • Emergency room physician Edwin Leap writes in his blog that heart attacks are on the rise in younger people.
    • “While I certainly try not to inflame anyone’s fears, I write this to say that people should be attentive to their symptoms. Even a person who is relatively young should be cautious if they have chest pain, difficulty breathing, profound weakness or dizziness/passing out. Of course, associated symptoms can include nausea, unexpected sweating (or diaphoresis), numbness or tingling in arms or face, or pain into jaw, neck or back. Of course, symptoms in women can be more subtle can can simply involve profound fatigue.
    • “What may be equally important is the idea that we should be take good care of ourselves. In the face of an increased level of risk for heart disease, it’s a good time to lose weight, exercise, stop smoking and eat a healthy diet. I would also suggest that everyone take their existing prescriptions, try hard to control their blood glucose in diabetes, manage their blood pressure and all the rest. We can’t control all of our health risks, but the ones which we can, we certainly should.
    • “Furthermore, even young people should find a primary care physician if possible, and establish a relationship with that physician. The screening exams that they perform, the regular exams, the attention to your health that they provide can truly be lifesaving.”
  • In the FEHBlog’s view, health plans should help all of their members connect with a primary care physician. Leverage that network.

From the Rx coverage front —

  • The Wall Street Journal confirms‘ that Novo Nordisk is preparing to request Food and Drug Administration approval for a Wegovy weight loss pill.
    • “Later this year, Novo Nordisk plans to ask U.S. and European drug regulators to approve the tablet.  Novo already sells a tablet form of semaglutide, Rybelsus, to treat Type 2 diabetes, though some people use it off-label for weight loss.
    • “Novo Nordisk’s Ozempic and Wegovy therapies and Lilly’s Mounjaro have emerged as viral sensations—touted by celebrities and discussed on Facebook and TikTok—because of their potential to help people lose significant weight.
    • “These types of drugs, first approved to treat diabetes, work by mimicking gut hormones that play a role in regulating blood sugar and, it has turned out, appetite. A key gut hormone is called glucagon-like peptide-1, or GLP-1. * * *
    • “BMO Capital Markets analyst Evan David Seigerman estimated that pill forms of weight-loss drugs could make up about 15% of the total market, which he predicts will reach $100 billion in annual sales worldwide in coming years.”

From the wellness front —

  • Fortune Well interviews longevity expert Dr. Peter Attia.
    • While Dr. Peter Attia, author of New York Times bestseller Outlive: The Science and Art of Longevity, said there’s no “silver bullet” to increase one’s health span and life span, there are still a variety of longevity-linked habits that may work for you to stave off age-related disease and early mortality. 
    • “People have so much more agency over this than they will ever believe if they don’t take the step to educate themselves on it,” Attia tells Oprah Winfrey this week for a series called The Life You Want on Oprah Daily. “A lot of people think, ‘Well, this is my lot in life’…It’s not the case at all.”
    • Exercise, nutrition, sleep, and managing emotional health by engaging with others and trying new hobbies are all associated with a longer, healthier life. 
    • For Attia, moving without distraction and staying outside is his secret sauce. 
  • and
    • offers guidance on the best timing for dinner from a health standpoint.
  • The Wall Street Journal discusses the health importance of controlling salt intake.

Friday Factoids

David Ermer–CDC, COVID-19, COVID-19 vaccine, Rx coverage, SCOTUS, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC —

  • MedPage Today reports
    • “On Friday, President Biden announced his intent to choose former top North Carolina health official Mandy Cohen, MD, MPH, to lead the CDC.
    • “Dr. Cohen is one of the nation’s top physicians and health leaders with experience leading large and complex organization and a proven track record protecting Americans’ health and safety,” Biden said in a statement.” * * *
    • “Cohen earned her bachelor’s degree at Cornell University in Ithaca, New York, her medical degree from the Yale School of Medicine in New Haven, Connecticut, and her master’s in public health from the Harvard Public School of Health in Boston. She completed her residency at Massachusetts General Hospital.”
  • STAT News suggests that Dr. Cohen’s political experience will benefit the CDC. Dr. Cohen’s nomination does not require Senate confirmation. Senate confirmation of CDC Directors will become a prerequisite in 2025.
  • Per Reuters,
    • “The U.S. Supreme Court on Friday preserved the Justice Department’s power to unilaterally dismiss lawsuits filed under a law that lets whistleblowers sue businesses on behalf of the government to recover taxpayer money paid to companies based on false claims in exchange for a portion of any recovery.”
    • In the FEHBlog’s opinion, this is a logical and welcome outcome as the federal government should have control over litigation brought on its behalf.
  • Per the FDA’s website,
    • “Today, the FDA posted information on its website regarding the formula for COVID-19 vaccines for the 2023-2024 fall and winter seasons. The FDA has advised manufacturers seeking to update their COVID-19 vaccines that they should develop vaccines with a monovalent XBB.1.5 composition. This recommendation incorporates advisory committee input and is based on the totality of the available evidence to select the vaccine composition that the FDA anticipates will best protect public health. The agency anticipates the timely submission of the data and filings to support FDA action on updated COVID-19 vaccines in order to make vaccines available this fall that meet our standards for safety, effectiveness and quality. 
    • “On Thursday, the FDA granted accelerated approval to glofitamab-gxbm (Columvi, Genentech, Inc.) for relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after two or more lines of systemic therapy. The prescribing information includes a Boxed Warning for serious or fatal cytokine release syndrome (CRS). Other warnings and precautions include neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity (ICANS), serious infections, and tumor flare. Glofitamab-gxbm should only be administered by a healthcare professional with appropriate medical support to manage severe reactions, including CRS. View full prescribing information for Columvi.”

From the miscellany department —

  • Healthcare Dive reports
    • A second major health insurer is warning investors about higher-than-anticipated outpatient care utilization that could hike medical costs, potentially cutting into profits. [UnitedHealthCare was the first.]
    • Humana filed an 8-K with the U.S. Securities and Exchange Commission on Friday morning saying elevated outpatient trends are expected to push its medical loss ratio, a marker of how much payers spend on patient care, toward the high end of its outlook for both the second quarter and the full year.
  • NPR tells us
    • Pfizer is facing a shortage of penicillin due to increased demand and more diagnoses of syphilis, the company said in a letter to its customers this week. 
    • The company said there is an “impending stock out situation” for select Bicillin L-A and Bicillin C-R prefilled syringes, Pfizer’s brand name of injectable penicillin. 
    • Prefilled Bicillin L-A pediatric syringes are expected to begin running low by the end of June, while all Bicillin C-R syringes could begin diminishing in the third quarter of this year. 
    • Inventory is predicted to start recovering in the second and third quarters of 2024, Pfizer said. 
    • Penicillin is an antibiotic used to treat various types of infections, including sexually transmitted diseases, such as syphilis and pneumonia.
  • Medscape points out
    • The American Medical Association (AMA) on Wednesday said it will advise doctors to pay less attention to body mass index (BMI) in determining if a patient is at a healthy weight, saying the measure does not predict disease risk equally well across racial and ethnic groups.
    • BMI, a ratio of weight to height, has long been used to define underweight, “normal” weight, overweight, obesity and morbid obesity, despite mounting evidence that it is an inaccurate predictor of health risks on an individual level.
    • At the influential physician group’s annual meeting in Chicago, members voted adopt a new policy that says BMI should be just one factor in determining whether a patient is at a healthy weight. Other measures such as body composition, belly fat, waist circumference, and genetic factors are also important, the AMA said. * * *
    • The AMA’s new policy also says BMI should not be used as a sole criterion for denying insurance reimbursement.
  • MedPage Today interviews the new AMA President-elect, Dr. Bruce Scott.