Monday Roundup

David Ermer

I am an attorney who practices law in Washington DC. My practice has involved the Federal Employees Health Benefits Program since 1983.

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.”

Weekend update

David Ermer–Congress, Medical / Rx research, U.S. Healthcare–

From Washington, DC,

  • Both Houses of Congress will be in session this week for floor voting and Committee business. Both Houses go on month-long State / District work breaks next week.
  • HR Dive reports
    • “The U.S. Senate on Thursday confirmed the nomination of Democrat Kalpana Kotagal to the U.S. Equal Employment Opportunity Commission. Her nomination as commissioner gives the workplace rights enforcement agency a Democratic majority. 
    • “The Senate voted 49-47 in favor of the Ohio native Thursday [July 13], after invoking cloture Wednesday. Kotagal will serve as the fifth commissioner of the agency with a term expiring July 1, 2027.” 

From the public health front,

  • Fierce Healthcare discusses an interesting United Healthcare population health program called Catalyst which operates in 28 states.
  • NPR Shots advises avoiding heat stroke and staying healthy when it’s hot outside.

From the medical research front,

  • The Wall Street Journal offers an essay about research underway to “get rid of menopause.”
    • “Imagine if women never reached menopause, that dreaded middle-age milestone—or could delay it, or decide when to have it.
    • “Women could remain fertile longer and would have more choice about when to start a family. They wouldn’t struggle with symptoms like hot flashes, mood swings and brain fog in the prime of their careers and family lives.
    • “Even more significantly, women might live longer and healthier lives. Though menopause—a full year without a menstrual cycle—is associated with the end of fertility, it also marks another profound but less recognized change. When the ovaries stop functioning and releasing important hormones, biological aging in women speeds up, increasing the risk of numerous health problems.
    • “Menopause is the single biggest accelerant of the diseases of aging for women across the board, whether it’s heart disease and stroke, autoimmune disorders, osteoporosis or cognitive decline,” says Piraye Yurttas Beim, founder and CEO of a biotech startup called Celmatix focused on improving ovarian health. “It’s the end of the function of a key organ in our body, and we should not normalize it any more than we would normalize tooth decay, osteoarthritis or cognitive decline.” * * *
    • “At Celmatix, the startup founded by Beim, researchers are seeking to develop what’s called an activator of the AMH hormone. A woman could take a drug to reduce the loss of follicles and eggs in her reserve and thus maintain optimal ovarian health and then go off the drug when she wants more eggs to be released to try to get pregnant.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy front —

  • Homeland Security Today reports
    • “This week, U.S. Senators Gary Peters (D-MI), Chairman of the Homeland Security and Governmental Affairs Committee, and Josh Hawley (R-MO), along with U.S. Representatives James Comer (R-KY) and Jamie Raskin (D-MD), Chairman and Ranking Member of the Committee on Oversight and Accountability, and Nancy Mace (R-SC) and Gerald E. Connolly (D-VA), Chairwoman and Ranking Member of the Subcommittee on Cybersecurity, Information Technology, and Government Innovation, introduced bicameral, bipartisan legislation to protect federal information technology systems. 
    • “The Federal Information Security Modernization Act (FISMA) of 2023 would improve coordination across the federal government to help civilian federal agencies and contractors protect their networks against cybersecurity threats. It also clarifies roles and responsibilities for key agencies that lead federal information security policy and operations.”
  • Cybersecurity Dive tells us,
    • The Biden administration released its implementation plan for the national cybersecurity strategy Thursday, delegating cyber initiatives to a smattering of government agencies.
    • The plan, which is designed to guide the government’s completion of the national cybersecurity strategy, comes four months after the policy blueprint was unveiled.
    • “If the strategy represents the president’s vision for the future, then this implementation plan is the roadmap to get there,” Kemba Walden, acting national cyber director, said Wednesday during a press briefing.
    • “Fundamentally, we are publishing this plan because we will only achieve our goals with a whole-of-society approach,” Walden said. * * *
    • The 57-page document divides the five pillars and 27 objectives of the national cybersecurity plan into a broader series of initiatives.
    • While the implementation plan calls for the majority of initiatives to be completed before the end of fiscal year 2024, 11 are slated to be done in FY23, which closes at the end of September.
  • Cyberscoop adds
    • “As a concept, I generally like the idea of pushing to try and harmonize regulations. There are so many different regulations for different sectors out there that it can be a little bit confusing for owner-operators,” said Will Loomis, associate director of the Atlantic Council’s Cyber Statecraft Initiative.
    • “In pushing for one big set of regulation for all critical infrastructure, you kind of risk missing a lot of the nuance that exists in the differentiation and the realities of different critical infrastructure sectors,” Loomis said.
    • “And as the U.S. government works to assess the scope of the Chinese hacking campaign that utilized a flaw in Microsoft’s cloud computing systems, Loomis said he was disappointed that the implementation plan did not look more closely at cloud security.”
  • The Wall Street Journal points out,
    • “The hack of email accounts of senior U.S. officials including the commerce secretary is the latest feat from a network of Chinese state-backed hackers whose leap in sophistication has alarmed U.S. cybersecurity officials. 
    • “The espionage was aimed at a limited number of high-value U.S. government and corporate targets. Though the number of victims appeared to be small, the attack—and others unearthed in the past few months linked to China—demonstrated a new level of skill from Beijing’s large hacker army and prompted concerns that the extent of its infiltration into U.S. government and corporate networks is far greater than currently known.”
  • In sum, crafting an effective cybersecurity strategy is a tall order.

From the cybersecurity vulnerabilities and breaches front —

  • Bleeping Computer reported on July 11,
    • “HCA Healthcare disclosed a data breach impacting an estimated 11 million patients who received care at one of its hospitals and clinics after a threat actor leaked samples of the stolen data on a hacking forum.
    • “HCA Healthcare is one of America’s largest healthcare facility owners and operators, with 182 hospitals and 2,200 care centers across 21 U.S. states and the United Kingdom.
    • “As first reported by DataBreaches.net, on July 5th, 2023, a threat actor began selling data allegedly belonging to HCA Healthcare on a forum used to sell and leak stolen data. This forum post includes samples of the stolen database, which they claim consists of 17 files and 27.7 million database records.
    • “The threat actor claims that the stolen data consists of patient records created between 2021 and 2023.
    • “The threat actor initially did not offer the database for sale but instead used the post to blackmail HCA Healthcare, giving them until July 10th to” “meet the demands.” This is likely related to financial demands, although it wasn’t explicitly mentioned.
    • “However, after not receiving a response from HCA, the hacker began selling the full database, with other threat actors expressing interest in purchasing the data.”
  • Cybersecurity Dive offers an update on the slow-moving MOVEit file transfer disasters.
    • “More than 300 organizations have been impacted by Clop’s mass exploitation of a zero-day vulnerability that Progress Software first disclosed in late May, according to threat analysts and researchers. Five additional vulnerabilities in the file-transfer service have subsequently been discovered.”
  • Speaking of zero-day vulnerabilities, Security Week reported on July 11
    • “In an unusual move, Microsoft documented “a series of remote code execution vulnerabilities” impacting Windows and Office users and confirmed it was investigating multiple reports of targeted code execution attacks using Microsoft Office documents.
    • “Redmond’s security response pros tagged the unpatched Office flaws with the CVE-2023-36884 identifier and hinted that an out-of-band patch may be released before next month’s Patch Tuesday.”
  • The Cybersecurity and Infrastructure Security Agency (CISA) added five known exploited vulnerabilities to its catalog on July 11 and two more on July 13.
  • HHS’s Health Sector Cybersecurity Coordination Center released its report on June Vulnerabilities of Interest to the Health Sector.
    • “In June 2023, vulnerabilities to the health sector have been released that require attention. This includes the monthly Patch Tuesday vulnerabilities released by several vendors on the second Tuesday of each month, along with mitigation steps and patches. Vulnerabilities for June are from Microsoft, Google/Android, Apple, Mozilla, SAP, Cisco, Fortinet, VMWare, and MOVEit. A vulnerability is given the classification as a zero-day if it is actively exploited with no fix available or is publicly disclosed. HC3 recommends patching all vulnerabilities with special consideration to the risk management posture of the organization.”
  • HC3 also posted a PowerPoint titled “Artificial Intelligence, Cybersecurity and the Health Sector.”
  • Health IT Security points out
    • The Healthcare and Public Health Sector Coordinating Council (HSCC) Cybersecurity Working Group (CWG) issued a new publication entitled “Health Industry Cybersecurity Coordinated Healthcare Incident Response (HIC-CHIRP).”
    • HIC-CHIRP provides healthcare organizations with a template for navigating a coordinated incident response when faced with disruptive cyber incidents. Specifically, the publication seeks to address healthcare-specific gaps in existing incident response resources.

In ransomware news,

  • Bleeping Computer lets us know,
    • “Data from the first half of the year indicates that ransomware activity is on track to break previous records, seeing a rise in the number of payments, both big and small.
    • “According to a report by blockchain analysis firm Chainalysis, ransomware is the only cryptocurrency crime category seeing a rise this year, with all others, including hacks, scams, malware, abuse material sales, fraud shops, and darknet market revenue, recording a steep decline.”

From the cybersecurity defenses front —

  • CSO Online shares best practices for an effective cybersecurity strategy.
  • Tech Republics discusses Gartner’s 2023-24 cybersecurity outlook.
  • Forbes offers twenty cybersecurity training tips designed to make the training “stick.”

Friday Factoids

David Ermer–Medical / Rx research, SDOH, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From the U.S. healthcare business front –

  • Healthcare Dive tells us
    • “All eyes were on UnitedHealth’s medical costs when the health insurance giant reported second-quarter financial results on Friday, but rising outpatient utilization among seniors that spooked investors left the payer’s earnings largely unscathed.
    • “UnitedHealth’s medical loss ratio — the share of premiums spent on healthcare costs — was 83.2% in the quarter, higher than the 81.5% notched in the second quarter last year but lower than analyst expectations.
    • “In the second quarter, outpatient care activity among seniors was a few hundred basis points above our expectations,” UnitedHealth CFO John Rex said on a Friday morning call with investors. “Specific orthopedic and cardiac procedures have increased far above that level of variation.”
  • The Wall Street Journal adds
    • “Americans of all ages are seeking far more mental-health care for conditions including anxiety, depression and substance-use problems.
    • “UnitedHealth Group, parent of the nation’s biggest health insurer, said the percentage of people getting psychological visits and other services was up by double digits just since last year, and it believes the shift represents a long-term change. The company said people feel increasingly comfortable seeking help for behavioral-health issues, but it sees a continuing shortage of mental-health-care providers that is leading to problems with access.
    • “The rising use of behavioral-health care was one driver of higher healthcare costs flagged by the company during a call discussing its second-quarter financial results, which overall beat analysts’ expectations.”
  • BioPharma Dive reports
    • “Eli Lilly has agreed to acquire privately held biotechnology company Versanis in a deal that will add an experimental antibody to Lilly’s pipeline of medicines for obesity.
    • “The companies did not disclose a purchase price, but said in a statement Friday that upfront and milestone payments by Lilly to Versanis shareholders could be worth as much as $1.9 billion.
    • “Founded in 2021 by Aditum Bio, Versanis is built around a drug licensed from Novartis. The antibody, called bimagrumab, is designed to block cellular communication via two types of protein regulators and is being studied in people who are overweight or obese.”
  • Beckers Payer Issues points out that “Competition between Blue Cross Blue Shield companies is increasing after a 2022 antitrust settlement that struck down some agreements limiting competition between BCBS Association members, according to a July 13 report from Advisory Board.“
  • Per Reuters
    • “An influential U.S. drug pricing watchdog raised the price estimate of two experimental gene therapies from Vertex Pharmaceuticals (VRTX.O)/CRISPR Therapeutics and bluebird bio (BLUE.O) to as much as $2.05 mln, saying the new price can be cost effective to treat sickle cell disease.
    • “A price of up to $2.05 million a year, higher than the prior estimate in April of up to $1.9 million would meet some commonly used thresholds for cost effectiveness, the Institute for Clinical and Economic Review (ICER) said.”

From the SDOH front, Healthcare IT News notes “Without the need for deep learning and neural network models, researchers were able to use machine learning to extract social determinants of health information on housing challenges, financial stability and employment status from unstructured patient data in electronic health records, a new research report from Regenstrief Institute shows.”

From the plan design front —

  • HR Executive offers six ways to make a primary care strategy blossom. Check it out.
  • Fierce Healthcare lets us know
    • “The Center for Medicare and Medicaid Innovation (CMMI) has released a request for information to design a future episode-based payment model.
    • “The center is looking for feedback on questions related to care delivery, incentive structure alignment, clinical episodes, participants, health equity, quality measures and multipayer alignment, payment methodology and structure, and model overlap, according to the request.
    • “Episode-based payment models intend to address inefficiencies in traditional Medicare fee-for-service beneficiaries, where providers are paid for each item or service. This leads to “volume over value and fragment care,” according to the request.”

From the mental healthcare front,

  • KFF created a brief on the success to date of the 988 national suicide and crisis number.
    • Since its launch in July 2022, the 988 national suicide and crisis hotline has received about 4 million contacts, a 33 percent increase from the year before, according to a new KFF analysis of publicly available data through May 2023. The contacts include more than 2.6 million calls, over 740,000 chats, and more than 600,000 texts. The total number of contacts rises to almost 5 million when nearly 1 million additional contacts from the Veterans Crisis Line (VCL) are included, which were reported by the federal Substance Abuse and Mental Health Services Administration (SAMHSA), but aren’t yet publicly available.

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.”

Tuesday Tidbits

David Ermer–Congress, Medical / Rx research, Medicare, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC —

  • The Senate Health Education Labor and Pensions Committee held its Superbugs hearing today.
  • STAT News informs us
    • “The witnesses largely seemed to organize behind the Pasteur Act in terms of how Congress should respond. This bipartisan legislation, which has been introduced in both the House and Senate, would encourage drug development by creating a subscription-style business model. In other words, the U.S. government would offer upfront payments to drugmakers in exchange for responsible stewardship policies and unlimited access to their antibiotics. A similar model has been successfully piloted in England over the past year, with the National Health Service planning a wider rollout to more pharmaceutical companies and to Northern Ireland, Scotland and Wales.
    • “The goal, as STAT has previously reported, is to enable pharmaceutical companies to recover their costs and make a profit — without predicating this on large volumes of antibiotics being prescribed. Helen Boucher, Dean of Tufts University School of Medicine, testified that this law would recognize these drugs “for their value, not for their use. It de-links incentives for overusing antibiotics.”
  • The Government Accountability Office released “a new report on the agency’s key findings and recommendations with an eye toward helping federal agencies be better prepared for future emergencies. GAO has regularly reported on the accountability and effectiveness of the federal government’s $4.7 trillion pandemic response since 2020.”
  • Per the White House,
    • “Today, in the continued efforts to fight the dangerous and deadly combination of xylazine mixed with fentanyl, the White House Office of National Drug Control Policy (ONDCP) released a National Response Plan to coordinate a whole-of-government response against this threat. Earlier this spring, ONDCP Director Dr. Gupta used an executive designation authority to designate fentanyl combined with xylazine as an emerging threat to the United States and proactively address this dangerous threat head-on.”
    • “Read the full National Response Plan to Fentanyl Combined with Xylazine HERE.
    • “Read about the Biden-⁠Harris Administration’s efforts to crack down on illicit fentanyl supply chains HERE.
    • “Read the Biden-Harris Administration’s National Drug Control Strategy HERE.”

From the public health front —

  • Federal News Network reports that twelve House of Representatives members are asking the Postal Service about steps being taken to protect letter carriers against the effects of high outdoor heat following the death of a letter carrier who passed away while delivering the mail in Texas.
    • “Eugene Gates Jr., a 66-year-old letter carrier in Texas, died June 20 while delivering mail during a heat wave with temperatures as high as 115 degrees. * * *
    • “The National Association of Letter Carriers, which represented Gates, said he collapsed and died in a customer’s yard while delivering mail. Gates, an Army veteran, served as a letter carrier for 36 years.
    • “Eugene was a dedicated letter carrier with a long and successful Postal Service career,” NALC National President Brian Renfroe said in a statement. “He will be greatly missed.”
  • STAT News tells us,
    • Weight loss medications from Novo Nordisk are being investigated by the European Medicines Agency after several reports of suicidal risks were referred to the watchdog, Bloomberg News reports. The regulator is looking at adverse events noted by the Icelandic Medicines Agency, including two cases of suicidal thoughts linked to the drugs Saxenda and Ozempic. One additional case relating to thoughts of self-injury has been raised in connection with Saxenda. The agency is investigating the possible side effects in relation to patients who have used medicines containing the active ingredients semaglutide or liraglutide for weight loss. Novo’s hit weight loss drug Wegovy also contains semaglutide.
  • The Bloomberg article adds,
    • “Wegovy is currently available in the US with a warning and precaution for suicidal behavior and ideation on the label. While clinical trials of Wegovy did not support an increased risk of suicidal behavior, suicidal ideation, or other psychiatric adverse events, clinical trials of other weight management drugs have reported suicidal behavior and ideation, a spokesperson for the Food and Drug Administration said Monday.
    • “If newly identified safety signals are identified, the FDA will determine what actions are appropriate after a thorough review of the body of evidence,” the spokesperson said.”

From the medical research front,

  • According to the National Science Foundation —
    • “While it’s known that sleep plays a crucial role in strengthening memory, scientists are still decoding how the process plays out in the brain overnight.
    • “U.S. National Science Foundation-supported research led by scientists at UCLA and Tel Aviv University offers new evidence from inside the human brain supporting the dominant theory of how the brain consolidates memory during sleep.
    • “The researchers found that targeted deep brain stimulation during a critical time in the sleep cycle improved memory consolidation. The result came from a novel “closed loop” system that delivered electrical pulses in one brain region that activated the cerebral cortex, synchronized with brain activity recorded in another area, the hippocampus.
    • “The research, published in Nature Neuroscience, could offer new clues to how deep brain stimulation during sleep could help patients with memory disorders, said study co-author and physician-scientist Itzhak Fried of UCLA.”

From the Medicare front, NerdWallet identifies four Medicare policies that “should come with warning labels.” Number 1 is the Part B late enrollment penalty. The article encourages picking up Part B at the first opportunity, even if health expenses at the time are modest. Granted, this article is aimed at people, like the FEHBlog, who have Medicare without supplemental employer coverage. Nevertheless, federal employees should consider the advice too.

From the Rx coverage front

  • Beckers Hospital Review notes
    • “The FDA is allowing 10 more lots of cisplatin from a China-based pharmaceutical company to be imported to the U.S. to ease the ongoing cancer drug shortage, Bloomberg reported July 10. The additional lots are set to arrive next week. 
    • “In June, federal regulators cleared four lots of cisplatin from Qilu Pharmaceutical. While the version of the drug is unapproved in the U.S., it is similar to the approved version distributed across the country. 
    • “We will continue the importation until manufacturers can meet all needs,” Chanapa Tantibanchachai, an FDA spokesperson, told Bloomberg.
    • “Shortages of the essential cancer drug began in February and have caused some cancer centers to ration cisplatin and carboplatin, another cancer drug in shortage, treatments for patients. More recently, there have been signs of supplies stabilizing.” 
  • Fierce Healthcare discusses a recent HHS report on approaches to avoiding drug shortages.
  • Following up on its recent report about the lead-covered cabling problem in our country, the Wall Street Journal points out
    • “Supplies are running out for a key antidote for life-threatening lead poisoning.
    • “The drug, named dimercaprol, has been a go-to treatment for years for the worst cases of lead poisoning. But doctors have had to scrounge for dwindling doses since the medicine’s sole manufacturer for the U.S. declared bankruptcy in February.
    • “Now that some parts of the country don’t have any supplies left, doctors have been forced to turn to other, less preferred treatments.
    • “We’re using whatever we can get, knowing it will help, but not knowing if it’s doing as good of a job,” said Dr. Diane Calello, who directs the New Jersey Poison Control Center at Rutgers New Jersey Medical School.”

In U.S. healthcare business news

  • Beckers Payer Issues tells us
    • “The Cigna Group’s network of behavioral health providers grew by more than 30 percent in 2022, according to the company’s 2022 Environmental, Social, and Governance Report.
    • “The July report said the behavioral health network has grown to include more than 300,000 mental health and substance use providers, doubling its size over the past four years. The company also nearly doubled its virtual care network, which has grown to include more than 163,000 virtual behavioral health providers. In-network providers who support cultural and race-related counseling were increased.
    • “For behavioral health providers that specifically work with children, Cigna added 27,000 providers to its network in 2022, or an increase of 19 percent. It also increased the numbers of facilities treating children by 8 percent to 2,700 total.”
  • The Wall Street Journal delves into high-priced “clinics cater[ing] to a growing number of people obsessed with fighting aging.”
    • “Practitioners at Healthy Longevity Clinic, which has locations in Boca Raton, Fla., and Prague, build patients a personalized “longevity road map.” Those maps can include recommendations for diet, exercise, sleep and supplements. Patients are encouraged to stick with the program for at least a year, over which time their bill can run between $25,000 to more than $100,000, says Petr Sramek, the clinic’s chief executive.
    • “Longevity-clinic treatments aren’t often covered by health insurance. Some providers say they work with insurers to get coverage for medications or laboratory tests. 
    • “Many clinics use membership-based models in an effort to keep client loads low enough that providers can spend time with each patient. Others are fee-for-service or use a combination of the two.”

Monday Roundup

David Ermer–Medicare, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the public health front

  • The New York Times reports,
    • “Drowning is the leading cause of death for children ages 1 to 4, according to the Centers for Disease Control and Prevention. Deaths are likely to surge this month, as they do every July, with children drowning just feet from their parents without a scream, struggle or splash. A 4-year-old at a Texas hotel pool, a 5-year-old in a California river, a 6-year-old at a Missouri lake and a 10-year-old at an Indiana public pool all drowned just this past week. * * *
    • “The National Institutes of Health recently published a call for research proposals to examine drowning prevention, writing that “little is known” about what intervention strategies work. The C.D.C. said it planned to do an in-depth analysis of childhood drownings in several states to better understand the contributing factors.
    • “But epidemiologists point to an array of factors that could make it increasingly difficult to close the gap, including shrinking recreation department budgets, a national lifeguard shortage and an era of distraction on pool decks as parents juggle child supervision with laptops and cellphones when they work from home.”
  • and
    • “When Dr. Benjamin Han, a geriatrician and addiction medicine specialist, meets new patients at the School of Medicine at the University of California, San Diego, he talks with them about the usual health issues that older adults face: chronic conditions, functional ability, medications and how they’re working.
    • “He asks, too, about their use of tobacco, alcohol, cannabis and other nonprescription drugs. “Patients tend to not want to disclose this, but I put it in a health context,” Dr. Han said.
    • “He tells them, “As you get older, there are physiological changes and your brain becomes much more sensitive. Your tolerance goes down as your body changes. It can put you at risk.”
    • “That’s how he learns that someone complaining about insomnia might be using stimulants, possibly methamphetamines, to get going in the morning. Or that a patient who has long taken an opioid for chronic pain has run into trouble with an added prescription for, say, gabapentin. * * *
    • “Aging boomers “still use drugs far more than their parents did, and the field wasn’t ready for that.”
    • “Evidence of a growing problem has been stacking up. A study of opioid use disorder in people over 65 enrolled in traditional Medicare, for instance, showed a threefold increase in just five years — to 15.7 cases per 1,000 in 2018 from 4.6 cases per 1,000 in 2013.”
  • Fierce Healthcare informs us,
    • “Americans are likely to skip important health screenings, and women have a less positive outlook than men regarding their current and future health prospects, according to a survey released by Aflac.
    • “The survey, based on about 2,000 employed adults, examined attitudes, habits and opinions about health and preventive care and found that half of adults have avoided at least one common health screening. These screenings include tests for certain diseases.
    • “But for the 51% of respondents who said they have had cancer, that diagnosis came following a routine checkup or screening. For Hispanic survey respondents, 72% of individuals said a diagnosis was discovered at a routine checkup.
    • “Skipping regular checkups is common among individuals who feel healthy. One in 4 respondents said they miss routine checkups. Reasons cited include a conflict with work hours, the individuals are “not thinking about it,” a general dislike for going to the doctor’s office, insurance issues, fear of hearing bad news and the time commitment required.”
  • In the FEHBlog’s view, the best action for a health plan to take in response to these concerns is to connect members with in-network primary care providers.

From the Medicare front, Beckers Payer Issues points out that “Caps on Medicare prescription drug costs will save Part D enrollees a collective $7.4 billion in 2025, according to a report from HHS’ Office of the Assistant Secretary for Planning and Evaluation.  The report, published July 7, broke down expected savings from price caps by state. An estimated 18.7 million people, around 1 in 3 Medicare Part D enrollees, will save on drug costs in 2025. The average annual saving per person is estimated at $396.08.” That’s good news for FEHB and PSHBP plans with Part D EGWPs.

From the Rx coverage front, Fierce Healthcare notes

  • “On the heels of a similar announcement from Optum Rx, pharmacy benefit management giant Express Scripts said Monday that it will add three biosimilars to its formulary to compete with Humira.
  • “The PBM announced that it will include Boehringer Ingelheim’s Cyltezo and two biosimilars produced by Novartis’ Sandoz in its National Preferred Formulary. Humira, a drug for people with inflammatory conditions, is the top-selling pharmaceutical product in the world and has been viewed as a key target for savings thanks to biosimilar products.
  • “Express Scripts said its trend data show that anti-inflammatory drugs accounted for nearly 25% of total drug spending for its commercial business last year. An analysis from its parent company, Evernorth, found that increased biosimilar competition could save $225 billion to $375 billion over the next decade.”

Those savings will benefit FEHB and PSHBP plans.

From the employment front, the Society for Human Resource Management discusses steps that employers can take to support employees who have children with developmental disabilities.

STAT News and its readers offer 27 healthcare reads and podcasts for the beaches and mountains.

 

Weekend Update

David Ermer–Congress, Mental health care, U.S. Healthcare–
Mount Rushmore

From Washington, DC, both Houses of Congress return to work here this week for floor voting and Committee business. On Tuesday, July 11, 2023, the Senate Health, Education, Labor and Pensions Committee will hold a hearing titled “Superbugs: The Impact of Antimicrobial Resistance on Modern Medicine.”

From the public health front, the Wall Street Journal reports

  • “The U.S. has spent decades eradicating lead from well-known sources such as paint, gasoline and pipes. The Journal’s investigation reveals a hidden source of contamination—more than 2,000 lead-covered cables—that hasn’t been addressed by the companies or environmental regulators. These relics of the old Bell System’s regional telephone network, and their impact on the environment, haven’t been previously reported.
  • “Lead levels in sediment and soil at more than four dozen locations tested by the Journal exceeded safety recommendations set by the U.S. Environmental Protection Agency. At the New Iberia fishing spot, lead leaching into the sediment near a cable in June 2022 measured 14.5 times the EPA threshold for areas where children play. “We’ve been fishing here since we were kids,” said Tyrin Jones, 27 years old, who grew up a few blocks away.
  • “For many years, telecom companies have known about the lead-covered cables and the potential risks of exposure to their workers, according to documents and interviews with former employees. They were also aware that lead was potentially leaching into the environment, but haven’t meaningfully acted on potential health risks to the surrounding communities or made efforts to monitor the cables.” * * *
  • “The Journal’s findings “suggest there is a significant problem from these buried lead cables everywhere, and it’s going to be everywhere, and you’re not even going to know where it is in a lot of places,” said Linda Birnbaum, a former EPA official and director of the National Institute of Environmental Health Sciences, a federal agency.”

Big ruh-roh.

From the health care cost front —

  • Health Payer Intelligence informs us
    • “What drivers influence the medical cost trend, and what steps can payers take to address these factors?
    • “The medical cost trend is the percentage that experts anticipate treatment costs will grow year-over-year, the PwC Health Research Institute’s (HRI) medical cost trend report for 2024 explains.
    • “The higher medical cost trend in 2024 reflects health plans’ modeling for inflationary unit cost impacts from their contracted healthcare providers, as well as persistent double-digit pharmacy trends driven by specialty drugs and the increasing use of the GLP-1 agonists for Type 2 Diabetes or weight loss,” the report summarized.
    • “In 2024, overall inflation, consolidation, pharmaceutical costs, and other factors will drive medical cost trend inflation, while biosimilars and site-of-care changes will exert deflationary force.”
  • Revcyle Intelligence points out
    • “Healthcare spending is still on the rise, with median costs per person increasing to over $6,000 in 2021, according to a new analysis from the Health Care Cost Institute (HCCI).
    • “Median per person healthcare spending increased by 24 percent from 2017 through 2021, HCCI’s latest Healthy Marketplace Index shows. But healthcare spending varied significantly depending on where people lived. For example, patients in metropolitan areas with the highest utilization rates paid nearly three times more for healthcare services that year compared to their neighbors in metropolitan areas with the lowest utilization rates.”
    • The American Medical Association (AMA) reports patients spent $433.2 billion, or 10.2 percent of total healthcare spending, in 2021, the same year of the HCCI analysis.
    • “High and growing health spending is forcing families, employers, and governments across the country to make difficult tradeoffs,” Katie Martin, HCCI’s president and CEO, said in a statement. “The Healthy Marketplace Index shows that health care costs depend a great deal on where you live, the result of market dynamics like prices, practice patterns, and competition. Therefore, we need a multi-dimensional approach to making [healthcare] more affordable.”
  • FEHBlog note — The AMA report indicates that health plan cost sharing for members is reasonable.
  • In related news, the Wall Street Journal warns us the “Last mile of the inflation flight will be the hardest; Housing and used-car sectors are expected to help push down the core index, but progress could then stall so long as the economy doesn’t weaken.”

From the medical research front, NPR offers a story about personal achievement

  • “Sixteen years ago, when Calliope Holingue was in high school, she had a problem. Two, actually. She developed gastrointestinal symptoms severe enough to force her to give up running, plus she had a long history of anxiety and obsessive-compulsive disorder. 
  • “And I wondered if maybe there was a link between my mental health and the GI symptoms I was experiencing,” she recalls now. 
  • “Her doctors shrugged off her questions. “That led me to start reading a lot about the gut microbiome, the autonomic nervous system, and their connection with the brain and mental health,” she says. 
  • “Today, Holingue [who holds a Ph.D degree in public health] has joined the ranks of scientists seeking to understand the interplay between the brain (and the rest of the nervous system) and the gut microbiome – that is the vast array of organisms, including bacteria, fungi and viruses, that thrive in the human gut. 
  • “She’s now an assistant professor of mental health at the Johns Hopkins School of Public Health and part of the faculty at the Center for Autism and Related Disorders at Kennedy Krieger Institute. She’s currently leading research on gut microbes and symptoms that cooccur with autism, including GI and behavioral symptoms.”

The article goes on to interview Dr. Holingue. The FEHBlog wishes her good luck.

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity breaches and vulnerability front —

  • Cybersecurity Dive informed us on July 5,
    • “The widely exploited vulnerability in Progress Software’s MOVEit file transfer service has impacted nearly 200 organizations, according to Brett Callow, a threat analyst at Emsisoft.
    • “The scope of damage caused by Clop’s mass exploit of a zero-day vulnerability in MOVEit continues to snowball as third-party vendors expose multiple downstream victims. Progress discovered the zero-day over Memorial Day weekend on May 28.
    • “Despite the number of victims so far, experts anticipate more will come forward. “While many organizations have made a disclosure, a significant number have yet to do so,” Callow said via email.
    • “Progress on Wednesday released another update, including security fixes, and said it will consistently release MOVEit product updates every two months going forward.”
  • Here is a Cybersecurity and Infrastructure Security Agency (CISA) link about the Progress Software MOVEit patch.
  • CISA added another known exploited vulnerability yesterday.
  • On July 6, CISA issued a “Joint Cybersecurity Advisory on Newly Identified Truebot Malware Variants.”
    • “The Cybersecurity and Infrastructure Security Agency (CISA), Federal Bureau of Investigations (FBI), the Multi-State Information Sharing and Analysis Center (MS-ISAC), and the Canadian Centre for Cyber Security (CCCS) released a joint Cybersecurity Advisory (CSA), Increased Truebot Activity Infects U.S. and Canada Based Networks, to help organizations detect and protect against newly identified Truebot malware variants. Based on confirmation from open-source reporting and analytical findings of Truebot variants, the four organizations assess cyber threat actors leveraged the malware through phishing campaigns containing malicious redirect hyperlinks.
    • “Additionally, newer versions of Truebot malware allow malicious actors to gain initial access by exploiting a known vulnerability with the Netwrix Auditor application (CVE-2022-31199). As recently as May 2023, cyber threat actors used this common vulnerability and exposure to deliver new Truebot malware variants and to collect and exfiltrate information against organizations in the U.S. and Canada.
    • “CISA, FBI, MS-ISAC, and the CCCS encourage all organizations to review this joint advisory and implement the recommended mitigations contained therein—including applying patches to CVE-2022-31199, to reduce the likelihood and impact of Truebot activity, as well as other ransomware-related incidents.” 
  • Bleeping Computer reports
    • “CISA ordered federal agencies today to patch a high-severity Arm Mali GPU kernel driver privilege escalation flaw added to its list of actively exploited vulnerabilities and addressed with this month’s Android security updates.
    • “The flaw (tracked as CVE-2021-29256) is a use-after-free weakness that can let attackers escalate to root privileges or gain access to sensitive information on targeted Android devices by allowing improper operations on GPU memory.
    • “A non-privileged User can make improper operations on GPU memory to gain access to already freed memory and may be able to gain root privilege, and/or disclose information,” Arm’s advisory reads.”
  • and
    • “Security researchers have dissected a recently emerged ransomware strain named ‘Big Head’ that may be spreading through malvertising that promotes fake Windows updates and Microsoft Word installers.
    • “Two samples of the malware have been analyzed before by cybersecurity company Fortinet, who looked at the infection vector and how the malware executes.
    • “Today [July 8], Trend Micro published a technical report on Big Head that claiming that both variants and a third they sampled originate from a single operator who is likely experimenting with different approaches to optimize their attacks.”
  • Cybersecurity Dive points out
    • “More than two-thirds of Fortinet’s FortiGate firewalls remain at risk of exploits through a vulnerability the company disclosed on June 12, according to research Bishop Fox released Friday.
    • “Researchers at Bishop Fox, an offensive security testing firm, identified 490,000 affected SSL VPN interfaces exposed to the internet and determined 69%, around 338,000, of those FortiGate firewalls are unpatched.
    • “The heap-based overflow vulnerability, CVE-2023-27997, could allow a remote attacker to execute arbitrary code or commands and has a CVSS score of 9.8 out of 10.”
  • ISACA warns us
    • “In the US, the FBI and FCC recently warned that free USB charging stations in public spaces, such as airports, hotels, hospitals, business buildings and any other type of publicly available location, can have devices hidden within them to steal data, spread malware and commit other malicious activities broadly referenced as juice jacking. The term “juice jacking” started being used several years ago to mean that while individuals using USB charging ports to charge (or “juice”) their phones, they were also having their data highjacked (“jacked”) through malicious, unnoticed skimming tech. I actually started covering this risk at a few onsite security and privacy training courses in 2010 when I first became aware of what was then an emerging new threat from a business friend, an electrical engineer, who I think may have invented what the first juice jack blocker—a data blocker for USB ports was.
    • “The malicious USB charging connection not only gives access to the phone apps and data, but it creates a connection to all the networks that the phone is connected to that do not have active access controls and blocks established when the phone was connected to the USB charger. So, malicious USB charging ports, cables and possibly other components of the public charging stations can also be used to plant ransomware, keystroke loggers and other types of malware, GPS tracking and audio eavesdropping. They can also take control of the device being charged. All these malicious activities can occur not only on the device being charged (phone, laptop, tablet, etc.) but also on devices and network components within those other connected networks.”
  • The FEHBlog notes the ISACA article offers the following suggestions plus policy advice
    • “Juice jack blockers attach to the end of your USB cable to protect against skimmers when you charge your devices in public places. This is not as bulky as hauling around most portable chargers and extra cables. I’ve purchased USB juice jack blockers for as low as two for US$12. They’re small and easily fit in a pocket without any bulkiness.
    • “It’s also a good idea to travel with personal charging devices. While not as small as juice jack blockers, they have become much smaller, with much more power, and less expensive in recent years. They limit the need to use public chargers at all.
    • “Ideally, it would be best to make sure only non-data power-only ports and cables are used in public areas. However, most cables used to support data transfer, and there is not an easy way for most folks to visually tell if a cable is charge-only.”

From the cybersecurity defenses front —

  • Cybersecurity Dive discusses “the role for AI in cybersecurity; generative AI can be an ally for new security professionals. For more seasoned security analysts, it can offer time to refine their skills through automation of repetitive tasks.” Check it out.