Happy Flag Day!

David Ermer

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

Happy Flag Day!

David Ermer–ACA, CMS, Congress, FDA, No Surprises Act, Rx coverage, U.S. Healthcare–
Thanks to Aaron Burden for sharing their work on Unsplash.

From Washington DC —

  • The Senate Finance Committee announced
    • “Senate Finance Chairman Ron Wyden (D-Ore.), Senate Finance Ranking Member Mike Crapo (R-Idaho) alongside U.S. Senators Bob Menendez (D-N.J.), Marsha Blackburn (R-Tenn.), Jon Tester (D-Mont.), Roger Marshall (R-Kan.), today introduced the Patients Before Middlemen (PBM) Act to delink the compensation of pharmacy benefit managers (PBMs) from drug price and utilization in order to better align incentives that will help lower prescription drugs costs for Medicare Part D beneficiaries.”
  • Fierce Healthcare informs us
    • “While national health spending growth slowed in 2022, that trend isn’t likely to stick around.
    • “Experts at the Centers for Medicare & Medicaid Services’ Office of the Actuary predict that health spending growth will outstrip growth in the economy over the next decade, according to a study published in Health Affairs. Between 2022 and 2031, the actuaries predict spending will increase by 5.4% on average each year, faster than the estimated annual gross domestic product growth of 4.6%.”
  • As the French say, Plus ça change, plus c’est la même chose (literally the more it changes, the more it’s the same thing”.
  • CMS made its No Surprises Act website more consumer friendly.

In conference news, MedPage Today fills us in on the American Medical Association conference and Smartbrief does the same for the AHIP conference.

From the Rx coverage front —

  • Beckers Hospital Review tells us,
    • “Mark Cuban Cost Plus Drug Co. considered selling insulin but found the price doubled with shipping costs, CEO and co-founder Alex Oshmyansky, MD, PhD, said June 13 at the AHIP conference. * * *
    • “We were working on bringing in an insulin product to the market for quite some time,” he said at the conference. “We did actually bring one to the market, we did it as sort of a closed beta pilot to see what consumer response would be. But ultimately, direct to consumer mail-order it was $35 for a month’s supply but $65 for the shipping and handling. It didn’t quite make sense within our model. We almost viewed it as a solved problem from the consumer perspective at this point. You know, almost everyone has access to $35 insulin in one form or another now.”
  • Reuters reports,
    • “Pfizer (PFE.N) has warned that a drug used to treat syphilis and other bacterial infections in children could run out by the end of June because it has had to prioritize versions made for adults due to a spike in syphilis infections in that population.
    • “Supply of the pediatric version of the drug, Bicillin L-A, is expected to be exhausted by the end of this quarter, the company said in a letter to the U.S. health regulator dated Monday. Pfizer said in an email on Tuesday that the pediatric formulations of the antibiotic are not widely used.”
  • Medscape informs us
    • The US Food and Drug Administration (FDA) has expanded the indication for linaclotide (Linzess) to children as young as age six years with functional constipation, making it the first approved treatment for pediatric functional constipation.
    • The recommended dosage in pediatric patients is 72 mcg orally once daily.
    • Functional constipation is common in children and adolescents. Symptoms include infrequent bowel movements with hard stools that can be difficult or painful to pass.
    • There is no known underlying organic cause, and there are typically multiple contributing factors, the FDA notes in a statement announcing the approval.

From the U.S. healthcare business front —

  • Healthcare Dive notes,
    • “Pent-up demand for delayed healthcare during the COVID-19 pandemic is pressuring medical costs for health insurers that had a financial windfall during the pandemic amid low utilization.
    • “UnitedHealth, the parent company of the largest private payer in the U.S., expects its medical loss ratio — the share of premiums spent on member’s healthcare costs — to be higher than previously expected in the second quarter of 2023, due to a surge in outpatient care utilization among seniors,” CFO John Rex said Tuesday during Goldman Sachs’ investor conference.”
  • Fierce Healthcare relates,
    • “Cerner brought in $1.5 billion in revenue in the latest quarter, boosting strong growth for enterprise software giant Oracle. The health IT company also generated $5.9 billion in revenue for Oracle’s 2023 fiscal year, which ended May 31.
    • “Oracle’s revenue reached an all-time high of $50 billion last year, driven by growing demand for its cloud offerings from companies deploying AI.”

In litigation news —

  • Health Payer Intelligence points out,
    • On June 13, “A federal appeals court approved an agreement between parties in Braidwood Management v Becerra, preserving the mandate requiring health plans to cover preventive care services based on recommendations from the US Preventive Services Task Force (USPSTF). * * *
    • “While the federal government works to appeal Judge O’Connor’s ruling, it cannot penalize Braidwood Management for refusing to cover USPSTF-recommended preventive care services. Additionally, if the court upholds the mandate in the appeal, the Biden administration cannot retroactively penalize the plaintiff.”

Tuesday Tidbits

David Ermer–Congress, COVID-19, COVID-19 vaccine, Medical / Rx research, Medicare, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC —

  • The House of Representatives Committee on Education and the Workforce held a hearing today to examine the policies and priorities of the Department of Health and Human Services.
  • STAT News adds
    • “A key House Republican ramped up his criticism of pharmacy benefit managers Tuesday, calling for the government to dismantle companies that have consolidated drug supply chain operations.
    • “We should break these PBMs up,” House Oversight Committee Chair James Comer (R-Ky.) said during an Education and Workforce Committee hearing. Health Secretary Xavier Becerra testified at the hearing on his department’s priorities. * * *
    • “Comer asked Becerra what the administration thinks should be done to reform PBMs.
    • “Transparency,” Becerra responded. “As they say, sunshine is the best disinfectant.”
  • STAT News reports from the Senate
    • “In another bid to lower prescription drug prices, U.S. Sen. Bernie Sanders (I-Vt.) issued a report showing that medicines developed with help from the National Institutes of Health have often cost Americans more than what is paid in other countries. And he called on the agency to reinstate a provision in federal law that would require companies to set reasonable prices when they license NIH inventions. * * *
    • “The report was issued as the Biden administration seeks confirmation of Monica Bertagnolli, who currently heads the National Cancer Institute and was nominated to run the NIH. But the confirmation cannot proceed without support from Sanders because, as chair of the Senate health committee, he controls when nominees are reviewed for positions in the Department of Health and Human Services.
    • “However, Sanders threatened that he will not proceed until the Biden administration provides a “comprehensive” plan to lower prescription drug prices. The White House reportedly responded by acknowledging that prescription drug costs remain high for many Americans and pointed to the Inflation Reduction Act, a recently enacted law that allows Medicare to negotiate prices for certain medicines.”
  • Fierce Healthcare reports
    • “The Biden administration is rolling out new flexibilities that aim to prevent procedural coverage losses as states work through a backlog of Medicaid eligibility determinations.
    • “The Department of Health and Human Services announced that managed care plans can take on a more direct role in assisting members in completing renewal forms. This extends to filling out certain parts of the paperwork on behalf of the member.
    • “In addition, states are able to delay administrative disenrollments by a month for further outreach, which will allow for greater time to fill out necessary forms and paperwork. The agency will also allow pharmacies and community-based organizations to assist in getting coverage reinstated for people who are still eligible but lost coverage for procedural reasons.
    • “Procedural disenrollment is a key concern during the Medicaid redetermination period, as many people who are at risk of losing coverage are not aware that the process is even going on. A recent analysis from KFF looking at early redetermination data found that in a number of states, large numbers of disenrollments are linked to administrative issues.”
  • and
    • “Industry hospital groups are pushing the Centers for Medicare & Medicaid Services (CMS) to consider a higher annual pay bump and to shed some light on why it believes the number of uninsured patients won’t be increasing during fiscal year 2024.
    • “In April, CMS released its proposed fiscal year 2024 Inpatient Prospective Payment Systems (IPPS) rule with a 2.8% increase in payments for the 12-month period beginning in October.
    • “The tentative pay raise for eligible participating hospitals translates to a collective $3.3 billion increase, CMS said at the time, and is based on a 3% projected hospital market basket update minus a 0.2 percentage point productivity adjustment.
    • “Comment letters submitted by the American Hospital Association (AHA) and other major hospital industry groups on Friday homed in on the 2.8% net update as “woefully inadequate” in light of cost pressures, such as inflation and labor spend, that have not subsided since the height of the COVID-19 pandemic.”

From the public health front —

  • The Wall Street Journal tells us
    • “Longevity researchers have spent decades hunting for a magic pill to slow the aging process. But the best solution—at least for now—may be the simplest one: Move more.
    • “No single thing—whether it’s regular cold plunges or off-label drugs and supplements like metformin, rapamycin or taurine—has a track record that can match exercise’s in terms of protecting against age-related diseases and helping people get more from their later years, a vast body of research shows.
    • “The muscle and bone growth stimulated by exercise can help older adults maintain their independence, lessen fatigue and protect against bad injuries from falls, the leading cause of injury-related death among those over 65. 
    • “Regular exercise can reduce the risk of developing certain age-related diseases, including Alzheimer’s, cancer, diabetes and cardiovascular disease. * * *
    • “Any amount of physical activity can help extend a person’s life, research suggests, especially for people who currently are doing very little. Federal guidelines recommend that adults get at least 150 minutes of moderate-intensity exercise a week. 
    • “A team of researchers who analyzed data on more than 650,000 adults over about a decade found that, compared with those who were inactive, those who got about half the government’s recommended physical activity added an average of 1.8 years to their lives. Those who exercised for roughly five to eight hours weekly gained an average of 4.2 years.
    • “When you think about that, in terms of how many years you’re gaining per how many minutes of activity, it’s a very sizable yield,” says Steven C. Moore, the study’s lead author and senior investigator at the National Cancer Institute.”
  • Healthcare Dive informs us
    • “Uber will soon be able to deliver groceries and other over-the-counter items to patients of its payer and provider clients, in the latest benefits expansion of its Uber Health platform.
    • “Uber Health, which already provides non-emergency medical transportation and prescription delivery, has been expanding beyond medical transportation to care coordination across multiple benefits, Catilin Donovan, the head of the division, said in an interview. Soon, provider users will have access to patient benefit data and eligibility files from their health insurers, so they can prescribe services they know are covered.
    • Uber is not yet giving specifics of Uber Health’s financial performance, but Uber Health grew bookings by 75% year over year in the first quarter. Donovan declined to say whether Uber Health was profitable.”
  • The Government Accountability Office released a watchdog report on law enforcement-oriented approaches to reducing deaths from drunk driving.
  • The All of Us campaign issued its June report.

From the medical research front,

  • The National Institutes of Health announced
    • “Repeat treatment with corticosteroid injections improved vision in people with persistent or recurrent uveitis-related macular edema better than two other therapies, according to results from a clinical trial funded by the National Eye Institute (NEI). Compared with methotrexate or ranibizumab intravitreal (in-the-eye) injections, the corticosteroid treatment achieved greater reductions in retinal swelling and was the only therapy in the study that improved vision. The report was published today in the journal Ophthalmology. NEI is part of the National Institutes of Health.”
  • The Cigna Newsroom relates,
    • “A new study by Cigna Healthcare found that site-of-care redirection is associated with favorable clinical outcomes and increased access and affordability for peg­filgrastim, an injection used to prevent infection in cancer patients. The results showed that patients experienced better outcomes when the injection was administered in a home setting rather than a nonhome setting. The study was recently published in the Journal of Clinical Pathways.
    • “This study shows that we can help improve health outcomes by providing cancer patients with treatment such as infusions in a setting where many are most comfortable – home,” said Dr. Scott Josephs, chief medical officer, Cigna Healthcare. “These findings confirm that home infusion of complex and expensive specialty medications presents new opportunities to maximize access, improve effectiveness, increase affordability, and enhance convenience for patients.”

Monday Roundup

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

From Washington, DC —

  • Roll Call tells us “A disagreement between Speaker Kevin McCarthy and House conservatives that jammed up legislative business last week eased Monday evening, but members of the rebel bloc made clear it may not be the end of trouble for their leadership.”
  • Govexec informs us
    • “After multiple years of significant spending increases at non-defense agencies, Congress has reverted to austerity by demanding an overall freeze of discretionary funding for domestic agencies. 
    • “The pullback, agreed to as part of a deal struck by President Biden and House Republicans to meet GOP demands for raising the debt ceiling, will force agencies to make difficult decisions as they abandon some efforts to launch new programs and grow existing ones. The 2023 Fiscal Responsibility Act set only a top-level cap for non-defense spending, leaving it to Congress to establish line-by-line funding levels across government. 
    • “The impacts will look different agency to agency,” said Rachel Snyderman, a senior associate director at the Bipartisan Policy Center and former Office of Management and Budget official.”
  • Federal News Network helpfully reviews the 71 public comments submitted to OPM in response to its April 6, 2023, interim final rule implementing the Postal Service Health Benefits Program.
  • Health Payer Intelligence relates, “AHIP offered four recommendations to the Senate Finance Committee on Consolidation and Competition (the Committee) [last week] to support healthy competition and lower healthcare spending in the healthcare industry.”

From the litigation front —

  • Yahoo News reports,
    • “The Biden administration on Monday finalized a deal to preserve the federal mandate requiring U.S. health insurers to cover preventive care like cancer screenings and HIV-preventing medication at no extra cost to patients while a legal challenge continues.
    • “The agreement, first disclosed on Friday and now finalized in a filing in the New Orleans-based 5th U.S. Circuit Court of Appeals, leaves the mandate in place nationwide while the administration appeals a court order striking it down.
    • “It does allow Texas-based Braidwood Management, one of a group of businesses and individuals that sued to challenge the mandate, to stop covering pre-exposure prophylaxis (PrEP) against HIV and other preventive services for its employees for now. The administration agreed not to take any retroactive enforcement action against the company, which operates an alternative health center if the mandate is restored on appeal.”
  • STAT News adds,
    • “The U.S. Chamber of Commerce sued the federal government over its new Medicare drug-price negotiation program on Friday, arguing that Congress tried to take too much power away from the courts.
    • “The lawsuit is the second to challenge the new program, enacted by Democrats last August in the Inflation Reduction Act, within a week’s time, but relies on different legal reasoning. Merck, which makes a diabetes drug that could be subject to negotiation, sued on Tuesday.
    • “Medicare is supposed to choose the first ten drugs to be negotiated by the program by Sept. 1. The goal of the lawsuits is to slow down or stop the process from going into effect.”

From the public health front —

  • Politico relates,
    • “The FDA’s independent advisers will discuss and recommend this week which strain of SARS-CoV-2 should be included in the newest Covid booster to be rolled out ahead of fall and winter. The FDA doesn’t have to follow its advisers’ recommendations, but it often does.
    • “Since the beginning of the year, the regulatory agency has made it clear that it will shift gears to prepare for annual Covid-19 shots as the virus becomes endemic. Now that we’re four months out from the intended rollout, the FDA must select a strain that will most likely be prevalent so manufacturers can start developing vaccines.
    • “Novavax, Pfizer-BioNTech and Moderna, the companies that manufacture the three vaccines available in the U.S., need the FDA’s recommendations to begin tweaking their existing platforms. They must also conduct clinical trials to show that the updated formulas generate a similar immune response to their existing products.”
  • MedPage Today reports,
    • “Oseltamivir (Tamiflu) has not panned out for reducing the risk of influenza hospitalization, according to a large meta-analysis.
    • “Among over 6,000 flu patients across 15 studies, the 0.14-percentage point difference in hospitalization rate between those who took oseltamivir and those who did not was not significant (RR 0.77, 95% CI 0.47-1.27), Emily McDonald, MD, MSc, of McGill University Health Centre in Montreal, and colleagues reported in JAMA Internal Medicine.
    • “I wouldn’t prescribe it to an otherwise healthy person,” McDonald told MedPage Today. “There was little evidence that it would prevent you from going to the hospital.”
    • “What’s more, she added, “it’s not completely benign. It does cause uncomfortable side effects.”
  • The Wall Street Journal reports,
    • “During the pandemic, Carl Prudhomme of Alpine, Texas, got his cancer drugs mailed directly to him from his oncologist.
    • “No longer. With the end of the Covid-19 public-health emergency, independent cancer doctors can no longer send prescriptions directly to their Medicare patients—creating hurdles for some people in rural areas who say they have to travel to get their medications. Prudhomme plans to drive the 569 miles each way to his oncologist’s office in Houston every three months to pick up his drugs in person.
    • “The Centers for Medicare and Medicaid Services in September 2021 posted a list of frequently asked questions that said independent oncologists can dispense prescriptions only to a patient who is physically in the doctor’s office at the time. 
    • “Sending oral chemotherapy drugs by mail violates the Stark law, the agency said. The law bans doctors from making referrals of Medicare and Medicaid patients to other organizations or medical businesses where they have a financial stake. The restriction also applies to other independent practices, such as urology, that have an on-site dispensing pharmacy.
    • “Roughly 30% of the more than 5,000 independent oncologists in the U.S. have on-site pharmacies in their practices, according to an analysis led by the University of Pennsylvania’s Perelman School of Medicine. 
    • “The restriction was suspended during the pandemic public-health emergency. Its return has alarmed cancer doctors who are lobbying Congress and CMS to rescind the restriction, even if that means undergoing new rule-making to do so.”

From the U.S. healthcare business front —

  • Fierce Healthcare tells us,
    • “Prior authorization has been a flashpoint for providers, and, while insurers have taken steps to ease these utilization management protocols, they still play a key role as the industry shifts to value-based care.
    • “David Brailer, M.D., executive vice president and chief health officer at the Cigna Group, told Fierce Healthcare in an interview that ultimately the goal is to ensure patients are receiving the best treatment option for them.
    • “And the insurer has seen that in more advanced value-based arrangments, it can relax prior authorization and other utilization management tools, Brailer said. 
    • “That’s going to be a few years before the market shifts,” he said. “We’ve already announced that we’re starting to step down the number of prior auths that we have.”
  • STAT News relates,
    • “Novartis said on Monday it would purchase Chinook Therapeutics for $3.2 billion upfront, picking up two drugs for a chronic kidney disease that are in late-stage clinical trials.
    • “The transaction values Seattle-based Chinook at $40 a share, compared to Friday’s closing price of under $24. The agreement includes another $300 million if certain regulatory milestones are reached.”
  • Healthcare Dive points out
    • CVS Health’s decision to shut down its two-year-old clinical trials unit means less competition for the growing group of retailers in research, but the area is still nascent and potentially challenging for new entrants, experts said.
    • “It may sort of spook some pharma companies who may think that if CVS exited, maybe these other companies will also exit, and it may make them a little bit more hesitant to partner up with the retailers,” said Sari Kaganoff, general manager of consulting at Rock Health. “At the same time, there’s a lot of opportunity, we believe, for pharma companies to use retailers for clinical trials.”
    • CVS will fully exit the clinical trials business by the end of 2024, winding down the business in phases and working with trial sponsors to ensure patients continue to receive care. 

From the Rx coverage front —

  • The Wall Street Journal informs us,
    • Kristen Ireland struggled with bulimia nervosa for years, working with a therapist and taking medications for anxiety and depression.
    • It wasn’t until her psychiatrist prescribed Victoza, a diabetes medication that works much like Ozempic, Wegovy and Mounjaro, that her binges and purges faded away.
    • “I feel free now,” said Ireland, 27 years old, who manages sports-merchandise stores in Jackson Hole, Wyo. 
    • Treating eating disorders is another potential application for a class of drugs that has taken the weight-loss world by storm. The drugs, synthetic versions of the GLP-1 hormone that act on appetite centers in the brain and gut, have helped patients lose 15% of their body weight on average
    • Some studies and the experience of doctors in the field suggest they could also help people stop binge eating.
  • CBS News discusses the side effects of these new weight loss drugs.

Weekend update

David Ermer–Congress, Rx coverage, SCOTUS, U.S. Healthcare–

From Washington, DC —

  • The House of Representatives and the Senate are in session this week for floor voting and Committee business.
  • The Supreme Court has over 20 opinions to issue before it can end its October 2022 term.
  • Fierce Healthcare reports,
    • The Federal Trade Commission is building out its deep dive into the pharmacy benefit management industry yet again.
    • The agency said Thursday that it has sent an order to the group purchasing organization Emisar Pharma Services, requiring it to provide information and records pertaining to its business practices. The order follows similar missives sent to two other GPOs, Zinc Health Services and Ascent Health Services, last month.
    • Emisar negotiates rebates with drugmakers on behalf of Optum Rx, a UnitedHealth Group subsidiary and one of the three largest PBMs.
    • The FTC said its order to Emisar is “substantially similar” to those issued to Zinc and Ascent.

Fortune Well offers us advice on the following topics:

McKinsey and Company explains how to improve children’s developmental trajectories.

Washington Post columnist discusses her recent experience taking Ozempic at length.

  • “I cannot claim to have done this for my health — certainly, appearance was my primary motivation — but the health impact has been impressive. My sleep apnea had been so severe that tests showed I was waking up an alarming 54 times every hour; new testing put it in the mild range, and my sleep apnea machine has been stashed in the closet. In November 2020, my LDL cholesterol — the “bad” kind, which raises your risk of heart disease and stroke — was at 146; it was down to 133 by March 2022 and, a year later, to 120. My A1c levels, measuring blood sugar, have fallen from on the cusp of prediabetes to safely in the normal range. My blood pressure is lower, and my C-reactive protein, an indicator of cardiovascular disease, has plummeted. * * *
  • “There are two things that are important for readers to know: My response to the medication has been extraordinary, and my experience with insurance coverage has also been unusually positive. Most insurers do not currently cover medications for obesity alone. But my doctor was able to point to my risk of developing diabetes, and my insurer, thankfully, did not question the need for coverage. “Ozempic, $24.99,” the Walgreens website informs me when I look back at my prescription records. “Insurance saved you: $1,046.10.”

Cybersecurity Dive

David Ermer–Cybersecurity–

From the cybersecurity policy front —

  • A CSO analysis reports, “Federal cyber incidents reveal challenges of implementing US National Cybersecurity Strategy. As federal government cybersecurity incidents continue to mount, the Biden administration’s National Cybersecurity Strategy should help, although experts say implementing it won’t be easy.”
    • “More than any previous administration, the Biden administration has taken a serious step forward to secure federal government infrastructure (and, by extension, the private sector through government contractor requirements) with its expansive National Cybersecurity Strategy, released in March.
    • “The strategy outlines five broad “pillars” of cybersecurity efforts that civilian agencies must meet, including approaches to defending critical infrastructure, disrupting and dismantling threat actors, shaping market forces to drive security and resilience, investing in a resilient future, and enhancing public-private operational collaboration to disrupt adversaries.
    • “But the details of how agencies should start tackling the challenges won’t be fully understood until the administration releases the strategy’s implementation guidance, which officials say could occur over the next month or so.
    • “No matter how the guidance shakes out, government agencies’ challenges in implementing the strategy will undoubtedly be significant. First off is the sheer size and complexity of the federal government.”
  • The Wall Street Journal similarly explains that while “The Biden administration’s proposal to hold software makers accountable offers a starting point, it leaves a lot of questions open.

From the cybersecurity vulnerabilities and breaches front —

  • Health IT Security tells us,
    • “Just like in years past, threat actors are leveraging ransomware, social engineering, denial of service, and basic web application attacks to disrupt operations and compromise data with great success. Verizon’s newly released 2023 Data Breach Investigations Report (DBIR) provided significant evidence of these trends through its analysis of more than 16,300 security incidents that occurred between November 1, 2021, and October 31, 2022.
    • “Of the 16,312 security incidents analyzed, 5,199 of them were confirmed data breaches. What’s more, 74 percent of all breaches involved a human element, such as social engineering, use of stolen credentials, or privilege misuse. * * *
    • “Verizon defines a “breach” as an incident that results in confirmed data disclosures to an unauthorized party, while an “incident” is a security event that compromises the integrity, availability, or confidentiality of information.
    • “Top attack patterns in healthcare included system intrusions, basic web application attacks, and miscellaneous errors, which collectively accounted for 68 percent of all healthcare breaches.
    • “The [h]ealthcare vertical is highly targeted by ransomware gangs, which results in both the loss of use of their systems—potentially with life-threatening consequences—as well as data breaches,” the report stated.”
  • Cybersecurity Dive reports (June 9)
    • “Barracuda’s email security gateway appliances, which were compromised by a zero-day vulnerability disclosed last month, need to be scrapped and replaced immediately, the company said Tuesday in an action notice.
    • “The vulnerability, CVE-2023-2868, has been actively exploited for at least eight months. Despite a series of patches issued to all appliances last month, Barracuda said, regardless of patch version level, its “remediation recommendation at this time is full replacement of the impacted ESG.”
    • “Barracuda’s decision to effectively retire all compromised ESG appliances is akin to an admission the company could not fully remove threat actor access and recover the devices for customers, according to experts.”
  • and (also June 9)
    • “Microsoft is investigating claims by an alleged hacktivist group that it launched a series of DDoS attacks that disrupted the company’s OneDrive and other Microsoft 365 services. 
    • “The company suffered a series of outages this week that impacted a range of services, including Microsoft Teams, SharePoint Online and OneDrive for Business. The OneDrive disruption was still impacting customers as of Thursday. 
    • “The group, known as Anonymous Sudan, has claimed credit for the alleged DDoS attacks and made additional threats against the company. Microsoft officials acknowledged the public claims and are working to fully restore services. 
    • “We are aware of these claims and are investigating,” a Microsoft spokesperson said via email. “We are taking the necessary steps to protect customers and ensure the stability of our services.”
  • HHS’s Health Sector Cybersecurity Coordination Center offers a PowerPoint presentation titled “Types of Cyber Threat Actors That Threaten Healthcare.”
  • Cybersecurity Dive adds
    • “Senior level corporate executives are increasingly being targeted by sophisticated cyberattacks that target their corporate and home office environments and even extend to family members, according to a study released Monday from BlackCloak and Ponemon Institute. 
    • “About 42% of organizations surveyed had a senior executive or an executive’s family member attacked over the past two years. The study is based on a survey of more than 550 IT security leaders. 
    • “These attacks often lead to the theft of sensitive company data, including financial information, intellectual property or other information. In one-third of these cases, hackers are reaching these executives through insecure home-office networks used during remote work.”

From the ransomware front –

  • Cybersecurity Dive informs us,
    • “Most of Dallas’ network and IT infrastructure has been restored following a ransomware attack in early May that took most of the city’s services offline and disrupted operations, the city said Monday.
    • “Our staff has worked tirelessly to restore and rebuild systems and return all systems to full functionality as quickly and securely as possible,” the city said Monday in a statement. “At this time, we are more than 90% restored, with most public-facing services restored.”
    • “Dallas previously cautioned full functionality would take weeks, and some services are still non-operational. The city’s municipal court reopened on May 30, but trials and jury duty remain canceled until further notice and library staff are still tracking item availability manually.
  • CISA and the FBI released an “Advisory on CL0P Ransomware Gang Exploiting MOVEit Vulnerability” on June 7.
    • Cyberscoop provides background on the advisory.
    • Bleeping Computer’s The Week in Ransomware” focuses on this case.
  • Security Week reports
    • “Cybersecurity firm Obsidian has observed a successful ransomware attack against Sharepoint Online (Microsoft 365) via a Microsoft Global SaaS admin account rather than the more usual route of a compromised endpoint.
    • “The attack was analyzed post-compromise when the victim employed the Obsidian product and research team to determine the finer points of the attack. In its blog account of the incident, Obsidian did not disclose the victim but believes the attacker was the group known as 0mega.”
  • and
    • “Japanese pharmaceutical giant Eisai [a developer of the new Alzheimer’s Disease drug Leqembi] this week announced that it has fallen victim to a ransomware attack that forced it to take certain systems offline.
    • “Headquartered in Tokyo, the company has manufacturing facilities in Asia, Europe, and North America and has subsidiaries on both American continents, in Asia-Pacific, Africa, and Europe. Last year, the company reported more than $5 billion in revenue.
    • “The ransomware attack, the company says in an incident notification on its website, was identified on June 3 and resulted in the encryption of multiple servers.
    • “Eisai says it immediately implemented its incident response plan, which involved taking systems offline to contain the attack, and launched an investigation.”

From the cybersecurity defenses front —

  • On June 6, “CISA, Federal Bureau of Investigation (FBI), the National Security Agency (NSA), Multi-State Information Sharing and Analysis Center (MS-ISAC), and the Israel National Cyber Directorate (INCD) released the Guide to Securing Remote Access Software. This new joint guide is the result of a collaborative effort to provide an overview of legitimate uses of remote access software, as well as common exploitations and associated tactics, techniques, and procedures (TTPs), and how to detect and defend against malicious actors abusing this software.”  
  • ISACA discusses the increasing importance of information technology audits to Boards of Directors.
  • Security Boulevard offers ten “go-to” tips for achieving/maintaining HIPAA Security Rule compliance.
  • Help Net Security suggests twenty cybersecurity projects on GitHub you should check out.

Friday Factoids

David Ermer–CMS, FDA, Federal employment benefits, Generative AI, Medicare, SDOH, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From the FDA front —

  • MedPage Today tells us
    • “Lecanemab (Leqembi) showed clinical benefit in early Alzheimer’s disease in its confirmatory trial, paving the way for traditional approval of the drug, an FDA advisory committee said Friday.
    • “In a 6-0 vote, the agency’s Peripheral and Central Nervous System Drugs Advisory Committee fully backed the evidence supporting the anti-amyloid monoclonal antibody. * * *
    • “The agency is expected to make its final decision about lecanemab by July 6.
  • KFF provides a cost perspective in anticipation of FDA approval of this drug, which action is expected to trigger CMS approval for Medicare Part B coverage.

From the FEHB front, Tammy Flanagan writing in Govexec delves into FEHB and Medicare Part B coverage.

From the litigation front —

  • The Wall Street Journal reports
    • “Pharmaceutical industry giants completed a deal to pay $19 billion to states that accused them of fueling the opioid crisis, infusing more money into communities still struggling with how to address the scourge of drug use.”
    • “Most states agreed to the deal to settle agreements with manufacturers Teva and Allergan as well as pharmacy chains CVS and Walgreens. The agreement is in addition to a $26 billion so-called global settlement with drug distributors McKesson, Cardinal Health and AmerisourceBergen and manufacturer Johnson & Johnson. The latest settlements close lawsuits against most of the major players and brings the total income from opioid litigation that states will have to spend to about $50 billion. 
    • “The legal fight stretches back nearly a decade, when more than 3,000 lawsuits from states, Native American tribes and counties alleged the drugmakers, pharmacies and distributors played down the risk of painkillers and didn’t stem their flow. Misuse of prescription painkillers sparked a health crisis that was supercharged as fentanyl infiltrated the illicit drug supply and now claims more than 100,000 lives in the U.S. each year. 
    • “Money from the recent settlements will begin to flow to states this year. More than $3 billion from the global settlementhas already been dispersed. The funds are distributed to states based on population adjusted to account for the burden of the opioid epidemic based on deaths and people using drugs. The agreements require most of the money to be spent on abating the opioid crisis, but the parameters are broad and officials are using different strategies to spend it.”
  • KFF has created a tracker to follow the distribution of the opioid litigation settlement funds.

From the CMS front —

  • Healthcare Dive informs us,
    • “CMS is exploring programs that would pay social or community health workers to address patients’ social needs in a bid to invest more heavily in food, housing, transportation and other social determinants of health, according to agency officials.
    • “We are looking at that. For example, in maternal health, thinking about the role of doula and community health workers,” Liz Fowler, director of the Center for Medicare and Medicaid Innovation, said on Thursday during the CMS’ inaugural health equity conference.”
  • and
    • “CMS announced a new model that aims to strengthen and improve primary care, including by ensuring small and rural organizations are able to enter into value-based care arrangements. 
    • “The Making Care Primary Model will run for more than 10 years in eight states — in Colorado, Massachusetts, Minnesota, New Jersey, New Mexico, New York, North Carolina and Washington.
    • “Research shows primary care is key to improving health outcomes and lowering costs. The CMS noted Medicare and Medicaid patients are often diagnosed with multiple chronic conditions, and primary care providers are charged with prevention, screening and management. But, because many patients will see multiple specialists, coordinating care can be challenging.”
  • Fierce Healthcare relates,
    • “The Department of Health and Human Services (HHS) has released a 43-drug list of the Medicare Part B prescription treatments that must repay the program for raising prices above the rate of inflation.
    • “The second quarterly list takes effect in July and is an expansion over the 20 price-capped drugs from April through June. According to HHS, the rebates could save Medicare beneficiaries taking the treatments anywhere from $1 to $449 per average dose in out-of-pocket costs.
    • “The Medicare Prescription Drug Inflation Rebate Program is a critical way to address long-term price increases by drug companies, and [the Centers for Medicare and Medicaid Services (CMS)] is continuing our work to make prescription drugs more affordable for people with Medicare,” CMS Administrator Chiquita Brooks-LaSure said in a release.
    • “The full list of prescription drugs and biological products with adjusted coinsurance amounts for July 1 to Sept. 30 is available here (PDF).
    • “Of note, CMS said the list could be adjusted before or after July 1 based on public feedback notifying the agency of any potential discrepancies, as was the case during the program’s inaugural quarter when a highly publicized list of 27 drugs was later trimmed down to 20.”

From the U.S. healthcare business front —

  • Beckers Hospital Review reports
    • “In the first quarter of 2023, 17 healthcare companies with more than $10 million in liabilities filed for Chapter 11 bankruptcy, a sharp rise compared to seven bankruptcies in the first quarter of 2022, Bloomberg Law reported June 9.
    • “High-profile bankruptcies from Envision, Invacare Corp. and Sorrento Therapeutics contributed to the numbers. The first three months of 2023 saw a slight slump in bankruptcies but remain higher than the same period a year ago.
    • “Despite the year-over-year increase, the first quarter of 2023 still had fewer healthcare bankruptcies than the fourth quarter of 2022.
    • “Once the government money ran out, once all the stimulus dollars around healthcare ran out, there was essentially going to be this backwash,” Timothy Dragelin, a healthcare director at FTI Consulting, told Bloomberg. “The fact that labor costs increased substantially—you also had the issues with supply chain and supply chain caused some disruptions.”
  • Fierce Healthcare tells us
    • “Walgreens Boots Alliance sold its remaining stake in post-acute care and infusion services company Option Care Health for $330 million.
    • “The drugstore chain announced Thursday it sold 10.8 million shares of Option Care Health and plans to use the proceeds primarily for debt paydown, continued support of the company’s strategic priorities and to help fund its healthcare-focused business initiatives, according to a press release.
    • “The transaction is another decisive action WBA is taking to unlock value and further simplify the company’s portfolio,” the company said.
    • “Back in March, Walgreens cut its stake in Option Care Health when it sold 15.5 million shares at $30.75 per share. The transaction reduced Walgreen’s ownership in the company, formerly known as Walgreens Infusion Services, from 14% to 6%, according to a Walgreens news release. “

From the generative AI front —

  • Beckers Hospital CFO Report points out the steps the Google and Microsoft are taking to integrate generative AI in healthcare systems.
  • HR Dive discusses the impact of generative AI on employers and the workplace.

Thursday Miscellany

David Ermer–CMS, Congress, COVID-19 vaccine, FDA, HSA, Medical / Rx research, Medicare, Rx coverage, Telehealth–
Photo by Josh Mills on Unsplash

From Washington, DC —

  • The Senate Finance Committee held a hearing today about “Consolidation and Corporate Ownership in Health Care: Trends and Impacts on Access, Quality, and Costs.”
  • Mercer Consulting informs us
    • “Two key House committees voted this week to send a series of health care bills to the House floor, including legislation to make permanent the ability of health savings account-qualifying high-deductible health plans (HSA-qualifying HDHPs) to cover telehealth and other remote care services on a predeductible basis. Originally enacted as part of the 2020 Coronavirus Aid, Relief and Economic Security (CARES) Act, this flexibility was most recently extended as part of the 2023 Consolidated Appropriations Act, and now is set to expire on Dec. 31, 2024, for calendar-year plans (later for noncalendar-year plans).”
  • “The U.S. Department of Health and Human Services (HHS) released the STI Federal Implementation Plan to detail how various agencies and departments across the federal government are taking a comprehensive approach to making meaningful and substantive progress in improving public health. This new plan builds on other key HHS actions to protect the public’s health by addressing the growing threat of sexually transmitted infections (STIs) in America.”
    • Roll Call identifies potential obstacles to implementing this plan.
  • Govexec reports
    • “As smoke from Canadian wildfires moves into the Northeast and Mid-Atlantic regions of the United States, triggering air quality warnings in several cities, the Office of Personnel Management on Thursday reminded agencies to protect the health of federal workers who ordinarily may work or commute to work amid the hazardous haze.”
      • Healthcare Dive discusses health system reactions to this problem.
        • “Hospitals in the northeastern U.S. are keeping an eye on air quality as smoke from Canadian wildfires envelops the region. Most health systems contacted by Healthcare Dive did not report significant spikes in patient volumes yet, but they said they’re continuing to monitor the situation.
        • “Millions of people live in areas currently under air quality alerts, and meteorologists say conditions may not significantly improve for a few more days.
        • “Health systems in the region are urging residents to stay indoors and use masks — particularly snug-fitting N95s — when traveling outside. Though everyone should limit their time outdoors, it’s especially important for older people, children and pregnant women as well as those with conditions like heart or lung disease or asthma, according to Kristin Fless, a pulmonologist at RWJBarnabas Health Medical Group.”
  • The Wall Street Journal relates
    • “Ashish Jha, the White House Covid-19 czar, will be leaving his post next week in the latest sign the Biden administration is confident the country is on stronger footing in its fight against the virus.
    • “Jha plans to leave June 15 and return July 1 to his previous position as dean of Brown University’s School of Public Health. He will be the last of the administration’s rotating Covid-19 czars. Instead, the director of the White House’s nascent Office of Pandemic Preparedness and Response Policy, who hasn’t been named, will advise the president and coordinate federal responses to various biological and pandemic threats.”

From the  public health front —

  • Mercer Consulting tells us
    • Our research over the past few years has tracked the ways employers are working to align employee benefit programs with their organizations’ overarching DEI goals. For Pride month, here’s a round-up of survey results relating to health and well-being benefits of particular importance to the LGBTQ+ community.
    • Here’s a link to the article.
  • The American Hospital Association reports
    • “The first data on the safety of a third mRNA COVID-19 vaccine dose among young children show that a third dose is safe for children ages 6 months to 5 years old, similar to findings for doses one and two, the Centers for Disease Control and Prevention reportedtoday, based on reports to the Vaccine Adverse Event Reporting System and v-safe voluntary smartphone health checker for use after vaccination.
    • “This study’s findings can reassure health care professionals, parents, and caregivers that a third dose of COVID-19 vaccine is safe for children ages 6 months to 5 years and can protect them from severe illness,” CDC said.
    • “While CDC recommends that all children ages 6 months through 5 years old receive at least 1 bivalent mRNA COVID-19 vaccine dose, vaccination rates among this age group have been low.”
  • Health Payer Intelligence informs us
    • “Group health insurance plan members with high healthcare spending often have one or more of the same five chronic diseases, according to a fast facts sheet from the EBRI Center for Research on Health Benefits Innovation (EBRI CRHBI).
    • “The study covered healthcare claims from 8.6 million group insurance health plan members using 2021 data from the Merative MarketScan Commercial Database. Members were 65 years of age or younger and the health plans covered a variety of types.
    • “Five conditions were very common among the group health insurance plan members with the highest healthcare spending: heart disease, respiratory conditions, musculoskeletal conditions, nervous system conditions, and skin disorders. A couple of these are among the most expensive chronic diseases in the US. They are also some of the most common comorbidities.”

From the Rx coverage front —

  • BioPharma Dive notes that tomorrow a Food and Drug Administration advisory committee will consider recommending that the FDA give full marketing approval to the Alzheimer’s drug Leqembi.
    • “A closely watched Alzheimer’s disease medicine appears to be heading toward broader approval, as documents released Wednesday show the Food and Drug Administration appears to have few concerns with it.”
  • BioPharm Dive also tells us that “After years of disappointment, cancer vaccines show new promise. Moderna presented new data at ASCO for its melanoma shot, highlighting progress with a personalized approach that’s also being pursued by BioNTech and Gritstone.”
    • “Moderna is testing its shot, mRNA-4157, together with Merck’s immunotherapy Keytruda in people with melanoma who have had their primary tumors removed. The goal of such “adjuvant” treatment is to prevent cancer from returning.
    • “In December, the company reported the two drugs reduced the relative risk of death or recurrence by 44% over Keytruda alone. The new data came from an analysis of the risk of cancer spreading to distant organs or tissues, or “distant metastasis free survival.”
    • “One-third of patients who receive Keytruda in this setting experience such spread, driving researchers’ work to come up with better options. “We know that patients with distant metastases experience more morbidity and mortality,” said Adnan Khattak, a clinical professor at Edith Cowan University in Australia, who presented the Moderna data at ASCO.
    • “In the combination trial, mRNA-4157 and Keytruda reduced the risk of distant spread or death by 65% compared to Keytruda alone.”
  • The Associated Press reports
    • “A growing shortage of common cancer treatments is forcing doctors to switch medications and delaying some care, prominent U.S. cancer centers say.
    • “The National Comprehensive Cancer Network said Wednesday that nearly all the centers it surveyed late last month were dealing with shortages of carboplatin and cisplatin, a pair of drugs used to treat a range of cancers. Some are no longer able to treat patients receiving carboplatin at the intended dose or schedule. 
    • “Dr. Kari Wisinski has had to turn to other treatments for some patients or switch the order in which people receive their drug combinations. She said she’s done that “hoping that within three months there will be a better carboplatin supply.” * * *
    • “The U.S. Food and Drug Administration has taken some steps to try to ease the chemotherapy shortage. The agency is allowing the temporary importation of some foreign-approved versions of cisplatin from factories registered with the FDA.”
  • Beckers Hospital Review adds “Seventy percent of the 20 most commonly prescribed medications from GoodRx are in shortage, according to databases from the FDA and the American Society of Health-System Pharmacists.” The article goes on to list the drugs subject to shortages.

From the Medicare front —

  • Beckers Payer Issues informs us
    • “The FDA and CMS are discussing how to handle obesity drugs in Medicare, Bloomberg Law reported June 7. 
    • “The two agencies are in talks over “what to do about obesity drugs,” FDA Commissioner Robert Califf said at the Biotechnology Innovation Organization convention in Boston. Mr. Califf’s comments indicate CMS could expand weight loss benefits, according to Bloomberg Law’s report. 
    • “New GLP-1 drugs to treat obesity and diabetes can be expensive, costing upward of $10,000 a year without insurance coverage. GLP-1 drugs, including Ozempic, Trulicity, Victoza and Mounjaro, are used to treat Type 2 diabetes. Wegovy and Saxenda are approved for weight loss.  
    • “Under current law, Medicare is prohibited from covering weight loss drugs. Drug manufacturers are lobbying Congress to require the program to pay for the drugs. Proposed legislation to pay for the drugs has stalled. 
    • “The drugs could have a big effect on Medicare Part D spending. If 10 percent of people with obesity covered by Medicare were prescribed a brand-name semaglutide, a type of GLP-1, the drug would cost Medicare $26.8 billion annually, according to a study published in the New England Journal of Medicine in March.”
  • and
    • “Medicare spending per person grew by an average of 4.6 percent annually between 2000 and 2022, according to a June 6 analysis from KFF. 
    • “KFF analyzed data from the 2023 Annual Report of the Boards of Trustees of the Federal Hospital Insurance and Federal Supplementary Medical Insurance Trust Funds. 
    • “KFF said the “influx of the Baby Boomer Generation added many relatively younger, healthier people to the Medicare beginning in 2011,” while the share of adults aged 80 and older enrolled in the program also continues to grow. Growth in healthcare spending is attributed to this increased volume and use of services, along with the availability of new technologies and rising prices.”
      • 2018: $13,579
      • 2019: $14,189
      • 2020: $14,373
      • 2021: $15,139
      • 2022: $15,727

Midweek update

David Ermer–Generative AI, Medical / Rx research, Mental health care, Patient safety, SDOH, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington DC —

  • STAT News tells us,
    • “Ahead of a major Food and Drug Administration meeting on a new Alzheimer’s treatment this week, several Democratic lawmakers are ratcheting up their criticism of how the Biden administration is planning to handle a potential approval this summer.
    • “Sen. Bernie Sanders (I-Vt.), who leads the Senate’s health committee, wrote to health secretary Xavier Becerra on Wednesday asking him to ”use the full extent” of his authority to ensure Medicare doesn’t pay the list price of $26,500 for Eisai and Biogen’s Leqembi.”

From the U.S. healthcare business front —

  • Healthcare Dive informs us,
    • “The financial performance of the seven largest publicly traded U.S.-based insurers remains stable so far this year, despite “continued challenges” in the healthcare sector, according to a report out Tuesday from credit ratings agency Fitch Ratings.
    • “Though persistent staffing shortages and high inflation has been pressuring healthcare providers, the largest payers, which Fitch estimates to account for about 70% of the privately ensured U.S. population, reported a 7.7% operating EBITDA margin in the first quarter compared with 7.6% during the same period in 2022.
    • “However, the report noted that cost pressures at the provider level could impact payer and provider contract negotiations and cause premium rates to increase over the next few years, contributing to “heightened public discourse around healthcare costs for consumers.”
  • Per the Lown Institute —
    • A recent New York Times investigation found that Allina Health System, a nonprofit health system in the Midwest, has been rejecting patients for appointments if they have unpaid medical bills. If patients amass at least $1,500 in medical debt three separate times, they may not be allowed to come back to a clinic or hospital until they pay up. In many cases, Allina’s electronic health record system precludes doctors from making new appointments with patients that have unpaid debt.
    • The policy, which was started in 2006, applies to patients struggling with chronic conditions like diabetes and depression, and is even applied to children. The Times heard from doctors and patients who described being unable to complete medical forms that children needed to enroll in day care or show proof of vaccination for school. Allina’s dominance in the region also means that patients who are rejected for care–especially patients in rural areas–may have trouble finding other providers. 
    • How is a nonprofit system allowed to deny needed care for patients with debt? While nonprofit hospitals are required by federal law to accept any patient for emergency care regardless of ability to pay, the same requirement doesn’t apply to non-emergency care. 
    • Because there aren’t regulations against this practice, Allina is not alone in rejecting patients with debt. According to a 2022 KFF Health News investigation of 528 hospitals sampled nationwide, 55 indicated in their written policy that they do allow deniels of non-emergency care for patients with medical debt, 22 said this is allowed but not current practice, and 85 others had no information in their policy on whether or not they do this. (Allina Health Faribault Medical Center was included in this last group, but no other Allina hospitals were included in the study). Among the hospitals that allow for care denials are within some of the largest nonprofit systems in the country, including Ascension, Indiana University Health, Cedars-Sinai Medical Center, Mayo Clinic, Trinity Health, and more.

From the healthcare research front, BioPharma Dive offers its wrap-up report on the ASCO conference held in Chicago this week.

From the SDOH front —

  • Healthcare Dive points out,
  • “Patients of color, or those on public insurance, are still at increased risk for certain adverse events compared to White patients, regardless of high hospital safety ratings, according to a report out Wednesday from the Leapfrog Group.
  • “Although higher hospital safety ratings generally correspond with fewer adverse safety events, the report found that pattern doesn’t hold true for patients of color or those on Medicare or Medicaid, who were more likely to experience adverse events after surgery, including sepsis, blood clots and respiratory failure.
  • “Rather than suggesting problems with individual hospitals, the data points to a “systemic issue impacting the quality of care for Black and Hispanic patients and those with public insurance plans,” according to the report.”

From the mental healthcare front, Health Payer Intelligence discusses six strategies that payers can use to promote behavioral health prevention, along with a strong provider network.

From the litigation front —

  • Fierce Healthcare reports
    • “A federal appeals court held a brief hearing Tuesday afternoon to hear from attorneys on both sides as it decides whether to lift a nationwide freeze on a lower court’s ruling that struck down preventive care protections in the Affordable Care Act (ACA).
    • “A panel of judges at the Fifth Circuit Court of Appeals, based in New Orleans, issued a stay on the District Court ruling while the appeals process plays out, though it could choose to lift the stay following Tuesday’s hearing. Legal experts expect a decision on the pause in short order.”
  • The FEHBlog is willing to bet the ranch that the panel will uphold the existing stay.

From the generative AI front —

  • Healthcare Dive relates
    • “Google is linking up with longtime collaborator Mayo Clinic to explore generative artificial intelligence’s applications in the hospital, the tech giant announced Wednesday morning.
    • “Mayo will use a Google Cloud tool that lets organizations create chatbots and search applications using generative AI to answer complex questions and produce summaries faster than traditional search functionalities.
    • “Mayo could improve the efficiency of clinical workflows and make it easier for clinicians and researchers to find information, Google said.”

In federal employee benefits news, Federal News Network tells us

  • “The Office of Personnel Management’s backlog of retirement claims dropped by 2,259 in May. OPM received 6,096 claims, just over 2,200 fewer than in April, which saw 8,298. OPM processed 8,355 claims, bringing down the inventory backlog to 18,125, the lowest it has been since June 2020, when it reached 17,432.
  • “OPM still has improvements to make, as the inventory backlog is more than 5,000 claims above the steady state goal of 13,000.”

Tuesday Tidbits

David Ermer–Medical / Rx research, Medicare, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the public health front —

  • STAT News reports,
    • “Ten years ago, clinicians in a handful of hospitals around the United States began sequencing the genomes of apparently healthy babies, seeking to understand how the technology might turn up hidden genetic disorders that aren’t being caught by routine newborn blood testing. New research from one such trial suggests the impact of having that kind of information extends far beyond the baby whose DNA is being decoded.
    • “In a study published Monday in the American Journal of Human Genetics, researchers from Mass General Brigham and Boston Children’s Hospital reported that of the first 159 infants to undergo screening through genomic sequencing, 17 were discovered to have unanticipated mutations in disease-associated genes.
    • “Over the next three to five years, in the majority of the 17 infants’ families, these discoveries prompted parents and other relatives to get additional testing that led to uncovering the cause of diseases running through their family trees. In three cases, mothers who learned they carried a gene that drastically elevated their risks of certain cancers chose to undergo prophylactic surgeries to reduce those risks — a finding that the lead researcher says undercuts ethical objections to informing families of genetic findings even when they aren’t immediately actionable for the newborn.
    • “This is a real-world rebuttal to the prevailing notion that we should not be sharing adult-onset disease-risk variants in children,” said Robert Green, a medical geneticist at Harvard and Brigham and Women’s Hospital who leads the BabySeq study that produced the new research. “There are ethicists who say a child should not be used as a genetic canary in a coal mine — that one member of a family should not be used without their consent as the access point for a whole family, but I’d like to challenge that. Look at these mothers. We arguably saved their lives. Are you really going to put that up against a theoretical loss of autonomy at some point in the child’s future?”
  • Health Day tells us,
    • “Women who consistently adhered to mammography guidelines had better odds for survival if they were then diagnosed with breast cancer, study found.
    • “Delays in screening can contribute to being diagnosed with advanced disease.
    • “The findings were to be presented [last] Sunday at the annual meeting of the American Society of Clinical Oncology in Chicago. Findings presented at medical meetings should be considered preliminary until published in a peer-reviewed journal.
    • “There has been much debate about when to start breast cancer screening, how often screening should occur, and how many screening exams are necessary. “This study suggests that a missed breast cancer screening has consequences,” said Dr. Arif Kamal, chief patient officer for the American Cancer Society.”
  • The NIH Director discusses “Encouraging First-in-Human Results for a Promising [mRNA] HIV Vaccine.”
  • As we enter the summer months, Bloomberg Prognosis provides insights into suncreens.

From the U.S. healthcare business front —

  • STAT News and EndPoints offer fascinating interviews respectively with Susan Galbraith, head of AstraZeneca’s oncology research and development and Emma Walmsley, the Glaxo Smith Kline (GSK) chief executive officer.
  • Beckers Hospital Review ranks health systems by operating margins.
  • The Wall Street Journal examines why “a growing group of physicians are ditching medicine’s traditional career path and hitting the road as temporary doctors-for-hire.”
  • Kaiser Foundation News reports that doctors of osteopathy are filling the growing MD gap in rural areas of the U.S.
  • MedCity News reports that “Doulas — who provide physical, emotional and informational support to expectant mothers — have shown to improve maternal health outcomes, but there’s little insurance coverage of their services. That’s starting to change, however, particularly in Medicaid programs.”
  • Fierce Healthcare tells us,
    • “Evernorth has inked a strategic partnership with CarepathRx Health System Solutions that aims to boost access to specialty pharmacy care.
    • “Through the partnership, the two will provide integrated specialty pharmacy services to CHSS’ growing clientele, which includes more than 600 hospitals, health systems and physicians. This will allow these providers to diversify the ways they can support patients, according to an announcement.
    • “As part of the partnership, Evernorth will make a “significant minority investment” in CHSS that it expects to close late in the second quarter or in the third quarter of 2023.”
  • and
    • “Humana’s primary care arm opened its 250th clinic in Dallas on Tuesday, marking another milestone in the insurer’s growth in the provider space.
    • “The Medicare Advantage giant has established a multiyear effort to continue scaling CenterWell and expects to open between 30 and 50 centers per year through 2025. In addition to the senior-focused primary care clinics, CenterWell also houses Humana’s home health business, another key strategic focus, and is sister to the Conviva Care Center brand.
    • “Collectively, Humana’s Primary Care Organization cares for 266,000 seniors across its markets.
    • “The ongoing expansion cements CenterWell as one of the country’s fastest-growing providers of value-based, senior-focused care. It operates clinics in 12 states: Arizona, Florida, Georgia, Kansas, Kentucky, Louisiana, Missouri, Nevada, North Carolina, South Carolina, Tennessee and Texas.”

From the litigation front —

  • Roll Call tells us,
    • “Drugmaker Merck & Co. Inc. sued the federal government Tuesday, seeking an injunction against parts of last year’s reconciliation law that allow the Health and Human Services Department to negotiate for lower prices on [a certain subset of prescription] drugs.
    • “The lawsuit, filed in the U.S. District Court for the District of Columbia, argues that the negotiation program is “extortion” and violates the Fifth Amendment by not paying the company “just compensation” for its products.
    • “By coercing Merck to provide its drug products at government-set prices, the Program takes property for public use without just compensation in violation of the Fifth Amendment,” Robert Josephson, Merck’s executive director of global media relations, said in a statement.”
  • Beckers Payer Issues relates,
    • “A federal judge in St. Louis issued a preliminary injunction barring former Cigna executive Amy Bricker from working for CVS Health, while a lawsuit over her noncompete clause moves forward. 
    • “In the June 5 order, Judge Ronnie White said that Ms. Bricker is prohibited from providing any services to CVS Pharmacy, CVS Health, any of its entities or any other business that is “engaged in a business similar to, or that competes with, the business of Cigna.” She is also barred from disclosing Cigna trade secrets or confidential information.” 

From the miscellany / tidbits department

  • The Office of National Health Information Technology Coordinator released
    • “the draft USCDI+ Quality data element list for public comment on the eCQI Resource Center website. This release provides an initial, high-level picture of the USCDI+ initiative in action. It is a harmonized set of data elements for quality measurement that could be used to support measurement and reporting across a wide number of quality programs. ONC requests feedback on this draft list by 11:59pm ET on June 30, 2023, particularly its level of completeness, level of specificity, and the usefulness of companion guidance.
    • “The draft USCDI+ Quality is the most recent milestone for the USCDI+ initiative, which supports our federal agency partners to build on the USCDI standard adopted by ONC in 2020 and was first described in this blogfrom October 2021. The draft USCDI+ Quality includes data elements in the USCDI; however, as a core data set, the USCDI standard itself does not include each data element needed for quality measurement use cases. Through USCDI+ Quality, ONC is seeking to extend from the USCDI model to establish a consistent baseline of harmonized data elements for a wide range of CMS and other quality measurement use cases. Once mature, the USCDI+ Quality data element list can inform technical specifications and implementation guidance needed to enable more flexible, modernized, and robust approaches to standardizing and sharing data.”
  • Fierce Healthcare adds,
    • “The roughly half of American smartphone users with iPhones will notice new health and privacy features on their devices starting today.
    • “In addition to iPhones being equipped with new health features, Apple’s update will give iPad and Apple Watch users access to new tools. All three platforms will gain features that encourage healthy behaviors, reduce the risk of myopia, or nearsightedness, and provide ways to assess and address depression, according to the company. The new features were announced as part of Apple’s Worldwide Developers Conference 2023Monday.
    • “By bringing the Health app to the iPad, the tech giant hopes to inspire even more Apple users to take a proactive approach to their health.
    • “Our goal is to empower people to take charge of their own health journey. With these innovative new features, we’re expanding the comprehensive range of health and wellness tools that we offer our users across iPhone, iPad and Apple Watch,” said Sumbul Desai, M.D., Apple’s vice president of Health, in a press release. “Mental health and vision health are important, but often overlooked, and we’re excited to introduce features that offer valuable new insights to provide users with an even better understanding of their health. These insights help support users in their daily decisions and offer more informed conversations with their doctors.”

Monday Roundup

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

From the public health front —

  • The Wall Street Journal reports
    • “Doctors are coalescing around the ironic idea that for some cancer treatment, less can be better. 
    • Some patients with cervical and pancreatic cancer can do as well with less invasive surgery, according to research presented at the American Society of Clinical Oncology conference in Chicago over the weekend. Other studies at the annual meeting showed some patients with rectal cancer or Hodgkin lymphoma can safely get less radiation. 
    • “The findings expand a body of evidence doctors are using to design treatment plans that aim to reduce side effects and costs. They call the strategy de-escalation: cutting back on some therapies to improve a patient’s quality of life without hurting their odds of survival.
    • “Newer treatments and tests are extending patients’ lives and moving cancer care away from a blunt, one-size-fits-all approach. On the strength of studies like those presented in Chicago, doctors are getting better at determining who needs the most aggressive care and who can get away with less treatment and less collateral damage.
  • The Journal also reminds readers that
    • “The approach of summer means warmer days, more time outside—and nagging worries about ticks. What to do if you find one on yourself?
    • “Get it off, pronto. To infect you with Lyme disease, a tick must bite and attach to your skin, typically for at least 24 hours. Take care as you remove it. In some cases, you should call your doctor after you take it off.
    • “Lyme disease is especially common in the Northeast and Midwest, transmitted by blacklegged ticks. They can transmit other pathogens that cause different diseases, too. And other types of ticks can transmit other diseases.
    • “This year, parts of the Northeast should expect a particularly bad season for tick-borne diseases, says Richard S. Ostfeld, a senior scientist at the Cary Institute of Ecosystem Studies in Millbrook, N.Y., who has been monitoring local tick populations and their hosts for 30 years.”
  • Fierce Healthcare tells us,
    • “Self-insured employers face myriad challenges in trying to manage growing healthcare costs, and one of those results from recent history, according to a survey by the National Alliance of Healthcare Purchaser Coalitions (NAHPC).
    • “Employers are seeing a rise in high-cost claims for younger plan members, with $1 million+ claims disproportionately weighted toward this demographic,” the NAHPC survey said. “The top conditions for these claims include cancer, prenatal/neonatal care, and treatment for COVID-19/long COVID.”
    • “The NAHPC survey is based on input from the Alabama Employer Health Consortium, the Dallas Fort-Worth Business Group on Health, HealthCareTN and the Nevada Business Group on Health. NAHPC and affiliated organizations represent 45 million Americans who spend over $400 billion annually on healthcare. 
    • “The employers’ concerns come from a pre-survey of 39 firms that was conducted in October and November 2022 and a series of roundtables that NAHPC held with 50 employers conducted in November 2022.

From the Rx coverage front —

  • BioPharma Dive informs us,
    • “Johnson & Johnson expects its cancer cell therapy Carvykti to become a go-to option for treating multiple myeloma earlier, presenting Monday a fuller look at clinical trial results that show the therapy substantially outperformed the current standard.
    • “In the trial, Carvykti reduced the risk of disease progression or death by 74% versus one of two commonly used drug combinations in patients for whom a mainstay medicine called Revlimid no longer works. According to J&J, it’s the largest relative risk reduction to be reported in a Phase 3 study of a treatment for the blood cancer.”
  • Medscape relates,
    • “Patients with a certain type of brain tumor could soon be treated with an oral targeted drug instead of undergoing more toxic chemotherapy and radiation, say researchers reporting new results that could potentially change the treatment landscape.
    • “The investigational drug vorasidenib (Servier) is awaiting approval for use in gliomas bearing mutations in isocitrate dehydrogenase 1 and 2 (IDH1, IDH2).
    • “Results from the pivotal phase 3 INDIGO trial show that the drug was associated with a significant delay in time to disease progression when compared with placebo.  
    • “The median progression-free survival (PFS) was 27.7 months for patients on vorasidenib, compared with 11.1 months for patients assigned to placebo (hazard ratio (HR) for progression or death with vorasidenib of 0.39 (P < .0001).”
  • BioPharma Dive adds,
    • “Wedged into the surface of a tumor cell, the protein called HER2 acts as a homing beacon for some of the most potent cancer medicines developed. Its discovery decades ago, and abnormal abundance in some breast cancers, led to the development of targeted drugs like Herceptin that have greatly improved patient care.
    • “Results from an exploratory clinical trial unveiled Monday suggest targeting HER2 could also be a useful strategy against other cancers that are not as widely associated with the protein.
    • “The findings, which will be presented at the American Society of Clinical Oncology’s annual meeting in Chicago, show that a newer HER2-targeting drug called Enhertu shrank tumors of the uterus, cervix, ovaries, bladder and, to a lesser extent, bile duct. In this way, they’re another data point in a yearslong shift toward describing cancers by their genetics, rather than only by their location in the body.
    • “Developed by AstraZeneca and Daiichi Sankyo, Enhertu is different from drugs like Herceptin, which interfere with how HER2 incites tumor growth. Instead, Enhertu combines a targeting molecule aimed at HER2 with a cell-killing toxin in a biochemical assemblage known as an antibody-drug conjugate.
    • “The reason why this [result] is exciting is that the tumor doesn’t have to be addicted to HER2 to respond to this therapy,” said Angela DeMichele, a medical oncologist at Penn Medicine. “The HER2 in this case is acting as a docking station for delivery of the chemotherapy.”
  • The Institute for Clinical and Economic Research proposed today
    • “a set of changes to its methods and processes for conducting value assessments, beginning in 2024. These proposals are based on ICER’s experience in methods development for health technology assessment (HTA) reports in the US, benchmarking with HTA agencies around the world, and input from stakeholders across the US health system. ICER is accepting public comment on these proposals through June 30, 2023.
    • “Areas with proposed changes include:
      • “Clinical trial diversity ratings and other methods adaptations related to health equity.
      • “Cost-effectiveness scenarios related to potential effects of Medicare drug price negotiation.
      • “New methods to ensure that cost-effectiveness analyses done according to a modified societal perspective have “non-zero” inputs for impacts on productivity for the patient and caregivers, even when direct data are lacking.”

From the U.S. healthcare business front —

  • Fierce Healthcare reports
    • “The home health bidding wars are heating up as UnitedHealth Group’s Optum unit is making a big play for home health and hospice firm Amedisys.
    • “Just one month ago, Amedisys agreed to be bought by another healthcare company, Option Care Health, a provider of post-acute care and infusion services. That deal valued Amedisys at $3.6 billion. That deal was expected to close in the second half of 2023.
    • “Optum has made an all-cash offer of $100 per share to Amedisys’ board of directors, the healthcare behemoth announced Monday morning. The deal represents a “superior proposal for Amedisys shareholders, with price certainty at a 26% premium over most recent share price,” Optum executives said. According to news reports, the deal is valued at $3.26 billion
    • “Option Care Health proposed last month to buy the company for roughly $97.38 per share.
    • “On May 27, 2023, the Board determined that the unsolicited proposal received from Optum could reasonably be expected to result in an ‘Amedisys Superior Proposal’ as defined in Amedisys’ merger agreement with Option Care Health,” Amedisys wrote in a filing with the Securities and Exchange Commission (SEC). “As permitted by the terms of Amedisys’ merger agreement with Option Care Health, Amedisys entered into a confidentiality agreement with Optum on May 30, 2023, and is currently engaging in exploratory discussions with Optum with respect to Optum’s proposal.”

From the plan design front —

  • Govexec encourages federal and postal employees to consider a high deductible health plan with a health savings account for 2024. Although the Govexec headline is directed at federal and postal employees under age 65 also can take advantage of health savings accounts.
    • “Once you turn 55, you’ll be able to contribute an additional $1,000 per year as a “catch-up” contribution on top of the normal contribution maximum.
    • “Once you turn 65, a big change with your HSA takes place: You’re allowed to make non-medical distributions and only pay your regular tax obligations. Prior to age 65, non-medical distributions would create a 20% income-tax penalty on top of your normal taxes. This change gives you more flexibility on how to use your HSA funds, including as supplemental retirement income.
    • “There are other healthcare-related qualified expenses that you can choose to use your HSA for in retirement and pay no taxes on. The premium for long-term care insurance, which pays for nursing homes and assisted living centers, is a qualified expense, as are Medicare Part B and D premiums both for you and a spouse.”