FEHBlog

Tuesday’s Tidbits

David Ermer–AHRQ, CDC, FDA, Medical / Rx research, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the public health front —

  • Health Affairs launched a new publication called Health Affairs Scholar. Health Affairs also made available its lead article in the new publication titled “Ten Health Policy Challenges for the Next Ten Years.”
  • MedPage Today reports
    • “An increase in pediatric type 2 diabetes cases that began during school closures amid the COVID-19 pandemic has not returned to baseline, according to a retrospective study.
    • “Compared with the year before COVID emerged, the number of new pediatric type 2 diabetes cases ballooned during the first year of the pandemic (March 2020 through February 2021; P=0.005), and then jumped again during the second year (March 2021 through February 2022; P=0.0006), reported Esther Bell-Sambataro, MD, of Nationwide Children’s Hospital and the Ohio State University in Columbus, during ENDO 2023opens in a new tab or window, the annual meeting of the Endocrine Society.”
  • The Food and Drug Administration adds
    • “Today, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as additions to diet and exercise to improve blood sugar control in children 10 years and older with type 2 diabetes. These approvals provide a new class of medicines taken by mouth to treat pediatric type 2 diabetes. Metformin, the only other oral therapy available for the treatment of children with type 2 diabetes, was first approved for pediatric use in 2000.
    • “Compared to adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidly in children,” said Michelle Carey, M.D., M.P.H., associate director for therapeutic review for the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “Today’s approvals provide much-needed additional treatment options for children with type 2 diabetes.”
  • Also from the FDA
    • “Today, the U.S. Food and Drug Administration announced a new voluntary pilot program for certain oncology drug products used with certain corresponding in vitro diagnostic tests to help clinicians select appropriate cancer treatments for patients. 
    • “We believe this guidance and the launch of the pilot program are important steps towards addressing safety risks posed by the use of poorly performing laboratory-developed tests,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The pilot aims to help by making transparent performance recommendations for diagnostic tests used to select certain oncology drug treatments.”
  • The National Institutes of Health informs us
    • “A recent follow-up analysis of data from an international, National Institutes of Health-funded clinical trial suggests daily low-dose aspirin increases the risk of anemia in people age 65 years and older by approximately 20%. Given these findings, older adults on low-dose aspirin and their care providers may want to consider periodic monitoring of red blood cells or hemoglobin. Anemia in older adults is associated with functional decline, increased fatigue, disabilities, depressive symptoms, and cognition problems.
    • “Published in the Annals of Internal Medicine, scientists from the Aspirin in Reducing Events in the Elderly (ASPREE) study examined the effect of long-term low-dose aspirin use on incident anemia and the effect of aspirin on changes in hemoglobin concentration, as well as ferritin levels, as an indicator of iron deficiency. The researchers found that low-dose aspirin led to increased incident anemia in otherwise healthy older adults at enrollment, independent of major bleeding.”
  • The U.S. Preventive Services Task Force released a new recommendation — “Adults 64 years or younger, including pregnant and postpartum persons: Screen for anxiety. Grade: B” — and reissued a 2014 recommendation — “Adults, including pregnant and postpartum persons, and older adults (65 years or older): Screen for major depressive disorder (MDD). Grade: B.”
  • ICD10 Monitor alerts us
    • “The Centers for Disease Control and Prevention (CDC) released the ICD-10-CM codes for the 2024 fiscal year (FY) on Friday, June 16. This release included 395 additions, 25 deletions, and 13 revisions. The deletions are due to the expansion of the diagnosis codes. The total ICD-10-CM codes for FY 2024 is 74,044. These codes will be effective starting with Oct. 1, 2023, visits or discharges.”

From the federal employment front —

  • FedWeek tells us
    • “A hearing set for this week on three high-profile work backlogs likely will add to the pressure from House Republicans for agencies to reduce their levels of telework.
    • “The hearing in the House federal workforce subcommittee will “examine the backlogs of military and civil service personnel records requests, the Social Security Administration’s customer service line and disability claims, and passport backlogs. This hearing will also examine what steps agencies are taking to clear backlogs and provide timely service and support to the American people,” according to the panel.”
  • Govexec reports
    • “An advisory council dedicated to examining issues related to federal employee compensation issued no new recommendations for changes to the map of locality pay areas in a newly released report, instead urging quick implementation of proposals that already received a green light from the president’s pay agent.
    • “In a report dated Feb. 4 but only published by the Office of Personnel Management this month, the Federal Salary Council said none of the regions currently being studied by the Bureau of Labor Statistics regarding the pay disparity between federal workers and private sector employees currently meet the criteria to become locality pay areas.
    • “Instead, the council, which is made up of a mix of presidentially appointed federal human resources experts and representatives of unions and other federal employee organizations, focused its report on reiterating a series of recommendations approved last December by the president’s pay agent, a body made up of OPM Director Kiran Ahuja, Office of Management and Budget Director Shalanda Young and then-Labor Secretary Marty Walsh. But in order for those recommendations to be implemented, OPM must first issue regulations.
    • “In terms of discreet additions to the map of locality pay areas, the salary council urged swift action to implement the new locality pay areas of Fresno, Calif.; Reno, Nev.; and Spokane, Wash. Additionally, Dukes and Nantucket counties, Mass., would join the Boston locality pay area; Huron County, Mich., will join the Detroit locality pay area; and Pacific and San Juan counties, Wash., would be included in the Seattle locality pay area. And Greensville County and the city of Emporia in Virginia would both become part of the Richmond locality pay area.”
  • and
    • “The U.S. Postal Service is preparing layoff notices that could take effect in September, notifying staff earlier this month of the potential for workforce reductions. 
    • “USPS is allowing impacted workers to apply for lateral or downgraded positions, anticipating it can absorb the employees elsewhere. The changes will affect non-union staff in the logistics division serving in management positions. James Lloyd, a USPS director for labor relations policies and programs, said the reductions were developed “based on an evaluation of staffing criteria and manager levels” by headquarters personnel.”

From the U.S. healthcare business front —

  • HHS’s Agency for Healthcare Quality and Research released its annual update to the Compendium of U.S. Health Systems.
    • “The Compendium of U.S. Health Systems includes information on U.S. health systems, defined in this analysis to include at least one hospital and at least one group of physicians providing comprehensive care, and who are connected with each other and with the hospital through common ownership or joint management. The Compendium is updated on a regular basis, with the newest files released in June 2023:
    • “2021 Compendium (New)
    • “2020 Compendium (New)
    • “2018 Compendium“
  • Beckers Hospital Review ranks 35 health systems by revenue.
  • BioPharma Dive reports
    • “Eli Lilly has agreed to buy Dice Therapeutics for about $2.4 billion in a deal that gives the pharmaceutical giant a promising oral autoimmune disease drug in clinical testing.”
    • “Lilly will buy Dice, a young biotechnology company that went public in 2021, for $48 per share in cash, the companies announced Tuesday. The purchase price equates to a roughly 42% premium to Dice shares’ closing price Friday and about 40% above the average trading price over the last month.
    • “The deal is expected to close in the third quarter, pending regulatory clearance and the tender of a majority of Dice’s outstanding stock.”

Happy Juneteenth

David Ermer–Congress, Generative AI, Rx coverage, SCOTUS, SDOH, Telehealth, U.S. Healthcare–
Photo by Derek Lamar on Unsplash

Mercer Consulting offers us this background

  • “On June 19 this year, 96 year-old Opal Lee will once again invite others to join her on a 2.5 mile Walk for Freedom in Fort Worth, Texas. Known as the “Grandmother of Juneteenth,” Opal began campaigning decades ago for a national holiday to commemorate the anniversary of the day in 1865 when news of the Emancipation Proclamation finally reached the enslaved people in Galveston, Texas. In 2016, at age 89, Opal began a symbolic walk from Fort Worth to Washington D.C. in an effort to get 100,000 people to sign a petition to create the holiday. She was transported from city to city where she would walk 2.5 miles, representing the 2.5 years it took for freedom to reach Texas. By the time she made it to Washington, she had obtained over 1.5M signatures. In June 2021, her efforts succeeded – a bill to make Juneteenth a federal holiday was passed by Congress and signed into law by President Joe Biden.  
  • “Juneteenth has long been celebrated by Black people; Opal Lee has vivid memories of celebrating Juneteenth as a child in East Texas with music, food, and games. Since the creation of the federal holiday, more employers are recognizing its importance and embracing their role in promoting Juneteenth in the workplace. In 2021, just 9% of employers had made Juneteenth a paid company holiday. That jumped to 33% in 2022 and rose again this year, to 39%.”

Mercer Consulting adds

  • “For employers, the JAMA Open Network study [on healthcare disparities] underscores the pressing need to expand provider networks to be inclusive of diverse clinicians. By improving networks, and actively working with partners to dismantle barriers and biases within healthcare, we can begin to empower employees with choice – the ability to connect with providers who better understand their unique needs, experiences, and challenges. Diverse physician networks lead to stronger doctor-patient relationships, which ultimately lead to better health outcomes for marginalized populations.”

From Washington, DC —

  • The U.S. Supreme Court handed down five opinions last week. NPR identifies the remaining cases that it is tracking. (One of them the Indian Child Welfare Act was decided last week in favor of the Indian tribes.)
  • Last week, OMB’s Office of Information and Regulatory Affairs posted its Spring 2023 federal regulatory agenda. Here is a link to the OPM agenda. OPM is planning a second Postal Service Health Benefits Program rule and a rule that would accelerate the effective date of FEHB coverage for new federal employees.

Healthcare Dive reports

  • “The group that advises Congress on Medicare policy released a new report Thursday [June 15] with recommendations on telehealth, overpayments to Medicare Advantage plans and site-neutral payments across some outpatient care settings.
  • “The Medicare Payment Advisory Commission, or MedPAC, included telehealth in the report to satisfy a mandate from Congress after virtual care surged during the COVID-19 pandemic. Telehealth coverage under Medicare was limited before the public health emergency, and it was expanded to preserve access to care.
  • “The report found fee-for-service Medicare spending for telehealth care was $4.8 billion in 2020 and $4.1 billion in 2021, more than 30 times greater than 2019. Early findings show more telehealth use was associated with little change in quality, slightly improved access to care for some beneficiaries and slightly increased costs to Medicare.”

From the MD opinion front —

  • An emergency room doctor writing in MedPage Today gives us his take on the fentanyl crisis.
  • An oncologist writing in STAT News gives us her take on the cancer drug shortage. Her article’s title says it all: “Cancer drug shortages should have patients rioting in the streets.”

From the generative AI front, Healthcare IT News tells us, “An NYU Langone Health [large language model] LLM can predict hospital readmissions. The large language model is still in testing, but the AI tool had a median accuracy score of 77.8% compared to a physician score of 62.8%. The code base is now available to all healthcare organizations [via GitHub].

From the semaglutide drug front —

  • The Wall Street Journal reports that these drugs designed for weight loss also may bring alcohol and tobacco use from an addiction to a controllable level.
  • Politico discusses manufacturer lobbying efforts to convince Congress to cover these drugs for weight loss unconnected to diabetes.
  • Bloomberg informs us
    • “Some dosages of Eli Lilly & Co.’s Mounjaro are again in shortage, the latest in a line of recurring supply issues caused by patients using the diabetes medication as a weight-loss treatment.
    • “The latest shortage will result in “intermittent backorders” for three of six doses through July, according to an update posted by the US Food and Drug Administration on its website on Friday.
    • “Lilly spokesperson Jessica Thompson said the backorders were “due to continued dynamic patient demand” and would affect the three highest doses of Mounjaro. She also said the company is investing in expanding manufacturing capacity.”

From the miscellany front –

  • CNBC reports
    • “Bristol Myers Squibb on Friday sued the Biden administration over Medicare’s new powers to slash drug prices, the third such lawsuit to be filed against the program in a matter of days.
    • “The lawsuit filed in federal district court in New Jersey argues the Medicare negotiations violate the First and Fifth Amendments of the U.S. Constitution.
    • “Bristol Myers Squibb has asked the court to declare the program unconstitutional and prevent the Health and Human Services Department from forcing the company to enter negotiations.
    • “Bristol Myers Squibb’s arguments mirror those lodged last week by Merck, the first company to sue the federal government over the drug negotiations. The U.S. Chamber of Commerce has also sued HHS over the program with similar arguments.”
  • Fierce Healthcare relates
    • “Simple HealthKit has inked a deal with Walmart to bring at-home diagnostic tests, including diabetes, respiratory wellness and sexual wellness labs, to the largest retailer in the world.
    • “Through the retail giant’s website, customers can purchase tests bolstered by Simple HealthKit’s end-to-end healthcare infrastructure, including testing, follow-up and treatment. The digital health company’s HbA1c test identifies key markers for Type 2 diabetes. Respiratory wellness tests include influenza A, influenza B and respiratory syncytial virus. In light of a decrease in sexual health testing during the pandemic, customers can test for three of the most common STDs at home, chlamydia, gonorrhea and trichomoniasis.”
  • Health Payer Intelligence points out
    • Employer-sponsored health plan enrollment among nonelderly Americans will grow after 2025, accompanied by higher private payer premiums, a Health Affairs study found.
    • The study used Congressional Budget Office projections to estimate future coverage trends. However, the researchers noted many uncertainties embedded in these trends, including future economic, policy, and healthcare utilization changes. * * *
    • After 2025, enhanced subsidies will end and employment will increase, driving more people to employer-sponsored coverage. Approximately 157 million individuals may have employer-sponsored coverage in 2027. By 2033 this population will grow to 159 million.
    • Private-payer premiums will also trend upward from 2023 through 2033. In 2023, the private payer premium growth rate will be 6.5 percent. Premiums will grow 5.9 percent from 2024 to 2025 and 5.7 percent from 2026 to 2027. By 2033, the average premium increase will be 4.6 percent.
  • Of course, depending on the outcome of the 2024 federal election, it is possible that the ACA subsidies could be made permanent in 2025. Time will tell.

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy front, the Wall Street Journal offers its quarterly cyber regulations update for June 2023.

From the cybersecurity vulnerabilities and breaches front —

  • On June 16, HHS’s health sector Cybersecurity Coordination Center (HC3) announced
    • “On May 31, 2023, a Progress Software (formerly IPSwitch) published a notification disclosing that a critical vulnerability exists in their MOVEit Transfer software, which could result in unauthorized access and privilege escalation. The vulnerability is a SQL injection flaw that allows for escalated privileges and potential unauthorized access. An attacker could submit a crafted payload to a MOVEit Transfer application endpoint which could result in modification and disclosure of MOVEit database content. As of June 15, 2023, the vulnerability has been serialized with two separate CVEs: CVE-2023-35708 and CVE 2023-35036. The updates can be found on the Progress Security Center webpage.”
  • HC3 also released its May 2023 Cybersecurity Vulnerabilities Bulletin.
  • The Cybersecurity and Infrastructure Security Agency (CISA) added one more known exploited vulnerability to its catalog.
  • Health IT Security reports
    • “Johns Hopkins University and Johns Hopkins Health are actively investigating a cyberattack and data breach that occurred on May 31. Johns Hopkins said that the attack involved a “widely used software tool” and impacted “thousands of other large organizations across the world.”
    • “While the notice does not explicitly mention MOVEit, the timeline of the attack lines up with the discovery of a critical vulnerability in Progress Software’s MOVEit Transfer software, a widely used software tool.
    • “As previously reported, Clop ransomware has taken a special interest in this vulnerability and began exploiting the previously unknown SQL injection vulnerability on May 27.”
  • The Associated Press adds
    • “The Department of Energy and several other federal agencies were compromised in a Russian cyber-extortion gang’s global hack of a file-transfer program popular with corporations and governments [MOVEit], but the impact was not expected to be great, Homeland Security officials said Thursday.
    • “But for others among what could be hundreds of victims from industry to higher education — including patrons of at least two state motor vehicle agencies — the hack was beginning to show some serious impacts. 
    • “Jen Easterly, director of the Cybersecurity and Infrastructure Security Agency, told reporters that unlike the meticulous, stealthy SolarWinds hacking campaign attributed to state-backed Russian intelligence agents that was months in the making, this campaign was short, relatively superficial and caught quickly. 
    • “Based on discussions we have had with industry partners … these intrusions are not being leveraged to gain broader access, to gain persistence into targeted systems, or to steal specific high value information— in sum, as we understand it, this attack is largely an opportunistic one,” Easterly said.”

From the cybersecurity threat actors front —

  • HC3 issued a threat actor profile on FIN11
    • “FIN11 is a cybercriminal group that has been active since at least 2016, originating from the Commonwealth of Independent States (CIS). While the group has historically been associated with widespread phishing campaigns, the group has shifted towards other initial access vectors. FIN11 often runs high-volume operations mainly targeting companies in various industries in North America and Europe for data theft and ransomware deployment, primarily leveraging CL0P (aka CLOP). The group has targeted pharmaceutical companies and other health care targets during the COVID-19 pandemic and continues to target the health sector. The group is behind multiple high-profile, widespread intrusion campaigns leveraging zero-day vulnerabilities. It is likely that FIN11 has access to the networks of far more organizations than they are able to successfully monetize, and choose if exploitation is worth the effort based on the location of the victim, their geographical location, and their security posture. This Threat Actor Profile provides information associated with FIN11, including recent campaigns, associated malware, CVEs exploited, and TTPs.”
  • HHS’s Administration for Strategic Preparedness and Response released a TimisoaraHackerTeam analysis.
  • On June 13, “CISA, the Federal Bureau of Investigation (FBI), the Multi-State Information Sharing and Analysis Center (MS-ISAC), and international partners released Understanding Ransomware Threat Actors: LockBit, a joint Cybersecurity Advisory (CSA) to help organizations understand and defend against threat actors using LockBit, the most globally used and prolific Ransomware-as-a-Service (RaaS) in 2022 and 2023. This guide is a comprehensive resource detailing the observed common vulnerabilities and exposures (CVEs) exploited, as well as the tools, and tactics, techniques, and procedures (TTPs) used by LockBit affiliates. Additionally, it includes recommended mitigations to help reduce the likelihood and impact of future ransomware incidents.”
  • On June 15 Cybersecurity Dive reported
    • “A suspected threat actor affiliated with China is exploiting a subset of compromised Barracuda Email Security Gateway SG devices to launch a widespread espionage campaign in support of the People’s Republic of China, according to a report released Thursday by Mandiant. 
    • “The threat actor, tracked as UNC4841, has been sending emails with malicious attachments since October 2022, in order to exploit the zero-day vulnerability disclosed in May. The hackers used a variety of custom malware to maintain a presence in targeted systems, and most of the exploitation taking place in the Americas. 
    • “This is the broadest cyber espionage campaign known to be conducted by a China-nexus threat actor since the mass exploitation of Microsoft Exchange in 2021,” Charles Carmakal, CTO of Mandiant Consulting, Google Cloud said in a statement. “In the Barracuda instance, the threat actor compromised email security appliances of hundreds of organizations.”

From the ransomware front, we have the latest Week in Ransomware from the Bleeping Computer.

From the cybersecurity defenses front

  • Cybersecurity Dive tells us “LastPass CEO reflects on lessons learned, regrets and moving forward from a cyberattack; Karim Toubba is ready to talk nearly a year after LastPass suffered a cyberattack that became one of the biggest security blunders of 2022.”
  • On June 13,
    • “The Cybersecurity and Infrastructure Security Agency (CISA) today issued Binding Operational Directive (BOD) 23-02, Mitigating the Risk from Internet-Exposed Management Interfaces, which requires federal civilian agencies to remove specific networked management interfaces from the public-facing internet or implement Zero Trust Architecture capabilities that enforce access control to the interface within 14 days of discovery.
    • “Recent threat campaigns underscore the grave risk to the federal enterprise posed by improperly configured network devices. As part of CISA and the broad U.S. government’s effort to move the federal civilian enterprise to a more defensible posture, this Directive will further reduce the attack surface of the federal government networks.”
  • On June 14,
    •  CISA, together with the National Security Agency (NSA), released a Cybersecurity Information Sheet (CSI), highlighting threats to Baseboard Management Controller (BMC) implementations and detailing actions organizations can use to harden them. 
    • “BMCs are trusted components designed into a computer’s hardware that operate separately from the operating system (OS) and firmware to allow for remote management and control, even when the system is shut down. Hardened credentials, firmware updates, and network segmentation options are often overlooked, leading to a vulnerable BMC. A vulnerable BMC broadens the attack vector by providing malicious actors the opportunity to employ tactics such as establishing a beachhead with pre-boot execution potential.  
    • “CISA and NSA encourage all organizations managing servers to apply the recommended actions in this CSI.”
  • Also on June 15,
    • “Progress Software has released a security advisory for a privilege escalation vulnerability (CVE-2023-35708) in MOVEit Transfer—a Managed File Transfer Software. A cyber threat actor could exploit this vulnerability to take control of an affected system.
    • “CISA urges users and organizations to review the MOVEit Transfer advisory, follow the mitigation steps, and apply the necessary updates when available.”

Friday Factoids

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

From Washington, DC —

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

From the miscellany department —

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

Thursday Miscellany

David Ermer–Congress, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, D.C.

  • Politico tells us,
  • “The House Energy and Commerce Committee will examine how Medicare pays doctors, Robert King reports.
  • “The panel’s Investigations and Oversight Subcommittee will hold a hearing next week to get an update on the 2015 Medicare Access and CHIP Reauthorization Act, which overhauled the formula used to pay doctors under Medicare, members confirmed.
  • “Doctors have complained that their Medicare payments are effectively being cut under the current system, fueling consolidation among doctors and hospitals.”
  • HR Dive informs us
    • Employers will have to wait at least a few more months for some long-awaited regulatory changes, the U.S. Department of Labor said Tuesday.
    • A proposal to increase the Fair Labor Standards Act’s overtime salary threshold previously expected in May has been pushed to August, DOL’s Wage and Hour Division indicated in its spring regulatory agenda.
    • A final rule expected from WHD, one that would likely tighten rules for classifying workers as independent contractors, was similarly delayed to August. Just days before the agency published its agenda, it also indicated in a court filing that it expects to have the independent contractor rule out soon — by October at the latest.

From the public health front –

  • Health Day points out
    • “Most women diagnosed with early breast cancer will become long-term survivors, according to new research that finds a substantial reduction in the risk of death since the 1990s.
    • “This news should reassure both patients and their doctors, researchers report June 13 in the BMJ.
    • “Our study is good news for the great majority of women diagnosed with early breast cancer today because their prognosis has improved so much,” said the authors, who included Dr. Carolyn Taylor, a professor of oncology at the University of Oxford in England. 
    • “Most of them can expect to become long-term cancer survivors,” they added in a journal news release.”
  • The National Institutes of Health announced
    • “Men were significantly more vulnerable than women to overdose deaths involving opioid and stimulant drugs in 2020-2021, according to a new study(link is external) analyzing death records data from across the United States. The study found that men had a 2–3 times greater rate of overdose mortality from opioids (like fentanyl and heroin) and psychostimulants (like methamphetamine and cocaine). While it has been known that men use drugs at higher rates than women, the researchers found that this alone does not explain the gap in overdose deaths, noting that biological, behavioral, and social factors likely combined to increase the mortality risk for men.
    • “The study, published in Neuropsychopharmacology, was led by investigators at the Icahn School of Medicine at Mount Sinai in New York City and the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health.
    • “Though men and women are being exposed to the modern, fentanyl-contaminated drug supply, something is leading men to die at significantly higher rates. It may be that men use drugs more frequently or in greater doses, which could increase their risk of death, or there may be protective factors among women that reduce their risk of death compared to men,” said Nora Volkow, M.D., director of NIDA and one of the co-authors on the study. “Understanding the biological, behavioral, and social factors that impact drug use and our bodies’ responses is critical to developing tailored tools to protect people from fatal overdose and other harms of drug use.”
  • NFC relates,
    • “Over the past 12 months, roughly half (45%) of American workers reported spending between $500 and $6,000 on mental health services, with nearly one-third (32%) saying they spent more than $1,501. This comes at a time when 95% of workers report they are concerned about the economic situation in the US, and financial worries are adding to their stress and burnout.
    • “Despite rising employee stress, fewer than 6% of employers say they spend more than $500 on mental health per employee, and 72% do not plan to add additional mental health support in the year ahead.
    • “These are among the findings from leading benefits consultant NFP’s 2023 US Benefits Trend Report.”
  • Bloomberg reports on chemotherapy drug shortages facing our country.

In conference news, AHIP reports on the final day of its conference while Healthcare Dive discusses the actions taken at the AMA House of Delegates meeting. Beckers Hospital Review reports on Kaiser Permanente CEO Greg Adams’ keynote speech at the AHIP conference.

From the U.S. healthcare business front —

  • Beckers Hospital Review tells us
    • “A data visualizer shows the ten most similar hospitals to any one benchmark hospital, challenging traditional, ordinal rank lists in a time of great volatility for hospitals. 
    • “SimilarityIndex | Hospitals comes from Trilliant Health, which created the tool so health economy stakeholders can learn how similar a selected benchmark hospital is to — or different from — highly regarded U.S. hospitals. 
    • “Becker’s took the ten top-ranked hospitals from the latest U.S. News and World Report’s Honor Roll to find their five most similar aggregate peers. Their similarity scores are listed [in the article].” 
  • BioPharma Dive reports
    • “Coherus BioSciences has batted back a legal challenge from AbbVie weeks before it plans to launch a much cheaper version of the latter company’s best-selling rheumatoid arthritis drug Humira.
    • “The latest dispute began after Coherus on June 1 announced plans to sell its biosimilar, dubbed Yusimry, at an 85% discount to Humira and work with Mark Cuban’s online pharmacy to provide it to other patients for even less starting in July. On June 6, Coherus received a notice from AbbVie saying that the plans violated a licensing agreement between the two companies.
    • “After a round of correspondence and dueling court filings, the companies resolved the dispute on Wednesday. AbbVie won’t terminate the license agreement based on its June 6 notice and agreed not to try to terminate the license in the future unless it both notifies Coherus of an alleged breach and also gives the company a chance to fix the problem, Coherus said in a regulatory filing.”
  • KFF reports
    • “A new report has provided the first national count of Americans who rely on health care sharing plans — arrangements through which people agree to pay one another’s medical bills — and the number is higher than previously realized.
    • “The report from the Colorado Division of Insurance found that more than 1.7 million Americans rely on sharing plans and that many of the plans require members to ask for charity care before submitting their bills.
    • “The total membership numbers are likely even higher. The state agency collected data from 16 sharing plans across the U.S. but identified five other plans that did not report their data.
    • “These plans cover more people than we had previously known,” said JoAnn Volk, co-director of the Center on Health Insurance Reforms at Georgetown University.
    • “Under the arrangements, members, who usually share some religious beliefs, agree to send money each month to cover other members’ health care bills. At least 11 of the sharing plans that reported data operated in or advertised plans in all 50 states in 2021.”
  • The Washington Post reports on consumer concerns about employer-sponsored and public health plans.
    • “By the numbers:
    • “About 26 percent said that a doctor covered by their insurance didn’t have any available appointments. One-third of Medicaid enrollees reported having such an issue.
    • “Roughly 18 percent of those surveyed indicated their insurance didn’t pay for care they thought was covered. That complaint was more common among those with employer-sponsored health insurance and Obamacare plans.
    • “Nearly 3 in 4 insured adults who have received mental health treatment in the past year report experiencing a problem with their insurance.” 

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.