FEHBlog

Monday Roundup

David Ermer–ACA, CDC, CMS, Medical / Rx research, Medicare, Mental health care, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Healthcare Dive reports,
    • “The Biden administration is making it harder for insurance agents and brokers to change people’s plans on the federal Affordable Care Act marketplace following mounting consumer complaints about unauthorized changes.
    • “On Friday, the CMS announced agents can’t make changes to a consumer’s enrollment in the federal exchanges unless they’re already associated with that consumer. If agents and brokers are unassociated, they have to take additional steps to update a consumer’s marketplace enrollment — even with that consumer’s consent, according to the notice.
    • “Unassociated brokers will have to have a three-way call with the beneficiary and the marketplace’s call center, or have the beneficiary change their enrollment themselves through HealthCare.gov or another approved portal. The changes, which don’t apply to the 18 states (and Washington, D.C.) that run their own insurance marketplaces, took effect immediately.”
  • Per an HHS press release,
    • “The Biden-Harris Administration’s Kids Online Health and Safety Task Force, co-led by the U.S. Department of Health and Human Services’ (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) and the U.S. Department of Commerce’s (DOC) National Telecommunications and Information Administration (NTIA), released a new report today with recommendations and best practices for safer social media and online platform use for youth. The recommendations in the report, Online Health and Safety for Children and Youth: Best Practices for Families and Guidance for Industry, underscore the Administration’s efforts to address the ongoing youth mental health crisis and support the President’s Unity Agenda for the nation. Task Force members also committed to future actions, including providing more resources for kids, teenagers and families, guidance for pediatricians and conducting more research.”
  • Healthcare Innovation lets us know,
    • “On July 17, the Office of the National Coordinator for Health IT (ONC) released the agency’s latest Data Brief and Quick Stat. According to ONC’s survey findings, 64 percent of U.S. hospitals plan to participate in TEFCA™, the Trusted Exchange Framework and Common Agreement. The agency notes that “This is an increase over 2022, when 51 percent of U.S. hospitals said they planned to participate.”
    • “Other findings:
      • “Approximately 7 out of 10 hospitals that participated in national networks or health information exchanges (HIEs) planned to participate in TEFCA, compared to 4 out of 10 hospitals that did not participate in either type of network.
      • “Hospitals with more resources, such as those that are larger, non-critical access, and affiliated with health systems, indicated greater awareness and had higher levels of planned participation in TEFCA when compared to smaller, critical access, and independent hospitals with fewer resources.
      • “The percent of hospitals that were aware of TEFCA but did not know if they would participate decreased from 23% to 9% from 2022 to 2023.”
    • FEHBlog Note — TEFCA is the government’s backbone for the healthcare electronic medical records system.

From the public health and medical research front,

  • The Washington Post reports,
    • “More than 40 percent of women said they skipped or delayed a screening recommended by a health professional, according to a recent survey by Gallup for the medical technology company Hologic.
    • “In the survey of 4,001 adult women across the United States, 90 percent of respondents agreed that it is important to get regular preventive health screenings for cancer, heart disease, sexually transmitted infections and other key health conditions. But 43 percent also said they skipped or delayed a recommended screening, including for breast cancer, cervical cancer and colorectal cancer.
    • “The respondents cited multiple reasons for doing so: anxiety about medical tests, pain concerns, cost, lack of time or not believing a screening was necessary.
    • “In addition, only 42 percent of the participants said they were “very confident” about which health screenings they needed. Many women also had trouble finding pertinent information, with 31 percent of Gen Z women saying it was hard for them to find relevant health information.”
  • Medscape tells us,
    • “Illicit use of the veterinary tranquilizer xylazine continues to spread across the United States. The drug, which is increasingly mixed with fentanyl, often fails to respond to the opioid overdose reversal medication naloxone and can cause severe necrotic lesions.
    • “A report released by Millennium Health, a specialty lab that provides medication monitoring for pain management, drug treatment, and behavioral and substance use disorder treatment centers across the country, showed the number of urine specimens collected and tested at the US drug treatment centers were positive for xylazine in the most recent 6 months.” * * *
    • “Because xylazine exposure remains a significant challenge in the East and is a growing concern in the West, clinicians across the US need to be prepared to recognize and address the consequences of xylazine use — like diminished responses to naloxone and severe skin wounds that may lead to amputation — among people who use fentanyl,” said Millennium Health Chief Clinical Officer Angela Huskey, PharmD, in a press release.”

From the U.S. healthcare business front,

  • Fierce Healthcare names the most influential minority executives in healthcare. Kudos to that group.
  • Beckers Payer Issues points out recent physician hires to executive roles at payer organizations.
  • Fierce Healthcare informs us,
    • “Embattled Steward Health Care has canceled auctions for its hospitals in Ohio and Pennsylvania after it did not receive qualified bids for those facilities, according to a court filing.
    • “The health system said in a document filed Sunday with bankruptcy court in Texas that it is working to determine alternatives for those facilities and expects to make an announcement at a later date. It had initially set a bid deadline for June 24 for these assets, which was later pushed back to July 15.
    • “Steward filed for chapter 11 bankruptcy in the Southern District of Texas in May.”
  • Fierce Healthcare also relates,
    • “Cigna has created a new impact fund that aims to address health disparities commonly impacting local communities.
    • “The insurer’s philanthropic arm, the Cigna Group Foundation, will operate the Cigna Group Health Equity Impact Fund. Through the program, Cigna will contribute $9 million over the next three years to tackle disparities and inequities across priority states.
    • “According to an announcement, the program will initially focus in Houston, Texas and Hartford, Connecticut. By drilling down to these specific communities, Cigna said it can “optimize” the level of assistance needed to put toward the unique equity challenges they’re facing.”

Weekend update

David Ermer–CDC, Congress, Medicare, U.S. Healthcare–

From Washington, DC,

  • The House Oversight and Accountability Committee will hold its third hearing on prescription benefit managers this Tuesday July 23 at 10 am.
  • Over the past two weeks —
    • Tammy Flanagan, writing in Govexec, offered tips on creating a smooth transition from federal employee to federal annuitant.
    • Kevin Moss, writing in the Federal Times, discusses the pros and cons of paying for both FEHB and Medicare Part B coverage. He summarizes as follows:
      • “The main reason to not consider enrolling in Part B is the cost of the extra premium. For federal annuitants that are not subject to IRMAA, adding Part B will most likely be worth it. Having Part B gives you the option to see doctors outside of the plan network and if you enroll in an FEHB plan that waives some out-of-pocket costs or consider MA plans offered by FEHB plans, you could see a reduction in your total healthcare spending.
      • “For federal annuitants that are subject to IRMAA, most of the benefits of enrolling in Part B will erode by having to pay more. This is especially true if your income places you in the second tier or higher of IRMAA and you expect that level of income throughout your retirement.”
    • The FEHBlog points out that the IRMAA tax is temporary because incomes usually subside in retirement below the IRMAA relatively high thresholds while the Medicare Part B late enrollment penalty is forever.

From the public health and medical research front,

  • Fortune Well lets us know,
    • “As U.S. health officials investigate a fatal outbreak of listeria food poisoning, they’re advising people who are pregnant, elderly or have compromised immune systems to avoid eating sliced deli meat unless it’s recooked at home to be steaming hot.”
    • “The U.S. Centers for Disease Control and Prevention didn’t mandate a food recall as of early Saturday, because it remains unclear what specific products have been contaminated with the bacteria now blamed for two deaths and 28 hospitalizations across 12 states. This means the contaminated food may still be in circulation, and consumers should consider their personal risk level when consuming deli meats.
    • “Federal health officials warned on Friday that the number of illnesses is likely an undercount, because people who recover at home aren’t likely to be tested. For the same reason, the outbreak may have spread wider than the states where listeria infections have been reported, mostly in the Midwest and along the U.S. eastern coast.
    • “The largest number known to get sick — seven — were in New York, according to the CDC. The people who died were from Illinois and New Jersey.
    • “Of the people investigators have been able to interview, “89% reported eating meats sliced at a deli, most commonly deli-sliced turkey, liverwurst, and ham. Meats were sliced at a variety of supermarket and grocery store delis,” the CDC said.”
  • The Wall Street Journal reports,
    • “How much drinking is bad for you?
    • “Though more people are calling themselves sober-curious or are trying zero-proof replacements for alcohol, drinking is a regular part of social life for most of us. A coupe of champagne can add fun to a celebration. A cocktail can take the edge off a tough day. And a cold beer can liven up a sports game. 
    • “Yet scientists’ warnings about the potential health problems of even small amounts of alcohol are growing more dire. For moderate drinkers, it can be hard to know what’s actually OK to consume: Is two a day that much worse than one? Are two drinks over a week the same as two in a day? 
    • “Averaging no more than about one drink a day is relatively low risk, according to scientists who study alcohol. They warn the risk of cancer rises significantly when you exceed that. Studies have suggested that alcohol contributes to about half a dozen types of cancers, including breast and colorectal, as well as heart and liver disease, among other conditions.” 
  • MedPage Today reports,
    • “U.S. health officials on Friday said a new study in Michigan suggested the bird flu virus is not causing asymptomatic infections in people, while also announcing two new human cases in Colorado.
    • “Last month, the Michigan Department of Health and Human Services launched a study of workers who were around cows sickened by the bird flu. The researchers drew blood from 35 people.
    • “One goal was to determine if there were people who never had any symptoms but did have evidence of past infections. None of the blood testing showed antibodies that would indicate infections with the highly pathogenic avian influenza (HPAI) A(H5N1) virus circulating among dairy cattle and poultry, the CDC reported on Friday.
    • “The lack of antibodies to avian influenza A(H5N1) virus suggests these people were not previously infected with an avian influenza A(H5N1) influenza virus,” the agency said. “These data are consistent with other dataopens in a new tab or window demonstrating the seroprevalence to HPAI A(H5N1), even among workers with known exposures, is low.”
    • “Many of the workers did show antibodies to seasonal flu, which was used as a control virus in the study. Researchers will continue to sample workers, and the data will be analyzed and prepared for a peer-reviewed publication, the CDC said.
  • Per Medscape,
    • “One in five children (20.2%) who have an older sibling with autism spectrum disorder (ASD) are likely to be diagnosed with the disorder as well, according to a study published in Pediatrics.
    • “When a baby had more than one older sibling with autism, the family recurrence rate rose to 36.9%, the study found. * * *
    • “Dr Ozonoff’s team found that sex and race played a part in likelihood of recurrence. Younger siblings of females with ASD were much more likely to develop the disorder (34.7%) than siblings of boys (22.5%). And male younger siblings were more likely to have ASD than girls (25.3% vs 13.1%).”

Cybersecurity Saturday

David Ermer–Cybersecurity–
  • The Wall Street Journal reports,
    • “Hemant Rathod, an Indian executive, was sipping tea in a conference room Friday morning in Delhi, about to send a long email to his team, when his computer went haywire.
    • “The HP laptop suddenly said it needed to restart. Then the screen turned blue. He tried in vain to reboot. Within 10 minutes, the screens of three other colleagues in the room turned blue too.
    • “I had taken so much time to draft that email,” Rathod, a senior vice president at Pidilite Industries, a construction-materials company, said by phone half a day later, still carrying his dead laptop with him. “I really hope it’s still there so I don’t have to write it again.”
    • “The outage, one of the most momentous in recent memory, crippled computers worldwide and drove home the brittleness of the interlaced global software systems that we rely on.  * * *
    • “Adding to the chaos—and further underlining the vulnerability of the global IT system—a separate problem hit Microsoft’s Azure cloud computing system on Thursday shortly before the CrowdStrike glitch, causing an outage for customers including some U.S. airlines and users of Xbox and Microsoft 365.
    • The CrowdStrike problem laid bare the risks of a world in which IT systems are increasingly intertwined and dependent on myriad software companies—many not household names. That can cause huge problems when their technology malfunctions or is compromised. The software operates on our laptops and within corporate IT setups, where, unknown to most users, they are automatically updated for enhancements or new security protections.
  • The irony lies in the fact that
    • “The global outage began with an update of a so-called “channel file,” a file containing data that helps CrowdStrike’s software neutralize cyber threats, CrowdStrike said. The update was timestamped 4:09 a.m. UTC—just after midnight in New York and around 9:30 a.m. in India.
    • “That update caused CrowdStrike’s software to crash the brains of the Windows operating system, known as the kernel. Restarting the computer simply caused it to crash again, meaning that many users had to surgically remove the offending file from each affected computer.”

From the cybersecurity policy front,

  • Cybersecurity Dive informs us,
    • “A U.S. District Court judge dismissed most of the charges in a civil fraud case filed against SolarWinds by the Securities and Exchange Commission Thursday.
    • “The SEC filed suit in October alleging SolarWinds misled investors about the company’s cybersecurity practices leading up to the Sunburst supply chain hack, which was disclosed in December 2020. The attack that targeted SolarWinds Orion platform impacted thousands of customers, including major U.S. companies and government agencies that used the platform. 
    • “Judge Paul Engelmayer of the U.S. District Court Southern District of New York sustained the SEC’s claims of securities fraud based on SolarWinds’ security statement. However, the court dismissed other claims, including all claims involving post-Sunburst disclosures. * * *
    • “Allegations related to a 2017 statement made about the company’s security capabilities on the “trust center” page of its website will continue to be litigated.” 
  • The Wall Street Journal points out,
    • “A spokesman said SolarWinds is pleased with the judge’s ruling. “We look forward to the next stage, where we will have the opportunity for the first time to present our own evidence and to demonstrate why the remaining claim is factually inaccurate,” he said. * * *
    • “David Shargel, a partner at law firm Bracewell, said the dismissal of part of the SEC’s claims was a victory for SolarWinds “by any measure.” Companies rarely defeat the SEC’s lawsuits so early in the litigation process.”
    • “It’s definitely a serious charge that remains, and it serves as a reminder that, as with any public-facing statement, companies need to ensure that their disclosures are accurate and not misleading,” he said.” * * *
    • Notably, Engelmayer also dismissed the SEC’s claim that SolarWinds violated rules that govern how companies guard against accounting errors. The judge said cybersecurity controls aren’t part of that process. “That reading is not tenable,” the judge wrote, saying the controls clearly apply only to financial accounting. 
    • “I think that might give some compliance departments some comfort going forward in terms of the parameters of the disclosure requirements,” Shargel said.
  • The National Institute of Standards and Technology issued a special publication concerning Personal Identity Verification (PIV). Experience-rated FEHB carriers must employ PIV for their employees who access OPM’s letter of credit system.

From the cybersecurity vulnerabilities and breaches front,

  • Security Week informs us that “The massive AT&T breach has been linked to an American hacker living in Turkey and reports say the telecom giant paid a $370,000 ransom.”
  • Cybersecurity Dive lets us know,
    • “Weak credentials and misconfigurations across cloud systems were at the root of 3 in 4 network intrusions during the first half of 2024, Google Cloud said Wednesday in its latest Threat Horizons Report.
    • “Google Cloud said systems with weak or no credentials were the top initial access vector, accounting for 47% of cloud environment attacks during the first six months of the year. That’s a slight decrease from the second half of 2023 when weak or no credentials were at the root of 51% of attacks, according to Google Cloud.
    • “Misconfigurations were the initial access vector for 30% of all cloud environment attacks during the first half of 2024, marking a significant jump from 17% in the second half of 2023.”
  • The Cybersecurity and Infrastructure Security Agency added four known exploited vulnerabilities to its catalog this week:

From the ransomware front,

  • Per Cybersecurity Dive,
    • “Ransomware activity jumped in the second quarter as threat groups listed 1,237 organizations on data leak sites during the period, marking a 20% increase from Q1, Reliaquest said in a Tuesday report. 
    • “May was an especially active month due to a spike in posts from the ransomware group LockBit, which accounted for 36% of the month’s alleged victims, the report found. Yet, an abnormally slow June dragged the total count of alleged ransomware victims down 13% year over year, according to Reliaquest.
    • “U.S.-based businesses bore the brunt of ransomware attacks during Q2, composing more than half of all claimed ransomware victims listed on data leak sites during the period. Sectors targeted most heavily by cybercriminals during the quarter included manufacturing and professional, scientific and technical services, the report found.”
  • The Wall Street Journal notes,
    • “Rite Aid disclosed customer data was accessed in a June cybersecurity breach.
    • “The drugstore operator said an unknown third-party impersonated a company employee on June 6. It detected the incident within 12 hours and launched an investigation and reported it to law enforcement.
    • “Rite Aid said by June 17 it determined the party acquired certain data associated with the purchase or attempted purchase of specific retail products, including purchaser name, address, date of birth and driver’s license number or other form of government-issued ID presented at purchase between June 6, 2017, and July 30, 2018.”
  • Dark Reading adds on July 15,
    • “[Rite Aid] has not released an official statement revealing who the threat actors are, but the RansomHub gang has claimed that it breached the company’s systems.
    • “While having access to the Rite-Aid network, we obtained over 10GB of customer information equating to around 45 million lines of people’s personal information,” the ransomware group said on its Dark Web leak site. “This information includes name, address, dl_id number, DoB, Rite Aid rewards number.”
    • “Rite Aid reportedly stopped negotiating a ransom, prompting the ransomware group to share snippets of what it claims is stolen data as proof and add a two-week deadline before more information will be leaked.”

From the cybersecurity defenses front,

  • The Wall Street Journal reports,
    • “Google parent Alphabet is in advanced talks to acquire cybersecurity startup Wiz for roughly $23 billion, according to people familiar with the matter, in what would be its largest acquisition ever. 
    • “A deal could come together soon, assuming the talks don’t fall apart, the people said. 
    • “Alphabet is eyeing the deal at a time of intense antitrust scrutiny of the search company and other tech giants. The acquisition could also help boost Alphabet’s efforts in cloud computing, an important and growing business but one where it has lagged behind peers. * * *
    • “Google has been working to bulk up its cybersecurity business, focused on the cloud. Its biggest recent acquisition—and second largest ever—is the nearly $5.4 billion purchase two years ago of another security company, Mandiant.” 
  • TechTarget shares “best practices for protection from ransomware in cloud storage” and advises “CISOs on how to improve cyberthreat intelligence programs.”
  • Dark Reading explains why “In Cybersecurity, Mitigating Human Risk Goes Far Beyond Training.”

Friday Factoids

David Ermer–CDC, COVID-19, Cybersecurity, Federal employment benefits, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Govexec reports,
    • “The Office of Personnel Management on Thursday encouraged federal agencies to conduct their own analyses to correct potential pay disparities within their workforces.
    • “In 2021, President Biden signed a sweeping executive order aimed at improving diversity, equity, inclusion and accessibility at federal agencies, including provisions requiring the creation of a governmentwide strategic plan on the issue and that the OPM director consider banning the use of past salary history to set pay during the hiring process. OPM followed through on that edict earlier this year.
    • “In a memo to agency heads Tuesday, acting OPM Director Ron Shriver highlighted OPM’s governmentwide study of pay gaps in the federal workforce, which found that in 2022, the gender pay gap was 5.6%, meaning women on average earned about 94 cents for every dollar male federal workers earned. The figure marks a slight improvement over the 2021 gender pay gap of 5.9% and is significantly better than the nationwide gender pay disparity of 16%.
    • “Shriver directed that federal agencies that operate their own pay systems governing at least 100 employees must now conduct the same review of pay policies that OPM did for the General Schedule, Federal Wage System and Senior Executive Service workforces. And he encouraged all agencies to conduct their own gap analyses to search for pay disparities along gender or racial and ethnic lines affecting their own workforces, regardless of pay system.”
  • HHS’s Administration for Strategic Preparedness and Response announced,
    • “awards totaling $18.5 million to two U.S. companies to expand the nation’s manufacturing of key starting materials and active pharmaceutical ingredients needed to make essential medicines. The awards are the first through ASPR’s BioMaP-Consortium, a public-private partnership established in January 2024.
    • “ASPR is committed to expanding our nation’s domestic manufacturing infrastructure,” said Assistant Secretary for Preparedness and Response Dawn O’Connell. “Today’s announcement advances our efforts to build resilient U.S.-based supply chains for pharmaceutical ingredients and mitigate risk and reliance on foreign supplies. Having this capability in the U.S. is critical for our emergency preparedness.”
    • “California-based Antheia will receive approximately $11 million to support U.S.-based production of pharmaceutical ingredients, and Virginia-based Capra Biosciences will receive approximately $7.5 million to leverage its bioreactor platform to manufacture three active pharmaceutical ingredients.” 
  • Mercer Consulting projects that for 2025 the health flexible spending account contribution limit will increase by $100 from $3200 to $3300 and the carryover limit will increase from $640 to $660.”

From the public health and medical research front,

  • The CDC tells us today
    • Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is increasing in many areas.
    • COVID-19
      • Many areas of the country are experiencing consistent increases in COVID-19 activity. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations are increasing, particularly among adults 65+. CDC will continue to closely monitor trends in COVID-19 activity.
    • Influenza
    • RSV
      • Nationally, RSV activity remains low.
    • Vaccination
  • The University of Minnesota’s CIDRAP notes,
    • Along with the CDC’s report of high wastewater levels of SARS-CoV-2, WastewaterSCAN, a national wastewater monitoring system based at Stanford University in partnership with Emory University, notes that detections are in the high category, with no significant trend up or downward over the past 3 weeks. It said all regions of the country are in the high category, except for the Midwest, which is at the medium level.
  • STAT News adds,
    • “STAT spoke with experts in infectious disease, virology, and public health to find out what people need to know about this summer’s Covid surge.
    • “One key message: Despite the increase in cases, the protection people have built up thanks to rounds of vaccination and prior infections is still sparing the vast majority of people from severe illness.”
    • “Once you really get a decent immunity, you may get the virus again, but you’re probably not going to get very sick from it,” said Aaron Glatt, chair and professor of medicine at Mount Sinai South Nassau.”

From the U.S. healthcare business front,

  • The American Hospital Association News lets us know,
    • “A non-malicious global technology outage that began in the early morning of July 19 is continuing to affect many industries and is having varying effects on hospitals and health systems across the country. The outage was caused by a faulty software update issued by the cybersecurity firm CrowdStrike, which is widely used by businesses and government agencies that run on Microsoft computers. 
    • “CrowdStrike is actively working with customers impacted by a defect found in a single content update for Windows hosts,” the organization posted on its website early today. “Mac and Linux hosts are not impacted. This is not a security incident or cyberattack. The issue has been identified, isolated and a fix has been deployed. We refer customers to the support portal for the latest updates and will continue to provide complete and continuous updates on our website. We further recommend organizations ensure they’re communicating with CrowdStrike representatives through official channels.
    • “CrowdStrike’s webpage includes more information about the issue and workaround steps organizations can take. The Cybersecurity and Infrastructure Security Agency also posted an alert on the incident.” 
  • The Hill reports,
    • “After peaking during the COVID-19 pandemic, physician burnout has dipped under 50 percent for the first time in four years, but doctors say working conditions in the medical field remain far from ideal. 
    • “A survey published by the American Medical Association (AMA) this month found that 48.2 percent of physicians in 2023 experienced at least one symptom of burnout, down nearly 15 percent from when this metric peaked in 2021. 
    • “Reported job satisfaction rose from 68 percent to 72.1 percent between 2022 and 2023, while job stress dropped in the same time frame, going from 55.6 percent to 50.7 percent. 
    • “It’s good news and it’s bad news,” Steven Furr, president of the American Academy of Family Physicians, told The Hill. “It’s good news that the numbers have gone down but still they’re higher than what we’d like them to be.” 
    • “The AMA has tracked physician burnout rates since 2011 along with the Mayo Clinic and Stanford Medicine. Prior to the pandemic, burnout rates ranged from 43.9 percent in 2017 to 54.4 percent in 2014.” 
  • mHealth Intelligence points out,
    • “Telehealth visits at United States hospitals skyrocketed during the COVID-19 pandemic, rising 75 percent between 2017 and 2021; however, adoption was uneven, with hospitals citing challenges to electronic health information exchange, according to a new study.
    • “Published in the Journal of General Internal Medicine, the study examined US hospitals’ adoption of telehealth before and during the pandemic, aiming to provide targeted policy implications.” * * *
    • “The researchers found that telehealth encounters increased from 111.4 million in 2020 to 194.4 million in 2021, a 75 percent jump. Additionally, hospitals offering at least one form of telehealth increased from 46 percent in 2017 to 72 percent in 2021.
    • “However, the adoption was not uniform across hospitals. Larger, nonprofit, and teaching hospitals were more likely to adopt telehealth than their counterparts. Notably, the study found no significant telehealth adoption disparities between hospitals in urban and rural areas.
    • “Further, more than 90 percent of hospitals allowed patients to view and download medical records, but only 41 percent permitted online data submission. One-quarter (25 percent) of hospitals identified certified health IT developers, such as EHR vendors, as frequent culprits in information blocking.
    • “Most US hospitals also reported challenges in exchanging health information electronically, with 85 percent citing barriers related to vendor interoperability.
    • “The researchers concluded that comprehensive policy interventions are necessary to address telehealth adoption and other IT-related disparities across the US healthcare system.”

Thursday Miscellany

David Ermer–CDC, Congress, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, OPM, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Modern Healthcare reports,
    • “A powerful Senate committee plans to commence a bipartisan investigation into the Steward Health Care meltdown next week.
    • “The Senate, Health, Education, Labor and Pensions Committee will convene next Thursday for a vote to officially kick off a probe into the insolvent Dallas-based health system. Steward Health Care Chair and CEO Dr. Ralph de la Torre will be subpoenaed to testify at a hearing Sept. 12, HELP Committee Chair Bernie Sanders (I-Vt.) and ranking member Dr. Bill Cassidy (R-La.) said in a news release Thursday.
    • “Given the serious harm and uncertainty Steward’s bankruptcy and financial arrangements are having on hospitals, patients and healthcare workers throughout the country, Dr. de la Torre has given us no choice but to compel him to testify at this hearing,” Sanders and Cassidy said.
    • “De la Torre declined to attend a HELP Committee hearing last month and a subcommittee session in April.
    • “We have a number of questions to ask Dr. de la Torre about the bankruptcy of Steward Health Care and the financial arrangements leading up to its insolvency. It is time for Dr. de la Torre to answer them before Congress and the American people,” Sanders and Cassidy said.
  • Federal News Network informs us,
    • “The Office of Personnel Management will soon be reopening enrollments into the government’s Flexible Spending Account program, FSAFEDS.
    • “OPM previously suspended all new enrollments in the program after a recent surge in fraudulent activity that impacted hundreds of federal employees with Flexible Spending Accounts. OPM’s inspector general said the suspension came “out of an abundance of caution,” and to try to prevent further fraud in the program.
    • “Enrollments in FSAFEDS, including any enrollments based on Qualifying Life Events (QLEs), will reopen Aug. 1, OPM wrote in an email to agency benefit officers Thursday afternoon, shared with Federal News Network. Also beginning Aug. 1, the program will transition to a “.gov” website domain, FSAFEDS.gov, rather than the current domain, FSAFEDS.com.
    • “Enrollees who missed a QLE deadline due to the pause on enrollments should still be able to make modifications once the enrollment pause is lifted, OPM said. Employees who are in that situation will have to call FSAFEDS at 877-372-3337 to request a change to the effective date for the QLE.
    • “Additionally, federal employees will be able to get reimbursed for any claims that were incurred after the effective date for the QLE, OPM said.
    • “OPM is also taking more long-term steps to address security concerns in FSAFEDS, including transitioning to Login.gov, the government’s platform for accessing government benefits and services online.”
  • Per Govexec,
    • “The Office of Personnel Management wants federal agencies to let it know how many senior executives, scientific/professionals and other senior-level personnel they estimate they will need for the next two years.
    • “OPM outlined its biennial review of agency executive allocations in a July 10 memorandum, calling on agency and department heads to examine their potential Senior Executive Service needs through fiscal 2026 and 2027 and how they may have changed. 
    • “The biennial review, which is required by statute, will give agencies until Nov. 22 to fully outline their anticipated SES needs, but they must also detail the projections of their position needs in their Senior Level and Scientific/Professional pay systems by Aug. 23. 

From the public health and medical research front,

  • Beckers Hospital Review tells us,
    • “The highest numbers of breast and cervical cancer deaths are found mostly in southeastern states, according to new data from the “2024 State Scorecard on Women’s Health and Reproductive Care” released July 18 by The Commonwealth Fund.
    • “The analysis is based on 2021-22 data from publicly available sources. Learn more about the methodology here.
    • “Alabama, Arkansas, Delaware, the District of Columbia, Indiana, Kentucky, Louisiana, Mississippi, Missouri, Nevada, Oklahoma, Tennessee and West Virginia had 23.2 to 27.8 breast and cervical cancer deaths per 100,000 female population, the highest numbers in the country.”
  • The NIH Director, in her weekly blog, lets us know,
    • “Alzheimer’s disease is currently the seventh leading cause of death in the U.S. While your likelihood of developing Alzheimer’s-related cognitive impairment increases with age, risk for this disease and age of its onset depend on many factors, including the genes you carry. An intriguing new study suggests that having just one copy of a protective gene variant may be enough to delay cognitive impairment from this devastating disease in individuals who are otherwise genetically predisposed to developing early-onset Alzheimer’s dementia.
    • “The findings, from a study supported in part by NIH and reported in The New England Journal of Medicine, offer important insights into the genetic factors and underlying pathways involved in Alzheimer’s dementia. While much more study is needed, the findings have potential implications for treatments that could one day work like this gene variant does to delay or perhaps even prevent Alzheimer’s dementia.”
  • The Washington Post reports,
    • “If you want to increase your odds of living a long and healthy life, watch less television and become more physically active, because even a small amount of physical activity can improve overall health, according to an observational study published last month in JAMA Network Open.
    • “While there have been many studies showing that moderate to vigorous physical activity is associated with healthy aging, researchers wanted to know if light physical activity compared with sedentary behaviors also improves healthy aging, and if not, how can people’s time be reallocated.
    • “They found that replacing a sedentary behavior such as watching TV with even low-intensity activity — such as standing or walking around while cooking or washing clothes — increased one’s odds of healthy aging. And at work, replacing some of the time spent sitting with simple movements such as standing or walking around the office can improve health.
    • “These findings indicate that physical activity need not be high intensity to potentially benefit various aspects of health, which have especially important public health implications as older people tend to have limited physical ability to engage in moderate-to-vigorous physical activity,” Molin Wang, an associate professor in epidemiology at the Harvard T.H. Chan School of Public Health and an author of the study, wrote in an email.”
  • Per Medscape,
    • “An analysis based on a massive database of US electronic health records (EHRs) adds to evidence favoring the safety of glucagon-like peptide 1 (GLP-1) medications, finding no increased risk for many neurologic and psychiatric ailments when semaglutide was compared with other diabetes drugs.
    • “Riccardo De Giorgi, MD, DPhil, of the University of Oxford, Oxford, England, and colleagues published their research in eClinicalMedicine.”
  • Bloomberg informs us,
    • “Opioids. They’re a public-health pariah, leading to more than 80,000 overdose deaths a year. Patients worry they’ll get addicted to them. Doctors want nothing to do with them. And politicians of all stripes are calling for less dangerous options for treating pain.
    • “We are looking for absolutely anything that’s not an opioid,” says Seth Waldman, an anesthesiologist and director of pain management at Hospital for Special Surgery, a top orthopedic medicine center.
    • “Against that backdrop, the success of a safer painkiller would seem assured. A new drug, which Vertex Pharmaceuticals Inc. is developing, has been hailed as a scientific breakthrough because it treats pain without entering the brain, where opioids create addicts. The drug, suzetrigine, met its goal this year in pivotal trials for acute pain and is poised to become the first new class of pain medication in more than two decades.
    • “But all that may not be enough to loosen the grip opioids have on American medicine. Despite their dismal reputation, they have two powerful things going for them: They’re cheap, and they work. The number of opioid prescriptions has been cut by half over the past decade, but some 130 million are still doled out each year.” * * *
    • “Vertex is betting the nonaddictive properties of its drug will make it an attractive alternative to opioids. But it isn’t leaving anything to chance. Knowing it faces an uphill battle commercially, the company last year boosted its lobbying spending almost 50%, to more than $3 million. Vertex is pressing Congress for new policies that remove “structural impediments” blocking access to opioid alternatives, says Stuart Arbuckle, its chief operating officer.
    • “Vertex has scored at least one legislative victory: The No Pain Act, which goes into effect next year, provides an extra Medicare reimbursement to hospitals that prescribe alternatives to opioids. Another bill introduced this year in Congress would prohibit step therapy and limit how much Medicare patients pay out of pocket for non-opioids.
    • “Other types of new drugs face this cost hurdle, too. The rollout of new contraceptives or antibiotics has been hampered by insurers guiding doctors and patients to older, less pricey meds. The difference is that those generics haven’t been declared a public-health emergency.”
  • Mercer Consulting points out “four things employers need to know about summer heat.”
  • The New York Times reports,
    • “A daily dose of a widely used antibiotic [doxycycline] can prevent some infections with syphilis, gonorrhea and chlamydia, potentially a new solution to the escalating crisis of sexually transmitted infections, scientists reported on Thursday.
    • “Their study was small and must be confirmed by more research. Scientists still have to resolve significant questions, including whether S.T.I.s might become resistant to the antibiotic and what effect it could have on healthy gut bacteria in people taking it every day.
    • “The approach would be recommended primarily to people at elevated risk of sexually transmitted infections during certain periods, said Dr. Jeffrey Klausner, an infectious diseases physician at the University of Southern California who was not involved in the new work.
    • “The number of people who are really going to be offered this and take this is still very small,” he said. “In general, the more choices we have for people, the more prevention options we have, the better.”

From the U.S. healthcare business front,

  • Per Fierce Pharma,
    • “GoodRx is joining forces with drugmaker Boehringer Ingelheim to make its Humira biosimilar adalimumab available at an affordable price.
    • “The pharmaceutical company will offer citrate-free adalimumab-admb at a cash price available only on GoodRx, according to an announcement. This will allow anyone with a prescription to obtain the drug at one of 70,000 pharmacies nationwide, even if they’re uninsured.
    • “Beginning on July 18, Boehringer and GoodRx will offer high-concentration and low-concentration formulas of the drug in auto-injectors or pre-filled syringes at a price of $550 per two pack. The companies said that this is a 92% discount compared to a Humira prescription.”
  • Per Beckers Hospital Review,
    • “The FDA is allowing Mark Cuban Cost Plus Drug Co. to temporarily import a syphilis drug that has been in shortage for more than a year. 
    • “Penicillin G benzathine injection fell into low supply in April 2023, and since then, clinicians have been rationing the product. In January, the FDA issued a temporary authorization for French drugmaker Laboratoires Delbert to import penicillin G benzathine. 
    • “On July 17, the FDA updated its post on the drug’s shortage. To address the scarcity, the agency cleared Cost Plus Drugs to import the medication from Laboratórios Atral.
    • “The Portugal-based drug company will export two presentations of Lentocilin (benzathine benzylpenicillin tetrahydrate), according to FDA documents.
    • “Cost Plus Drugs is selling this medication to healthcare businesses for less than $15, the company said in July 17 post on X.” 
  • Segal Consulting relates,
    • “The average stop-loss coverage premium increase is 9.4 percent for the nearly 240 health plans in Segal’s 2024 national medical stop-loss dataset.”
    • “The average includes groups that increased specific stop-loss deductible levels and/or aggregating specific stop-loss deductibles resulting in an overall reduced rate action. The average premium increase for groups that maintained similar specific stop-loss benefit levels as the prior year is 11.5 percent.”
  • Per Fierce Healthcare,
    • “Telehealth giant Teladoc is partnering with startup Brightline to extend virtual mental healthcare services for children, adolescents and their families.
    • “Through the partnership, members under the age of 18 will have access to Brightline’s behavioral health solutions through Teladoc’s virtual “front door,” the companies said.
    • “The collaboration with Brightline builds on Teladoc’s existing mental health offerings and expands access to care to members of all ages, a Teladoc spokesperson said.”
  • Beckers Hospital Review identifies seven U.S. hospitals that have received brain tumor care certification by the Joint Commission.
    • Chippenham and Johnston-Willis Hospital, Richmond, VA
    • Hackensack (N.J.) University Medical Center Hackensack
    • Jewish Hospital, Cincinnati, OH
    • Pitt County Memorial Hospital, Greenville, N.C.
    • Santa Barbara (Calif.) Cottage Hospital
    • St. Vincent Hospital and Health Care Services, Indianapolis, IN
    • Texas Health Harris Methodist Hospital – Fort Worth, TX
  • Healthcare Dive lets us know,
    • “Humana has made a minority investment in Healthpilot, a company that aims to help beneficiaries choose Medicare plans, the insurer said Wednesday. Financial terms of the deal weren’t disclosed.
    • “Healthpilot uses an artificial intelligence model to recommend Medicare Advantage, Medicare supplement and prescription drug plans based on enrollee information.
    • “Healthpilot will continue to recommend plans options from other payers following the investment, Humana said in the release. 

Midweek Update

David Ermer–AHRQ, CDC, COVID-19, FDA, Generative AI, Medical / Rx research, Mental health care, Obesity, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The Wall Street Journal adds,
    • “A summer Covid wave is hitting the country, but there’s one consolation: Your chances of developing long Covid have fallen since the start of the pandemic. 
    • “That’s the finding from a new study in the New England Journal of Medicine. It concluded that about 10% of people infected with the virus’s original strain developed long Covid. By contrast, the risk of developing long Covid dropped to 3.5% with the virus’s Omicron variant among vaccinated people. For the unvaccinated, the risk was 7.7.%.
    • “Researchers defined long Covid as people who experienced persistent and debilitating symptoms such as a racing heartbeat or brain fog, or other new health problems linked to the initial illness, a month or more after their infection.
    • “About 70% of the drop in long Covid cases was due to vaccination and 30% because of changes in the virus itself, the study determined. 
    • “Four years since the start of the pandemic, we’re getting used to periodic waves of Covid cases, including the uptick we’re seeing now, driven by Omicron subvariants. The threats of severe illness and lingering health problems have significantly subsided, though they haven’t disappeared.”
  • Beckers Hospital Review reports,
    • “As the House Committee on Oversight and Accountability investigates pharmacy benefit managers regarding alleged anticompetitive practices, the committee scheduled a hearing with leaders of the top three PBMs. 
    • “On July 23, [at 10 am ET], members of the House Committee on Oversight and Accountability plan to ask executives at Express Scripts/Evernorth, CVS Caremark and OptumRx about the alleged anticompetitive policies, which committee members say raise prescription drug costs, harm independent pharmacies and obstruct patient care. 
    • “The three PBMs account for about 80% of the market share. 
    • “The called witnesses are Adam Kautzner, PharmD, president of Evernorth Care Management and Express Scripts; David Joyner, executive vice president of CVS Health and president of CVS Caremark; and Patrick Conway, MD, CEO of OptumRx.”
  • The FEHBlog discovered today that on July 11, 2024, Rep. Gary Palmer (R Ala.) introduced House Jt. Resolution 187 which reads,
    • “Resolved by the Senate and House of Representatives of the United States of America in Congress assembled, That Congress disapproves the rule submitted by the Office of Personnel Management relating to Postal Service Reform Act; Establishment of the Postal Service Health Benefits Program (89 Fed. Reg. 37061), and such rule shall have no force or effect.”
  • The cited rule is the OPM’s May 2024 supplemental rule implementing the PSHBP. In the FEHBlog’s opinion, the provision of the rule which offends Rep. Palmer (and the FEHBlog) for that matter is found in an OPM FAQ:
    • “While the proposed rule reflects that Medicare Part D-eligible annuitants and their Part D-eligible family members would be automatically group enrolled into the Part D EGWP, it reflects that they may choose to opt out of receiving prescription drug coverage through the PSHB Part D EGWP. This proposed rule provides, consistent with the statute, that the Part D EGWP offered by their PSHB plan is the only PSHB prescription drug benefit available for Part D-eligible PSHB annuitants and their Part D-eligible covered family members. As proposed, Medicare Part D-eligible annuitants and their family members who choose to opt out of or disenroll from the PSHB plan’s Part D EGWP would not have access to prescription drug benefits through their PSHB plan and would not pay a lower premium than those enrolled in the Part D EGWP.“
  • Nothing in the Postal Service Reform Act suggests that Congress intended to impose such a penalty. It’s a penalty because OPM does not reduce the premium for members who are deprived of their plan’s prescription drug benefits. Furthermore, when Congress included a mandate for PSHBP annuitants to enroll in Part B, it also provided grandfathering protections and exemptions. The Part D penalty applies across the board.
  • In any case, because Part D benefits will feature improvements such as a $2,000 out of pocket cost maximum for 2025, the carrot approach to incenting Part D EGWP enrollment should be tried first.
  • The American Hospital Association News lets us know,
    • “The Administration for Strategic Preparedness and Response July 16 announced it will work with the Department of Commerce on an assessment of the active pharmaceutical industrial base to better understand the pharmaceutical supply chain and how it has changed since the COVID-19 pandemic. The assessment is based on a survey conducted last winter. The study will inform federal strategies and funding decisions related to the API supply chain and raise awareness of potential supply chain issues, such as the current limited domestic manufacturing capabilities and other potential issues. The study will survey more than 200 companies, including manufacturers, distributors, suppliers and customers. A Bureau of Industry and Security webpage answers FAQs about the project.”

From the public health and medical research front,

  • STAT News tells us,
    • “The Centers for Disease Control and Prevention just released a trove of data on Americans with disabilities that found that more than a quarter of U.S. adults have a disability — over 70 million people, a bump from prior years. This slice of the population was also much more likely to report long Covid symptoms such as chronic fatigue and brain fog. This comorbidity looms large for many disabled communities as another surge in Covid cases sweeps the country.
    • “The data, gathered in 2022, is part of the agency’s Disability and Health Data System, which has annual state and national-level data stretching back to 2016. This is the first year that the agency has released long Covid data, finding that 11% of people with disabilities had long Covid symptoms while only 7% of people without disabilities reported symptoms.
    • “For many disabilities, the highest populations exist in a swath that extends from the Deep South and Louisiana up to Appalachian communities in West Virginia and Ohio. Disability benefits claims are typically highest in these areas, but for long Covid, the geography shifted west. Idaho and other states along the Continental Divide saw much higher rates of symptoms, with Montana recording the highest prevalence at 18%.”
  • The New York Times adds,
    • “A large new study provides some of the strongest evidence yet that vaccines reduce the risk of developing long Covid.
    • “Scientists looked at people in the United States infected during the first two years of the pandemic and found that the percentage of vaccinated people who developed long Covid was much lower than the percentage of unvaccinated people who did. 
    • “Medical experts have previously said that vaccines can lower the risk of long Covid, largely because they help prevent severe illness during the infection period and people with severe infections are more likely to have long-term symptoms.
    • “But many individuals with mild infections also develop long Covid, and the study, published Wednesday in The New England Journal of Medicine, found that vaccination did not eliminate all risk of developing the condition, which continues to affect millions in the United States.”
  • STAT News also informs us,
    • “A study published Wednesday in the Journal of Clinical Oncology found that certain unmatched donors, or people whose bone marrow does not as closely resemble that of the patient’s, provided similar outcomes to matched donors so long as patients receive a key drug called cyclophosphamide to prevent dangerous complications. That suggests that patients who need a transplant might be able to safely consider both matched and some unmatched donors, vastly expanding the pool of potential acceptable donors for all patients, though particularly those of African, Latino, or Asian ancestry.
    • “It’s much harder to find a match for most of my patients. Looking to people who are donor unrelated and aren’t a perfect match for my patients has become the norm,” said Sekeres, who is the chief of hematology at Sylvester Cancer Center at the University of Miami and did not work on the study. “That’s why this study really resonated with me. The classic teaching is you want a perfect match as opposed to less than perfect. What this study suggests is, if you use the right drugs after transplant, it may not be as big of a deal.”
    • “If so, up to roughly 84% of African American patients might have a potential donor in the national registry. Currently, less than 30% of African American patients have a potential match in the NMDP registry, previously called the National Marrow Donor Program.”
  • Per BioPharma Dive,
    • “A closely watched obesity pill being developed by Roche helped people in a small Phase 1 trial lose 7.3% of their body weight over four weeks when taken once daily — 6.1 percentage points more than those given a placebo, the company said Wednesday.
    • “The data comes two months after the Swiss drugmaker disclosed trial results from another obesity drug in its pipeline, which showed the once-weekly injection helped reduce body weight by 19% over six months. Roche disclosed more detailed data for that drug, indicating none of the trial participants stopped taking it due to side effects — a reason users might quit taking Wegovy or Zepbound.
    • “The two drugs came from Roche’s $2.7 billion acquisition of biotechnology startup Carmot Therapeutics in December. The deal was part of a rush by pharmaceutical companies to enter a market estimated to be worth more than $100 billion annually by early next decade.”
  • Beckers Hospital Review interviews NYU Langone’s bariatric surgery chief about the first GLP-1 generic and other GLP-1 issues.
  • Per a National Institutes of Health press release,
    • “A neuroimaging study of young people who exhibit a persistent pattern of disruptive, aggressive, and antisocial behavior, known as conduct disorder, has revealed extensive changes in brain structure. The most pronounced difference was a smaller area of the brain’s outer layer, known as the cerebral cortex, which is critical for many aspects of behavior, cognition and emotion. The study, co-authored by researchers at the National Institutes of Health (NIH), is published in The Lancet Psychiatry.
    • “Conduct disorder has among the highest burden of any mental disorder in youth. However, it remains understudied and undertreated. Understanding brain differences associated with the disorder takes us one step closer to developing more effective approaches to diagnosis and treatment, with the ultimate aim of improving long-term outcomes for children and their families,” said co-author Daniel Pine, M.D., chief of the Section on Development and Affective Neuroscience in NIH’s National Institute of Mental Health. “Critical next steps are to follow children over time to determine if differences in brain structure seen in this study are a cause of conduct disorder or a long-term consequence of living with the disorder.”
  • The National Cancer Institute posted its latest cancer information highlights.
  • The Institute of Clinical and Economic Review “released a Draft Evidence Report assessing the comparative clinical effectiveness and value of acoramidis (BridgeBio Pharma, Inc.), tafamidis (Vyndamax®/Vyndaqel®, Pfizer Inc.), and vutrisiran (Amvuttra®, Alnylam Pharmaceuticals, Inc.) for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM).”
  • AHRQ’s Patient Safety Network informs us,
    • “Patients presenting to the emergency department (ED) are triaged to prioritize care based on level of illness. In this study, 2,543 patients presenting to an ED in Switzerland were asked to self-triage using an electronic symptom-checker. (Patients were triaged and treated based on standard-of-care nurse triage.) Recommendations were given regarding time to treat (e.g., emergency) and point-of-care (e.g., self-care) and subsequently evaluated by three panels of experts. Fifty of the 2,543 patients were judged as undertriaged, but none were judged as potentially hazardous.”

From the U.S. healthcare front,

  • Healthcare Dive points out,
    • “Elevance reported solid second-quarter results on Wednesday — including $2.3 billion in profit — but the company still lowered long-term revenue growth guidance for its health insurance business. That disconnect raised red flags for analysts.”
    • “Changing revenue growth forecasts for health benefits in the middle of the year “is unusual,” commented Jefferies analyst David Windley in a Wednesday note. “We can’t identify a single, large item that would compel [the reduction] off-cycle.”
    • “During a call with investors Wednesday, Elevance management cited several factors for dropping the guidance, including significant member losses from Medicaid redeterminations and Medicare Advantage bids for 2025 that could slow growth.”
  • Fierce Pharma reports,
    • “As myriad pharma industry attempts to challenge the Inflation Reduction Act (IRA) fall flat, Johnson & Johnson is settling into a reality of pricing rebates and Medicare drug cost negotiations.”
    • “While J&J is “not in alignment” with IRA or its price setting process, the company has accepted the reality of the situation and baked assumptions about the future costs of its drugs into its growth projections through the end of the decade, Jennifer Taubert, EVP, worldwide chairman, innovative medicine at J&J, said on an analyst call Wednesday.
    • “As it stands, J&J currently expects to grow its business by 3% next year and then 5% to 7% out through 2030, Taubert said.”
  • Per Fierce Healthcare,
    • “Electronic health record messages to patients drafted by generative AI were of similar quality and accuracy to those written by healthcare professionals, according to a newly published study conducted using queries from NYU Langone Health patients.”
    • “The analysis, headed by researchers at the system’s affiliate NYU Grossman School of Medicine, had 16 primary care physicians rate AI and human drafts without knowing how each was written.
    • “Among a sample of 334 AI-drafted messages and 169 from professionals (both physicians and non-physicians), the raters found both sets to be on par regarding informational content, completeness and whether the grader would use the draft or start again from scratch.”
    • “The findings “suggest chatbots could reduce the workload of care providers by enabling efficient and empathetic responses to patients’ concerns,” study lead William Small, M.D., of the medical school, said in a release.”

Tuesday’s Tidbits

David Ermer–CDC, CMS, Congress, COVID-19, Medical / Rx research, Medicare, Mental health care, NIH, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Fierce Healthcare tells us
    • “A bipartisan quartet of House representatives have introduced a bill peeling back restrictions on new or expanded physician-owned hospitals.
    • “The Physician Led and Rural Access to Quality Care Act, brought late last week, would create an exception to an Affordable Care Act’s ban that aimed to reduce conflicts of interest in care. Specifically, it would permit new physician-owned hospitals to open in rural areas that are at least 35 miles from another existing hospital or critical access hospital (or 15 miles in difficult-to-traverse areas).
    • “The new bill would also sunset a prohibition on expanding any existing physician-owned hospitals.”
    • FEHBlog note: The bill pits the American Medical Association (pro) against the American Medical Association (con).
  • Per a Department of Health and Human Services press release,
    • “Today, CMS is releasing the final part two guidance – PDF regarding plan outreach and education for the Medicare Prescription Payment Plan, which aims to ensure that people with Medicare prescription drug coverage, especially those most likely to benefit, are aware of the payment option. Starting in 2025, the Medicare Prescription Payment Plan provides the option to people with Medicare prescription drug coverage to spread the costs of their prescription drugs over the calendar year rather than paying in full at the pharmacy counter each time they fill a prescription. People with Medicare must opt into the Medicare Prescription Payment Plan to utilize the new benefit. Notably, this payment option launches at the same time that all individuals with Medicare prescription drug coverage will begin to have their annual out-of-pocket prescription drug costs capped at $2,000, providing needed financial relief for high prescription drug costs.” * * *
    • “Today’s Medicare Prescription Payment Plan final part two guidance, which complements the final part one guidance – PDF released on February 29, is also accompanied by the release of the final Medicare Prescription Payment Plan model materials. Medicare Part D plans can use the model materials when communicating to Part D enrollees about the Medicare Prescription Payment Plan.” * * *
    • “For the fact sheet on the final part two guidance for the Medicare Prescription Payment Plan, please visit: https://www.cms.gov/files/document/fact-sheet-medicare-prescription-payment-plan-final-part-two-guidance.pdf – PDF
    • “For the updated Information Collection Request (ICR) for the Medicare Prescription Payment Plan model plan materials, please visit: https://www.cms.gov/files/zip/medicare-prescription-payment-plan-model-materials.zip
    • “For an updated implementation timeline for the Medicare Prescription Payment Plan, please visit: https://www.cms.gov/files/document/medicare-prescription-payment-plan-timeline.pdf – PDF“
  • Another HHS press release brings us up to date on improvements to the 988 mental health lifeline which was launched two years ago today.
  • Healio adds,
    • “Since the launch of the 988 Suicide & Crisis Lifeline in 2022, counselors have answered more than 10 million calls, texts and chats from people seeking help for suicidal thoughts and mental health crises, according to HHS officials.
    • “During a press conference, HHS Deputy Secretary Andrea Palm said the lifeline “has become one of the most effective first-line responses that we have to help individuals who feel alone and without options.” * * *
    • “HHS has invested nearly $1.5 billion into the lifeline, according to an agency press release. It has lines that are tailored to people who speak Spanish, veterans, American Sign Language (ASL) users and the LGBTQI+ community. Since these lines were added to the 988 lifeline in 2023, there have been about 20,000 chats and texts with Spanish speakers, more than 475,000 texts, calls and chats with LGBTQI+ individuals and approximately 20,000 videophone contacts with ASL users.
    • “Among all contacts over the past 2 years, about 1.7 million were texts, according to the release. In the past year, HHS reported a 51% increase in texts and a 34% increase in calls, with support provided by more than 200 contact centers nationwide.”
  • CMS shares the following statement from CMS Administrator Chiquita Brooks-LaSure:
    • “Remembering Gail R. Wilensky, Ph.D., a health care policy savant who knew how to work across the aisle. Her Influence and leadership can still be felt today. She was very generous to the CMS leaders who served after her, including me. My deepest condolences to her loved ones. CMS is grateful for her service to our country.”
    • FEHBlog note — Dr. Wilensky, who passed away on July 11 at age 81, served as CMS (then HCFA) Administrator for President George H. W. Bush.
  • Per the AHA News,
    • “The AHA July 16 urged the Center for Medicare and Medicaid Innovation not to implement its newly proposed Increasing Organ Transplant Access Model as currently constructed, expressing concerns about many of its design features. The proposed mandatory payment model would test whether performance-based incentive payments paid to or owed by participating kidney transplant hospitals would increase access to kidney transplants while preserving or enhancing the quality of care and reducing Medicare expenditures. AHA said that IOTA features could exacerbate inequities and negatively impact quality of care. Specifically, AHA said the IOTA model would add unnecessary disruption and uncertainty to the transplant ecosystem, potentially incentivize sub-par matches given the heavy emphasis on volume and would be discordant with other regulatory requirements.” 

From the public health and medical research front,

  • Per a press release, the Institute for Clinical and Economic Review published its Final Evidence Report on Treatment for Chronic Obstructive Pulmonary Disease 
    • “Independent appraisal committee voted that current evidence is adequate to demonstrate superior net health benefits for ensifentrine added to maintenance therapy compared to maintenance therapy alone; ICER calculated a health-benefit price benchmark (HBPB) for ensifentrine between $7,500 to $12,700 per year, and the therapy is priced at $35,400 per year.
  • The National Institutes of Health announced,
    • “In a new analysis of data, researchers at the National Institutes of Health (NIH) have found that taking a daily supplement containing antioxidant vitamins and minerals slows progression of late-stage dry age-related macular degeneration (AMD), potentially helping people with late-stage disease preserve their central vision. Researchers reviewed the original retinal scans of participants in the Age-Related Eye Diseases Studies (AREDS and AREDS2) and found that, for people with late-stage dry AMD, taking the antioxidant supplement slowed expansion of geographic atrophy regions towards the central foveal region of the retina. The study was published in the journal Ophthalmology.
    • “We’ve known for a long time that AREDS2 supplements help slow the progression from intermediate to late AMD. Our analysis shows that taking AREDS2 supplements can also slow disease progression in people with late dry AMD,” said Tiarnan Keenan, M.D., Ph.D., of NIH’s National Eye Institute (NEI) and lead author of the study. “These findings support the continued use of AREDS2 supplements by people with late dry AMD.”
  • Beckers Hospital Review shares ophthalmologist organization opinions on eye conditions and Ozempic use.
    • A week after a study connected Ozempic and Wegovy to an eye condition that can cause partial blindness, two ophthalmology organizations said they have “been aware of other vision changes for some time.”
    • Changing sugar levels can affect the shape of the eye’s lens, according to the American Academy of Ophthalmology and North American Neuro-Ophthalmology Society. Because of this, semaglutide, the active ingredient of Type 2 diabetes drug Ozempic and weight loss medication Wegovy, might lead to blurry vision. 
    • The ophthalmology groups said previous studies have also found that semaglutide can exacerbate diabetic retinopathy and macular complications. 
    • “The medical community has been aware of other vision changes with semaglutide for some time,” the organizations said in a July 8 joint statement. However, the research associating the drug to non-arteritic anterior ischemic optic neuropathy [NAION] is the first of its kind. 
    • “The condition restricts blood flow to the optic nerve, which causes sudden, painless loss of vision in one eye, the statement said. The research did not confirm a causal relationship between the medications and NAION, but it identified a potential link.: * * *
    • “The subjects in this study were either overweight or obese or had Type 2 diabetes. People who have diabetes are already at risk of NAION,” the organizations said. “Other risk factors for NAION include heart disease, history of heart attack, high blood pressure and sleep apnea” — health risks that also are tied to diabetes and obesity. 
    • “In response to the study, Novo Nordisk, the manufacturer of Ozempic and Wegovy, said it takes adverse event reports seriously. 
    • “The ophthalmology groups said they recommend patients continue taking the medications unless they experience a sudden vision loss.”  
  • The AHA News points out,
    • “Antimicrobial-resistant infections remained above pre-pandemic levels in 2022, the Centers for Disease Control and Prevention reported July 16. CDC data show that infections, which increased 20% during the pandemic compared to the pre-pandemic period — peaked in 2021.
    • “The increases in antimicrobial resistance (AR) burden seen in 2020 and 2021 are likely due in part to the impact of COVID-19, which pushed healthcare facilities, health departments and communities near their breaking points,” the agency notes. “This resulted in longer hospital stays for hospitalized patients (including those diagnosed with COVID-19), challenged the implementation of infection prevention and control practices and increased inappropriate antibiotic use.” 
    • “The AHA provides resources which promote the appropriate use of medical resources.”
  • Medscape summarized the June meeting decisions of the CDC’s Advisory Committee on Immunization Practices and identifies the five immunizations that adults need beyond Covid and the flu vaccines.
  • Medscape also discusses the use of remote trials to accelerate the testing of new long Covid treatments.

From the U.S. healthcare business front,

  • Beckers Payer Issues and Fierce Healthcare report on UnitedHealthcare’s second quarter financial results announced today.
    • BPI – “UnitedHealth Group posted $4.2 billion in net income during the second quarter of 2024, a 23% decline year over year.
    • “The company said it has restored the majority of affected Change Healthcare services and has provided more than $9 billion in advance funding and loans to providers. The total full year impact of the breach is estimated at $1.90 to $2.05 per share, with the company raising the estimated total cost of the attack to around $2.45 billion.”
    • FH – “UnitedHealth saw an elevated medical loss ratio in Q2, and executives pointed to the Change Healthcare cyberattack as a key factor.
    • “UnitedHealthcare had an MLR of 85.1% in the second quarter, compared to 83.2% in the prior year quarter. The insurer called out multiple elements that contributed to the elevated ratio in its earnings call on Tuesday morning. For one, UHC CEO Brian Thompson said there’s a clear difference in coding intensity after the insurer ended care waivers offered following the cyberattack.
    • “Amid the cyberattack, UnitedHealth eased prior authorization and utilization management to support cash flow to providers.”
  • Beckers Hospital Review provides details on U.S. News and World Report’s latest U.S. hospital rankings by State and by specialty.
  • pwc reports,
    • “Commercial health care spending growth is estimated to grow to its highest level in 13 years, according to PwC’s newest research into annual medical cost trend. PwC’s Health Research Institute (HRI) is projecting an 8% year-on-year medical cost trend in 2025 for the Group market and 7.5% for the Individual market. This near-record trend is driven by inflationary pressure, prescription drug spending and behavioral health utilization.
    • “HRI is also restating the 2023 and 2024 medical cost trends as higher than previously reported based on the input of health plans we surveyed and their trend experience. This unfavorable trend reflects higher than expected utilization of glucagon-like peptide-1 (GLP-1) drugs as well as higher acuity (higher levels of care) inpatient and outpatient utilization. Inpatient and outpatient utilization were driven by demand from care deferred since the pandemic, which was met by newly created capacity as sites of care shifted to outpatient, professional and ambulatory care settings.
    • “The same inflationary pressure the healthcare industry has felt since 2022 is expected to persist into 2025, as providers look for margin growth and work to recoup rising operating expenses through health plan contracts. The costs of GLP-1 drugs are on a rising trajectory that impacts overall medical costs. Innovation in prescription drugs for chronic conditions and increasing use of behavioral health services are reaching a tipping point that will likely drive further cost inflation.
    • “Meanwhile, cost deflators are not enough to offset cost inflators. The growing adoption of biosimilar medications may provide some relief, while many health plans are looking inward to find opportunities across business operations to generate additional cost savings. Today’s medical cost trend is an urgent call to action for healthcare organizations to rethink their strategies to manage the total cost of care more effectively – a challenge that is inextricably linked to the broader challenge of affordability, defined by the Affordable Care Act as the percentage of a member’s household income used for healthcare expenses.”
  • FEHBlog note — OUCH!
  • MedCity News discusses the improving state of the digital health fundraising market.

Monday Roundup

David Ermer–CDC, Congress, COVID treatment, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Reuters reports,
    • “Democratic U.S. Senate aides will meet with Novo Nordisk executives on Tuesday to discuss fallout from its decision to stop selling one of its long-acting insulins in the country, two sources familiar with the meeting told Reuters.
    • “Novo Nordisk (NOVOb.CO), opens new tab will meet with the aides for Senators Jeanne Shaheen, Raphael Warnock, and Elizabeth Warren. In April, the lawmakers wrote to the company expressing alarm at its decision, announced in November, that it would permanently discontinue Levemir by the end of 2024.
    • “Novo said it has given patients enough time to switch to other options, according to a May letter seen by Reuters. The company is unaware of plans for drug manufacturers to produce a biosimilar version of the insulin, the letter said, adding Novo would not assert any patent against such a version.
    • “The sources declined to be named citing the sensitivity of the matter.”
  • STAT News lets us know,
    • “For now, the doctor groups are lobbying [Congress] in unison toward the same goal of increasing the pot of money for physician services, which stood at about $71 billion in 2022, or 16% of Medicare fee-for-service spending. A Medicare spokesperson said that number is expected to reach about $90 billion this year. Doctors would also like to get credit for saving money by keeping patients out of the hospital.
    • “Those demands would pit doctors against others in the health care system, including hospitals, because Congress typically requires that increases in Medicare spending be paid for by cuts elsewhere in the program. That’s a heavy lift. Congress has been considering equalizing certain Medicare payments between hospitals and physicians’ offices to save money, but that site-neutral policy has faltered.
    • “That’s not the only thing working against doctors. If Congress increases spending on physician services, seniors’ Medicare Part B premiums will go up, according to the nonpartisan research arm of Congress. Congress could prevent premiums from increasing, but that would add to the government tab.
    • “For those reasons, doctor lobbyists privately doubt Congress will meaningfully increase physician pay rates overall, leaving doctors to fight over how a fixed sum of money should be split up.
    • “Courtney Savage, founder of Savage Health Policy, said she sees signs of trouble ahead for specialists. Republicans and Democrats in the Senate want to boost primary care pay. Sens. Bill Cassidy (R-La.) and Sheldon Whitehouse (D-R.I.) unveiled a plan to “improve the adequacy of pay for primary care providers in Medicare.” Two days later, Senate Finance Committee Chair Ron Wyden (D-Ore.) and the committee’s ranking Republican, Idaho’s Sen. Mike Crapo, published their plan to improve chronic care, which would likely favor primary care doctors, too.”
  • In this regard, the American Hospital News tells us,
    • The AHA July 15 commented to Sens. Sheldon Whitehouse, D-R.I., and Bill Cassidy, R-La., responding to a request for information based on the Pay PCPs Act, legislation designed to improve support and pay for primary care providers. The AHA expressed concerns that its proposed hybrid per-member-per-month and fee-for-service payment structure in the physician fee schedule for primary care could result in payment cuts, and that there may be variation in the PMPM depending on the type of provider. The bill also has language implying that there is latitude for the PMPM to not be risk-adjusted and possibly restrict what could be included in the risk adjustment, AHA said. 
    • The AHA voiced support for a provision in the legislation that would reduce beneficiary cost-sharing for primary care services by 50% under the hybrid payment model. The association also shared principles for Congress to consider when designing alternative payment models to make participation more attractive for potential participants.
  • Per Axios,
    • “The Centers for Medicare and Medicaid Services last week proposed creating three new payment codes that would allow physicians to get paid for incorporating digital therapies into patients’ mental health treatment, starting in 2025. 
    • “The codes would only apply to products approved by the Food and Drug Administration.
    • “Insurers have so far been reluctant to pay for apps, video games and other therapeutic software. There isn’t long-term data on the effectiveness, and differences in the therapies make it difficult to standardize billing.
    • “The first company to get FDA clearance for a digital therapy, Pear Therapeutics, declared bankruptcy last year after struggling to secure insurance coverage for its products.”

From the public health and medical research front,

  • The AHA News points out,
    • “The Centers for Disease Control and Prevention July 14 announced four confirmed human cases of H5N1 bird flu among farm workers who were working at a Colorado poultry facility. The agency is also aware of a fifth presumptive-positive case, which is pending confirmation. All of the workers who tested positive reported having a mild illness, with symptoms that include conjunctivitis, eye tearing, fever, chills, coughing, sore throat and a runny nose. The CDC said they believe a risk to the public remains low.” 
  • STAT News adds,
    • The announcement of the fourth [H5N1 bird flu] case, on the eve of the July 4 holiday, led Adam Kucharski, the co-director of the Centre for Epidemic Preparedness & Response, at the London School of Hygiene and Tropical Medicine, to ask on the social platform X: “What’s the plan?”
    • Kucharski posed a bunch of hypotheticals — What if there are clusters of cases? Cases among people who haven’t had contact with cows? Cases exported to other countries? — to convey the point that a mere four years after the start of the worst pandemic since the 1918 Spanish Flu, the world does not appear to be grappling with the fact that H5 virus spreading in cows could lead to H5 virus spreading in people.
    • “What, here in 2024, is the plan for dealing with an outbreak of a potentially pandemic pathogen like H5N1?” he asked.”
  • Medscape notes,
    • “Parkinson’s disease (PD) and dementia with Lewy bodies are currently defined by clinical features, which can be heterogeneous and do not capture the presymptomatic phase of neurodegeneration.
    • “Recent advances have enabled the detection of misfolded and aggregated alpha-synuclein protein (synucleinopathy) — a key pathologic feature of these diseases — allowing for earlier and more accurate diagnosis. This has led two international research groups to propose a major shift from a clinical to a biological definition of the disease.
    • “Both groups emphasized the detection of alpha-synuclein through recently developed seed amplification assays as a key diagnostic and staging tool, although they differ in their approaches and criteria.” * * *
    • “Commenting for Medscape Medical News, James Beck, PhD, chief scientific officer at the Parkinson’s Foundation, said the principle behind the proposed classifications is where “the field needs to go.”
    • “Right now, people with Parkinson’s take too long to get a confirmed diagnosis of their disease, and despite best efforts, clinicians can get it wrong, not diagnosing people or maybe misdiagnosing people,” Beck said. “Moving to a biological basis, where we have better certainty, is going to be really important.”
  • The New York Times reports, “Families pay thousands of dollars to store their children’s stem cells with the hope of a healthier future. But the cells are rarely useful, and sometimes contaminated.” No bueno.
  • A STAT News journalist observes,
    • If you read Derek Lowe — and come on, you must read the bearded chemist who has been blogging about pharma for two decades — you’ve already thought about ibuzatrelvir, Pfizer’s potential heir to Paxlovid, which would be given as a single pill and potentially without that metallic taste.
    • “I read this eagerly, but I had another question that I asked virologist Michael Mina when he posted Derek’s article on X. How do we test it?
    • “Plenty of people still get Covid and die from it. But I’ve been watching clinical trials of Paxlovid and other antivirals. And these drugs keep failing in studies. Even Paxlovid worked best when it was given to high-risk people who have not been vaccinated. Shionogi’s Paxlovid follow-up recently failed in a large study.“Plenty of people still get Covid and die from it. But I’ve been watching clinical trials of Paxlovid and other antivirals. And these drugs keep failing in studies. Even Paxlovid worked best when it was given to high-risk people who have not been vaccinated. Shionogi’s Paxlovid follow-up recently failed in a large study.
    • “It’s very hard to prove an antiviral drug works, a problem that has long dogged Tamiflu. The benefit only shows up if people are at very high risk, or if the study is very big. Otherwise, it just appears the drug is reducing symptoms a very tiny bit.
    • “On this, David Boulware of the University of Minnesota had one perspective: Shionogi’s drug failed because regulators wanted its study to contain too few high-risk patients. But my suspicion is that getting better Covid drugs will be less a problem of chemistry than of clinical trials. This is part of why we don’t have more monoclonal antibodies against new strains. Paxlovid sales have come in higher than many analysts were expecting so far this year. Maybe that will encourage drug.” companies to solve this problem.
  • The Washington Post and Consumer Reports explain “what to do when you need medical care fast,”
    e.g., self-triage.
  • Per MedPage Today,
    • “A mammography screening decision aid with information about the benefits and harms of screening increased the percentage of average-risk women in their 40s who wanted to delay mammography, according to a national online survey.
    • “Before viewing the decision aid, 27% of women ages 39 to 49 preferred to delay screening. The decision aid raised that percentage to 38.5%, reported Laura Scherer, PhD, of the University of Colorado in Aurora, and colleagues.
    • “The survey also showed a narrower majority of women preferred to undergo mammography at their current age after viewing the decision aid (57.2% vs 67.6% beforehand) and more preferred to wait until age 50 (18% vs 8.5%).
    • “As to what information shifted their view, 37.4% of women surveyed said they found the information about overdiagnosis in the decision aid “surprising,” and 28.1% said it differed from what their doctor had told them, Scherer and colleagues reported in the Annals of Internal Medicine.
    • “While the U.S. Preventive Services Task Force (USPSTF) recommends biennial screenings starting at age 40 years — compared with a previous recommendation that screening begin at 50 — it “endorses informed choice and shared decision making at all levels of its recommendations,” Scherer’s group wrote.
    • “However, “a lack of language promoting informed choice in the guideline itself may create confusion among clinicians about whether they should discuss both screening benefits and harms with patients or instead provide only information that maximizes screening uptake,” they added.”

From the U.S. healthcare business front,

  • AIS Daily reports,
    • “Blue Shield of California caught the attention of the industry last August when it announced a switch to a pharmacy benefits model using five vendors. While some insurers and plan sponsors have considered a similar move following Blue Shield’s revelation, benefits consultants tell AIS Health that most payers continue to have a traditional arrangement where one PBM handles all pharmacy-related activities. They add that Blue Shield’s so-called unbundled approach could be difficult to manage and may not achieve significant cost savings.”
  • Per Fierce Pharma,
    • “While patent cliffs are looming for many of biopharma’s top-selling products, the industry has enormous capacity to respond as “conditions for M&A are favorable,” according to a research note from Morgan Stanley.
    • “In the July 11 report, the analysts calculate that products losing exclusivity through 2030 are generating a combined $183.5 billion in annual sales, with Amgen, Bristol Myers Squibb and Merck facing the most exposure of their revenue.
    • “Meanwhile—citing company financial reports and data from Visible Alpha and FactSet—Morgan Stanley estimates that Big Pharma has $383.1 billion of firepower available for dealmaking. The companies sitting on the most dry powder are Johnson & Johnson, Merck and Novo Nordisk, the analysts said.
    • “We continue to see the conditions as generally favorable for bolt-on M&A as large-cap pharma companies have balance sheet capacity and a need to acquire outer-year revenue,” the Morgan Stanley team, led by Terence Flynn, Ph.D., wrote.”
  • BioPharma Dive offers a chart with “Years of expiration for principal patents protecting the top 30 pharmaceutical products by 2023 sales.”
  • Beckers Hospital Review discloses the gender breakdown of physicians across the fifty states and DC.
  • Per MedCity News, “Walgreens’ Finances Are in Dire Straits — But All Hope Is Not Lost. Walgreens’ financial performance is still rocky, but experts agree there is a good chance that CEO Tim Wentworth can lead the company to recovery. To make this happen, Walgreens will have to let go of its retail clinic dreams and focus more on making its core pharmacy business as strong as possible.”

Weekend Update

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

From Washington, DC,

  • Fierce Healthcare discusses a Senate Special Committee on Aging hearing about healthcare price transparency held last Thursday July 11.
    • “If consumers or business departments received a major charge on their monthly statements with no pricing breakdown or itemized receipts, many would demand more information if not outright refuse to pay.
    • “But that’s not the case in healthcare, where unexpected fees billed from insurers and hospitals and multiplicative markups are delivered after the fact and with little explanation.
    • “That was the message senators heard loud and clear during a Thursday morning hearing of policy researchers and purchasers of commercial insurance for employees and union members.” * * *
    • [Ranking Member Sen. Mike} Braun [R Ind.] kept the legislative focus squarely on price transparency, highlighting a bipartisan package he brought with Sens. John Hickenlooper, D-Colorado; Bernie Sanders, I-Vermont; Chuck Grassley, R-Iowa; and Tina Smith, D-Minnesota, earlier this year.
    • That bill, the Health Care PRICE Transparency Act 2.0 [S. 1130], received the explicit support of multiple witnesses and other price transparency advocacy groups whose written comments were entered into the hearing’s record. It would impose data sharing standards, require negotiated rates and cash prices on machine-readable files rather than estimates, increase maximum annual noncompliance penalties and give group health plans the right to audit and review claims data.

From the public health and medical research fronts,

  • MedPage Today discusses four exceptional papers from JAMA Open Forum.
    • Item 1: Smartphone App Decreases Distracted Driving
    • Item 2: Vaping and Secondhand Nicotine Exposure in Kids
    • Item 3: New Data Adds Confidence to RSV Vaccine Safety During Pregnancy
    • Item 4: Mental Health Care Access Via Telehealth Decreased After the COVID Emergency Period.
  • The Washington Post points out
    • “A study published in the journal Alcohol: Clinical & Experimental Research looked at the reasons young adults give for not drinking, which researchers say could help in crafting public health messaging aimed at reducing alcohol abuse.
    • “Researchers focused on 614 participants who took online surveys about their alcohol use from mid-February to mid-May 2022. Participants were an average of 21.5 years old, and the majority were White (64.5 percent) and male (54.2 percent). About 65 percent were college students.
    • “Among the respondents, 49.9 percent said they were moderate drinkers, with 31.5 percent reporting binge drinking five to nine drinks in a row in the prior two weeks and 18.6 percent reporting “high-intensity drinking” of 10 or more drinks on a day in the previous two weeks, researchers at the University of Michigan’s Institute for Social Research and Texas State University report. The study was funded by the National Institute on Alcohol Abuse and Alcoholism and the National Institute on Drug Abuse.”
  • The Wall Street Journal warns,
    • “With their fitness-influencer endorsements and wellness sheen, energy drinks have become more appealing to women. They’ve also become a go-to for teenage girls and young women with eating disorders.  
    • “Overconsumption of low-cal, highly caffeinated energy drinks is on the rise among young women with unhealthy eating and exercise habits, say doctors at more than a dozen of the nation’s top hospitals and eating-disorder treatment centers. Taking in too much caffeine can cause serious health problems, especially for people who aren’t eating enough, doctors say.   
    • “Brands like Celsius and Alani Nu pitch themselves as fitness aids, and, in the case of Celsius, claim to boost metabolism and burn fat. Attaining a toned body, the brands’ social-media posts suggest, looks as easy as sipping a can of the sparkling sugar-free beverages before a sweat sesh.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “The rural hospital collaborative in North Dakota has secured two value-based contracts with commercial insurers and more are expected this year, building momentum for those considering similar alliances.
    • “Cibolo Health in October created the Rough Rider High-Value Network comprised of 23 critical access hospitals in North Dakota. The rural hospital advisory firm has since helped launch a similar venture in Minnesota and is in early talks to expand the model in several other states, CEO Nathan White said.
    • “The Rough Rider network inked a Medicare shared savings contract with CVS Health and a contract with Blue Cross Blue Shield of North Dakota that includes quality-based payments and shared savings, White said. Other payers are interested in Medicare Advantage and accountable care organization contracts, he added.”
  • Healthcare Dive lets us know,
    • “Geisinger will begin a $880 million expansion of its Danville, Pennsylvania-based medical center next year, with plans to include a new 11-story medical tower, the system said Tuesday.
    • “The project will include a larger emergency department, expanded intensive care units and operating suites, as well as private rooms for each patient.
    • “The Risant Health-owned nonprofit plans to execute the expansion in phases, with a target completion date of 2028.” 
  • HR Dive informs us,
    • “With the Great Resignation far in the rearview mirror, companies now are facing another challenge: what to do when employees stay.
    • “The U.S. quit rate — often used as a measure of turnover — has remained steadily at 2.2% for the past seven months, according to the Bureau of Labor Statistics’ Job Openings and Labor Turnover Summary released July 2. 
    • “The lull in employee exits is the perfect time for employers to work on succession planning and enhancing their value proposition, according to Lauren Geer, senior vice president and chief human resources officer of IAC, a holding company to media and internet brands including Dotdash Meredith, Care.com and Angi.
    • “It’s quieter now, but I don’t think we can rest on our laurels by any means or pat ourselves on the back for what a great job we’re doing retaining our employees,” Geer said. “Now’s the time to get the house in order, because I do think there’ll be a time when the employee market picks up.” 

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy front –

  • The Wall Street Journal reports,
    • “[On July 9, 2024,] Australia, the U.S. and six other allies warned that a Chinese state-sponsored hacking group poses a threat to their networks, in an unusual, coordinated move by Western governments to call out a global hacking operation they say is directed by Beijing’s intelligence services.
    • “Tuesday’s advisory was a rare instance of Washington’s major allies in the Pacific and elsewhere joining to sound the alarm on China’s cyber activity. Australia led and published the advisory. It was joined by the U.S., U.K., Canada and New Zealand, which along with Australia are part of an intelligence-sharing group of countries known as the Five Eyes. Germany, Japan and South Korea also signed on.” * * *
    • “The technical advisory detailed a group known in cybersecurity circles as Advanced Persistent Threat 40, or APT40, which conducts cybersecurity operations for China’s Ministry of State Security and has been based in the southern island province of Hainan. The advisory detailed how the group targeted two networks in 2022—though it didn’t identify the organizations—and said the threat is continuing.”
  • Federal News Network informs us,
    • “A top Department of Homeland Security official says DHS is working to harmonize new cyber incident reporting rules, as industry and even some lawmakers criticize the draft rule’s scope and potential duplicative requirements.
    • “The comment period for the Cybersecurity and Infrastructure Security Agency’s draft rule closed July 3. The proposal would implement the Cyber Incident Reporting for Critical Infrastructure Act (CIRCIA) of 2022. CISA expects to finalize the rule next spring. The rules will require organizations across the 16 critical infrastructure sectors to report cyber incidents to CISA within 72 hours.
    • “Iranga Kahangama, DHS assistant secretary for cyber, infrastructure, risk, and resilience, said officials are just starting to adjudicate all the feedback it received. But Kahangama acknowledged widespread comments from industry about the “burden” of duplicative cyber incident rules.
    • “We are going to be viewing and administering CIRCIA with an eye towards harmonization,” Kahangama said during a July 10 event in Washington hosted by the Homeland Security Defense Forum. “We’re also establishing conversations between the department and all the other agencies that have cyber reporting requirements to identify ways that we can harmonize reporting.”
    • “He pointed to interagency agreements that “allow for reciprocal sharing of information such that … a report to one will count as a report to another and vice versa through CISA.”
    • “We want to make sure we’re maximizing the ability to do that,” Kahangama said. “That’s quite complicated, because each agency has different requirements. And so, you need to make sure that they’re substantially similar enough and that those are fleshed out. But those are really wonky but interesting conversations that my office is actively having right now as we develop CIRCIA.”
  • The FEHBlog finds it interesting that recent cyberbreach news articles rely on Securities and Exchange Commission 8-K reports from public companies.
  • Cyberscoop summarizes a variety of criticisms levelled against the CIRCIA proposed rule in the public comments.
  • Cyberscoop adds,
    • “New legislation from a bipartisan pair of senators would create an interagency committee tasked with streamlining the country’s patchwork system of cybersecurity regulations if signed into law.
    • “The Streamlining Federal Cybersecurity Regulations Act [S. 4630] from Sens. Gary Peters, D-Mich., and James Lankford, R-Okla., calls on the White House’s national cyber director to create a committee that would harmonize the myriad cyber requirements imposed on companies by federal regulatory agencies, according to bill text shared with CyberScoop.
    • “The introduction of the bill comes a month after a Senate hearing in which Nicholas Leiserson, the assistant national cyber director for cyber policy and programs, warned lawmakers of increasing “fragmentation” of cybersecurity regulations. “It is a problem that requires leadership from ONCD and Congress informed by the private sector,” he said.”
  • Cybersecurity Dive tells us,
    • “The Cybersecurity and Infrastructure Security Agency and FBI advised software vendors to eliminate operating system command injection vulnerabilities from products before they ship. The agencies issued the advisory Wednesday [July 10, 2024] as part of their secure-by-design alert series.
    • “Threat groups have exploited several OS command injection vulnerabilities in widely used network devices this year, including CVE-2024-20399 in Cisco products, CVE-2024-21887 in Ivanti remote access VPNs and CVE-2024-3400 in Palo Alto Networks firewalls. 
    • “OS command injection vulnerabilities arise when manufacturers fail to properly validate and sanitize user input when constructing commands to execute on the underlying OS,” CISA and the FBI said in the advisory.” 
  • Per the HeathIT.gov website,
    • “ONC’s HTI-2 proposed rule [released July 10] implements provisions of the 21st Century Cures Act and reflects ONC’s focused efforts to advance interoperability and improve information sharing among patients, providers, payers, and public health authorities.
    • “Key proposals include:
      • “Two sets of new certification criteria, designed to enable health IT for public health as well as health IT for payers to be certified under the ONC Health IT Certification Program. Both sets of certification criteria focus heavily on standards-based application programming interfaces to improve end-to-end interoperability between data exchange partners (health care providers to public health and to payers, respectively).
      • “Technology and standards updates that build on the HTI-1 final rule, ranging from the capability to exchange clinical images (e.g., X-rays) to the addition of multi-factor authentication support.
      • “Requiring the adoption of United States Core Data for Interoperability (USCDI) version 4 by January 1, 2028.
      • “Adjustments to certain “exceptions” to the information blocking regulations to cover additional practices that have recently been identified by the regulated community, including a new “Protecting Care Access” exception, which would cover practices an actor takes in certain circumstances to reduce its risk of legal exposure stemming from sharing information.
      • “Establishing certain Trusted Exchange Framework and Common AgreementTM (TEFCATM) governance rules, which include requirements that implement section 4003 of the 21st Century Cures Act.”
    • The public comment deadline will end in early September, depending on the date of the proposed rule’s publication in the Federal Register.

From the cybersecurity vulnerabilities and breaches front,

  • Cybersecurity Dive lets us know,
    • “A cyberattack targeting AT&T’s Snowflake environment compromised data on nearly all of the telecom provider’s wireless customers, the company said in a Friday filing with the Securities and Exchange Commission. Nearly 110 million customers are impacted, according to AT&T’s annual report for the period of compromised data.
    • “Data stolen during the intrusion includes records of AT&T customers’ calls and text messages spanning a six-month period ending Oct. 31, 2022, and records from Jan. 2, 2023, the company said in the SEC filing. 
    • “The attack did not expose the content of calls or text messages, customer names or personally identifiable information, according to AT&T. Yet, the stolen records include the phone numbers AT&T wireless customers interacted with, counts of those interactions and aggregate call duration for a day or month.”
  • Dark Reading adds,
    • “Nearly all” of AT&T’s wireless customers are affected, the company admitted, as well as customers of mobile virtual network operators (MVNOs) using AT&T’s network. According to public resources, those MVNOs likely include popular wireless service providers like Boost Mobile, Cricket Wireless, H2O, and Straight Talk Wireless.” * * *
    • “Earlier this year, data belonging to more than 70 million AT&T customers leaked to the Dark Web. The trove included all the hallmark personally identifying information (PII) types, like Social Security numbers, mailing addresses, and dates of birth.
    • “This time, none of the stolen data has as yet been observed on the public web, and customers’ most sensitive PII has remained untouched. [FEHBlog note the theft occurred in April — the public notice was delayed with Justice Department approval.]
    • Still, AT&T warned, “There are often ways, using publicly available online tools, to find the name associated with a specific telephone number.”
  • Cyberscoop notes that Snowflake “announced on Thursday that administrators can now enforce mandatory multi-factor authentication for Snowflake users.”  
  • On a related note, Help Net Security discloses,
    • “On July 1, Twilio – the company that develops the Authy MFA mobile app – shared with the public that attackers have leveraged one of its unauthenticated API endpoints to compile a list of phone numbers and other data belonging to Authy users.
    • “Company systems were not breached, Twilio said, and Authy accounts have not been compromised, but the company warned that “threat actors may try to use the phone number associated with Authy accounts for phishing and smishing attacks.”
    • “The list, which apparently holds data of 33 million Authy users, has been offered for sale by ShinyHunters, a threat actor that specializes in breaching companies and stealing their customers data, then holding it for ransom and/or selling it to the highest bidder on forums and markets frequented by cybercriminals.”
  • Cybersecurity Dive calls attention to a recent survey,
    • “Almost 60% of organizations can’t track what happens to their information once it goes out in an email or through another communication channel, a survey by data security company Kiteworks finds. 
    • “That’s a risk management problem because data breaches are correlated with how information leaves an organization. 
    • “The more communication tools an organization uses — email, file sharing, managed file transfer, secure file transfer protocol, web forms, among others — the higher the risk of information ending up where it wasn’t intended, the survey finds. 
    • “Respondents with over seven communication tools experienced 10-plus data breaches — 3.55x higher than the aggregate,” the survey report says. “
  • On July 9, 2024 —
    • “CISA added three new vulnerabilities to its Known Exploited Vulnerabilities Catalog, based on evidence of active exploitation.
      • “CVE-2024-23692 Rejetto HTTP File Server Improper Neutralization of Special Elements Used in a Template Engine Vulnerability
      • “CVE-2024-38080 Microsoft Windows Hyper-V Privilege Escalation Vulnerability”
      • “CVE-2024-38112 Microsoft Windows MSHTML Platform Spoofing Vulnerability”
    • Health IT Security pointed out recent breaches involving healthcare entities.
    • HHS’s Health Sector Cybersecurity Coordination Center (HC3) posted its bulletin on June 2024 vulnerabilities of interest to the health sector.
  • Health IT Security alerts us,
    • “Change Healthcare published a substitute data breach notice on its website [earlier this week] to inform affected individuals of the breach that resulted from the February 2024 cyberattack against the company. Change has publicly stated that the cyberattack involved the data of approximately one-third of Americans.
    • “Change Healthcare said that it would begin mailing written letters to affected individuals on June 20, once it completed its data review. Additional customers may be identified as impacted as the review continues.
    • “The company provided a brief timeline of events in its substitute notice, which was published on its website. Although the cyberattack began on February 21, it was not until March 13 that Change was able to obtain a dataset of exfiltrated files that was safe to investigate. * * *
    • “Any individual who believes that their information has been impacted by the data breach can enroll in two years of complimentary credit monitoring and identity theft protection services. Ahead of the breach notice, state attorneys general encouraged consumers to take advantage of these free resources.”

From the ransomware front,

  • Cyberscoop reports,
    • “The ransomware group linked to a June cyberattack against auto industry software provider CDK Global received a payment of more than $25 million two days after the attack that hobbled software used by roughly 15,000 car dealerships in the U.S. became public, researchers told CyberScoop. 
    • “A cryptocurrency wallet likely controlled by BlackSuit — the ransomware group believed to be responsible for the attack — received approximately 387 bitcoins on June 21, worth roughly $25 million, researchers with blockchain intelligence firm TRM Labs told CyberScoop. 
    • “The evidence uncovered by TRM Labs is firmest evidence yet to indicate that CDK Global paid a ransom in order to resolve the attack on its systems, though TRM’s findings do not conclusively prove that the payment came from CDK.”
  • SC Media and Bleeping Computer discuss RansomHub attacks on the Florida Department of Health and the Rite Aid pharmacy chain.
  • Dark Reading reports,
    • “Akira ransomware actors are now capable of squirreling away data from victims in just over two hours, marking a significant shift in the average time it takes for a cybercriminal to move from initial access to information exfiltration.
    • “That’s the word from the BlackBerry Threat Research and Intelligence Team, which today released a breakdown of a June Akira ransomware attack on a Latin American airline. According to BlackBerry’s anatomy of the attack, the threat actor, using Secure Shell (SSH) protocol, gained initial access via an unpatched Veeam backup server, and immediately set about heisting information before deploying the Akira ransomware the next day.
    • “The likely culprit is Storm-1567 (aka Punk Spider and Gold Sahara), a prolific user of the Akira ransomware-as-a-service (RaaS) platform and the group that maintains the Akira leak site, according to the report. The gang is known for using double-extortion tactics and has attacked more than 250 organizations across numerous industry verticals globally since emerging from the shadows in March 2023. It mainly sets its sites on Windows systems, but has developed Linux/VMware ESXi variants as well, and has consistently shown a high level of technical prowess.”
  • The Register (UK) tells us,
    • “As ransomware crews increasingly shift beyond just encrypting victims’ files and demanding a payment to unlock them, instead swiping sensitive info straight away, some of the more mature crime organizations are developing custom malware for their data theft.
    • “In a report published on Wednesday by Cisco Talos, the threat intelligence unit reviewed the top 14 ransomware groups and analyzed their tactics, techniques and procedures (TTPs). Talos selected the 14 based on volume and impact of attacks and “atypical threat actor behavior,” using data from the criminals’ leak sites, internal tracking, and other open-source reporting.
    • “The 14, listed here by number of victims on their respective shaming sites, are the ones you’d likely expect: LockBit, ALPHV, Play, 8base, BlackBasta, BianLian, CLOP, Cactus, Medusa, Royal/Blacksuit, Rhysida, Hunters International, Akira, and Trigona. 
    • “Over the past year, we have witnessed major shifts in the ransomware space with the emergence of multiple new ransomware groups, each exhibiting unique goals, operational structures and victimology,” the report’s authors note.”

From the cybersecurity defenses front,

  • Cybersecurity Dive discusses “What does your CEO need to know about cybersecurity? CEOs don’t necessarily have to become experts in the technical aspects of cybersecurity to be prepared in case of an attack or — hopefully — stop one before it starts.”
  • Per a July 11, 2024, CISA press release,
    • “CISA released CISA Red Team’s Operations Against a Federal Civilian Executive Branch Organization Highlights the Necessity of Defense-in-Depth in coordination with the assessed organization. This Cybersecurity Advisory (CSA) details key findings and lessons learned from a 2023 assessment, along with the red team’s tactics, techniques, and procedures (TTPs) and associated network defense activity.
    • “The CSA also provides recommendations to assist executives, leaders, and network defenders in all organizations with refining their cybersecurity, detection, response, and hunt capabilities.
    • “CISA encourages all organizations review the advisory and apply the recommendations and mitigations within, including applying defense-in-depth principles, using robust network segmentation, and establishing baselines of network traffic, application execution, and account authentication.”