Weekend Update

David Ermer

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

Weekend Update

David Ermer–Congress, Federal employment benefits, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Tomorrow afternoon, the House Rules Committee will take up HR 4664, the financial services and general government appropriations bill that includes OPM and FEHB funding. The bill includes the typical FEHB appropriations provisions — the abortion coverage restriction, the contraceptives coverage mandate, and the prohibition against applying full Cost Accounting Standards coverage to experience-rated FEHB plan carriers.
  • The Federal Benefits Open Season begins next Monday, November 13, and ends on Monday, December 11, 2023. OPM has refreshed the Open Season website with 2024 plan information.

From the public health and research front,

  • NPR Shots discusses the impact of chronic drug shortages on hospitals and patients.
  • The Washington Post reports that “the hunt quickens” for vaccines and antibody therapies against opioids. For example,
    • “The federal government recently awarded an additional $14.8 million for research into a monoclonal antibody that would target fentanyl — the nation’s deadliest street drug — by binding to its molecules before they can invade the brain and shut down breathing. Cessation Therapeutics, a North Carolina biotech company, touts its monoclonal antibody as a way both to prevent overdoses and to treat overdoses and opioid addiction.”
  • Fortune Well tells us,
    • “Whether you snag some vitamin C at the first sign of a cold or stock up on probiotics to keep your gut health in check, you’re not alone in turning to dietary supplements—an estimated 75% of Americans use them.
    • “Among the various types, vitamin K is gaining popularity due to its potential benefits for healthy aging. Specifically, it is thought to aid in the prevention of age-related conditions such as osteoporosis and cardiovascular disease.”
  • Medscape informs us,
    • “Prescriptions for semaglutide jumped 150% in the past year, with an 80% increase in prescriptions written per provider, new data suggest.
    • “Among more than 350,000 prescribers in the nationwide DrFirst network between December 2022 and June 2023, prescriptions for the weight loss formulation Wegovy rose sixfold while those for Ozempic, the lower-dose version for treating type 2 diabetes, increased by 65%.”
  • and
    • “With nutrient-stimulated hormone therapies for obesity in phase 3 trials and activin-receptor inhibitors in the next upcoming drug class, highly effective treatments for obesity are on the horizon.
    • “We are at a watershed [moment] brought on by the recent introduction of highly effective antiobesity medications,” said Ania M. Jastreboff, MD, PhD, in a lecture at ObesityWeek.
    • “Jastreboff, from Yale University and the Yale Center for Weight Management, New Haven, Connecticut, provided an overview of the many nutrient-stimulated hormone-based antiobesity therapies in late phases of development — including dual and triple therapies with glucagon-like peptide 1 receptor agonists (GLP-1 RAs), glucose-dependent insulinotropic polypeptide (GIP) agonists, glucagon, and amylin.”
  • and
    • “New research suggests terminating metformin may raise the risk for dementia in older adults with type 2 diabetes, providing more evidence of metformin’s potential neuroprotective effects.”
  • and, last but not least,
    • “T3D-959, an oral dual delta/gamma peroxisome proliferator-activated nuclear receptor (PPAR) agonist, has shown promise in a phase 2 randomized, placebo-controlled study of adults with mild-to-moderate Alzheimer’s disease (AD).”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy front,

  • The FAR Council extended the public comment deadline for its October 3, 2023, proposed cybersecurity rules from December 4, 2023, to February 2, 2024. The FEHBlog noticed that the proposed rules (cited in the link) would be added to FAR Part 39 captioned “Acquisition of Information Technology.” In contrast, the FAR cybersecurity rules already found in the FEHB contract are found in FAR Part 4, captioned “Administrative and Information Matters.” For this reason, the FEHBlog has formed the opinion that these rules would not apply to FEHB plan contracts. In any event, the OPM FEHB contracts already include requirements for reporting data breaches and cyber incidents (Section 1.37).
  • Health IT Security tells us,
    • “HITRUST issued a response to the White House’s request for information (RFI) on the harmonization of cybersecurity regulations, suggesting that regulation alone is not a fix to the ongoing cyber challenges that critical infrastructure entities face.
    • “Rather, HITRUST recommended a shift away from further regulations in favor of a renewed focus on accountability and reciprocity within existing standards. Additionally, HITRUST emphasized the importance of reliable cybersecurity assessments and assurances.”
  • and
    • “The HHS Office for Civil Rights (OCR) released an educational video to help covered entities understand how the HIPAA Security Rule can help them defend against cyberattacks. The video was produced in recognition of National Cybersecurity Month.
    • “Hosted by Nick Heesters, senior advisor for cybersecurity at OCR, the 43-minute video explores cyberattack trends gleaned from OCR breach reports and discusses how Security Rule compliance can help covered entities combat these threats.”
  • Cyberscoop informs us,
    • “The White House announced a long-awaited executive order on Monday that attempts to mitigate the security risks of artificial intelligence while harnessing the potential benefits of the technology. 
    • “Coming nearly a year after the release of ChatGPT — the viral chatbot that captured public attention and kicked off the current wave of AI frenzy — Monday’s executive order aims to walk a fine line between over-regulating a new and potentially groundbreaking technology and addressing its risks.
    • “The order directs leading AI labs to notify the U.S. government of training runs that produce models with potential national security risks, instructs the National Institutes of Standards and Technology to develop frameworks for how to adversarially test AI models, and establishes an initiative to harness AI to automatically find and fix software vulnerabilities, among other measures. 
    • “Addressing questions of privacy, fairness and existential risks associated with AI models, Monday’s order is a sweeping attempt to lay the groundwork for a regulatory regime at a time when policymakers around the world are scrambling to write rules for AI. A White House fact sheet describes the order as containing “the most sweeping actions ever taken to protect Americans from the potential risks of AI systems.”

From the cyber vulnerabilities and breaches front,

  • Per Cybersecurity Dive,
    • “The Securities and Exchange Commission charged SolarWinds and its CISO Timothy Brown with fraud and internal control failures for allegedly misleading investors about its cybersecurity practices leading up to the Sunburst attack discovered in December 2020. 
    • “The SEC on Monday [October 29] alleged the company overstated its cybersecurity practices and failed to disclose known risks from October 2018, when the company went public, up to at least the Sunburst attack. 
    • “Public statements from the company contradicted internal assessments, including a 2018 assessment by a company engineer, shared with Brown and others, showing the company’s remote access setup was “not very secure,” the SEC complaint said.
    • “SEC officials allege SolarWinds and Brown ignored repeated red flag warning signs that put the company’s cybersecurity at risk. 
  • Security Week offers industry reaction to the lawsuit.
    • “It remains to be seen how the lawsuit against the SolarWinds CISO will unfold and what implications it will have for the cybersecurity industry as a whole. Regardless of the outcome, it serves as a stark reminder that the role of CISOs is continually evolving, and they must navigate a complex landscape of legal and regulatory challenges.”
  • HHS’s Heath Sector Cybersecurity Coordination Center (HC3) issued its October vulnerability bulletin.
    • “In October 2023, vulnerabilities to the health sector have been released that require attention. This includes the monthly Patch Tuesday vulnerabilities released by several vendors on the second Tuesday of each month, along with mitigation steps and patches. Vulnerabilities for October are from Microsoft, Google/Android, Apple, Mozilla, Cisco, SAP, VMWare, Adobe, Fortinet, Atlassian, SolarWinds, NextGen Healthcare, and F5. A vulnerability is given the classification as a zero-day when it is actively exploited with no fix available or if it is publicly disclosed. HC3 recommends patching all vulnerabilities, with special consideration to the risk management posture of the organization.”
  • Cyberscoop points out
    • “The exploitation of zero-day vulnerabilities is on the rise globally and directly impacting federal agencies, part of what a senior Cybersecurity and Infrastructure Security Agency official called a “very eventful past six months” in the cyber threat landscape.
    • “Michael Duffy, the associate director for capacity building within CISA’s cybersecurity division, said that in the past month or so, the agency has seen “a really high increase in zero-day activity, exploits that we’re seeing across the globe, really affecting the federal government networks throughout the federal government.”
    • “Duffy’s comments, made during a cybersecurity governance panel this week at ACT-IAC’s Imagine Nation ELC conference in Hershey, Pa., come following a notable decline in so-called in-the-wild zero days last year. According to a July report from Google’s Threat Analysis Group, 41 zero days were detected and disclosed in 2022, down from 69 in 2021.
    • “Despite the decline, the number of zero-day exploits observed in the wild remained the second-highest number since TAG started tracking such exploits in 2014. U.S. government officials recently have described a tendency toward growing sophistication in the state-backed hacking campaigns, one hallmark of which is the use of the previously unknown vulnerabilities known as zero days.”  
  • The Cybersecurity and Infrastructure added two known exploited vulnerabilities to its catalog on Tuesday, October 31, and another on Thursday, November 2.

From the ransomware front,

  • Health IT Security reports,
    • “The International Counter Ransomware Initiative (CRI) held its third summit in Washington, DC, with representatives from 50 countries joining together to build upon counter-ransomware projects and announce new focus areas. Among the commitments announced, at least 40 of the member countries agreed not to pay ransoms to cybercriminals, Reuters first reported.
    • “As long as there is money flowing to ransomware criminals, this is a problem that will continue to grow,” said Anne Neuberger, US deputy national security adviser for cyber and emerging technology in the Biden Administration. [see The Week in Ransomware’s observation below.]
    • “The Federal Bureau of Investigation (FBI) has long encouraged ransomware victims to avoid paying the ransom when faced with a ransomware attack. Paying the ransom can embolden cybercriminals to continue targeting other victims and does not guarantee the safe return of data. * * *
    • “In addition to the pledge, CRI members continued to expand upon the commitments they made at last year’s summit. Key deliverables at the 2023 summit were centered around “developing capabilities to disrupt attackers and the infrastructure they use to conduct their attacks, improving cybersecurity through sharing information, and fighting back against ransomware actors,” the White House noted in a press release.”
  • and
    • “The HHS Office for Civil Rights (OCR) announced a $100,000 settlement to resolve a data breach investigation with Doctors’ Management Services, a Massachusetts-based medical management company and healthcare business associate that suffered a ransomware attack in 2018. The settlement marks the first-ever ransomware agreement that OCR has reached.
    • “In April 2019, Doctors’ Management Services filed a breach report with HHS, acknowledging that 206,695 individuals were impacted by a cyberattack carried out by GandCrab ransomware actors. Although the report was filed in 2019, the initial intrusion occurred in 2017. Doctors’ Management Services only detected the breach in December 2018, when ransomware was used to encrypt its files.”
  • HC3 released an analyst note about 8Base ransomware.
    • A recent attack on a U.S.-based medical facility in October 2023 highlights the potential threat of the ransomware gang, 8Base, to the Healthcare and Public Health (HPH) sector. Active since March 2022, 8Base became highly active in the summer of 2023, focusing their indiscriminate targeting on multiple sectors, primarily across the United States.
    • This surge in operational activity included the group’s engagement in double extortion tactics as an affiliate of Ransomware-as-a-Service (RaaS) groups against mostly small- to medium-sized companies.
    • While similarities exist between 8Base and other ransomware gangs, the group’s identity, methods, and motivations remain largely unknown. What follows is an overview of the group, possible connections to other threat actors, an analysis of their ransomware attacks, their target industries and victim countries, impacts to the HPH sector, MITRE ATT&CK techniques, indicators of compromise, and recommended defenses and mitigations against the group.
  • Of course, here’s a link to Bleeping Computer’s The Week in Ransomware.

From the cybersecurity defenses front,

  • Per Cybersecurity Dive,
    • “Microsoft is overhauling its cybersecurity strategy, called the Secure Future Initiative, to incorporate key security features into its core set of technology platforms and cloud services. 
    • “The plan follows a massive government and industry backlash to Microsoft after the state-linked email theft from the U.S. State Department. Microsoft came under fierce criticism from key members of Congress and federal officials who were concerned that the company was forcing federal agencies to rely on software products that lacked the necessary security features to protect against sophisticated attackers. 
    • “The pushback related to the State Department case was that Microsoft was upcharging customers for additional, important security features. 
    • “Microsoft plans to enable secure default settings out of the box, so customers will not have to engage with multiple configurations to make sure a product is protected against hackers. 
    • For example, Microsoft will implement Azure baseline controls, which include 99 controls across nine security domains by default. 
  • An ISACA expert explains how to craft a corporate generative AI policy.
  • The Wall Street Journal reports,
    • “Economic uncertainty continues to chip away at corporate cybersecurity. 
    • “Layoffs, budget cuts and general skimping are putting more pressure on cybersecurity teams, which, in some cases, are pausing hiring and technology investment.
    • “Because of the economic pressure, there are more questions being asked about backfills or head counts,” said Diego Souza, chief information security officer at engine and generator manufacturer Cummins.
    • “Of 14,865 cyber professionals asked, 47% said there had been some form of cutbacks in cybersecurity—layoffs, budget cuts, hiring or promotion freezes—in the past 12 months, according to a survey by trade group ISC2 in collaboration with Forrester Research. Of that group, 22% said there had been layoffs on their teams, while 53% saw delays in buying or implementing technology, according to the study published Tuesday [October 31].

Friday Factoids

David Ermer–CDC, CMS, Congress, Electronic health records, Federal employment benefits, Medicare, Mental health care, No Surprises Act, OPM, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The Department of Health and Human Services discusses its efforts to support rural healthcare.
  • Today, the proposed No Surprises Act regulation that would change current Independent Dispute Resolution processes was published in the Federal Register. OPM’s proposed FEHB rules changes are described on page 75,808 and may be found on page 75,851.
  • The Centers for Medicare and Medicaid Service issued FAQs on its new final rule imposing civil monetary penalties on Section 111 reporting violations. The rule, which impacts FEHB carriers, becomes enforceable on October 11, 2024.
  • Congressman Gerry Connolly (D VA) released a “statement in support of the Office of Personnel Management’s (OPM) expansion of infertility coverage benefits for Federal Employee Health Benefits (FEHB) program enrollees.” The FEHBlog is pleased to read about Congressman Connolly’s support.
  • The Office of the National Coordinator of Health Information Technology created a blog post titled “Coming in Hot! TEFCA Will Soon Be Live and Add Support for FHIR-Based Exchange.” The post indicates that this critically important electronic health record key to data sharing will be going live soon.
    • “Our TEFCA timelines will remain aggressive and ambitious as ONC and the RCE help support the industry to usher in a new era of data exchange for the United States.
    • “For more information on TEFCA in general, please check out the RCE resources and sign up for the RCE newsletter and monthly public calls.”
  • Govexec reports, “The Office of Personnel Management on Friday announced new plans aimed at helping the federal government’s HR agency better weather the annual surge of retirement applications from departing federal employees that occurs each winter.” Good luck.
  • HR Dive reports,
    • “The U.S. Equal Employment Opportunity Commission opened its 2022 EEO-1 Component 1 data collection Oct. 31. Reports must be submitted by Dec. 5, the agency said in a news release. 
    • “The EEO-1 Component 1 report is a mandatory demographic data report the EEOC requires from all private-sector employers with 100 or more employees, and from certain federal contractors.
    • “EEOC’s Office of Enterprise Data and Analytics released a booklet to help filers complete the process. It has also provided a Filer Support Team Message Center and other resources, the agency said.”

From the public health front,

  • The Centers for Disease Control posted its inaugural issue of FluSight for the current flu season. Here’s the kickoff forecast.
  • Health Payer Intelligence explains how public and private payers cover healthcare for the LGBTQ+ community.
  • The Institute for Clinical and Economic Research published
    • “its third annual “Barriers to Fair Access” assessment of prescription drug coverage policies (Report |Supplemental Materials) within US commercial insurance and the Veterans Health Administration. The analysis found that major payer coverage policies for 18 drugs often met fair access criteria for cost sharing, clinical eligibility, step therapy, and provider restrictions. However, the report’s findings suggest that major improvements are needed in the transparency of coverage policy information for consumers and in detailing out-of-pocket costs for patients.” 
  • Beckers Hospital Review shares CMS statistics on emergency department wait times across our country.
  • The Wall Street Journal gives advice on how to avoid the gloom associated with turning the clock to standard time this weekend.
    • “Daylight hours affect our brain chemistry. As days grow shorter, light receptors in the eyes receive less light and send a signal to the brain about what chemicals to produce, says Lina Begdache, associate professor of health and wellness studies at Binghamton University. 
    • “Our brains begin producing more melatonin—the sleep-related hormone—and less serotonin, which enhances mood and controls appetite. When the brain starts making more melatonin at 4 p.m. due to the earlier dusk, people can feel prematurely sluggish, which can affect mood, diet, exercise and sleep patterns.  
    • “Focusing on improving one area that is affected by the time change, such as exercise, can help the others and might be more doable than trying to improve everything at once, says Begdache, the associate health and wellness studies professor.  * * *
    • “If you improve your diet, you’re more likely to exercise more. And if you exercise more, you’re more likely to sleep better,” says Begdache, who led a 2021 study on mental well-being and seasonal changes. “
  • The FEHBlog personally likes having more sunlight in the morning.

From the U.S. healthcare business front,

  • Here’s a link to the American Medical Association’s reaction to the 2024 Medicare Part B pay cut announced this week. The pay cut is a wash for FEHB carriers because the cut applicable to Medicare prime annuitants will be offset by price increases for younger members. The big problem is that the cut will drive more doctors out of Medicare Part B. When the FEHBlog, who is on traditional Medicare, lived inside the Beltway, his primary care doctor joined the crowd of local PCPs who had dropped out of Medicare. When the FEHBlog moved to Texas last year, he had no problem finding a PCP who takes Medicare, and what’s more, his PCP participates in an accountable care organization. Access to affordable healthcare and dental care is better in central Texas than inside the Beltway, at least for now. The FEHBlog agrees with the AMA that Congress needs to step up.
  • BioPharma Dive informs us,
    • “Moderna on Thursday shifted its revenue forecast for the year to “at least” $6 billion from a previous range of between $6 billion to $8 billion, a change it said reflected COVID-19 vaccination trends in the U.S.
    • “The biotechnology company also disclosed third-quarter earnings showing a net loss of $3.6 billion, driven mainly by non-cash charges of $3.1 billion related to a “manufacturing resizing” and a tax charge. Shares slumped 6% Thursday on the news but traded up Friday morning.
    • “Moderna said it plans to break even in 2026 through “disciplined investment” and launches for new products like its mRNA flu and respiratory syncytial virus vaccines as well as a combination flu and COVID shot.”
  • MedTech Dive shares medtech executives’ views on the new GLP-1 obesity drugs.
    • “Strong patient interest in GLP-1 drugs to treat obesity has prompted medtech companies to take a hard look at the potential impact on demand for procedures like bariatric surgery and products such as glucose monitors and sleep apnea devices.
    • “The potential threat to medical device sales has spooked investors, who have sold shares in companies across the sector.
    • “Fears that medications such as Ozempic, Mounjaro and Wegovy, which are used for diabetes and weight loss, will eventually reshape treatment for a variety of diseases have driven the most severe correction in the medtech sector since the onset of COVID-19, wiping out about $370 billion in market capitalization, according to Mizuho analyst Anthony Petrone.”

Thursday Miscellany

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, NIH, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Roll Call reports,
    • “Speaker Mike Johnson said Thursday that Republicans are considering a new approach to stopgap funding that would extend pieces of current appropriations for different time periods, effectively setting up a series of funding cliffs while avoiding a single deadline that could trigger a partial government shutdown for all agencies.
    • “With current funding for the entire government set to expire on Nov. 17, Johnson has proposed a CR to extend funding through Jan. 15, though that date is the federal Martin Luther King Day holiday. But the Louisiana Republican said at a press conference some GOP members raised the idea of a “laddered CR” to extend funding on a piecemeal basis.”
  • “Senate Finance Committee Chair Ron Wyden, D-Ore., and Ranking Member Mike Crapo, R-Idaho, today released a discussion draft including policies aimed at expanding mental health care under Medicaid and Medicare and reducing prescription drug costs for seniors at the pharmacy counter. The package also includes essential Medicaid and Medicare provisions that will expire this year, as well as changes to Medicare payment to support physicians and other professionals. The Committee intends to advance these legislative proposals, in addition to pharmacy benefit manager (PBM) reforms previously passed out of the Committee in July, and pursue full Senate passage and enactment. As part of that process, the Committee intends to hold a markup on Wednesday, November 8 at 10 a.m. In keeping with Finance Committee rules, the Chairman’s Mark will be released 48 hours in advance of the markup.”
  • It was a very busy day for the Centers for Medicare and Medicaid Services. We learned from the American Hospital Association that
    • The Centers for Medicare & Medicaid Services Nov. 2 issued a final rule that increases Medicare hospital outpatient prospective payment system rates by a net 3.1% in calendar year 2024 compared to 2023. This includes a 3.3% market basket update, offset by a 0.2% cut for productivity.
    • In a statement shared with the media, AHA Executive Vice President Stacey Hughes said “The AHA is concerned that CMS has again finalized an inadequate update to hospital payments. Today’s increase for outpatient hospitals of only 3.1% comes in spite of persistent financial headwinds facing the field. Most hospitals across the country continue to operate on negative or very thin margins that make providing care and investing in their workforce very challenging day to day. Hospitals’ and health systems’ ability to continue caring for patients and providing essential services for their communities may be in jeopardy, which is why the AHA is urging Congress for additional support by the end of the year.” 
    • The rule also finalizes several changes to the hospital price transparency rule, including requiring a new standard format with an additional data element and a completeness and accuracy affirmation statement. CMS also makes updates to streamline the enforcement process. Compliance dates for the changes range from Jan. 1, 2024, to Jan. 1, 2025. Most formatting changes take effect July 1, 2024.
  • and
    • “Following last year’s unanimous Supreme Court decision in favor of the AHA and others, the Department of Health and Human Services Nov. 2 issued a final rule outlining the agency’s remedy for the unlawful payment cuts to certain hospitals that participate in the 340B Drug Pricing Program. 
    • “HHS’ final rule contains two central components. First, HHS will repay 340B hospitals that were unlawfully underpaid from 2018 to 2022 in a single lump sum payment. The final rule contains the calculations of the amounts owed to the approximately 1,600 affected 340B covered entity hospitals. Second, HHS finalizes a policy to recoup funds from those hospitals that received increased rates for non-drug services from 2018 to 2022. HHS will recoup these funds by adjusting the outpatient prospective payment system conversion factor by minus 0.5% starting in calendar year 2026 (one year later than HHS had originally proposed and as AHA advocated), making this adjustment until the full amount is offset, which the department estimates to be 16 years.
    • “In a statement shared with the media, AHA President and CEO Rick Pollack said, “Following years of litigation and a unanimous Supreme Court win, the AHA is very pleased that 340B hospitals finally will be reimbursed in full for what HHS unlawfully withheld from them for five years. The one-time, lump-sum repayment hospitals will soon receive will help them to continue providing high-quality care to their patients and communities. However, HHS made a grievous mistake in choosing to claw back billions of dollars from America’s hospitals, especially those that serve rural, low-income and other vulnerable communities. HHS decided to ignore hundreds of comments from hospitals and other providers explaining why this Medicare cut is both illegal and unwise. The AHA will continue to review this rule and consider all available options going forward.”
  • and
    • “The Centers for Medicare & Medicaid Services Nov. 2 released its calendar year 2024 final rule for the physician fee schedule. The rule will cut the conversion factor by 3.4%, to $32.74 in CY 2024, as compared to $33.89 in CY 2023. This reflects the expiration of the 2.5% statutory payment increase for CY 2023; a 1.25% statutory payment increase for 2024; a 0.00% conversion factor update under the Medicare Access and Children’s Health Insurance Program Reauthorization Act; and a budget-neutrality adjustment. 
    • “As urged by the AHA, CMS addressed the fact that on Jan. 1 practitioners who render telehealth services from home would have been required to report their home address on enrollment and claims forms. The agency delayed this provision until Jan. 1, 2025, and solicits comments on the issue for future rulemaking.
    • “In addition, the agency finalized a revised definition of the substantive portion of a split (or shared) visit. Specifically, for CY 2024, for purposes of Medicare billing, the definition of “substantive portion” means more than half of the total time spent by the physician and non-physician practitioner performing the split (or shared) visit or a substantive part of the medical decision-making.
    • “CMS finalized its proposals to advance access to behavioral health services. First, CMS will implement regulations as directed by the Consolidated Appropriations Act of 2023 to create a new benefit category for marriage and family therapists and mental health counselors under Part B, who will be eligible to provide telehealth services and behavioral health integration services. CMS also established new payment codes for mobile psychotherapy for crisis services as required by the CAA. Separately, the agency will apply an adjustment to psychotherapy services payments billed with a new increased complexity code and will increase the payment rate for the substance use disorder bundle.”
  • What’s more, AHA News reports,
    • “The AHA, joined by the Texas Hospital Association, Texas Health Resources, and United Regional Health Care System, Nov. 2 sued the federal government to bar enforcement of an unlawful, harmful and counterproductive rule that has upended hospitals’ and health systems’ ability to share health care information with the communities they serve, analyze their own websites to enhance accessibility, and improve public health.  * * *  
    • “Today’s lawsuit challenges a “Bulletin” issued by HHS’ Office for Civil Rights. The December 2022 “Bulletin” restricts hospitals from using standard third-party web technologies that capture IP addresses on portions of hospitals’ public-facing webpages that address health conditions or health care providers. For example, under HHS’ new rule, if someone visited a hospital website on behalf of her elderly neighbor to learn more about Alzheimer’s disease, a hospital’s use of any third-party technology that captures an IP address from that visit would expose that hospital to federal enforcement actions and significant civil penalties.”  
  • The U.S. Office of Personnel Management announced “the recipients of the 2023 Presidential Rank Awards (PRA) chosen by President Joe Biden. The PRAs are one of the most prestigious awards in the career civil service, recognizing the important contributions of public servants across the federal government.” Congratulations to the recipients.   

In FEHB news, FedWeek discusses the relationship between FEHBP and FEDVIP plans.

  • “FEDVIP is the “secondary” payer to any benefits provided under an FEHB plan. If you are enrolled in both FEDVIP and FEHB, you must provide your FEHB enrollment information during the FEDVIP enrollment process (which takes place online, on www.benefeds.com). It’s a good idea to provide your FEHB information to the medical office that is providing the dental or vision services under FEDVIP.
  • “Also, if you change your FEHB health plan during the year, you need to notify BENEFEDS immediately. If you fail to provide this information, payment of claims will be delayed.”

From the public health and research front,

  • The U.S. Preventive Services Task Force released its final research plan for “Healthy Diet, Physical Activity, and/or Weight Loss to Prevent Cardiovascular Disease in Adults: Behavioral Counseling Interventions.”
  • The NIH Director’s Blog discusses “How Double-Stranded RNA Protects the Brain Against Infection While Making Damaging Neuroinflammation More Likely.”
    • “The findings show how this tricky balance between susceptibility to infection and inflammation in the brain works in both health and disease. It also leads to the tantalizing suggestion that treatments targeting these various players or others in the same pathways may offer new ways of treating brain infections or neuroinflammatory conditions, by boosting or dampening dsRNA levels and the associated immune responses. As a next step, the researchers report that they’re pursuing studies to explore the role of dsRNA-triggered immune responses in ALS and Alzheimer’s, as well as in neuropsychiatric symptoms sometimes seen in people with lupus.”
  • The Food and Drug Administration released
    • “data from the 2023 National Youth Tobacco Survey (NYTS) on tobacco product use among U.S. youth. The findings, which were collected between March and June 2023, show that 10% of U.S. middle and high school students (2.8 million youth) reported current use of any tobacco product.
    • “Among U.S. high school students, current overall tobacco product use declined during 2022-2023 (16.5% to 12.6%). This decline was primarily attributable to reduced e-cigarette use (14.1% to 10%), which translates to 580,000 fewer high school students who reported current use of e-cigarettes in 2023. Among high school students, declines in current use were also observed during 2022-2023 for cigars and overall combustible tobacco smoking, representing all-time lows.”
    • “It’s encouraging to see this substantial decline in e-cigarette use among high schoolers within the past year, which is a win for public health,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “But we can’t rest on our laurels. There’s more work to be done to build on this progress.”  

From the U.S. healthcare business front

  • Per Healthcare Dive
    • “Cigna has hiked its membership expectations for 2023. The health insurer previously expected to lose commercial members in the back half of the year, prepping for an economic downturn that might cause Americans to lose their jobs — and subsequently, their insurance.
    • “But the expected economic downturn has yet to materialize, leading Cigna to say on Thursday it expects to add at least 1.6 million members this year, up 200,000 lives from previous forecasts.
    • “We’ve not seen the disenrollment levels we incorporated into our prior outlook,” said CFO Brian Evanko on a Thursday call with investors. Cigna also raised its revenue and adjusted earnings per share outlook for 2023, after releasing third-quarter earnings.”
  • and
    • “Amwell posted a growing net loss in the third quarter as the telehealth firm notched another hefty goodwill impairment charge.
    • “The Boston-based company’s losses reached $137.1 million — a 94% increase from the same period in 2022 —  including $78.9 million in impairment charges linked to sustained decreases in its share price and market capitalization. Revenue declined 11% year over year to $61.9 million. 
    • “But a recent contract with the Department of Defense’s Health Agency that aims to digitize the military healthcare system “fortifies our path to profitability,” expanding Amwell’s reach within the public sector, CEO Ido Schoenberg said on a call with investors Wednesday.”
  • BioPharma Dive adds
    • “Novo Nordisk and Eli Lilly on Thursday reported strong sales growth for their rival GLP-1 metabolic disease drugs, setting up a 2024 showdown as the latter company’s latest product Mounjaro nears approval as a weight-loss rival to Novo’s Wegovy.
    • “Both companies cautioned about potential supply constraints, however. Wegovy still has limited availability at the starter dose, and Lilly CEO David Ricks said there is a need to increase manufacturing capacity “pretty dramatically from the current levels.
    • “Wegovy sales jumped nearly five-fold to 21.7 billion Danish krone, or about $3.1 billion, through the first nine months of this year, according to Novo. Sales of Ozempic, which is approved as a diabetes drug but used off-label in weight loss, were 65.7 billion krone, a 58% rise. * * *
    • “Lilly on Thursday revealed equally promising sales numbers for Mounjaro, which is so far approved only as a blood sugar-lowering agent for people with Type 2 diabetes. Sales of the dual-acting drug were $3 billion for the first nine months of 2023, which will be its first full year on the market. It is now Lilly’s second-biggest seller after another GLP-1 drug called Trulicity, sales of which have declined as Mounjaro’s have grown.
    • “A Food and Drug Administration decision on approving Mounjaro, known also as tirzepatide, in obesity should come by the end of 2023 * * *.”
  • The Wall Street Journal points out
    • “Both Lilly and Denmarks Novo Nordisk, which makes Ozempic and its sister drug Wegovy, are struggling to meet skyrocketing demand for their medications. There is no quick fix for that given the complexity of building out manufacturing capacity for the injections. Both companies are investing billions of dollars a year to try to catch up. * * *
    • “Keeping up with demand requires investments in factories that take years to build. Morgan Stanley analysts recently forecast the global anti-obesity market would be worth $77 billion by 2030. Mounjaro, Ozempic and Wegovy are injectables, which are complex to manufacture. Some oral medications currently in clinical trials, such as Lilly’s orforglipron, are smaller molecules, which are simpler to make. Supply constraints may only be truly remedied whenorals come to the market, the analysts said.”

Midweek Update

David Ermer–CDC, CMS, Congress, COVID-19 testing, Federal employment benefits, Medicare, OPM, Patient safety, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Roll Call tells us, “The Senate on Wednesday voted 82-15 to pass the first three of its fiscal 2024 appropriations bills in a “minibus” as the House tees up votes this week on three of its remaining seven fiscal 2024 appropriations bills.”
    • The minibus included “the fiscal 2024 Military Construction-VA, Agriculture, and Transportation-HUD appropriations bills.” 
  • The Centers for Medicare and Medicaid Services issued its “calendar year 2024 Home Health Prospective Payment System (HH PPS) Rate Update final rule.”
  • Per Fierce Healthcare, the rule
    • increases the 2024 home health payments by 0.8%, or $140 million.
    • “The $140 million increase in estimated payments for CY 2024 reflects the effects of the CY 2024 home health payment update percentage of 3% ($525 million increase), an estimated 2.6% decrease that reflects the effects of the permanent behavioral assumption adjustment ($455 million) and an estimated 0.4% increase that reflects the effects of an updated FDL ($70 million increase),” the unpublished rule said.
    • “CMS expects increasing the rate will bring home health payments in line with statutory payment authority.”
  • BioPharma Dive informs us,
    • “An experimental sickle cell disease treatment made with CRISPR technology is one step closer to approval in the U.S., following a meeting Tuesday in which advisers to the Food and Drug Administration seemed generally comfortable with its safety.
    • “Made up of scientists and physicians, the advisory panel spent hours discussing highly technical questions around how best to assess the risk that CRISPR — the gene editing technique often likened to a pair of scissors — might make unwanted, or “off-target,” cuts to DNA.
    • “Ultimately, the panel appeared convinced that Vertex Pharmaceuticals, which developed the sickle cell treatment, had done enough to show the therapy is safe, although they pointed to several avenues for further study.”
  • Reuters adds, “Analysts have been optimistic the therapy, which is a first-of-its-kind product to reach the FDA for review, will win the health regulator’s nod by Dec. 8.”
  • On a related note, an article in Health Affairs Scholar prognosticates,
    • “Despite the potential of gene therapy to transform the lives of patients with rare genetic diseases, serious concern has been raised about the financing of the high up-front costs for such treatments and about the ability of the employer-sponsored insurance system in the United States, particularly in small firms, to pay for discoveries of this type. In this paper, we provide a conceptual framework and empirical evidence to support the proposition that, at present, private group insurance financing of cost-effective gene therapies is not only feasible and competitively necessary in the labor market for employers, regardless of group size, but also that, currently, the number of US workers in small firms who might be stressed by very high-priced claims is a tiny fraction of the group market for genetic treatments. The current system of employer-paid self-insurance supplemented by stop-loss coverage should be able to facilitate the use of new cost-effective gene therapies. Other alternative methods of financing that have been proposed may not be urgently needed. There are, however, some concerns about the long-term resilience of this system if stop-loss premiums continue to have high growth.”
  • The Society for Human Resource Management reminds us,
    • “Employers are required to use the latest version of Form I-9 beginning today.
    • “The new form from U.S. Citizenship and Immigration Services has been available for use since August but becomes mandatory for all employers as of Nov. 1. 
    • “The new I-9 does not make any new changes to employer or employee obligations involved in the verification of work authorization. Cosmetic changes include the reduction of Sections 1 and 2 to a single page, slight revisions to the Lists of Acceptable Documents, and a new box that eligible employers must check if the employee’s documents were examined remotely under the newly authorized alternative procedure for qualified E-Verify employers.”

In FEHB news, as we approach the Open Season,

  • FedSmith offers its perspective on factors to consider when selecting an FEHB plan during Open Season.
  • FedWeek offers retired OPM executive Reg Jones’s views on the upcoming Open Season.
  • The Federal Times highlights the fine points of fertility coverage in 2024 FEHB plans.

From the public health and research front,

  • The Centers for Disease Control reminds us,
    • Every U.S. household can order 4 more free COVID-19 self-tests. 
    • Self-tests (also called at-home tests and over-the-counter tests) are one of several tools that protect you and others by reducing the chances of spreading COVID-19.
    • Self-tests can be taken at home or anywhere, are easy to use, and produce rapid results.
    • You can place an order 
      • Online at COVIDTests.gov
      • By calling 1-800-232-0233 (TTY 1-888-720-7489)
      • By calling or emailing the Disability Information and Access Line (DIAL) at 1-888-677-1199 or DIAL@usaginganddisability.org (for people with disabilities)
  • The Washington Post reports,
    • “Dying from heart failure and ineligible for a human heart transplant, Lawrence Faucette knew that the last chance he had at extending his life was to receive a heart transplanted from a pig. The 58-year-old man said from his Baltimore hospital bed in September that he was “hoping for the absolute best,” but understood that he was the second person in the world to undergo the procedure — and the highly experimental surgery did not guarantee that he would get more time with his wife and two sons.
    • “We’re going to do the best we can,” he said in a video posted by the University of Maryland School of Medicine. “Now at least I have hope. And now I have a chance.”
    • “Faucette died Monday, nearly six weeks after the surgery, becoming the second patient to die after receiving a genetically modified pig heart, medical school officials announced Tuesday.”
  • RIP, Mr. Faucette.
  • The Wall Street Journal reports,
    • “The rate of babies dying in the U.S. increased significantly for the first time in two decades, raising new alarms about maternal-infant health in America.
    • “The nation’s infant mortality rate rose 3% from 2021 to 2022, reversing a decadeslong overall decline, the Centers for Disease Control and Prevention said Wednesday. The rate increased from 5.44 infant deaths for every 1,000 births to 5.6 in 2022, a statistically significant uptick. * * *
    • “The death rate increased significantly for babies born to American Indian and Alaska Native women, babies born to white women, babies born to women ages 25 to 29 years, male babies and preterm babies.
    • “Changes in the rates for other groups weren’t significant, though the agency’s data showed that mortality rates among racial groups in the U.S. remain wide. The rate for babies born to Black mothers was more than double that of white mothers.”
  • STAT New calls attention to the fact that
    • “Most lung cancer screening guidelines hinge on how much people smoked tobacco and when they last smoked, but the American Cancer Society now says it doesn’t matter how long ago they quit. On Wednesday, the ACS released guidance recommending that anyone with a significant smoking history get an annual low-dose CT scan for lung cancer.
    • “The new guidelines also expand the age range for lung cancer screening to 50 through 80, instead of 55 through 74, and lower the smoking history requirement from 30 cigarette pack years to 20 pack years or more. That means the equivalent of a pack a day for 20 years, which includes two packs a day for 10 years or four packs a day for five years. Most private insurance plans are required to cover screening guidelines with an A or B-grade recommendation from the U.S. Preventive Services Task Force, though some organizations do follow ACS guidelines.
    • “These recommendations bring the ACS’ new age range and smoking history requirements in line with that of the task force’s lung cancer guidelines, which were updated in 2021. However, the task force still only extends lung cancer screening eligibility to patients who quit smoking within the last 15 years. 
    • One of the main reasons the ACS wanted to strike the years-since-quit requirement from their guidelines was that many former smokers are still at high risk for lung cancer regardless of when they quit smoking. “The more we dug into the data, the more we saw there was no real evidence for that criterion,” said Robert Smith, the senior vice president of early detection science at the American Cancer Society.”
  • The Lown Institute issued a report on unnecessary heart stent procedures in the U.S.
    • “Every seven minutes, a Medicare patient receives an unnecessary coronary stent at a U.S. hospital, a new report finds. The Lown Institute, an independent think tank, examined the overuse of percutaneous coronary interventions (coronary stent or balloon angioplasty) at 1,733 general hospital inpatient and outpatient facilities and found more than 229,000 procedures met the criteria for overuse.
    • “While coronary stents can be lifesaving for someone having a heart attack, years of research shows that stents for stable heart disease provide no benefit over optimal medication therapy. Across all hospitals, Lown estimates that more than one in five stents were placed unnecessarily in Medicare patients from 2019 to 2021, at a cost of $2.44 billion.
    • “When physicians continue a practice despite the evidence against it, it becomes more dangerous than useful,” said Dr. Vikas Saini, a cardiologist and president of the Lown Institute. “The overuse of stents is incredibly wasteful and puts hundreds of thousands of patients in harm’s way.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • CVS Health beat Wall Street expectations for earnings and revenue in the third quarter, as growth in pharmacy benefits offset higher spending in its health insurance segment.
    • The Rhode Island-based healthcare behemoth continues to wrangle with headwinds including higher-than-expected healthcare utilization, a pharmacist strike and lost bonus payments in Medicare Advantage.
    • As a result, interim CFO Tom Cowhey cautioned investors on a Wednesday morning call to expect 2024 earnings at the low end of the company’s guidance.
  • and
    • “Humana reported growing medical costs in its insurance segment during the third quarter as a result of increased medical utilization among Medicare Advantage members and higher-than-anticipated COVID-19 admissions.
    • “The payer expects higher levels of utilization to continue for the remainder of the year, and is now forecasting its 2023 medical loss ratio (MLR) will outpace prior guidance. Humana is projecting an MLR of 87.5% for 2023, up from the 86.6% to 87.3% range it previously expected.
    • “Humana’s shares slid following the earnings release Wednesday, despite the insurer beating Wall Street expectations on revenue of $26.4 billion and profit of $1.1 billion.
  • Forbes reports that biopharma giant “GSK shares rose on Wednesday after the pharma giant upgraded its profit guidance for the second time this year amid booming demand for its new vaccine for respiratory syncytial virus (RSV).”

Tuesday’s Tidbits

David Ermer–CDC, COVID-19, FDA, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The Department of Health and Human Services announced,
    • “Take Action for Adolescents: A Call to Action for Adolescent Health and Well-Being a new effort to promote collaboration and spur action to improve the health and well-being of adolescents across the U.S.
    • “Young people today are facing significant challenges to their health and well-being,” said Admiral Rachel Levine, M.D., Assistant Secretary for Health. “We are committed to working closely with our allies and partners across the country to support improvements in adolescent health and well-being.”
    • “It is critical that we take action for adolescents now,” said Jessica Swafford Marcella, Deputy Assistant Secretary for Population Affairs. “This new Call to Action and accompanying toolkit will inspire collaborative efforts across youth-serving sectors to build a healthier future for America’s young people.”
    • “Take Action for Adolescents outlines a vision, key principles, eight goals, and a set of initial action steps. It is research-based and was developed with extensive input from adult and youth allies and partners, including nationally recognized adolescent health experts. It is accompanied by a Take Action Toolkit with tips and resources to spur collaboration in states and communities.” * * *
    • The Office of Population Affairs’ Take Action for Adolescents webpage features a suite of resources that are easy to download and share.
  • The Food and Drug Administration announced approving
    • “Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases. Wezlana, like Stelara, is approved to treat the following indications: 
      • “Adult patients with:
        • moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy;
        • active psoriatic arthritis;
        • moderately to severely active Crohn’s disease; and
        • moderately to severely active ulcerative colitis.
      • “Pediatric patients 6 years of age and older with:
        • moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and 
        • active psoriatic arthritis.
    • “Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.”
  • Assistant Secretary of Labor for Employee Benefit Security Lisa Gomez announced a proposed rule to improve retirement benefit security under ERISA.

From the public health front,

  • The Wall Street Journal reports,
    • “There’s some good news about flu season this year. Doctors and scientists don’t expect the worst. 
    • “The flu season in the Southern Hemisphere, where the cold-weather illness period wraps up as we head into ours, often serves as a harbinger of what’s to come for us. There, cases picked up a little earlier than usual in some countries but didn’t result in an especially large number of hospitalizations and deaths, say public health experts and doctors.
    • “Also encouraging: The components in this year’s flu vaccine are a good match to the predominant strain so far.” 
  • U.S. News and World Report tells us,
    • “COVID-19 hospitalizations in the U.S. remained relatively steady week over week following five weeks of larger declines, according to data from the Centers for Disease Control and Prevention.
    • “The U.S. tallied about 16,200 new hospitalizations of people with COVID-19 over the seven days ending Oct. 21, according to provisional data – only 40 hospitalizations less than the total for the previous week and effectively pausing a downward trend that began after hospitalizations totaled close to 21,000 during the week ending Sept. 9. Hospitalizations dipped to a low point of approximately 6,300 in late June before starting to trend back up.
    • “Relative to population, data points to 4.9 new COVID-19 hospital admissions per 100,000 people for the week through Oct. 21. Among states and territories, Montana saw the highest rate over the week at 10 per 100,000. West Virginia (8.3), the District of Columbia (8.1), and Colorado (7.6) had the next-highest rates. Compared with the week prior, Mississippi had the highest percentage increase in its COVID-19 hospitalization rate at 45%, followed by Kansas(41%), Indiana (40%) and Iowa (32%).
    • “Among patients visiting a subset of emergency departments, data indicates 1.3% were diagnosed with COVID-19 nationally – a rate down about 5% from the week before. New Mexico(3.1%), Colorado (2.4%) and Arizona (2.3%) saw the highest rates.”
  • MedPage Today informs us that
    • The CDC released new recommendations for hepatitis C virus (HCV) screening among perinatally exposed infants and children.
    • The four new recommendations are detailed in the MMWR Recommendations and Reports.

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Tenet Healthcare beat Wall Street expectations on revenue in the third quarter due to cost control measures and sustained revenue growth at its facilities. 
    • “The for-profit operator’s ambulatory care and hospital segments both experienced volume growth, with both divisions’ earnings coming in “well above” Tenet’s expectations, said CFO Dan Cancelmi during a call with investors on Monday.
    • “Executives raised the lower end of Tenet’s full-year revenue guidance. The operator now expects to capture between $20.3 billion and $20.5 billion this year.”
  • Per Fierce Pharma,
    • “For Pfizer, several years of pandemic megaprofits have soured as overstocked COVID-19 drugs and vaccines take a major toll on the drug behemoth’s financials.
    • “In the third quarter of 2023, Pfizer recorded $5.6 billion in coronavirus-related inventory write-offs and other charges, plus a $4.2 billion revenue reversal tied to the planned return of some 7.9 million Paxlovid doses from the U.S. government.
    • “Concerning the inventory write-offs, $4.7 billion of the sum is tied to Pfizer’s antiviral Paxlovid, with the remaining $900 million stemming from the company’s BioNTech-partnered mRNA vaccine Comirnaty, Pfizer said Tuesday.”
  • Here’s a link to Pfizer’s third-quarter report.
  • Beckers Payer Issues informs us,
    • Employers are looking to deductible-free health plans as employees report increasing concerns about the cost of healthcare, according to Mercer’s 2023-2024 “Inside Employees’ Minds” survey. 
    • The survey, published Oct. 30, interviewed 4,505 full-time employees in the United States, working for organizations with more than 250 employees. 
    • In 2023, 15% of organizations are offering some employees no-cost health plans, and 18% are using salary-based contributions. 
    • Around 4 in 10 employers offer a medical plan with low or no deductible. 
    • Plans with no deductibles are growing in popularity — UnitedHealthcare’s fastest-growing commercial plans have no annual deductibles, COO Dirk McMahon told investors Oct. 30. 
    • “UnitedHealthcare members in these offerings are receiving more preventive care, while paying about 50% less out of pocket, compared to people enrolled in traditional offerings, and their employers can reduce the total cost of care with an average savings of 11%,” Mr. McMahon said. 
    • According to Mercer’s survey, 79% of workers making between $60,000 and $100,000 each year say they can afford the healthcare their family needs without hardship, compared to 51% of workers making less than $30,000 annually. 
    • See the full report here. 
  • Beckers Health IT identifies 121 unicorns (companies with at least a one billion dollar valuation) operating in the healthcare space.
  • KFF tells us what to watch for in the eleventh Affordable Care Act open enrollment period, which begins tomorrow. Here’s an interesting tidbit from that article:
    • Private health plans must permit young adults the option of remaining covered as a dependent under their parent’s policy until they turn age 26. Starting in 2024, though, federal Marketplace health plans will officially not be allowed to terminate coverage for young adult dependents mid-year on their 26th birthday. Instead, they will have to continue the dependent coverage through the end of the calendar year. The federal Marketplace has already been keeping these individuals on the plan until the end of the year, and then automatically enrolling them in their own exchange coverage the following year, but this rule codifies that practice.

Monday Roundup

David Ermer–Uncategorized–
Photo by Sven Read on Unsplash

From Washington, DC,

  • The American Medical Association News tells us,
    • “President Biden, Oct. 30, directed federal agencies to take certain actions to protect Americans from the potential risks of artificial intelligence systems while promoting innovation and competition. The executive order calls for the Department of Health and Human Services to establish a safety program to regulate healthcare AI practices and for developers of high-risk AI systems to share their safety testing results and other relevant information with the federal government. Among other actions, the order urges Congress to enact data privacy safeguards for Americans, and requires federal agencies to develop best practices to investigate and prosecute AI-related discrimination and guidelines to prevent fraudulent and deceptive AI-generated content.”
  • Federal News Network adds
    • “The Biden administration is calling for a “governmentwide AI talent surge” across the federal workforce to build up its capacity to lead on this emerging technology.
    • “President Joe Biden, in an executive order Monday, is requiring agencies to set comprehensive policies for how they will use AI tools internally to further the business of government.
    • “The White House, in a fact sheet, said the executive order also “directs the rapid hiring of AI professionals, as part of a governmentwide AI talent search.”
    • “Biden, speaking at the White House, said that “without the right safeguards in place, AI can lead to discrimination, bias and other abuses.”
  • MeriTalk points out,
    • “The Office of Personnel Management (OPM) is getting close to releasing a proposal that would offer “equity around pay and flexibilities in the workplace” for Federal government tech and cybersecurity personnel, OPM Director Kiran Ahuja said today.
    • “Speaking at ACT-IAC’s Imagine Nation conference in Hershey, Pa., the OPM director talked about the soon-to-be-issued proposal as part of a reply to a question about what she’s most proud of accomplishing at the agency since taking the helm at OPM in 2021.
    • “One of those points of pride, she said, was “that we’ve spent a lot of time thinking about cyber and tech talent,” including OPM’s efforts to recruit private sector tech and cyber personnel into service with the government.”
  • On a related note, the AHA News reports,
    • “The Department of Health and Human Services, Oct. 30, released a proposed rule intended to create disincentives for health care providers to interfere with the access, exchange or use of electronic health information. Under the rule, which implements a provision of the 21st Century Cures Act, healthcare providers that HHS’ Office of Inspector General determines have committed information blocking and refer that determination to the Centers for Medicare & Medicaid Services would be ineligible for certain incentives under the Medicare Promoting Interoperability Program and Shared Savings Program, HHS said. The agency will publish the proposed rule in the Nov. 1 Federal Register with comments accepted through Jan. 2.”  
  • The Food and Drug Administration announced the recall of certain eye drop products due to the risk of serious infection.
  • AHA News calls attention to the fact that
    • “The Food and Drug Administration, the week of Oct. 23, cleared for marketing the first over-the-counter test to detect fentanyl in urine. The five-minute test provides only preliminary results and includes a pre-addressed mailing box for shipping samples to the manufacturer’s laboratory for confirmation testing using an alternative chemical method. The agency expedited its review of the Alltest Fentanyl Urine Test Cassette, clearing it only 16 days after the submission was received.
    • “Opioid abuse, misuse and addiction is one of the most profound public health crises facing the U.S. today,” said Jeff Shuren, M.D., director of FDA’s Center for Devices and Radiological Health. “…This test is an example of the FDA’s continued commitment to authorize tools that can reduce deaths associated with overdoses.”
  • On a related note, the Wall Street Journal calls our attention to effective over-the-counter treatments for congestion.

In FEHB news,

  • Govexec discusses the availability of Medicare Part D PDPs in nine “first out of the gate” FEHB plans (seventeen options) for 2024.

From the public health front,

  • The Institute for Clinical and Economic Review released a “Final Evidence Report on Gene Therapy for Metachromatic Leukodystrophy”
    • The Independent appraisal committee voted that across all patient subpopulations, arsa-cel demonstrated a net health benefit when compared to usual care; arsa-cel would achieve common thresholds for cost-effectiveness if priced between $2.3M and $3.9M.
  • The New York Times reports on a new surgical technique called component separation to resolve hernia conditions. A surgeon must undergo specialized training before operating on a living patient. Apparently, some surgeons jumped the gun, no doubt leading to malpractice lawsuits.
  • The American Health Association announced,
    • “Cardiovascular deaths from extreme heat in the United States are projected to increase by 162% by the middle of the century, based on a hypothetical scenario where currently proposed U.S. policies to reduce greenhouse gas emissions have been successfully implemented.
    • “A more dire scenario forecasts cardiovascular deaths from extreme heat could increase by 233% in the next 13-47 years if there are only minimal efforts to reduce emissions.
    • “The percentage increase in deaths will be greater among elderly people and non-Hispanic Black adults in either scenario.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Prices negotiated by health insurers vary widely between geographies — even for the same insurer, according to a new study that authors said is the first of its kind relying on federally mandated price transparency data.
    • “Humana members paid more for medical care in the Upper Midwest and Southeast than in the Central U.S. and Florida, according to the research published in JAMA Health Forum last week.
    • “More than half of Americans are covered by private insurers, which negotiate rates in local markets. The variability in cost between markets could be due to a number of factors, including imbalances in market power and negotiation leverage, anti-competitive practices and actual variation in clinical quality, study authors said.”
  • BioPharma Dive tells us,
    • “An experimental kidney disease drug Novartis acquired via a $3 billion deal earlier this year succeeded in a late-stage trial, the Swiss pharmaceutical company said Monday.
    • “The drug, called atrasentan, reduced protein in the urine of people with IgA nephropathy by significantly more than placebo, meeting the Phase 3 trial’s goal. IgA nephropathy is a leading cause of chronic kidney disease and often causes persistently high urine protein, or proteinuria.
    • “With the positive data in hand, Novartis plans to submit an application to U.S. regulators for accelerated approval of the drug. The company’s trial will continue to run for another two years to assess changes in kidney function over time.”
  • Fierce Healthcare explains how “Amazon Pharmacy’s focus on making it faster and more convenient for patients to get prescription medications comes as brick-and-mortar drugstores are limiting pharmacy hours and even closing locations across the country.”

Weekend update

David Ermer–CDC, Congress, COVID-19, Mental health care, U.S. Healthcare, Uncategorized–
Thanks to ACK15 for sharing their work on Unsplash.

From Washington, DC,

  • The federal marketplace open enrollment period for Affordable Care Act coverage will open on November 1. This enrollment opportunity closes on December 15.
  • The Wall Street Journal reports, “Insurers spar With Biden Administration over coverage for mental-health care; New requirements aim to reduce out-of-pocket costs for treatment; insurers cite a shortage of mental-health providers.” Per the Journal,
    • “A landmark law, the Mental Health Parity and Addiction Equity Act of 2008, helped curtail arbitrary annual limits imposed by insurers on mental-health coverage. Insurers aren’t supposed to put such limits on mental-health visits if they don’t also have similar limits on doctor visits for a chronic condition like asthma. They also aren’t supposed to impose higher copayments and deductibles or more restrictive prior authorization requirements for mental health care.
    • “But the promise of out-of-pocket parity remains far more elusive. The reasons are complex: There is a shortage of mental health clinicians, with an estimated 350 individuals for every one mental-health provider, according to Mental Health America.”
  • The legal issue is that the law requires parity in quantitative treatment limits (QTL), which health plan compliance with the law has created. The regulators, however, created a separate nonquantitative treatment limitation category, which includes network adequacy, prior authorization, and many, many other factors. The regulators in the proposed rule demand that the QTL parity factors be applied to all NQTLs. That is an infeasible, pointless task, in the FEHBlog’s opinion. The regulators need to try again.
  • On a related note, the Washington Post informs us,
    • “Beginning in January, Medicare [Part B], for the first time, will allow marriage and family therapists and mental health counselors to provide services. This cadre of more than 400,000 professionals makes up more than 40 percent of the licensed mental health workforce and is especially critical in rural areas.
    • “Medicare is also adding up to 19 hours a week of intensive outpatient care as a benefit, improving navigation and peer-support services for those with severe mental illness, and expanding mobile crisis services that can treat people in their homes or on the streets.”

From the public health front,

  • NBC News notes,
    • “A new Covid variant has become dominant in the U.S., but relatively few people have thus far gotten the new shots that could offer some protection against it.
    • “The variant, called HV.1, replaced EG.5 as the country’s most prevalent this week, according to data released Friday by the Centers for Disease Control and Prevention.
    • “The two variants are genetically similar versions of omicron.
    • “HV.1 makes up around 25% of Covid cases now, up from around 1% at the beginning of August. EG.5, meanwhile, represents nearly 22% of cases, down from 24% at the start of the month.
    • “Both are descendants of the XBB variant. The updated Covid vaccines from Pfizer and Moderna, which became available last month, target a different XBB descendant, called XBB.1.5.
    • “But disease experts say the new shots should offer cross-protection against the currently dominant strains. Dr. Scott Roberts, an infectious disease specialist at Yale Medicine, said that although the vaccine is not a “perfect match” for HV.1, “it’s still a good match because it’s still within the same family of variants.”
  • WTOP, a news radio station in Washington DC, reports,
    • “We’ve already been receiving warnings from the CDC that there are RSV cases in the Southeast, which is kind of an indication to us that it’s going to be moving our way soon,” said Dr. Christine Ashburn, a pediatrician with Kaiser Permanente’s Mid Atlantic Group.
    • “While an increase in RSV cases could be coming soon,  Ashburn says she doesn’t think it’ll be as bad as last year, which saw hospital systems across the region — and the country — overrun with cases in infants. * * *
    • “Ashburn says looking for early signs of this illness in infants and small children is key.
    • “Watch for fast, rapid breathing,” she said. “Sometimes in babies, you’ll even see the area around their chest sinking in as they’re breathing.”
    • “She also said flared nostrils, prolonged fever, and even rhythmic grunting — or any signs of respiratory distress — are signs your baby is struggling to get air.
    • “If you think your child could be suffering from RSV, it’s imperative you make an appointment with your health care provider,” she said.
    • “Dr. Ashburn said she’s also optimistic about a new antibody treatment for RSV, AstraZeneca’s Beyfortus™ (or nirsevimab, generically), which is designed to help prevent and mitigate the illness’s effects.”
  • Vox adds
    • Demand for Beyfortus currently exceeds supply. But as the need for the drug becomes more predictable, and as other monoclonal RSV antibodies in development make it onto the market, we can expect supply to better meet that demand. 
    • It’s more complicated to fix the fragmented US health care system that creates big barriers to Beyfortus access for some kids, [Dr. Sean] O’Leary [a pediatric infectious disease specialist at the University of Colorado’s medical school] said. That system is structured such that many pediatricians have to take huge financial risks to keep Beyfortus in stock. For patients who get care at those practices, access will likely be a little touch-and-go until demand also stabilizes and pediatricians can better forecast how much to stock. * * *
    • One dose costs a doctor’s office nearly $500 — and as a totally novel immunization, its popularity was hard to forecast. “For a medium-sized practice, they might have to spend $250,000 to cover their [privately insured”] patient population,” O’Leary said. “And that is not money they have lying around.”
    • “It’s not that pediatricians and family docs don’t want to do the right thing,” he added — but the financial risk of just keeping Beyfortus on the shelves is a barrier.
  • However, according to a 2018 survey about vaccine financing billing practices at medical practices serving adults
    • Of 242 practices approached, 43% (n=104) completed the survey. Reported payment levels and perceived profit varied by payer type. Only for preferred provider organizations did a plurality of respondents report profiting on adult vaccination services. Over half of respondents reported losing money vaccinating adult Medicaid beneficiaries. One-quarter to one-third of respondents reported not knowing about Medicare Part D payment levels for vaccine purchase and vaccine administration, respectively. Few respondents reported negotiating with manufacturers or insurance plans on vaccine purchase prices or payments for vaccination.
  • FEHBlog note: It’s no wonder that chain pharmacies are the principal distributors of vaccines.

From the U.S. healthcare business front,

  • Bloomberg reports,
    • “AbbVie Inc. raised its profit outlook for this year and next as demand for newer biologic drugs helped fill the gap left by falling Humira sales, but investors were disappointed as Botox sales missed estimates.
    • “Adjusted earnings will be $11.19 to $11.23 a share this year, up from the earlier range of $10.86 to $11.06, AbbVie said Friday in a statement. Profit for 2024 will be at least $11 a share, up from the earlier view of at least $10.70, the drugmaker said.
    • “However, sales of Botox, Juvaderm and other aesthetics products were $1.24 billion, missing the average sales estimate by about $100 million. Shares of the North Chicago, Illinois-based drugmaker dropped as much as 5.6% at the New York market open, their biggest intraday loss since April.”
  • Reuters points out,
    • “Healthcare companies who profit from treating obese and overweight patients are trying to convince investors that powerful new weight-loss drugs won’t shrink their businesses.
    • “The global market for obesity drugs could reach as much as $100 billion within a decade due to the effectiveness of Novo Nordisk’s (NOVOb.CO) Wegovy and similar medicines.
    • “Such forecasts have prompted a sell-off in a wide range of companies from makers of bariatric surgery devices to companies whose products address the health issues created by excess weight, from diabetes to sleep apnea.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy front,

  • The Cybersecurity and Infrastructure Security Agency and the Department of Health and Human Services held
    • “a roundtable discussion on the cybersecurity challenges that the U.S. healthcare and public health (HPH) sector system faces, and how government and industry can work together to close the gaps in resources and cyber capabilities. Ahead of the roundtable, CISA and HHS released a cybersecurity tool kit that includes resources tailored for the healthcare and public health sector. * * *
    • This toolkit is easy to navigate online at www.CISA.gov/healthcare and consolidates resources like:  
      • “CISA’s Cyber Hygiene Services, which use vulnerability scanning to help secure against known vulnerabilities, reduces the risk of cyberattacks and encourages the adoption of best practices.   
      • “HHS’s Health Industry Cybersecurity Practices, which was developed with industry, outlines effective cybersecurity practices healthcare organizations of all sizes can adopt to become more cyber resilient.  
      • “HHS and the HSCC’s HPH Sector Cybersecurity Framework Implementation Guide which helps organizations assess and improve their level of cyber resiliency and provide suggestions on how to link cybersecurity with their overall information security and privacy risk management activities.” 
  • Cybersecurity Dive informs us,
    • “The Cybersecurity and Infrastructure Security Agency (CISA) on Thursday issued a request for comment on how to create a more harmonized system of software identification as part of a larger effort to make the software supply chain more secure. 
    • “Since President Joe Biden issued an executive order on improving cybersecurity in 2021, CISA and other federal agencies have been working to prioritize software security by improving vulnerability management and the use of software bill of materials (SBOMs). 
    • “The request for comment is designed to establish some uniform parameters to track critical information required to improve software security. Information on known vulnerabilities, what mitigations or security patches are available, and which software is approved for use are all part of the effort, according to a white paper released by CISA.” 
  • The Wall Street Journal tells us,
    • “President Biden is expected to sign an executive order next week addressing rapid advances in artificial intelligence, laying the groundwork for Washington’s embrace of AI as a tool in the national security arsenal while also pressuring companies to develop the technology safely.
    • “The order, which hasn’t been finalized and was described by people briefed on its expected contents, is aimed at establishing guideposts for federal agencies’ own use of AI, while also leveraging the government’s purchasing power to steer companies to what it considers best practices. 
    • “The White House began inviting people this week to an event on “safe, secure and trustworthy AI,” according to people familiar with the matter. A spokeswoman for the White House declined to comment.”

From the cybersecurity vulnerabilities and defenses front,

  • Health Exec reports,
    • “A new report reveals there have been 480 healthcare data breaches in 2023 so far, with over 25% of Americans impacted. The estimated number of patients affected is 87 million this year so far, over double the 37 million in 2022. 
    • “The report comes from Atlas VPN, which utilized publicly available data from the U.S. Department of Health and Human Services (HHS), which keeps a running list of healthcare security incidents. Federal law requires data breaches that potentially leak more than 500 patient records to be reported to the HHS.  * * *
    • “The full report can be found here.”
  • HHS’s Health Sector Cybersecurity Coordination Center issued three warnings this week. Here are the executive summaries:
    • AI-Augments Phishing — “Phishing has historically been a very successful means for cyberattackers of any motivation to compromise an organization and launch a full-fledged cyberattack to achieve their goals. Phishing attacks are frequently utilized, and this is especially true with regard to the health sector. The two most common cyberattacks targeting the health sector are ransomware and data breaches. (And usually both together!)
    • “These attacks often begin with a successful phishing attack. The advent of artificial intelligence has only made phishing attempts more effective, especially since those tools are freely available to the public.
    • In this paper, we provide a brief overview of basic artificial intelligence concepts, phishing attacks, and the application of artificial intelligence to phishing. We conclude with efforts that should be made to reduce the likeliness of all phishing attacks, including those that have been augmented by the use of artificial intelligence.”
  • and
    • QR Code Based Phishing – Phishing – the use of phony e-mails to deliver malicious code – has historically been a successful means for cyber attackers to compromise victim organizations and launch full-fledged, multi-staged cyberattacks. Phishing attacks are frequently utilized as the first stage of an attack – the infection vector – and this is especially true for the health sector. A cyberattack that begins with phishing often ends with ransomware and/or a major healthcare data breach.
    • Quick response (QR) codes were designed to quickly read and transmit legitimate data but have become increasingly abused as part of phishing attacks, called “quishing”.
    • In this paper, we provide a brief overview of QR codes, phishing attacks, and the application of both of these to cyberattacks on the health sector. We conclude this analysis with recommended defense and mitigation actions to reduce the likeliness and effectiveness of phishing attacks, including those augmented by the use of QR codes.
  • and
    • SolarWinds has published security fixes for their Access Rights Manager (ARM). This update addressed eight vulnerabilities, with three of them being rated as critical (CVE-2023-35182, CVE-2023-35185, CVE-2023-35187) and can lead to remote code execution on the “SYSTEM” of a Windows computer. This could enable an attacker to operate with the highest level of privileges available on the machine. In early 2020, the SolarWinds Orion system was targeted by an attacker(s), which led to the supply chain compromise of up to 18,000 of its customers.
    • Due to the previous malicious targeting and wide use of SolarWinds, HC3 strongly encourages users to monitor and upgrade their systems to prevent serious damage from occurring to the Healthcare and Public Health (HPH) sector.

From the ransomware front,

  • Cybersecurity Dive reports,
    • “The threat group behind some of the most high profile, identity-based cyberattacks this year is also “one of the most dangerous financial criminal groups” currently in operation, Microsoft researchers said in a Wednesday report.
    • “The group, which Microsoft identifies as Octo Tempest and other researchers identify as Oktapus, Scattered Spider and UNC3944, uses multiple forms of social engineering to gain access to organizations’ infrastructure, steal corporate data and extort victims for ransom payments, according to Microsoft Threat Intelligence.
    • “The collection of young, native English-speaking threat actors, which was initially observed in 2022 and affiliated with the ransomware-as-a-service operation ALPHV or BlackCat in mid-2023, has claimed responsibility for major attacks against MGM Resorts, Caesars Entertainment and Clorox in the past few months. * * *
    • “The threat actors engage in aggressive communications with victims, such as leaving threatening notes within a text file on a system, contacting executives via text messages and emails, and infiltrating communication channels being used by victims to respond to incidents,” Mandiant, a Google Cloud unit, said last month in a report on UNC3944.
    • “We’ve seen very young individuals break into some of the biggest organizations by leveraging these techniques that are so hard to defend against,” Mandiant Consulting CTO Charles Carmakal said during an April briefing.
    • “They are incredibly disruptive and aggressive,” Carmakal told Cybersecurity Dive via email last month following the MGM Resorts attack.”

From the cybersecurity defenses front,

  • CISA announced,
    • “A new release of Logging Made Easy, a Windows-based, free and open log management solution designed to help organizations more effectively use available security data to detect and address cyber threats.
    • “In April 2023, CISA assumed Logging Made Easy from the United Kingdom’s National Cyber Security Centre (UK-NCSC). Following a period of transition and enhancement, it is now available with step-by-step installation instructions for both legacy and new users.
    • “Logging is critical for proactive monitoring of threats and retroactive investigation and remediation in the event of an incident. Logging Made Easy is a tested and reliable solution that can help organizations with limited resources needing a centralized logging capability,” said Chad Poland, Product Manager for Cyber Shared Services. “CISA is excited to offer this shared service capability to U.S. and international organizations that can help them mitigate risk and identify vulnerabilities.” * * *
    • For more information, visit CISA’s new Logging Made Easy webpage.
  • ISACA announced its “AI Survey Results: What Do Infosec Professionals REALLY Need to Know?”
  • “The HSCC Cybersecurity Working Group has reprinted its Health Industry Cybersecurity – Securing Telehealth and Telemedicine (HIC-STAT) document.” 

Friday Factoids

David Ermer–COVID treatment, COVID-19, Electronic health records, Mental health care, No Surprises Act, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • The American Medical Association News informs us,
    • “The Departments of Health and Human Services, Labor and the Treasury Oct. 27 issued a proposed rule intended to improve how the No Surprises Act independent dispute resolution process functions in response to feedback and challenges shared by stakeholders. The public will have 60 days to submit comments. The rule would require plans to include claim adjustment reason codes and remittance advice remark codes, among other new information, with the initial payment or notice of payment denial for certain items and services subject to the NSA protections. The rule proposes changes to the batching requirements so that Items and services could be batched in the same payment determination if they are: furnished to a single patient on one or more consecutive dates of service and billed on the same claim form (a single patient encounter); billed under the same service code or a comparable code under a different procedural code system; or anesthesiology, radiology, pathology and laboratory items and services billed under service codes belonging to the same Category I CPT code section, as specified in the agencies’ guidance. Batched items would be limited to 25 items or services in a single dispute. Lastly, the proposed rule would amend certain requirements related to the open negotiation period preceding the IDR process, the initiation of the process, the dispute eligibility review, and the payment and collection of administrative fees and certified IDR entity fees.”
  • The proposed rule will be published in the Federal Register next Friday, November 3, and the proposal creates a sixty-day public comment period.
  • Here’s a link to the government’s fact sheet on the proposed rule.
  • The FEHBlog noticed that the proposed rule would run open negotiations through the government’s IDR portal, which will increase the government’s administrative costs. It strikes the FEHBlog that the proposed rule could have established a process for the open negotiation for the parties to follow. The proposed rule will require health plan system changes, which is always expensive.
  • Also today, the Department of Health and Human Services wrote to stakeholders, including health plans, reminding them the cost of Paxlovid and other Covid drugs is shifting from the government to the private sector beginning on November 1.
  • STAT News reports,
    • “The Food and Drug Administration on Thursday approved an Eli Lilly drug that takes a new approach to treating ulcerative colitis, a chronic inflammatory disease that can cause intense gastrointestinal pain and distress.
    • “The therapy, dubbed Omvoh, is an antibody that blocks IL-23p19, an immune signaling molecule that plays a key role in sustaining the disease. It’s the first treatment to target this particular pathway in ulcerative colitis. The drug’s approval comes after two late-stage trials found that patients taking Omvoh showed a significant improvement in symptoms after both three months and a year compared with those given a placebo, and that the therapy had minimal side effects.
    • “Omvoh’s list price will be $9,593 per month for intravenous delivery and $10,360 per dose injected beneath the skin. A company spokesperson told STAT that patients who have the drug covered by commercial insurance may pay as little as $5 per month for up to 30 months.”

From the public health front,

  • Health Payer Intelligence points out,
    • “Americans are feeling more optimistic about their well-being than last year, but financial concerns and mental health challenges are still negatively impacting their health, according to a report from The Cigna Group.
    • “The second annual Vitality in America study reflects responses from 10,000 adults collected in June 2023 by Morning Consult. The study uses the Evernorth Vitality Index, a subjective measure of health and well-being, to assess Americans’ experiences with personal health, finances, and job satisfaction.
    • “Almost half of respondents said they look forward to each new day, up from 43 percent in 2022. However, fewer adults said they prioritize their physical health (39 percent), feel capable of managing their emotions (45 percent), and can financially support themselves (40 percent).
    • “The top driver of stress among US adults was finances (40 percent), followed by housing conditions (25 percent), work (25 percent), family or social relationships (25 percent), and health (24 percent).”
  • Per Fierce Healthcare,
    • “More patients are accessing their medical records online via patient portals or apps and are doing so more often than in years past, according to the Office of the National Coordinator for Health IT (ONC).
    • “From 2020 to 2022, the portion of U.S. adults who reported being offered access to their medical records by a provider or insurer increased 24% to about 3 in 5, the office wrote in a recent data brief. The percentage who said they were offered access and used it jumped 50% during the same period, from 38% to 57%, according to ONC.
    • “Together these findings demonstrate increased patient demand for and use of online health information by individuals in recent years,” the office wrote in the brief, citing data from the 6,252-respondent 2022 Health Information National Trends Survey.
    • “Patients who were offered access to their online medical records also used them more frequently—54% reported accessing their records at least three times during 2022, compared to 38% in 2020 and 26% in 2017.”
  • Healthcare IT News notes,
    • “The emergence of telehealth during the COVID-19 pandemic and the resulting surge in the adoption of telemedicine are helping address patients’ needs without major signs of safety concerns, according to a study by Kaiser Permanente.
    • “The study, published in the Annals of Internal Medicine, analyzed more than 1.5 million adult patients at Kaiser Permanente Northern California in 2021, and compared treatment and follow-up visits among primary care telemedicine (video and telephone) and in-person office visits.
    • “Of the 2,357,598 primary care visits analyzed, just over half (50.8%) utilized telemedicine, which broke down to just under 20% composed of video visits and 31.3% telephone visits.
    • “The findings indicate that medication prescriptions were lower for video and telephone visits at 38.4% and 34.6%, respectively, compared to in-person visits at 46.8%. Additionally, follow-up appointments within seven days were less frequent for in-person visits (1.3%) compared to video (6.2%) and telephone (7.6%) visits.”
  • Per Medscape,
    • “Among the 3188 people with type 2 diabetes who were adherent to their tirzepatide (Mounjaro, Lilly) regimen in four pivotal trials of the agent, a quarter achieved at least a 15% cut from their baseline body weight after 40–42 weeks of treatment, and researchers found seven baseline variables that were significantly linked with a higher incidence of this level of weight loss.
    • “These findings help inform which people with type 2 diabetes are most likely to achieve greater body weight reduction with improved cardiometabolic risk factors with tirzepatide,” say the authors.”
  • HR Dive offers advice to employers about how to extend a helping hand to employees in their first trimester of pregnancy.

From the U.S. healthcare business front,

  • Mercer Consulting offers plan design advice to self-fund health plan sponsors. For example,
    • “Commit to affordable plan designs. One of the biggest reasons people delay care is because they can’t afford to pay for care. Encourage use of preventive care and chronic condition management. 
    • “Provide advocacy support to help plan members get to the most appropriate care and setting. 
    • “Review the emerging spectrum of virtual care for options to help rein in costs while making care more accessible and affordable to plan members. 
    • “Now is the time to consider the long list of network options that exist in the market today and could result in cost savings.   
    • “If you haven’t explored reference-based pricing, you might want to do so. The protections offered by the No Surprises Act make this a more attractive and less risky option for plan members. 
    • “Make mental health a priority. People with medical conditions often have mental health needs. People with mental health needs often develop medical conditions. It is an investment you can’t afford to overlook. 
    • “Focus on pharmacy. Prescription drug costs are a top driver of medical plan cost increases mostly associated with new drugs and the cost of specialty drugs.” 
  • The Wall Street Journal reports,
    • Big Pharma is almost finished with the cough and cold medicine business.
    • French drug giant  Sanofi said Friday it plans to spin off its consumer-health business, which includes well-known brands like allergy medicine Allegra and the pain treatments IcyHot and Aspercreme.
    • — to hive off a division selling over-the-counter medicines and other retail products to focus on more commercially lucrative but scientifically riskier prescription drugs.
    • Once the split is completed as early as the fourth quarter of next year, there will be just one consumer-health business left under the umbrella of a big drugmaker parent. Germany’s Bayer will be the largest drugmaker with such a business. 
    • Sanofi and its rivals have made the moves in the hunt for higher margins and faster sales growth. “It allows Sanofi to become a pure-play biopharma company. We’ll be more agile and more focused in our areas of key areas of strength,” Chief Executive Paul Hudson said.
    • Yet the companies lose the crutch of a reliable source of cash flow and now face more pressure to hit on breakthrough medicines with large sales potential.