Thursday Miscellany

Uncategorized

Thursday Miscellany

David Ermer–CMS, FDA, Medical / Rx research, Medicare, Mental health care, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Per an HHS press release,
    • Today, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), is finalizing policies that continue to strengthen enrollee protections and guardrails to ensure Medicare Advantage and Medicare Part D (Part D) prescription drug plans best meet the needs of people with Medicare. The Contract Year (CY) 2025 Medicare Advantage and Part D final rule builds on existing CMS policies to promote competition, increase access to care, including important behavioral health services, and protect individuals from inappropriate marketing and prior authorization. * * *
    • [For example,] CMS is finalizing greater flexibility for Part D plans to substitute, more quickly, lower cost biosimilar biological products (biosimilars) for their reference products so that enrollees may have faster access to equally effective, but potentially more affordable, drug treatment options. * * *
    • View a fact sheet on the final rule at cms.gov/newsroom.
  • From the AHA News,
    • “Primary care providers who commit to practicing two years in a health professional shortage area can initially receive up to $75,000 in loan repayment under the National Health Service Corps Loan Repayment Program, $25,000 more than previously and the first significant increase in 30 years, the Health Resources and Services Administration announced April 4. Participants who extend their service beyond two years can receive additional funding under the program. HRSA also will offer up to $5,000 in additional loan repayment to participants who can demonstrate fluency in Spanish and commit to practice in a high-need area serving patients with limited English proficiency.”
  • The International Foundation of Employee Benefit Plans lets us know,
    • “The Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act (MHPAEA) requires group health plans that provide mental health or substance use disorder (MH/SUD) benefits to offer parity between coverage of physical health conditions and mental health conditions. The Department of Labor (DOL) Employee Benefits Security Administration (EBSA) enforces MHPAEA and reports annually to Congress on how agency investigators are working with plan sponsors and administrators to bring them into compliance.
    • “Recent DOL reports on MHPAEA enforcement indicate several pitfalls that self-funded plan sponsors and their administrative service providers should avoid in order to be compliant with mental health parity rules. A new priority in the 2023 report was impermissible exclusions of key treatments for MH/SUD.
    • One-Minute Summary
      • Recognize that autism spectrum disorder, opioid use disorder and eating disorders are mental health conditionsand therefore treatment of these disorders are mental health benefits covered by mental health parity laws.
      • Blanket exclusions of ABA therapy for autism spectrum disorder, nutritional counseling for eating disorders, and medication-assisted treatment (MAT) and medications for opioid use disorder (MOUD) are impermissible.
      • Methods that participants use to access care should be in parity. Prior authorization, gatekeepers such as EAP referrals and telehealth are impermissible barriers to access mental health benefits.
  • Per an OPM press release,
    • In the first week of the Biden-Harris Administration, President Biden revoked an Executive Order issued by the previous Administration that risked altering our country’s long-standing merit-based civil service system, by creating new excepted service schedule, known as “Schedule F,” and directing agencies to move potentially large swathes of career employees into this new excepted service status. This attempt would have stripped career civil servants of their civil service protections that ensure that decisions to hire and fire are based on merit, not political considerations.  
    • The [OPM] final rule [released today] advances these important policy goals by:  
      • Clarifying that the status and civil service protections an employee has accrued cannot be taken away by an involuntary move from the competitive service to the excepted service, or from one excepted service schedule to another. Once a career civil servant earns protections, that employee retains them unless waived voluntarily.  
      • Clarifying that the phrase “confidential, policy determining, policymaking, or policy-advocating” positions—a term of art to describe positions that lack civil service protections—means noncareer, political appointments. This rule prevents that exception from being misapplied to career civil servants.  
      • Establishing procedural requirements for moving positions from the competitive service to the excepted service and within the excepted service. This change both creates transparency and establishes an appeals process for federal employees when any such movement is involuntary and characterized as stripping employees of their civil service protections.   

From the public health and medical research front,

  • The Society for Human Resources Management tells us,
    • “Anxiety has skyrocketed in recent years, now becoming the top mental health issue plaguing workers, new data shows.
    • “An analysis of more than 300,000 U.S. cases from mental health provider ComPsych found that nearly a quarter of people (24 percent) who reached out to ComPsych for mental health assistance in 2023 did so to get help with anxiety.
    • “That makes anxiety the No. 1 presenting issue reported by U.S. workers, topping depression, stress, relationship issues, family issues, addiction and grief, ComPsych said.”
  • MedPage Today notes,
    • New U.S. hepatitis C infections dropped slightly in 2022, a surprising improvement after more than a decade of steady increasesopens in a new tab or window, federal health officials said Wednesday.
    • Experts are not sure whether the 6% decline is a statistical blip or the start of a downward trend. Seeing 2023 and 2024 data, when it’s available, will help public health officials understand what’s going on, said Daniel Raymond, director of policy at the National Viral Hepatitis Roundtable, an advocacy organization.
    • “We’ve had a decade of bad news … I am cautiously encouraged,” he said. “You always want to hope something like this is real, and a potential sign that the tide has turned.”
  • STAT News reports,
    • “The booming class of GLP-1 drugs that includes Ozempic and Wegovy is not only effective for diabetes and obesity, but is also showing early potential to help with conditions involving the brain, like mental health disorders, Alzheimer’s, and even, as new study results suggest — Parkinson’s disease.
    • “In a Phase 2 trial, patients with early Parkinson’s disease taking an older GLP-1 diabetes drug called lixisenatide experienced no worsening of motor symptoms over a year, in contrast to patients on placebo who did, according to the study, published Wednesday in the New England Journal of Medicine.
    • “The difference between the groups — as measured by a test looking at someone’s tremors and rigidity — was small, almost but not quite reaching what is deemed to be a clinically significant difference. Still, the authors said they were encouraged that patients on the drug did not get worse, and the findings add to a growing body of research that suggests this class of medications holds potential as a new way of addressing Parkinson’s, a slow-moving, debilitating disorder that currently lacks any treatments that can halt disease progression.”
  • and
    • “Moderna may be best known for its Covid-19 vaccine, but since its start, it’s always been set on developing therapies.
    • “It’s run into some hurdles as it’s pioneered turning mRNA — the strand of genetic material that’s at the heart of Moderna’s approach — into medicines. But the company’s vision of making cells into their own drug factories is showing signs of progress.
    • “On Wednesday, scientists reported interim results from an early study of Moderna’s most advanced rare-disease therapy, a treatment for propionic acidemia, a metabolic condition in which the body makes defective versions of enzymes that are required to break down fats and proteins. While the study primarily focused on safety and testing different doses, some patients — most of the participants were children — saw a reduction in the life-threatening metabolic emergencies that can crop up with the disease.
    • “And while most patients reported such side effects as fever and vomiting, they broadly wanted to stay on the drug even after the trial period wrapped up, according to the study, published in the journal Nature.”

From the U.S. healthcare business front,

  • American Hospital Association News informs us,
    • “Almost half of rural hospitals had negative total margins in 2022 and negative patient care margins both before and after the COVID-19 pandemic, according to a report prepared for the AHA by faculty at the Virginia Commonwealth University College of Health Professions. When provider relief funds are excluded from margins, the average total margin for rural hospitals was lower in 2022, the most recent year with data available, than in any year since 2017.” 
  • Mercer Consulting looks at the performance of exclusive provider organizations.
    • “We’re seeing growing adoption of network configurations that differ from the traditional broad PPO network. This might mean eliminating out-of-network benefits, offering a plan with a narrow network of high-performing providers, or both. According to our Survey on Health and Benefit Strategies for 2024, 24% of large employers (those with 500 or more employees) now offer a medical plan option with a High-Performance Network curated by a carrier. Most often, these are plans offered by a national carrier in which the providers are a subset of the carrier’s larger Preferred Provider Organization network and are selected based on quality and cost metrics. A few independent provider networks (for example, Centivo and Imagine Health) have gained some traction as well. The largest employers are moving the fastest – 38% of companies with 20,000 or more employees offer some type of high-performance network.” 
  • Healthcare Dive reports,
    • “Walmart is pushing back expansion plans for its health center superstores, as retail giants struggle to right-size their primary care networks.
    • “The company plans to open 22 health centers this year, according to a Walmart spokesperson. Previously, the retail giant said it would open more than 30 locations in 2024.
    • “Walmart plans to open 18 centers in Texas and another four in the Kansas City metro area, the spokesperson said. The clinic openings will start this month in Houston, and run throughout the fall.”
  • According to BioPharma Dive,
    • “Amylyx Pharmaceuticals is pulling from market one of the few approved treatments for ALS.
    • “Rarely do drugmakers voluntarily withdraw products. In Amylyx’s case, the decision comes just weeks after a large clinical trial meant to confirm the benefits of its medicine instead found it no better than a placebo at slowing the fatal, nerve-destroying disease.
    • “Starting Thursday, the medicine, which is sold as Relyvrio in the U.S. and Albrioza in Canada, will no longer be available for new patients. Those who are taking it and wish to continue may enter a free drug program. Additionally, a phase of that large trial that allows participants to continue on Relyvrio remains ongoing.”
  • MedTech Dive points out,
    • “The Food and Drug Administration granted de novo clearance to an AI tool to help clinicians predict and diagnose sepsis, the first time the agency has authorized such a tool.
    • “The Sepsis Immunoscore software, developed by Chicago-based Prenosis, provides a risk score for clinicians on a patient having or developing sepsis within 24 hours. The score is based on 22 parameters, including respiratory rate, blood pressure and white blood cell count. 
    • “Hospitals already use early sepsis detection tools, despite lacking FDA review. The agency clarified in a final guidance in 2022 that clinical decision support software that provides a risk score or probability of a condition should be regulated as a medical device.”

Weekend update

David Ermer–Uncategorized–
Wildflowers currently blooming in Central Texas

Happy St. Patrick’s Day.

From Washington, DC,

  • No later than this Friday March 22, Congress must enact the second package of six FY 2024 appropriations measures to avoid a partial government shutdown. Roll Call tells us
    • “The Biden administration is objecting to congressional leaders’ earlier plans to fund Homeland Security appropriations with a stopgap measure through Sept. 30, throwing a wrench into efforts to release the final fiscal 2024 appropriations package Sunday, sources familiar with the delay said. 
    • “The White House’s late ask for an extra $1.56 billion in border-related resources and reluctance to otherwise back the full-year continuing resolution under discussion for DHS was behind the latest hangup, these people said.
    • “However, White House and congressional staff were meeting Sunday to discuss options, and sources said offers are being exchanged as lawmakers continued to work toward a solution.”  
  • MedPage Today reports,
    • “Hospital inpatient and outpatient services should get 1.5% more in 2025 Medicare payments, skilled nursing homes should receive 3% less, base payment rates for home health agencies should drop by 7%, and physicians should receive what current law allows plus 50% of the projected increase in the Medicare Economic Index, the Medicare Payment Advisory Commission (MedPAC) said in its annual March report to Congress.
    • “In two of the report’s 15 chapters, which took up 20% of the 561-page report, the commission addressed major problems with private Medicare Advantage (MA) plan quality and payments, which have been frequent topics of regular meetings. Commissioners reiterated that “a major overhaul of MA policies is urgently needed” to address lack of quality and overpayments compared with fee-for-service (FFS) plans.
    • “Other issues include the need for Medicare to change policies that disadvantage FFS beneficiaries who don’t want to use MA provider networks or undergo prior authorization. The commission advised Congress to push harder for information that is lacking about the value of MA plans’ “extra benefits.”
    • “The lack of information about the use and value of many MA supplemental benefits prevents meaningful oversight of the program such that we cannot ensure that enrollees are getting value from those benefits,” the report noted.”

From the public health and medical research front,

  • The Washington Post reports,
    • “Healthy lifestyles are associated with better cognitive function in older adults — even those whose brains show signs of dementia, according to research published in JAMA Neurology last month. The study suggests a healthy lifestyle could buffer older adults against cognitive decline and boost their “cognitive reserve.”
    • “Researchers used data from the Rush Memory and Aging Project, a long-term study that looked at patients’ lifestyles and health and analyzed autopsy data from 1997 to 2022. * * *
    • “Among all the patients, higher healthy lifestyle scores in five domains — diet, late-life cognitive activity, physical activity, smoking cessation and low alcohol intake — were associated with better cognitive function before their deaths. The association held even when the autopsies showed signs of brain changes consistent with dementia.”
  • Medscape offers five keys to helping long term COVID patients recover and points on Opill, the new OTC female contraceptive pill, for doctors to share with their patients.

From the U.S. healthcare business front,

  • The Washington Post reports,
    • “People over 65 use more health care than other age groups and make up nearly half of hospital admissions. But there are just 7,300 board-certified geriatricians in the United States, which is fewer than 1 percent of all physicians, according to the American Geriatrics Society. By contrast, more than 60,000 pediatricians were practicing in 2021, according to the Association of American Medical Colleges (AAMC).
    • “Yet research suggests that geriatricians more effectively and efficiently manage older patients than doctors without such training — leading to lower inpatient death rates, shorter hospital stays and reduced patient costs. Right now, the United States has roughly 1 geriatrician for every 10,000 older patients. Only 41.5 percent of geriatric medicine fellowship positions were filled in late 2023, down from 43 percent in 2022. Meanwhile, the number of people over 65 is expected to grow by nearly 40 percent within the decade.
    • “The vast majority of older people are getting care from people who have little to no training in the care of older adults,” said Louise Aronson, a professor of geriatric medicine at the University of California at San Francisco and the author of “Elderhood: Redefining Aging, Transforming Medicine, Reimagining Life.” * * *
    • “Experts highlight creative ways to boost financial incentives and exposure. “[Rosanne M.] Leipzig[, a professor and vice chair emerita in the Brookdale Department of Geriatrics and Palliative Medicine at the Icahn School of Medicine at Mount Sinai in New York” pointed out that since Medicare funds part of residencies and fellowships, regardless of the specialty, “why doesn’t Medicare require that these trainees demonstrate basic competency in the geriatric field?” Making program funding contingent on this would ensure some knowledge of geriatric issues for residents across specialties. Aronson suggested student loan forgiveness programs for doctors who specialize in geriatrics, similar to medical school loan forgiveness offered to doctors at qualifying nonprofit or government hospitals.
    • “Leipzig pointed to a new pilot program in the works to encourage more geriatric expertise by creating a midcareer pathway for general internists, similar to executive MBA programs. Some experienced internists will be able to pursue intensive short-term geriatric training without sacrificing their salaries or established practices.”
  • MedPage Today informs us,
    • “A much-awaited treatment for postpartum depression, zuranolone (Zurzuvae), hit the market in December, promising an accessible and fast-acting medication for a debilitating illness. But most private health insurers have yet to publish criteria for when they will cover it, according to a new analysisopens in a new tab or window of insurance policies.
    • “The lack of guidance could limit use of the drug, which is both novel — it targets hormone function to relieve symptoms instead of the brain’s serotonin system, as typical antidepressants do — and expensive, at $15,900 for the 14-day pill regimen.
    • “So far [and the article was published today], only one of the country’s six largest private insurers, Centene, has set a policy for zuranolone.”
  • Last Tuesday, the Wall Street Journal reported,
    • After the [Change Healthcare] hack, Availity set up a pared-down claims-processing service on Feb. 23 that medical providers can use for six months at no cost. The company has set up around 300,000 medical providers so far and has a backlog of at least 50 health systems waiting to start using the platform, Thomas said.
    • Availity’s CEO said he didn’t want to charge desperate healthcare companies in the middle of a crisis, and negotiating contracts would have meant a lot of work for the company’s employees. After the six-month contract-for-free service ends, Thomas said customers can decide if they want to keep using Availity’s platform or want to return to Change. “This event is going to sort of forever change the dynamics in this space,” he said. 

Thursday Miscellany

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

From Washington, DC

  • Think Advisor lets us know,
    • “The U.S. House of Representatives voted 211-208 on Wednesday to pass H.R. 485, the Protecting Health Care for All Patients Act of 2023.
    • “The bill would prohibit federal health programs — including Medicare, Medicaid and the Federal Employees Health Benefits Program — from using a “quality-adjusted life year” measure or similar measures when allocating resources.
    • “All Republicans who voted supported the bill, and all Democrats who voted opposed it.
    • “The bill was introduced by Rep. Cathy McMorris Rodgers, R-Ore.”
  • Roll Call reports,
    • “House Energy and Commerce Chair Cathy McMorris Rodgers, a 10-term Republican from Washington state who has been a strong advocate for people with disabilities, announced Thursday she would not seek reelection this year.
    • “It’s been the honor and privilege of my life to represent the people of Eastern Washington in Congress. They inspire me every day,’’ Rodgers said in a statement. “After much prayer and reflection, I’ve decided the time has come to serve them in new ways. I will not be running for re-election to the People’s House.”
    • “The announcement comes as Rodgers is leading negotiations with the Senate on a wide-ranging health care package that touches all parts of the industry. The legislation would implement more transparency in data and pricing for prescription drugs and other medical services.”
  • BioPharma Dive informs us,
    • “The CEOs of three major drugmakers defended the prices they charge U.S. patients in a Senate [Health Education Labor and Pensions] committee hearing Thursday, claiming Americans gain access to cutting-edge medicines months or years earlier than people in countries that pay a fraction of the U.S. costs. * * *
    • “Sen. Ben Ray Luján, D-N.M., asked the CEOs to pledge to not block entry of generics or biosimilars to the respective drugs in the spotlight when their primary patents expire, which Merck and Bristol Myers agreed to. That question in the case of Bristol Myers Squibb was focused Opdivo, its cancer immunotherapy rival to Keytruda.
    • “For Merck, Davis committed to open competition with any forthcoming biosimilars of intravenous Keytruda. But he didn’t mention the company is trying to develop and launch a subcutaneous, or under-the-skin, version that would likely extend its market advantage beyond the anticipated 2028 expiration of its main patent. Bristol Myers is also working on subcutaneous Opdivo.
    • “Questioned by Luján on settlements that have pushed the launch of biosimilar Stelara to 2025, J&J’s Duato said the price of the drug will be lower when that happens and added that prices net of rebates have dropped ahead of biosimilar competition.”
  • Bloomberg reports,
    • “The pharmaceutical industry, Trump and Obama administration officials, and others are urging the Biden administration to reconsider a controversial plan for seizing patents on a drug when its cost gets too high, claiming the approach misinterprets decades-old law and threatens the delicate pipeline that produces innovative, life-saving drugs.
    • “Over 500 comments were filed by the Feb. 6 deadline for groups and individuals to weigh in on the Biden administration’s framework for the federal government to use its march-in rights. The proposal lays out the Biden administration’s stance in a longstanding debate over whether price is a justifiable reason for the government to “march in” and take over a patent on technology developed with the help of taxpayer dollars and then license it to an outside manufacturer.
    • “The Biden plan is already drawing blowback from a broad swath of players in the innovation space. A collection of former US Patent and Trademark Office directors and other government officials under the George W. Bush, Obama, and Trump administrations wrote to warn that the proposed framework, if adopted, would prove destabilizing.”
  • Per an HHS press release
    • “The Department of Health and Human Services’ Office of Intergovernmental and External Affairs (IEA) will be hosting a stakeholder webinar TOMORROW, February 9, 2024, from 2 – 3 PM ET to provide an update on patient privacy.  
    • “Today, the U.S. Department of Health and Human Services, through its Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration (SAMHSA), finalized modifications to the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at 42 CFR part 2 (“Part 2”), which protect the privacy of patients’ SUD treatment records. Specifically, today’s final rule increases coordination among providers treating patients for SUDs, strengthens confidentiality protections through civil enforcement, and enhances integration of behavioral health information with other medical records to improve patient health outcomes.
    • “Today’s rule was informed by the bipartisan Coronavirus Aid, Relief, and Economic Security Act (CARES Act) that, among other things, required HHS to bring the Part 2 program into closer alignment with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Breach Notification, and Enforcement Rules.
    • “The final rule includes the following modifications to Part 2:
      • “Permits use and disclosure of Part 2 records based on a single patient consent given once for all future uses and disclosures for treatment, payment, and health care operations.
      • “Permits redisclosure of Part 2 records by HIPAA covered entities and business associates in accordance with the HIPAA Privacy Rule, with certain exceptions.
      • “Provides new rights for patients under Part 2 to obtain an accounting of disclosures and to request restrictions on certain disclosures, as also granted by the HIPAA Privacy Rule.
      • “Expands prohibitions on the use and disclosure of Part 2 records in civil, criminal, administrative, and legislative proceedings.
      • “Provides HHS enforcement authority, including the potential imposition of civil money penalties for violations of Part 2.
      • “Outlines new breach notification requirements applying to Part 2 records.”
    • “A fact sheet on the final rule may be found at: https://www.hhs.gov/hipaa/for-professionals/regulatory-initiatives/fact-sheet-42-cfr-part-2-final-rule/index.html“
    • Register in advance for this webinar: REGISTER HERE  
  • Govexec tells us,
    • “The U.S. Postal Service was $2 billion in the red in the first three months of fiscal 2024—typically its busiest and most profitable period of the year—doubling its loss from the same period in the previous year. 
    • “The accelerated losses during the holiday season continue a longstanding trend of poor financial performance for the mailing agency, but mark a troubling sign as its leadership team undertakes significant operational transformations with a promise to right the ship.
    • “In a positive development, however, USPS turned a net profit of $472 million when accounting only for the part of the ledger postal management deems within its control. That figure, which does not include fluctuations in workers’ compensation and amortized payments toward employee retirement accounts, grew from $187 million in the first quarter of the prior year.” 
  • The U.S. Office of Personnel Management announced,
    • “[t]he Finalists for this year’s Presidential Management Fellows (PMF) Program, the federal government’s premier leadership development program. In total, 825 Finalists were selected from more than 7,000 applicants from around the world. 
    • “Presidential Management Fellows are the next generation of federal government leaders,” said Kiran Ahuja, Director of OPM. “The PMF Program gives Fellows the leadership skills and exposure they need to make a difference in government and an impact within their community. Congratulations to all the 2024 PMF finalists. We cannot wait to see what you will accomplish in public service.” 

From the public health and medical research front,

  • Medscape points out,
    • “Brain fog is one of the most common, persistent complaints in patients with long COVID. It affects as many as 46% of patients who also deal with other cognitive concerns like memory loss and difficulty concentrating. 
    • “Now, researchers believe they know why. A new study has found that these symptoms may be the result of a viral-borne brain injury that may cause cognitive and mental health issues that persist for years.
    • “Researchers found that 351 patients hospitalized with severe COVID-19 had evidence of a long-term brain injury a year after contracting the SARS-CoV-2 virus. The findings were based on a series of cognitive tests, self-reported symptoms, brain scans, and biomarkers.” 
  • STAT News reports,
    • “People receiving a double dose of naloxone are no more likely to survive an opioid overdose than people receiving a standard, 4-milligram nasal spray, according to a new study.
    • “The new paper, published Thursday in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report, showed no significant difference in survival rates between people who were revived using 4- and 8-milligram sprays of naloxone, commonly known by the brand name Narcan. People receiving the smaller dose also did not require a higher total number of sprays, despite having received just half the initial amount. The researchers found only one major contrast between those receiving different dose sizes: Those who received a double dose were over 2.5 times more likely to experience severe withdrawal symptoms, like vomiting.
    • “The study comes as pharmaceutical companies continue to market expensive high-dose formulations of naloxone, arguing that amid record drug death levels resulting from potent synthetic opioids like fentanyl, it’s essential to deliver as much of the overdose-reversal medication as possible. Public health experts and harm-reduction groups have pushed back, however, charging that the companies have used Americans’ fear of fentanyl as an excuse to sell needlessly expensive naloxone products to cash-strapped public health agencies.”
  • Beckers Hospital Review reports,
    • “Patients who take Ozempic, Mounjaro and Wegovy are less likely to be diagnosed with anxiety or depression compared to those who don’t receive the popular diabetes and weight loss drugs, according to a new study. 
    • “A review of more than 4 million patient records conducted by Epic Research found that diabetic patients are less likely to have anxiety if they are taking any glucagon-like peptide-1 receptor agonist. 
    • “The researchers analyzed five different GLP-1s: tirzepatide (Mounjaro, Zepbound), semaglutide (Ozempic, Wegovy, Rybelsus), dulaglutide (Trulicity), liraglutide (Saxenda, Victoza) and exenatide (Byetta, Bydureon). 
    • “The patients taking GLP-1s for weight loss were compared with those receiving another kind of weight loss drug, and diabetic patients were compared with people not taking a GLP-1.”
  • The American Hospital Association News notes how you can “[l’earn how hospitals and health systems are improving maternal and child health outcomes in this synopsis of the latest resources from AHA’s Better Health for Mothers and Babies initiative. READ MORE.”
  • The NIH Director discusses in her blog “What’s Behind that Morning Migraine? Community-Based Study Points to Differences in Perceived Sleep Quality, Energy on the Previous Day.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • AstraZeneca sees its revenue and core earnings per share growing by double-digit percentages in 2024, the pharmaceuticals major said as it reported fourth-quarter core earnings per share below expectations on higher costs, sending the stock lower.
  • CNBC discusses how “Novo Nordisk, Eli Lilly are tackling weight loss drug supply woes.”
    • “Last week, the Danish drugmaker [Novo Nordisk] said it had more than doubled its supply of lower-dose versions of its weight loss injection Wegovy in January compared to previous months. Supply shortages forced Novo Nordisk to restrict the availability of those lower doses in the U.S. since May. 
    • “But why are those lower doses important? It’s because people are supposed to start Wegovy at a low dose and gradually increase the size over time to mitigate side effects such as nausea. So, more of those low “starter” doses means more new patients can begin treatment with Wegovy. 
    • “The company plans to “gradually” increase the overall supply of Wegovy throughout the rest of the year, executives added on the company’s fourth-quarter earnings call Wednesday.”
  • Per Healthcare Dive,
    • “UnitedHealth’s chief operating officer Dirk McMahon is retiring after more than two decades at the company.
    • “McMahon plans to retire on April 1, the payer said in a Wednesday filing with the Securities and Exchange Commission on Wednesday.
    • “UnitedHealth has yet to name a replacement for McMahon.”
  • and
    • “Walgreens has named a new head of its healthcare unit as the pharmacy chain works to improve its halting finances and shift to delivering more healthcare services.
    • “John Driscoll, the current executive vice president and president of the U.S. Healthcare segment, will be replaced by Mary Langowski, who previously held the chief executive role at chronic condition management company Solera Health. Driscoll will serve in a senior advisory role, Walgreens announced Thursday.”
  • and
    • “Molina Healthcare lost half a million Medicaid members due to redeterminations by the end of 2023, executives said Thursday.
    • “States resumed checking beneficiaries’ eligibility for the safety-net program in April following a pause during the COVID-19 public health emergency. Some 16 million Americans have been disenrolled from Medicaid to date because of the redeterminations. The process is disproportionately impacting insurers with a heavy Medicaid presence like Molina, which brings in 80% of its revenue from the program.
    • “Molina still expects to retain 40% of its Medicaid membership once redeterminations are complete. However, on Thursday the insurer raised its estimate of members gained during COVID from 800,000 to 1 million because of new business adds. That implies a net member loss of 600,000 once redeterminations are complete.” 
  • and
    • “Tenet Healthcare beat Wall Street expectations for revenue in the fourth quarter of 2023 on continued cost control measures and sustained demand for services, particularly in its ambulatory care unit, executives said during an earnings call on Thursday.
    • “CEO Saum Sutaria told investors that Tenet was entering a “new era” in which a higher proportion of its performance was generated by its ambulatory surgical business. Same-facility revenue for ambulatory services grew 9.2% during 2023, above Tenet’s long-term goal of 4% to 6% top line growth.
    • “The Dallas-based for-profit will continue a careful watch on its debt levels, executives said. The company has recently taken steps to reduce its leverage, last week finalizing the sale of three hospitals to Novant Health and announcing the sale of four additional hospitals to UCI Health.”
  • Beckers Payer Issues discusses why it appears that insurers are split in two camps over rising Medicare Advantage costs.

Tuesday Tidbits

David Ermer–AHRQ, CDC, Congress, FDA, Medical / Rx research, No Surprises Act, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The Hill reports,
    • “Congress is struggling to lock down a deal on government funding with just days until lawmakers are set to leave town for the rest of the year, as both chambers appear to have given up on passing their own spending bills.
    • “Lawmakers had been hopeful leadership would strike a deal last week on an overall top-line level for government funding in fiscal 2024 as part of the annual appropriations process. But as negotiations continue, lawmakers say leadership is cutting it close. Congress is staring down a shutdown deadline next month, with little legislative time on the calendar.” 
  • Healthcare Dive explains the features of the Lowers Costs, More Transparency bill passed last night by the House of Representatives. The wide bi-partisan margin supporting the bill gives it more likelihood of success in the Senate.
  • American Hospital Association News tells us,
    • “The House Dec. 12 voted 386-37 to pass AHA-supported legislation (H.R. 4531) that would reauthorize key SUPPORT Act programs for patients with substance use disorder and permanently extend required Medicaid coverage for medication-assisted treatments. The Senate Health, Education, Labor & Pensions Committee today advanced its own SUPPORT Act reauthorization bill (S. 3393).”
  • Healthcare Dive informs us,
    • “Nationwide health data exchange under TEFCA, the Trusted Exchange Framework and Common Agreement, is now operational, the HHS’ Office of the National Coordinator for Health Information Technology announced on Tuesday.
    • “Five Qualified Health Information Networks, or QHINs, completed the onboarding process and are ready for data exchange: eHealth Exchange, Epic Nexus, Health Gorilla, KONZA and MedAllies.
    • “The go-live marks a significant milestone that’s been years in the making, HHS leaders said at a signing event. “I feel like we’re watching the Big Bang occur in 2023,” said Secretary Xavier Becerra.”
  • Yippee! Now, true interoperability begins. Bye, bye fax machines.
  • HHS also announced,
    • “release[ing] HHS’s National Plan to Address Alzheimer’s Disease: 2023 Update – PDF. The National Plan is a roadmap of strategies and actions of how HHS and its partners can accelerate research, expand treatments, improve care, support people living with dementia and their caregivers, and encourage action to reduce risk factors. It highlights the progress made in 2023, which was an historic year for the treatment of Alzheimer’s disease and related dementias (ADRD) and care for people with this condition.”
  • The U.S. Preventive Services Task Force is proposing to retain its Grade B recommendation that
    • “Clinicians provide or refer children and adolescents age six years or older with a high body mass index (BMI) (≥95th percentile for age and sex) to comprehensive, intensive behavioral interventions.”
    • The public comment period is open until January 16, 2024.
  • MedPage adds that
    • “To reap the “moderate net benefit,” kids should have 26 or more contact hours with the behavioral interventions for up to a year, [the USPSTF] advised.
    • “USPSTF fell short of recommending pharmacologic therapy, citing a lack of evidence. This did not mean the group recommended against this type of treatment; however, behavioral interventions should be the primary effective intervention for kids’ weight loss, the task force said.”
  • The CDC offers five healthy eating tips for the holidays.
  • The GAO issued a report on the rocky implementation of the No Surprises Act’s independent dispute resolution process.

From the public health and medical research front,

  • Beckers Hospital Review points out the fifteen states (and New York City), up from ten the previous week, with the highest rates of respiratory disease.
    • “Two states — Louisiana and South Carolina — reported “very high” respiratory virus activity levels. Thirteen states — Alabama, California, Colorado, Florida, Georgia, Mississippi, Nevada, New Jersey, New Mexico, North Carolina, Tennessee, Texas and Wyoming — and New York City reported “high” activity levels, which are a measure of the weekly percentage of visits to an outpatient healthcare provider or emergency department for fever and cough or sore throat.” 
  • Per STAT News,
    • “The sickle cell community has for the past few days been buzzing with news of the first-ever approved gene therapies for the devastating disease. Meanwhile, researchers at the American Society of Hematology meeting on Tuesday are reporting advances in a less expensive and more established strategy proven to cure patients: bone marrow transplant.
    • “This approach has been around for decades but required patients to have a well-matched donor and endure a hefty dose of chemotherapy, ruling out transplant as an option for the vast majority of patients. In a mid-stage trial, however, researchers said sickle cell patients who were given a gentler course of chemo and an infusion of half-matched cells fared well: They had less pain, and 95% of participants were alive two years after transplant and only 7% of recipients experienced a severe reaction caused by transplanted immune cells attacking their new home.”
  • and
    • “One of the toughest subtypes of acute leukemia involves a genetic alteration in the KMT2A gene. Many cancers with this genetic alteration end up relapsing or don’t respond to treatment, but new data presented at the annual American Society of Hematology meeting offer hope of a new targeted therapy for these patients.
    • “The study, called the Phase 2 Augment-101 trial, tested Syndax’s revumenib in patients with relapsed or refractory leukemia with these KMT2A genetic rearrangements. Overall, about 63% of the patients responded to the treatment, with many able to receive a potentially curative stem cell transplant later on, which is often the ultimate goal for patients with relapsed or refractory patients, said Ibrahim Aldoss, a hematologist-oncologist at City of Hope and the study’s presenter, in an interview.”
  • The New York Times asks why since 2009 pedestrian deaths at night continue climb?
    • “[P]ut together, it’s clear that there’s been a particularly American mix of technological and social changes over the past decade and a half. And they have all come on top of a road system and an ingrained culture that prioritizes speed over safety. Whatever has happened over this time has reversed years of progress on daytime pedestrian fatalities, too, leading to a modest increase in deaths. Nighttime, however, has the potential to amplify so many of these new risks.
    • “A transportation system that’s safer by design — as in many European countries — might better absorb any one of these dangers. Distracted drivers are safer at lower speeds. People out at night are safer with well-lit crosswalks.”
  • The New York Times furthermore reports,
    • “Zepbound, the newly approved weight loss drug, hit the market this month. People seeking out the medication may have to stay on it for the foreseeable future — potentially, for the rest of their lives — if they want to keep the weight off, new research confirms.
    • “A study published Monday followed 670 people who had taken tirzepatide, the compound in Zepbound and the diabetes drug Mounjaro, for 36 weeks. Eli Lilly, the company that makes both drugs, funded the study. Tirzepatide regulates insulin levels and slows down the emptying of the stomach. It also acts on areas of the brain that control hunger and appetite. As a result, people can lose significant weight: On average, the study participants lost around 20 percent of their body weight during that time.
    • “After that, half of the participants continued to take a high dose of tirzepatide for a year while the other half received a placebo shot. Those in the study also underwent lifestyle counseling, ensuring that they were eating fewer calories and exercising regularly.
    • “People who continued taking tirzepatide for an additional year lost, on average, another 5.5 percent of their body weight. Those who were switched to the placebo, however, gained 14 percent of their body weight on average. Those on the placebo also tended to have higher cholesterol, blood sugar and blood pressure than they did while taking tirzepatide, said Dr. Louis Aronne, the lead author on the study and the director for the Comprehensive Weight Control Center at Weill Cornell Medicine.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Optum Rx is launching a new weight management program aimed at improving outcomes and addressing affordability.
    • “The cost of GLP-1 drugs amid continued high demand is a key focus for pharmacy benefit managers and plan sponsors, especially as individual therapies can top $10,000 per year. Through the Optum Rx Weight Engage program, the PBM is aiming to support employers and other clients in designing benefits for their membership.
    • “The team will review the client’s goals to build a tailored program that will deploy clinical solutions as well as patient monitoring and motivation and support tools, the company said. Members can connect to an obesity management specialist who will direct them to the appropriate clinical services.”
  • Healthcare Dive reports,
    • “Healthcare prices typically rise faster than inflation, but 2023 may have bucked that trend.
    • “The cost of shoppable medical services at hospitals increased 2% in the first three quarters of the year, according to new data from Turquoise Health released Tuesday. That’s in line with the 1.9% overall growth of the economy.
    • “The findings — some of the first from new price transparency data disclosing the once-secret negotiated rates between health insurers and providers — illustrate how overall economic inflation could be catching up to faster health cost growth.”
  • STAT News notes,
    • “In its latest bid to police the pharmaceutical industry, the U.S. Federal Trade Commission sought to block Sanofi from licensing a Pompe disease treatment made by another drug company. And in response, Sanofi is ending the deal.
    • “Sanofi sought the rights to the medication from Maze Therapeutics, but the regulator argued the deal — valued at $775 million — would eliminate a “nascent competitor” that could, otherwise, challenge the monopoly Sanofi has in the market for Pompe disease treatments, according to an FTC statement. The agency had filed a complaint in a federal court in Boston and also planned to seek a preliminary injunction.”
  • BioPharma Dive adds,
    • “The scuttled deal came on the same day that the regulator gave final clearance to Pfizer’s $43 billion acquisition of Seagen, which had faced close scrutiny from the antitrust regulator. To ease the FTC’s concerns, Pfizer has agreed to donate royalties from sales of the cancer drug Bavencio to the American Association for Cancer Research.”
  • Beckers Hospital Review points out six innovative hospitals.
  • According to BioPharma Dive,
    • “AstraZeneca on Tuesday reached a deal to acquire vaccine developer Icosavax in a deal worth up to $1.1 billion. 
    • “Per deal terms, AstraZeneca will acquire Icosavax’s shares at $15 apiece, and could add another $5 per share to the buyout if certain milestones and sales targets are met. The upfront payment from AstraZeneca represents an equity value of about $838 million and a premium of about 43% to Icosavax’s closing price on Monday. The acquisition would reach $1.1 billion if AstraZeneca eventually makes the future payouts, which are known as “contingent value rights.”  
    • “Icosavax has been developing an experimental shot that simultaneously targets respiratory syncytial virus and human metapneumovirus, another lung infection. The biotech released Phase 2 study results on Tuesday showing the vaccine spurred an immune response against both viruses without causing any serious adverse events. AstraZeneca will now take over late-stage development, and, if successful, commercialization.”  

Thursday Miscellany

David Ermer–Uncategorized–

From Washington, DC,

  • The U.S. Office of Personnel Management released its Fiscal Year 2023 Agency Financial Report today. Worth reading is the OPM Director’s response to the OPM Inspector General’s Top Management Issues letter.
  • The Department of Health and Human Services (HHS) issued its proposed 2025 benefit and payment parameters notice. Here is the government’s fact sheet on the proposed rule. Published alongside the proposed rule is HHS’s final guidance on Maximum Annual Limitation on Cost Sharing for the 2025 Benefit Year, which does apply to FEHB plans.
    • “Under 45 CFR 156.130(a)(2), for the 2025 calendar year, cost sharing for self-only coverage may not exceed the dollar limit for calendar year 2014 increased by an amount equal to the product of that amount and the premium adjustment percentage for 2025. For other than self-only coverage, the limit is twice the dollar limit for self-only coverage. Under § 156.130(d), these amounts must be rounded down to the next lowest multiple of $50. Using the premium adjustment percentage for 2025 of 1.4519093322, and the 2014 maximum annual limitation on cost sharing of $6,350 for self-only coverage, which was published by the Internal Revenue Service on May 2, 2013, the 2025 maximum annual limitation on cost sharing is $9,200 for self-only coverage and $18,400 for other than self-only coverage. This represents an approximately 2.6 percent decrease from the 2024 parameters of $9,450 for self-only coverage and $18,900 for other than self-only coverage.”
  • Per MedTech Dive,
    • “Congress included a one-year delay to Medicare reimbursement cuts for clinical laboratory services in the short-term funding bill passed this week, granting a reprieve in targeted payment reductions of up to 15%.
    • “The stopgap bill to keep the government open, passed by the House on Tuesday and the Senate on Wednesday, provides a one-year reprieve from Medicare cuts that would have gone into effect in January for about 800 laboratory services.
    • “The American Clinical Laboratory Association (ACLA), a trade group whose members include Labcorp and Quest Diagnostics, called the delay “critically needed” to preserve patient access to many of the most commonly ordered lab tests.”
  • HHS also reminds us that
    • “Today [the agency] celebrates National Rural Health Day and recognizes the creativity and innovation of leaders across the country working to ensure access to high quality care for over 60 million Americans living in rural communities. National Rural Health Day is the third Thursday of every November and recognizes the efforts of rural providers, communities, organizations, state offices of rural health, and others dedicated to addressing the unique health care needs of rural America.” 

In FEHB Open Season news, Tammy Flanigan discusses Open Season and tax savings in Govexec.

From the public health and research front,

  • The New York Times points out the differences between Influenza A and Influenza B.
  • NCQA released its Quality Talks newsletter.
  • STAT News informs us,
    • “History just happened.
    • “For the first time, a regulator has cleared a treatment using CRISPR, the gene-editing technology, for patients. The regulator is the United Kingdom’s Medicines and Healthcare products Regulatory Agency. The product is Casgevy, a treatment for sickle cell disease and beta thalassemia, two blood disorders. It was developed by CRISPR Therapeutics, the Swiss company co-founded by Nobel laureate Emmanuelle Charpentier, and Vertex Pharmaceuticals, a large Boston-based biotech firm.”
    • The article covers questions and answers about this significant development.
  • “Smileyscope has made history by becoming the first virtual reality (VR) device to receive FDA Class II clearance for acute pain. This approval recognizes Smileyscope’s innovative Procedural Choreography™ technique, which uses positive virtual stimuli to reduce pain and anxiety during medical procedures. With this milestone, Smileyscope aims to revolutionize pain and anxiety management, partnering with hospitals and clinicians globally to enhance patient experiences and improve clinical workflows.”

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.”

Monday Roundup

David Ermer–Congress, COVID-19, OPM, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “House Republicans’ speaker nominee Rep. Jim Jordan (R., Ohio) won over some pivotal holdouts Monday as broader GOP opposition to his bid appeared to crumble, moving him closer to winning the gavel in a floor vote as soon as Tuesday afternoon.
    • “I feel real good about the momentum we have. It’s real close,” Jordan told reporters, citing recent endorsements and saying he was ready to move forward on Tuesday at noon. “We’re going to elect a speaker tomorrow; that’s what I think is going to happen.”
  • The U.S. Office of Personnel Management announced,
    • “[T]he Biden Administration has exceeded its goal of selecting 5,800 targeted positions helping implement the Bipartisan Infrastructure Law (BIL), a once-in-a-generation investment in America’s infrastructure and competitiveness. Over the last two years, OPM has served as a strategic workforce partner for seven federal agencies and supported surge hiring for key positions, including engineers, scientists, project managers, IT & HR specialists, construction managers, and many more. 
    • “The agencies included in targeted hiring positions are the Department of Agriculture, Department of Commerce, Department of Energy, Department of Homeland Security, Department of the Interior, Department of Transportation, and the Environmental Protection Agency.”
  • Govexec introduces us to the Partnership for Public Service’s Service to America Medal winners. Mazaal tov to the winners.
  • Thompson Reuters points out that last week, the Internal Revenue Service “released the final versions of the following 2023 Affordable Care Act (ACA) forms:
    • “(1) Form 1094-B, Transmittal of Health Coverage Information Returns;
    • “(2) Form 1094-C, Transmittal of Employer-Provided Health Insurance Offer and Coverage Information Returns;
    • “(3) Form 1095-B, Health Coverage; and
    • “(4) Form 1095-C, Employer-Provided Health Insurance Offer and Coverage.
    • The forms do not contain substantive changes.”

From the public health front,

  • The New York Times reports,
    • “A team of scientists is proposing a new explanation for some cases of long Covid, based on their findings that serotonin levels were lower in people with the complex condition.
    • “In their study, published on Monday in the journal Cell, researchers at the University of Pennsylvania suggest that serotonin reduction is triggered by remnants of the virus lingering in the gut. Depleted serotonin could especially explain memory problems and some neurological and cognitive symptoms of long Covid, they say.
    • “This is one of several new studies documenting distinct biological changes in the bodies of people with long Covid — offering important discoveries for a condition that takes many forms and often does not register on standard diagnostic tools like X-rays.
    • “The research could point the way toward possible treatments, including medications that boost serotonin. And the authors said the biological pathway that their research outlines could unite many of the major theories of what causes long Covid: lingering remnants of the virus, inflammation, increased blood clotting and dysfunction of the autonomic nervous system.
    • “All these different hypotheses might be connected through the serotonin pathway,” said Christoph Thaiss, a lead author of the study and an assistant professor of microbiology at the Perelman School of Medicine at the University of Pennsylvania.
    • “Second of all, even if not everybody experiences difficulties in the serotonin pathway, at least a subset might respond to therapies that activate this pathway,” he said.”
  • Last Friday, the Department of Health and Human Services announced,
    • “[T]he selection of initial next-generation vaccine candidates and more than $500 million in awards for Project NextGen – kick-starting planning for Phase 2b clinical trials and technologies that advance innovative next-generation vaccine and therapeutics platforms.
    • “The Biden-Harris Administration is committed to keeping people safe from COVID-19,” said HHS Secretary Xavier Becerra. “By investing in next-generation vaccines and treatments, we can improve our ability to respond to new variants, reduce transmission, stop infections, and save lives. Through Project NextGen, we are combining research and development expertise at HHS with the lessons learned throughout the pandemic to protect our nation from COVID-19.” 
    • “The over $500 million announced today builds on the over $1.4 billion awarded in August – accelerating products toward clinical trials and potential commercial availability.”
    • “The vaccine selections and funding announced today are important steps forward for Project NextGen – with vaccine and therapeutics candidates moving quickly to clinical trials that will start in the coming months,” said Assistant Secretary for Preparedness and Response Dawn O’Connell. “The technologies that BARDA is investing in, from intranasal vaccines to self-amplifying mRNA, will bolster our protection against COVID-19 for years to come.”

From the U.S. healthcare business front,

  • Beckers Payer Issues tells us that UnitedHealth Group executives and the FEHBlog are of one mind.
    • “UnitedHealth Group wants to lower the price of GLP-1 drugs such as Ozempic and Wegovy, but it needs drug manufacturers to get on board, executives said. 
    • “On an Oct. 13 call with investors, UnitedHealth Group CEO Andrew Witty said prices have to come down for more people to access the drugs. 
    • “We’re very positive about the potential for another tool in the toolbox to help folks manage their weight,” Mr. Witty said. “We recognize that has potential benefits, but we’re struggling, and frankly our clients are struggling, with the list prices which have been demanded of these products in the U.S., which are running at about 10 times the level of prices paid in Western Europe.” 
  • Per Biopharma Dive,
    • “Novo Nordisk said Monday it will spend up to $1.3 billion to buy an experimental hypertension drug from Singapore-based KBP Biosciences, adding to a string of acquisitions that builds out its metabolic disease business behind the blockbuster diabetes drug Ozempic.
    • “The pill, called ocedurenone, is in a Phase 3 trial in people with chronic kidney disease and uncontrolled high blood pressure. Results are due next year, and Novo said it plans to begin additional Phase 3 trials in other cardiovascular and kidney disease indications.
    • “Novo is putting its profits from accelerating Ozempic sales to work, having cut late-summer deals to buy a Danish metabolic startup called Embark Biotech and a Canadian metabolic company called Iversago. That followed on the billion-dollar-plus deals to buy rare disease drug developer Forma Therapeutics in 2022 and genetic medicine company Dicerna in 2021.”
  • Fierce Healthcare tells us why Amazon’s chief medical officer believes Amazon can make a big impact in tackling chronic illness.

Weekend update

David Ermer–Uncategorized–
Photo by Dane Deaner on Unsplash

From Washington, DC,

From the public health front,

  • The New York Times reports
    • “A steady uptick in [COVID-19] cases since July and reports of worrisome new variants have fueled concern that the virus is poised to make a comeback this fall and winter. But in interviews, experts offered reassurances that the country will not see a return to the nightmarish scenarios of previous years.
    • “There is no evidence that any of the variants in circulation cause more severe disease or evade immunity adroitly enough to render vaccines ineffective. And although hospitalizations and deaths are increasing week by week, the numbers remain low, noted Gigi Gronvall, a biosecurity expert at the Johns Hopkins Center for Health Security.
    • “These increases are more alarming by statistics than in reality,” Dr. Gronvall said.” 
  • Roll Call tells us
    • “During the same week that naloxone — a nasal spray that reverses opioid overdoses — became available for purchase without a prescription, the nation’s top substance use officials called for greater availability and training for the drug, with five federal officials receiving training to administer it during a public demonstration at Health and Human Services headquarters Friday. 
    • * * * “While the Food and Drug Administration initially approved naloxone in 1971 as an injectable drug used in medical settings, it wasn’t until 2015 that the FDA approved a nasal spray version for prescription use. But the agency only approved the first over-the-counter versions of the drug this year. It became available without prescription this week, with Emergent BioSolutions’ 4 mg nasal spray selling for $44.99 for a two-dose product. Harm Reduction Therapeutics’s RiVive, is expected to become available in eBloomarly 2024.
    • “The price point has been a concern for some advocates who worry it could limit accessibility and use. In an interview, Rahul Gupta, director of the White House Office of National Drug Control Policy, said the administration is working to bring the price point down as part of a larger effort to reduce healthcare costs.
    • “We’re constantly working with manufacturers because we’ve got to make this accessible and affordable. So we’re on this, and we’re exploring every pathway working with HHS and our other government partners as well,” he said.
  • Bloomberg offers a fascinating article about Lyme Disease. This tick-borne disease first made its appearance in the 1990s. An effective vaccine was made available in 1998, but the ultimately discredited “vaccines cause autism” campaign killed the vaccine in its cradle. Pfizer is now developing a new Lyme Disease vaccine, which is expected to receive FDA approval in 2026.
  • NPR Shots offers a comic strip explaining how to take care of your ears.

From the U.S. healthcare business front,

  • The Washington Post reports
    • “Kroger, one of the nation’s largest supermarket chains, has agreed to pay more than $1 billion to settle lawsuits alleging it failed to monitor suspicious orders of addictive pain pills that fueled the nation’s opioid crisis.
    • “The company announced Friday it will pay up to $1.2 billion to states and local governments, and $36 million to Native American tribes over 11 years.
    • “The money adds to more than $50 billion in settlements obtained by state and local governments suing opioid-industry players alleged to have flooded the nation with addictive pills, despite red flags that they were being diverted to the black market.
    • “Governments aim to use the money to ease the opioid crisis and save lives. Among the ways: paying for drugs to reverse overdoses, bolstering addiction treatment services and creating education campaigns.”
  • KFF Health News is tracking the distribution of these opioid-related class action settlements across the fifty states and DC.

 

Cybersecurity Saturday

David Ermer–Cybersecurity, Uncategorized–

From the cybersecurity vulnerabilities and breaches front,

  • Cyberscoop reports
    • “An international law enforcement operation disrupted the Qakbot botnet and associated malware that has been connected with countless cyberattacks and nearly $60 million in losses from victims around the world, the U.S. Department of Justice announced Tuesday. 
    • “The operation that included the FBI, DOJ and authorities in France, Germany, the Netherlands, Romania, Latvia and the United Kingdom — is “one of the largest U.S.-led disruptions of a botnet infrastructure” used by criminals to facilitate ransomware, financial fraud and other cyber-enabled criminal activity, the FBI said in a statement.
    • “There were no arrests in connection with the operation but the investigation remains ongoing, a senior FBI official told reporters Tuesday.
    • “Qakbot, also known as Qbot or Pinksipbot, is malware first detected in 2008 that has been associated with hundreds of millions of dollars in losses to individuals and businesses in the U.S. and around the world, according to the FBI. The malware has been an initial entry mechanism for a variety of ransomware groups over the years. Groups such as Conti, ProLock, Egregor, REvil, MegaCortex and Black Basta have been known to use it. Between October 2021 and April 2023, the FBI said, Qakbot administrators have received fees corresponding to approximately $58 million in ransoms paid by victims.
  • Cybersecurity Dive adds
    • “The FBI was able to redirect botnet traffic toward servers it controlled and disrupt the operation. More than 200,000 computers in the U.S. alone were found to be infected. Authorities also seized $8.6 million in illicit cryptocurrency as part of the takedown. ***
    • “The FBI and Dutch National Police have set up website links where stolen credentials can be accessed to find out if they were used.” 
  • Here are links to the related CISA announcement and Security Week’s report on industry reaction to this news.
  • Krebs on Security informs us,
    • “Domain names ending in “.US” — the top-level domain for the United States — are among the most prevalent in phishing scams, new research shows. This is noteworthy because .US is overseen by the U.S. government, which is frequently the target of phishing domains ending in .US. Also, .US domains are only supposed to be available to U.S. citizens and to those who can demonstrate that they have a physical presence in the United States.
    • “.US is the “country code top-level domain” or ccTLD of the United States. Most countries have their own ccTLDs: .MX for Mexico, for example, or .CA for Canada. But few other major countries in the world have anywhere near as many phishing domains each year as .US.
    • “That’s according to The Interisle Consulting Group, which gathers phishing data from multiple industry sources and publishes an annual report on the latest trends. Interisle’s newest study examined six million phishing reports between May 1, 2022, and April 30, 2023, and found 30,000 .US phishing domains.
    • “.US is overseen by the National Telecommunications and Information Administration(NTIA), an executive branch agency of the U.S. Department of Commerce. However, NTIA currently contracts out the management of the .US domain to GoDaddy, by far the world’s largest domain registrar.”
  • Go figure.
  • Cybersecurity Dive tells us last Monday
    • “The blast radius from the mass exploit of a zero-day vulnerability in the MOVEit file transfer service reached another milestone in its destructive spread: more than 1,000 organizations are impacted, according to Emsisoft and KonBriefing Research.
    • “The number of organizations hit by the wide-scale attack increased nearly 40% last week, underscoring the scope of impact and challenge organizations are encountering as they work to determine potential exposure.
    • “The pool of victims from Clop’s attack spree, which was discovered Memorial Day weekend, continues to grow as downstream victims, which lead to more downstream victims, are identified via public disclosures and the threat actor’s website.
  • Health IT Security adds
    • “This week, Singing River Health System in Mississippi is actively facing system downtime as it investigates a cyberattack on its network. What’s more, Prospect Medical Holdings, which operates 16 hospitals and more than 165 clinics across Southern California, Rhode Island, Pennsylvania, and Connecticut, is still experiencing a systemwide outage that began on August 9.
    • “As these incidents continue to develop, other entities have continued to report confirmed data breaches to HHS, as exemplified in this week’s data breach roundup. Third-party data breaches continue to dominate breach notifications, causing breaches across the country.”
    • The article goes on to highlight recent breach announcements. 

From the cybersecurity defenses front,

  • Per Cybersecurity Dive,
    • “Organizations are facing more obstacles obtaining or renewing cyber insurance coverage,  according to a survey of 300 organizations conducted by Censuswide, on behalf of Delinea. Organizations also face strict requirements to get a claim covered.
    • “The majority of organizations, 4 in 5,  said their insurance rates went up when they submitted a new application or applied for policy renewals, with two-thirds reporting premium hikes of between 50% and 100%. 
    • “It is also taking organizations longer to obtain new coverage. The process for 20 of those surveyed, roughly 7%, took six months or longer.”
  • The Healthcare and Public Sector Critical Infrastructure Security and Resilience Partnership released an updated version of its Health Industry Cybersecurity Tactical Crisis Response Guide.
  • An ISACA expert discusses “Contending with Artificially Intelligent Ransomware.”
  • HHS’s 405(d) group released a cyber-hygiene poster oriented toward healthcare providers. Nevertheless, it can be adapted for health plan use.
  • Forbes identifies ten “captivating” cybersecurity conferences being held in Fall 2023.