Midweek Update

Midweek Update

Photo by Manasvita S on Unsplash

From Washington DC,

  • The Wall Street Journal reports,
    • “GOP Rep. Jim Jordan failed again to win enough votes to be elected House speaker, as divisions hardened for House Republicans, with some lawmakers pursuing new paths to break the impasse that has paralyzed the chamber.
    • “More than two weeks after former House Speaker Kevin McCarthy (R., Calif.) was ousted, Republicans remained gripped in a fierce internal struggle over his successor. Jordan said he would keep up his campaign, but pushed off any further voting until Thursday at the earliest as mounting GOP defections on his second ballot left Republicans snarled into warring factions over what should happen next.”
  • The Federal Times informs us that the Senate is considering a bipartisan bill to improve benefits for the families of federal employees who die on the job.
  • Govexec tells us,
    • “A bipartisan trio of Senators hope to advance new legislation aimed at improving and “streamlining” federal agencies’ customer service across platforms, in part by adopting practices already employed in the private sector.
    • “Customer service at agencies that interact with members of the public has been top of mind for lawmakers and administration officials in recent years. During the height of the COVID-19 pandemic, that attention was on electronic means like phone and the Internet, while over the last 18 months, the focus turned toward in-person service as well as backlogs that cropped up over the course of the pandemic.
    • “The Improving Government Services Act (S. 2866), introduced by Sens. Gary Peters, D-Mich., James Lankford, R-Okla., and John Cornyn, R-Texas, last month but publicized Tuesday, tasks federal agencies that provide services to members of the public to develop annual customer experience action plans and submit them both to the director of the Office of Management and Budget and Congress. The Senate Homeland Security and Governmental Affairs Committee is slated to consider the bill next week.”
  • MedPage Today discusses today’s confirmation hearing for the President’s nominee to be NIH Director, Dr. Monica Bertagnolli.
    • “In laying out her vision for the agency, a key theme for Bertagnolli was equity. “NIH can and must support research that is equitable and accessible to all populations,” she said, stressing the need to diversify clinical trials.”
  • The Internal Revenue Service announced, “The applicable dollar amount that must be used to calculate the [PCORI] fee imposed by sections 4375 and 4376 for policy years and plan years that end on or after October 1, 2023, and before October 1, 2024, is $3.22. This is the per belly button fee that FEHB plans will owe for the current 2023 plan year next July 31, 2024.
  • HHS Office for Civil Rights issued “Resources for Health Care Providers and Patients to Help Educate Patients about Telehealth and the Privacy and Security of Protected Health Information.”
  • AHIP posted its helpful comments on the proposed mental health parity rule changes. The public comment deadline was yesterday.
  • Fedsmith offers its guidance on the upcoming Federal Employee Benefits Open Season.

From the public health front,

  • STAT News reports,
    • Treatments like Ozempic, Wegovy, and Mounjaro have been hailed for showing 15% to over 20% weight loss in trials, but those are just averages. In reality, there are big variations in how much weight people lose on the therapies, and it’s unclear what explains those differences.
    • “One way researchers are trying to figure this out is by focusing on genes.
    • “The variability is so wide that we want to understand what predicts response,” said Lee Kaplan, chief of obesity medicine at the Geisel School of Medicine at Dartmouth. Since genetics is a significant reason people develop obesity, and since early data also show that genetics may contribute to how people respond to bariatric surgery, “that would argue that there’s probably going to be a genetic contribution” to the amount of weight loss people experience on obesity drugs.”
  • Beckers Hospital Review discusses what the closure of various Walgreen’s and Rite Aid drug stores means for healthcare.
    • “The closures also disproportionately affect Black and Latino city neighborhoods, as well as rural areas, according to Serena Guo, MD, PhD, an assistant professor at the Gainesville-based University of Florida College of Pharmacy. 
    • “Closure has the potential to worsen disparities in access to pharmacies,” Dr. Guo told MarketWatch.”
  • The National Institutes of Health announced,
    • “Starting buprenorphine treatment for opioid use disorder through telehealth was associated with an increased likelihood of staying in treatment longer compared to starting treatment in a non-telehealth setting, according to a new study analyzing Medicaid data from 2019-2020 in Kentucky and Ohio. Published in JAMA Network Openthese findings(link is external) add to a growing body of evidence demonstrating positive outcomes associated with the use of telemedicine for treatment of opioid use disorder.
    • “In Kentucky, 48% of those who started buprenorphine treatment via telehealth remained in treatment for 90 continuous days, compared to 44% of those who started treatment in non-telehealth settings. In Ohio, 32% of those who started buprenorphine treatment via telehealth remained in treatment for 90 continuous days, compared to 28% of those who started treatment in non-telehealth settings.”
  • HealthDay points out,
    • “Researchers have identified a link between attention-deficit/hyperactivity disorder (ADHD) in adults and dementia.
    • “The risk of dementia is three times higher in adults with ADHD, according to a large study of Israelis who were followed for 17 years.
    • “More research is needed to verify the findings and understand the link.”
  • The Wall Street Journal reports,
    • Pfizer will price a course of its Covid-19 drug Paxlovid at nearly $1,400 when commercial sales begin later this year, more than double what the U.S. government has paid.
    • “Pfizer told the pharmacies and clinics that will dispense Paxlovid, in a letter dated Wednesday that was viewed by The Wall Street Journal, that a five-day course of the antiviral will list for $1,390. The U.S. government had paid $529.
    • “Health plans will probably pay much less than the list price for the pills, and most patients will have a small or no out-of-pocket cost because Pfizer is expected to offer price discounts and help patients with their out-of-pocket charges.
    • “Pfizer has already faced criticism from doctors and patient advocates that raising the price will limit patient access. Disclosure of the list price will probably fuel further criticism.”

From the U.S. healthcare business front,

  • KFF reports,
    • “Amid rising inflation, annual family premiums for employer-sponsored health insurance climbed 7% on average this year to reach $23,968, a sharp departure from virtually no growth in premiums last year, the 2023 benchmark KFF Employer Health Benefits Survey finds.
    • “On average, workers this year contribute $6,575 annually toward the cost of family premium, up nearly $500 from 2022, with employers paying the rest. Future increases may be on the horizon, as nearly a quarter (23%) of employers say they will increase workers’ contributions in the next two years.
    • “Workers at firms with fewer than 200 workers on average contribute nearly $2,500 more toward family premiums than those at larger firms ($8,334 vs. $5,889). In fact, a quarter of covered workers at small firms pay at least $12,000 annually in premiums for family coverage.
    • “This year’s 7% increase in average premiums is similar to the year-over-year rise in workers’ wages (5.2%) and inflation (5.8%). Over the past five years, premiums rose 22%, in line with wages (27%) and inflation (21%).”
  • Per WXYZ.com (Detroit MI),
    • “Henry Ford Health and Ascension Michigan have signed an agreement to enter into a joint venture, the latest merger between health systems in Michigan.
    • “According to the health systems, Ascensions Southeast Michigan and Genesys healthcare facilities will join with Henry Ford’s. * * *
    • According to the companies, the combined organization would employ around 50,000 team members at more than 550 sites of care across the area.”
  • Healthcare Dive adds,
    • “Thirty-nine percent of mergers and acquisitions announced in the third quarter included a hospital or health system that cited financial distress as a driver for deal, according to a report by Kaufman Hall. 
    • “Though M&A activity is continuing to trend back to pre-pandemic levels, the number of hospitals in distress shows the financial strain of the past two years, the report said. Eighteen transactions were announced in the third quarter, compared with just seven in the same period in 2021 and 10 during the third quarter in 2022.
    • “Increased costs, both for labor and other expenses, has been a significant challenge for smaller and medium-sized health systems. Now, more large systems — with annual revenue of $1 billion or more — are pointing to financial concerns as their reason for dealmaking, according to Kaufman.”
  • Beckers Payer Issues notes,
    • “In the third quarter, we completed a strategic review of our operations, assets, and investments to enhance operating efficiency, refine the focus of our investments in innovation and optimize our physical footprint,” the company wrote. “This resulted in a net charge of $697 million, comprised of the write-off of certain information technology assets and contract exit costs, a reduction in staff including the relocation of certain job functions, and the impairment of assets associated with the closure or partial closure of data centers and offices.”
    • “Elevance Health posted $1.3 billion in net income during the third quarter, a nearly 20% decrease compared to the same period last year, according to the company’s earnings report published Oct. 18.
  • and
    • “Consumers’ overall satisfaction with health insurers is up 4% over 2023, according to a report from the American Customer Satisfaction Index published Oct. 17. 
    • “Customer satisfaction with insurers reached a score of 76 out of 100, the highest in the index’s history, according to the report.” 
  • Per Fierce Healthcare,
    • “Amazon Pharmacy is launching drone delivery for prescription medication orders with the service initially taking flight in College Station, Texas, the company announced Wednesday.
    • “The pharmacy deliveries will be dropped, quite literally, outside a consumer’s front door within 60 minutes at no additional cost for eligible Amazon Pharmacy customers, the company said.
    • “Amazon Pharmacy is teaming up with the online retailer’s drone service, Prime Air, which kicked off commercial deliveries in the same Texas city in December.
    • “Delivery of medications via drone will be offered in College Station initially and will expand to additional cities in the coming years, an Amazon Pharmacy spokesperson said. The announcement was made this week as part of Amazon’s Delivering the Future event in Seattle focused on its latest innovations.”

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

October 10 is World Mental Health Day. The International Foundation of Employee Benefit Plans offers six steps toward addressing mental health in the workplace.

From Washington, DC,

  • The Foundation provides some basics on the final rule on imposing civil monetary penalties for violations of Medicare reporting requirements imposed on group health plans, including FEHB plans, and others. The new rule, which was released today, takes effect one year from its publication in the Federal Register.
  • Govexec tells us,
    • “The Biden administration on Monday has begun the queue of new regions to add to the federal government’s map where federal workers are entitled to higher pay for 2025, approving a recommendation to add Clallam and Jefferson counties in Washington state to the existing Seattle-Tacoma, Washington, locality pay area.
    • “The Office of Personnel Management on Monday published the President’s Pay Agent’s annual report on locality pay, the practice by which the federal government supplements its compensation to employees under the General Schedule to address pay disparities between federal workers and their private sector counterparts in a given region.
    • “In this year’s report, the pay agent, which is made up of OPM Director Kiran Ahuja, Office of Management and Budget Director Shalanda Young and Acting Labor Secretary Julie Su and acts upon the recommendations of a panel of political appointees and labor leaders, approved one change to the map of locality pay regions in the form of adding Clallam and Jefferson counties to the Seattle-Tacoma locality pay area. But federal employees in line for an additional pay raise from the decision will have to wait; OPM first must craft and publish regulations implementing the pay agent’s decision, which won’t be in place until the 2025 pay raise at the earliest.”

From the public health and medical research front,

  • MedPage Today reports,
    • “A multilevel primary care intervention that included automated electronic health record (EHR) reminders and patient outreach/navigation improved timely follow-up of overdue abnormal cancer screening test results, a cluster randomized trial showed.
    • “Among nearly 12,000 patients with an abnormal screening test result for colorectal, cervical, breast, or lung cancer, completion of follow-up testing within 120 days of study enrollment was significantly higher with EHR reminders, patient outreach, and patient navigation (31.4%) and EHR reminders and patient outreach (31.0%) compared with only EHR reminders (22.7%), and usual care (22.9%), reported Steven J. Atlas, MD, MPH, of Massachusetts General Hospital in Boston, and colleagues.”
  • The NIH Director’s Blog discusses “Taking a Deep Dive into the Alzheimer’s Brain in Search of Understanding and New Targets.”
  • The Wall Street Journal informs us,
    • Getting tested for Alzheimer’s disease could one day be as easy as checking your eyesight.

    • RetiSpec has developed an artificial intelligence algorithm that it says can analyze results from an eye scanner and detect signs of Alzheimer’s 20 years before symptoms develop. The tool is part of broader work by startups and researchers to harness AI to unlock the mysteries of a disease that afflicts more than seven million Americans. 

  • Per Medscape,
    • “Damaged mitochondrial DNA (mtDNA) initiates and spreads Parkinson’s disease (PD) pathology, potentially opening new avenues for early diagnosis, disease monitoring, and drug development.
    • “While defects in mitochondrial functions and in mitochondrial DNA have been implicated in PD in the past, the current study demonstrates “for the first time how damaged mitochondrial DNA can underlie the mechanisms of PD initiation and spread in brain,” lead investigator Shohreh Issazadeh-Navikas, PhD, with the University of Copenhagen, Denmark, told Medscape Medical News. 
    • “This has direct implication for clinical diagnosis” ― if damaged mtDNA can be detected in blood, it could serve as an early biomarker for disease, she explained.
    • “The study was published online October 2 in Molecular Psychiatry.”

From the U.S. healthcare business front,

  • Healthcare Dive shares information from the HLTH conference in Las Vegas.
    • “Microsoft announced a slew of new data and artificial intelligence offerings in the healthcare sector on Tuesday, including new generative AI models meant to help ameliorate administrative burden on clinicians.
    • “Microsoft’s cloud division Azure is releasing new capabilities meant to free up information for clinicians. Those include patient timelines, which use generative AI to extract specific elements from unstructured data — like medication information in an electronic health record — and organize them chronologically to give a full view of a patient’s history. Another functionality, called clinical report simplification, uses generative AI to simplify clinical jargon so patients can better understand medical information.
    • “The launches tie in with Microsoft’s ethos of developing high-impact but low-risk use cases for AI in healthcare, said David Rhew, Microsoft’s global chief medical officer and vice president of healthcare, in an interview at the HLTH conference in Las Vegas, where the offerings were announced.”
  • and
    • “Walgreens plans to launch telehealth visits on its website later this month, as the retail pharmacy giant continues its strategic pivot to healthcare services.
    • “Walgreens Virtual Healthcare will offer on-demand virtual consultations with providers for common medical needs and medication prescriptions.
    • “Walgreens is adding direct-to-consumer virtual care because “our goal is to be the most convenient health and wellness destination, whether you’re physically in our stores or virtually in our stores,” said Tracey Brown, Walgreens’ chief customer officer and president of retail, while debuting the new offering at the HLTH conference in Las Vegas on Monday.”
  • and
    • “Cigna’s health services division Evernorth has acquired the technology and clinical capabilities of asynchronous telehealth provider Bright.md for an undisclosed amount, the company announced on Tuesday at the HLTH conference in Las Vegas.
    • “Evernorth’s telehealth business MDLive plans to start offering asynchronous care using the new capabilities within its virtual urgent care platform in 2024, and eventually expand asynchronous care to chronic disease management and wellness visits.
    • “A spokesperson for the company said it was too early to share a specific timeline for the launch in virtual urgent care and the expansion to more clinical areas. Currently, more than 43 million people have access to MDLive virtual urgent care through their health plans and employers, Cigna says.”
  • Healthcare Finance points out,
    • “Aetna is modifying its commercial policy to no longer cover certain telemedicine services starting on Dec. 1, the company said in a statement.
    • “This is for audio-only and asynchronous text-based visits that were expanded under the public health emergency, the CVS subsidiary said. 
    • “The modifications are in line with the industry as a result of the expected PHE ending in May 2023,” Aetna said. “Telemedicine services that remain covered for Aetna Commercial plan sponsors are actually more extensive than what was provided pre-pandemic because of the access and value these services clearly bring to our members and providers.” 
    • “According to Aetna, currently covered telehealth services include routine care, sick visits, urgent care through walk-in clinics, prescription refills and behavioral health services.”
  • Reuters lets us know,
    • “The number of U.S. employers who cover obesity medications, including Wegovy from Novo Nordisk that belongs to a class of GLP-1 drugs, could nearly double next year, according to a survey. The survey of 502 employers by Accolade, a company that provides healthcare programs for employers, and research firm Savanta said 43% of the employers it polled could cover GLP-1 drugs in 2024 compared to 25% that cover them now.”
    • It will be helpful to the FEHB if other employers join the FEHB in covering these drugs.

Monday Roundup

Photo by Sven Read on Unsplash

Happy Columbus Day / Indigenous Peoples’ Day

In anticipation of my residential move to Texas, which occurred in April 2022, the FEHBlog applied to waive into the Texas bar. My application was approved on June 30, 2022. (The FEHBlog remains a member of the DC Bar.)

The FEHBlog then became acquainted with the Texas Bar’s continuing legal education requirement. Last year, I took a 15-hour televised course on eldercare. This year, I am attending the Texas Health Law Conference in downtown Austin.

The FEHBlog had lunch today (by happenstance) with a lawyer who told me that he represents a rural hospital near Odessa. The hospital has twelve beds. Beckers Hospital Review points out 2023 Texas hospital closings and bankruptcies.

There was a provider-oriented session on the No Surprises Act. The speakers quipped that the law is no balance billing law with surprises for providers. At least the speakers agree with the FEHBlog that the law is helping patients.

From the public health front,

  • Healthcare Finance tells us that telehealth may be the solution to the chronic illness problem plaguing a large part of our country, as reported by the Washington Post last week.
    • “More patients with chronic disease. Fewer providers to take care of them. An aging population. SDOH barriers. Telemedicine and remote patient monitoring are essential tools to help manage these healthcare hurdles, an expert says.”
  • The Hill adds,
    • “The Biden administration on Friday extended flexibilities regarding controlled substances to be prescribed via telemedicine. 
    • “The Drug Enforcement Administration (DEA) said in a notice it would allow providers to continue using telemedicine to prescribe certain controlled substances through the end of 2024.”  
  • NBC News reports,
    • “The coronavirus isn’t the only pathogen that can cause symptoms that last months, or even years after an initial infection is overcome, a new study published Friday in The Lancet’s eClinicalMedicine suggests. 
    • “In an analysis of data from 10,171 U.K. adults, the researchers found evidence of a “long cold” syndrome that can follow infection with a variety of common respiratory viruses, including common cold viruses and influenza.
    • “While some of the symptoms of long Covid and long colds overlapped, the study noted that people with long Covid were more likely to continue to experience lightheadedness, dizziness and problems with taste and smell; lingering long cold symptoms were more likely to include coughing, stomach pain and diarrhea. 
    • “Experts said the new research could help shine a light on the types of long-lasting symptoms that come after recovery from an illness, including chronic fatigue syndrome.”
  • Fierce Healthcare discusses how payers are tackling the food insecurity issue in our country.
  • Cardiovascular Business lets us know,
    • “The American Heart Association (AHA) has developed a brand new strategy for the prevention and management of cardiovascular disease (CVD). 
    • “This updated approach highlights the close relationship CVD has with three other significant health conditions: kidney disease, type 2 diabetes (T2D) and obesity. Patients with CVD, for example, often face a heightened risk of developing kidney disease, T2D or obesity. The opposite can also be true—patients with any of those three conditions may face a heightened risk of developing CVD. 
    • “With these close connections in mind, the AHA has defined a new health condition: cardiovascular-kidney-metabolic (CKM) syndrome. CKM syndrome involves nearly every major organ in the body, the group said in a new statement, though its biggest impact is on a patient’s cardiovascular system. 
    • “Anyone who has CVD, or even faces a risk of developing CVD in the future, may have CKM syndrome. By educating physicians and patients alike on the way these different conditions interact with one another and implementing a screening strategy for CKM syndrome, the AHA believes it can help patients get the care they need to live longer, healthier lives.”  

From the U.S. healthcare business front,

  • The Wall Street Journal informs us,
    • “The biopharmaceutical company on Sunday said that it had entered into a definitive merger agreement with Mirati under which it would pay $58.00 per share in cash. Mirati stockholders will also receive one non-tradeable contingent value right per share, potentially worth $12.00 per share in cash.
    • “Mirati’s board unanimously approved the transaction. * * *
    • “The acquisition of Mirati will add the Krazati lung cancer medicine to Bristol Myers Squibb’s commercial portfolio. It also includes access to clinical assets that Bristol Myers Squibb said would complement its oncology pipeline.”

The other business news comes from the HLTH conference ongoing in Las Vegas, NV.

  • Per Healthcare Dive,
    • “Venture capital firm General Catalyst plans to buy an unnamed health system to act as a proving ground for new technology to improve hospital operations and patient care. 
    • “The impending purchase is part of a new health business being spun out by General Catalyst, called the Health Assurance Transformation Corporation, or HATCo, General Catalyst managing director Hemant Taneja and former Intermountain CEO (and new HATCo CEO) Marc Harrison said Sunday at the HLTH conference in Las Vegas.
    • “Harrison and Taneja did not share details on what health system General Catalyst would be looking to acquire, when an acquisition could happen or how much the VC firm plans to spend.”
  • Per Fierce Healthcare,
    • Here’s an overview of the second day of the conference and moreover
    • “Headway, a startup that connects patients with mental health providers covered by insurance, picked up $125 million in fresh funding to build out its provider network to all 50 states. * * *
    • “This latest round of capital will go toward investing in technology and tools to help mental health providers grow their practice, Andrew Adams, co-founder and CEO, wrote in a blog post.
    • “We have plans to make Headway available to individuals seeking care in all 50 states and the District of Columbia very soon and will be building products to help providers deliver care across state lines in 2024. We’re also further investing in ensuring patients have a simplified experience understanding their insurance benefits and changes, with excellent visibility, support, and accuracy,” Adams wrote.”
  • and
    • “Main Street Health focuses exclusively in rural communities and partners with primary care clinics in these regions by placing a health navigator in each facility. The navigator then assists with care coordination, including reaching out to patients about preventive screenings, contacting them with medication reminders, scheduling primary care visits following a hospital discharge and providing support for social needs.
    • “The company currently operates in 18 states by partnering with more than 900 clinics. The expansion brings its total footprint to 26 states. The average clinic working with Main Street Health is based in a town with between 3,000 and 5,000 people and includes 2.5 providers, according to an announcement.
    • “Value-based care company Main Street Health is charting an expansion into eight additional states as it banks more than $315 million in new capital.”

Thursday Miscellany

Photo by Josh Mills on Unsplash

From Washington, DC

  • The Wall Street Journal reports,
    • “House Speaker Kevin McCarthy (R., Calif.) embraced border security as a possible way to break a congressional impasse over funding the government, saying it could be a key ingredient in any last-ditch push to avert a partial shutdown this weekend.  * * *
    • Speaking to reporters on Thursday morning, McCarthy said concerns among both Democrats and Republicans about the pace of migrants crossing the U.S.-Mexican border could provide enough common ground for them to work out a short-term deal to keep the government open past Sept. 30, when the fiscal year ends.
    • He said he had spoken with some Democratic senators about border enforcement as recently as Thursday morning.“They want something on the border. They’re working on it,” he said of Democrat senators. “And so I think there’s an opportunity here. We know we have to keep the government funded. We know we have a concern about the border—both sides.” Asked directly by a reporter if he expects a shutdown, McCarthy said: “No, I’m saying we work through this and get it done.”
  • Per Fierce Healthcare,
    • Following a Senate Finance Committee markup hearing in July, where members voted 26-1 in favor of the Modernizing and Ensuring PBM Accountability (MEPA) Act, Senators Ron Wyden, D-Oregon, and Mike Crapo, R-Idaho, formally introduced the bill on Thursday.
    • Designed to curb the power of pharmacy benefit managers, the bill would prohibit PBM compensation in Medicare from being tied to the price, increase audit and enforcement measures and aid independent community pharmacies that have struggled because of PBM practices, according to a news release.
  • AHIP announced that yesterday
    • Following reports of some patients having difficulties accessing new COVID-19 boosters without cost sharing, Alliance of Community Health Plans, Association for Community Affiliated Plans, AHIP, and Blue Cross Blue Shield Association came together in a letter to Xavier Becerra, Secretary of the Department of Health & Human Services, to reiterate their commitment to providing access, swiftly addressing any challenges, and continuing to partner with HHS and others across the health care system.”
    • Good to hear.
  • STAT News offers six approaches to resolving the drug shortages confronting our country.
  • STAT News also informs us
    • “A panel of independent advisers to the Food and Drug Administration voted overwhelmingly against a polarizing potential treatment for ALS on Wednesday, concluding that the medicine’s messy supporting data did not meet the standard for approval.
    • “After a day-long meeting that included impassioned testimony from ALS patients, the agency’s expert advisers voted 17-1 with one abstention that the case for NurOwn, a treatment from BrainStorm Cell Therapeutics, was based too heavily on convoluted clinical trial results and compelling but unreliable anecdotal evidence.”
  • Per Beckers Hospital Review,
    • “The label for Novo Nordisk’s weight loss drug Ozempic now acknowledges some users’ reports of ileus or intestinal blockage. 
    • “In its update, however, the FDA said it’s difficult to confirm a causal relationship between the side effect and the drug. 
    • “Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure,” the label says. 
    • “Wegovy and Mounjaro, also GLP-1 agonist medications, already acknowledge reports of ileus on their labels. Novo Nordisk is the maker of both Ozempic and Wegovy, which both use an injection of semaglutide.” 
  • The Affordable Care Act regulators released ACA FAQ 61, which updates interested parties on transparency in coverage and RxDc reporting issues.
  • The U.S. Office of Personnel Management announcedissuing an interim final rule today to extend the eligibility date for noncompetitive appointment of military spouses married to a member of the armed forces on active duty through December 31, 2028, as called for by enactment of the Fiscal Year (FY) 2023 National Defense Authorization Act (NDAA) (P.L. 117-263).” 

From the public health front,

  • STAT News tells us
    • “[A 36-year-old woman living in San Francisco was told her kidneys would heal. But they didn’t; dialysis became a regular routine. She moved to UCSF Medical Center, seeking better care and a place that would allow her parents to visit. There, she met Chi-yuan Hsu, UCSF’s chief of nephrology, who was looking to study patients who might be successfully weaned from dialysis. He believed many patients with acute kidney injury like Lawson stayed on dialysis for longer than they needed.
    • “The results of a new study by Hsu, published Thursday in the Journal of the American Society of Nephrology, validate his suspicions. The study of nearly 8,000 patients, nearly 2,000 with acute kidney injury, found 40% of patients with acute kidney injury recovered their kidney function. But of these patients, just 18% were weaned from dialysis through having fewer sessions, and 9% by having shorter sessions.
    • “More than 70% of these patients ended up eventually stopping dialysis without any weaning — “cold turkey” as Hsu puts it — suggesting they could have been having fewer, or shorter treatments earlier. This is important, he said, because dialysis not only impacts quality of life, as it did for Lawson, it can also lead to infection and heart damage, and possibly — this is still under debate — to additional kidney injury that could inhibit recovery and lead to a need for permanent dialysis.”
  • Health Leaders Media explains how to address the relationship between patient safety and health equity.
  • Employee Benefit News points out the need for mental health benefits to cover suicide prevention.

From the U.S. healthcare business front,

  • Forbes reports that CVS, Walgreens And Rite Aid are closing nearly 1,500 stores across the U.S.
    • “All three drug chains have different reasons for closing stores, but the downsizing prescription is the same. Chain drugstores cost a lot to operate, and they don’t have sufficient differentiation to attract customers feeling the economic pinch.”
  • STAT News says,
    • Ophthalmologists who accepted payments from drug companies were less likely to prescribe a cheaper medicine to treat an eye disease that causes blindness in older people, rather than a pair of more expensive alternatives, according to a new study. This led Medicare to spend an additional $643 million during a recent six-year period.
    • Specifically, physicians who received money prescribed Avastin, an older cancer medicine, 28% of the time for combating age-related macular degeneration. And they prescribed two costlier treatments, which have approved specifically to treat the eye disease, 72% of the time. Physicians who did not accept payments prescribed Avastin 46% of the time, nearly twice as often as those who accepted payments.
    • “As a result, Medicare shelled out an estimated $642.8 million from 2013 to 2019, presumably due to the company payments, according to the study, which was published in JAMA Health Forum. The researchers examined Medicare Part B data that encompassed nearly 21,600 ophthalmologists who accepted money from Roche and Regeneron Pharmaceuticals, which sell the pricier eye treatments.”
  • Per Healthcare Dive,
    • “Satisfaction with telehealth is significantly higher among younger patients, according to a study by consumer data company JD Power. 
    • “Members of Generation Y, who were born between 1977 and 1994, and Generation Z, born between 1995 and 2004, report a satisfaction score of 714 out of 1,000. But Baby Boomers, born between 1946 and and 1964, and people born earlier had a significantly lower score of 671.
    • “The satisfaction gap between older and younger generations is widest when it comes to digital channels and appointment scheduling, which could mean older users are struggling to use telehealth providers’ digital interfaces, the study argues.” 
  • Beckers Hospital Review lets us know
    • “Medicare Advantage provides health coverage to more than half of the nation’s seniors, but a growing number of hospitals and health systems nationwide are pushing back and dropping the private plans altogether.
    • “Among the most commonly cited reasons are excessive prior authorization denial rates and slow payments from insurers. Some systems have noted that most MA carriers have faced allegations of billing fraud from the federal government and are being probed by lawmakers over their high denial rates.
    • “It’s become a game of delay, deny and not pay,” Chris Van Gorder, president and CEO of San Diego-based Scripps Health, told Becker’s. “Providers are going to have to get out of full-risk capitation because it just doesn’t work — we’re the bottom of the food chain, and the food chain is not being fed.” 
    • “In late September, Scripps began notifying patients that it is terminating Medicare Advantage contracts for its integrated medical groups, a move that will affect more than 30,000 seniors in the region. The medical groups, Scripps Clinic and Scripps Coastal, employ more than 1,000 physicians, including advanced practitioners.”
  • and
    •  interviews an Aetna executive about successful value based care.
  • The Wall Street Journal reports about employer groups that are successfully advocating for lower hospital prices in their states. The flagbearer is Gloria Sachdev, who is chief executive officer of the Employers’ Forum of Indiana. Good luck.

Monday Roundup

Photo by Sven Read on Unsplash

From Washington, DC

  • Roll Call reports
    • “House Republicans unveiled a stopgap funding measure Sunday night that would avoid a partial government shutdown next month and provide border security measures sought by conservatives. But passage even in the GOP-controlled House was already in doubt as some hard-liners came out against the measure Sunday night while the ink on it was barely dry.
    • “The draft continuing resolution would extend current funding through Oct. 31, while cutting 8.1 percent from all nondefense accounts except for the Department of Veterans Affairs and disaster relief. That extension would give lawmakers an extra month to try to complete fiscal 2024 appropriations that are otherwise needed by Sept. 30. * * *
    • “The bill is set for floor consideration this week, along with the fiscal 2024 Defense spending bill that stalled last week when conservative detractors threatened to vote against the rule needed to take it up.”
  • Politico discusses where we stand with the proposed mental health parity rule changes.
    • “The Biden administration’s proposal substantially expands the law Bush signed. It would mandate that insurers analyze the outcomes of their coverage to ensure there’s equivalent access to mental health care and take action to comply if they’re falling short.
    • “Insurers respond: AHIP, the lobbying group for insurers, says the situation is more complicated than Biden makes out, and workforce shortages are behind barriers to access.
    • “For years, health insurance providers have implemented programs and strategies to expand networks and increase access,” AHIP spokesperson Kristine Grow said in a statement.
    • “The administration has set a deadline for comments on its proposed rules for early October; insurers and their allies are asking for more time to respond.
    • “The ERISA Industry Committee, which represents large employers’ benefit interests, joined AHIP, among other associations, employers and health plans, in writing to administration officials to ask that the comment period on the proposed rules be extended. They warned that the rules could create “unnecessary burdens” for providers, insurers and patients and “unintentionally” impede access to care.”
  • The Centers for Medicare and Medicaid Services (CMS) announced on its No Surprises Act website today:
    • Federal IDR Process update: Certain functions of the Federal IDR Process are temporarily paused in response to the TMA III Court Order.  On September 5, 2023, the Departments directed certified IDR entities to resume making eligibility and conflict of interest determinations and encouraged disputing parties to continue engaging in open negotiations.  The Departments expect to direct certified IDR entities to resume issuing payment determinations for some disputes very soon.”
  • The Office of Management and Budget’s Office of Information and Regulatory Affairs has completed work on a regulation that will affect the FEHB:
    • AGENCY: HHS-CMS RIN: 0938-AT86 Status: Concluded
    • TITLE: Medicare Secondary Payer and Certain Civil Money Penalties (CMS-6061) Section 3(f)(1) Significant: No
    • STAGE: Final Rule Economically Significant: No
    • RECEIVED DATE: 03/01/2022 LEGAL DEADLINE: Statutory
    • REVIEW EXTENDED
    • COMPLETED: 09/11/2023 COMPLETED ACTION: Consistent with Change
  • The FEHBlog will be watching the Federal Register for this one.
  • CMS also “finalized a rule to streamline enrollment in the Medicare Savings Programs (MSPs), making coverage more affordable for an estimated 860,000 people.”

From the public health and medical research fronts,

  • Per Healthcare Dive, “New RSV vaccines can be powerful tools, but rollout poses test; The recently approved shots will slot in alongside vaccines for influenza and COVID-19 this fall, raising communication challenges for public health officials.” The article dives into the details, but health plans can help communicate new vaccines’ benefits to their members with young kids and members who have reached senior citizen status.
  • NPR reports,
    • “The mixture of stimulants like cocaine and meth with highly potent synthetic opioids is a fast-growing driver of fatal overdoses in the U.S.
    • “Since 2010, overdoses involving both stimulants and fentanyl have increased 50-fold, and now account for 32% of U.S. overdoses in 2021 and nearly 35,000 deaths, according to a study published Thursday in the scientific journal Addiction.
    • “We’re now seeing that the use of fentanyl together with stimulants is rapidly becoming the dominant force in the U.S. overdose crisis,” says Joseph Friedman, the lead author of the study and a researcher at UCLA’s David Geffen School of Medicine. “Fentanyl has ushered in a polysubstance overdose crisis, meaning that people are mixing fentanyl with other drugs, like stimulants, but also countless other synthetic substances.”
  • Healio points out that based on a recent research study,
    • “Consumption of added sugar, total sugar, total glucose equivalent and fructose from added sugar and juice were linked to a higher risk for coronary heart disease.
    • “Fructose from vegetables and fruits was not.”
  • The American Medical Association informs us, “What doctors wish patients knew about social isolation.”
  • Health Day notes based on a Swedish study,
    • “Chronic acid reflux — also known as GERD — has long been thought to boost a person’s risk of esophageal cancer
    • “A new study refutes that, finding that only patients with evidence of injury to their esophagus from reflux have a higher cancer risk
    • “Researchers downplayed a “very moderate” increased risk for women, saying that it remains “extremely low.'”
  • MedPage Today calls our attention to a different Swedish study,
    • “Bariatric surgery for obesity was associated with a reduced risk of hematologic cancers in a prospective Swedish study spanning more than three decades.”
  • Per NIH,
    • “Artificial intelligence (AI) and machine learning (ML) can effectively detect and diagnose Polycystic Ovary Syndrome (PCOS), which is the most common hormone disorder among women, typically between ages 15 and 45, according to a new study by the National Institutes of Health. Researchers systematically reviewed published scientific studies that used AI/ML to analyze data to diagnose and classify PCOS and found that AI/ML based programs were able to successfully detect PCOS.
    • “Given the large burden of under- and mis-diagnosed PCOS in the community and its potentially serious outcomes, we wanted to identify the utility of AI/ML in the identification of patients that may be at risk for PCOS,” said Janet Hall, M.D., senior investigator and endocrinologist at the National Institute of Environmental Health Sciences (NIEHS), part of NIH, and a study co-author. “The effectiveness of AI and machine learning in detecting PCOS was even more impressive than we had thought.”

From the U.S. healthcare business and quality fronts,

  • Beckers Payer Issues reports
    • The National Committee for Quality Assurance has named the best-rated health plans of 2023 based on factors that include care quality, patient satisfaction and efforts to keep improving.
    • The ratings were released Sept. 15 and are based on 2022 data from commercial, Medicare, Medicaid and ACA plans that reported HEDIS and CAHPS results to the NCQA, which cover more than 200 million people. NCQA Accreditation status was also factored in. Plans were rated on a zero- to five-star scale, with five being the highest rating. In total, 1,095 plans received a rating. No Medicaid or Medicare plan received 5-stars this year.
    • Commercial plans that received a five-star rating:
      • Independent Health Association (New York)
      • Kaiser Foundation Health Plan of the Mid-Atlantic States (Washington D.C., Maryland, Virginia)
  • Per Healthcare Dive
    • ‘Hospitals have been required to post their prices for shoppable services online since 2021, but costs shared online rarely correlate to prices hospitals share with consumers on the phone, according to a new secret shopper survey.
    • ‘The study found wide variations when comparing hospitals’ online cash prices for childbirth and brain imaging with prices told to consumers who inquire over the phone.
    • ‘For example, researchers found five hospitals with online prices greater than $20,000 for vaginal childbirth but telephone prices less than $10,000. For a brain magnetic resonance imaging scan, two hospitals said the cost was more than $5,000 over the phone, but the price tag was $2,000 online.’
    • That’s a big bowl of wrong.
  • Reuters reports,
    • “Novo Nordisk (NOVOb.CO) has hired U.S. private contract manufacturer PCI Pharma Services to handle assembly and packaging of Wegovy, a source familiar with the matter said, as it races to boost output of the weight-loss drug to meet demand.
    • “Philadelphia-based PCI, which has 15 facilities in North America, Europe and Australia, is putting together the self-injection pens used to administer Wegovy, said the source, who declined to be named because the information is confidential.”
  • mHealth Intelligence tells us
    • The percentage of asynchronous telehealth claim lines for mental health conditions increased nationwide, with a particularly sharp rise in the Midwest, where it doubled between May and June, according to new telehealth usage data.
    • The data from FAIR Health’s Monthly Telehealth Regional Tracker represents the privately insured population, including Medicare Advantage and excluding Medicare Fee-for-Service and Medicaid. The tracker, launched in May 2020, uses data from FAIR Health to provide insights into month-to-month changes in the volume of telehealth claim lines and audio-only telehealth usage.
    • Nationally, telehealth remained stable at 5.4 percent of claim lines in May and June. In three US regions, telehealth use did not change during this period, but usage fell by 2.4 percent in the Midwest.

In general business news, HR Dive offers “A running list of states and localities that require employers to disclose pay or pay ranges.”

Thursday Miscellany

Photo by Josh Mills on Unsplash

From Washington, DC

  • Federal News Network offers its periodic update on the bills pending before Congress of interest to federal employees.
  • American Hospital Association News tells us that today
    • “The Department of Health and Human Services’ Office for Civil Rights released a proposed rule intended to update and clarify requirements under Section 504 of the Rehabilitation Act that prohibit discrimination on the basis of disability in programs receiving financial assistance from the department, including health care. According to HHS, the proposed rule would ensure that medical treatment decisions are not based on biases or stereotypes about individuals with disabilities; prohibit the use of value assessment methods that place a lower value on life-extension for individuals with disabilities when used to limit access or to deny aids, benefits and services; establish enforceable standards for accessible medical diagnostic equipment; and clarify obligations for accessible web and mobile applications and obligations to provide services in the most integrated setting appropriate to an individual’s needs. The rule will be published in the Sept. 14 Federal Register, with comments accepted for 60 days.”
  • The Federal Times points out
    • “The Office of Personnel Management received a small surge of retirement claims in July and August after applications had been falling steadily for months since January.
    • “The time it took the government to process retirements increased sharply in July to 85 days before falling back down to 74 days in August, according to data kept by OPM.
    • “Overall, the agency is sitting on an inventory of nearly 18,000 cases after it reduced its working caseload to new lows this year. About this time last year, there were 29,000 pending cases.
    • “Still, despite efforts to dispatch focus teams to address backlogs, the agency is failing to hit its target time or inventory goals, leaving retirees to wonder whether their case will be one that ends up sitting in limbo for longer. Ideally, retirement applications are processed in 60 days or fewer.”
  • CMS released its 2022 report on covered entity compliance with the HIPAA electronic transactions.
    • The transaction types experiencing the most violations during the 2020 and 2021 compliance reviews were specific to 835 [the claim transaction], 271 [Health Care Eligibility Response], and 277 [Claim Status Response] transactions. This changed slightly in 2022 as the most common transaction types experiencing violations are now 835, 271, and 834 [EOB] transactions.
    • CMS is sharing updated 2022 violation findings insights to inform and educate the industry, encourage widespread compliance, and assist covered entities with preparing for compliance reviews.
  • The Society for Human Resource Management relates,
    • The U.S. Equal Employment Opportunity Commission (EEOC) has released an updated deadline for employers to submit their demographic data. The EEO-1 Component 1 data collection for 2022 will start on Oct. 31, and the deadline for employers to file their EEO-1 reports is Dec. 5.
    • All private employers that have at least 100 employees are required to file the EEO-1 form annually, detailing the racial, ethnic and gender composition of their workforce by specific job categories.
    • Likewise, federal government contractors and first-tier subcontractors with 50 or more employees and at least $50,000 in contracts must file EEO-1 reports. State and local governments and public school systems are exempt.
  • KFF reports
    • “Over the past two years, the federal government has provided about $1 billion from the American Rescue Plan and Bipartisan Safer Communities Acts to launch the number, designed as an alternative to 911 for those experiencing a mental health crisis. After that infusion runs out, it’s up to states to foot the bill for their call centers.
    • “We don’t know what Congress will allocate in the future,” said Danielle Bennett, a spokesperson for the federal Substance Abuse and Mental Health Services Administration, which oversees 988. “But the hope is that there will be continued strong bipartisan support for funding 988 at the level it needs to be funded at and that states will also create funding mechanisms that make sense for their states.”
    • “Only eight states have enacted legislation to sustain 988 through phone fees, according to the National Alliance on Mental Illness, which is tracking state funding for the system. Others have budgeted short-term funding. But many predominantly rural states, where mental health services are in short supply and suicide rates are often higher than in more urban states, have not made long-term plans to provide support.”
  • MedPage reports,
    • When pseudoephedrine moved “behind-the-counter” nearly 20 years ago, it left oral phenylephrine (with brands including Sudafed PE and Suphedrine PE) as the only nasal decongestant available without pharmacy assistance. But there’s one big problem: phenylephrine doesn’t work, the FDA has finally determined.
    • FDA reviewers released the results of their long-running review of the evidence this week as background for a meeting of the Nonprescription Drugs Advisory Committee to be held on September 11 and 12.
    • The article explains the conundrum this finding creates for the FDA.

From the public health front,

  • MedPage reports that “the global incidence of early-onset cancer has increased by 79% over the past three decades, researchers reported.
    • “In a comment posted on Science Media Centre, Dorothy C. Bennett, MA, PhD, of St. George’s, University of London, cautioned that the increase in new cases of early-onset cancer is based on absolute numbers, rather than age-standardized rates.
    • “The world human population increased by 46% between 1990 and 2019, which explains part of the increase in total case numbers,” she said, adding that the increase in numbers of cancer deaths in this age group (28%) was notably lower than the number of new diagnoses, “which is below the increases in total population and case numbers, indicating a fall in the average cancer death rate in this group.”
  • Per the American Heart Association,
    • Obesity-related cardiovascular disease deaths tripled between 1999 and 2020 in the U.S.
    • Such deaths were higher among Black individuals (highest among Black women) compared with any other racial group, followed by American Indian/Alaska Native people.
    • Black adults who lived in urban communities experienced more obesity-related cardiovascular disease deaths than those living in rural areas, whereas the reverse was true for all other racial groups.
  • McKinsey Health offers a podcast about getting to the bottom of the teen health crisis.

From the U.S. healthcare business front,

  • Fierce Healthcare notes, “Employers’ health benefits costs are set to rise 5.4% next year, but this spike isn’t as high as may have been feared given inflationary pressures in the broader economy, according to a new analysis from Mercer.”
  • STAT News interviews “Amazon’s chief medical officers on where the company’s health care bets are headed next.”
  • Healthcare Dive informs us,
    • “Telehealth sessions comprised 5.4% of claim lines in June, the same amount as the prior month, according to Fair Health’s Monthly Telehealth Regional Tracker.
    • “Mental health conditions continued to top the list of Fair Health’s five most common telehealth diagnoses for June. The median allowed amount billed for a one-hour psychotherapy visit was $103.
    • “But Fair Health’s tracker showed regional variations. Although telehealth use decreased overall by 2.4% in the Midwest, asynchronous telehealth claim lines for mental health conditions more than doubled in the region from 15.9% in May to 36% in June. In asynchronous telehealth, providers collect data or medical images for review, instead of meeting with a patient in real time.” 
  • Per Health Affairs,
    • “Intensive care units (ICUs) are increasingly used for hospital care, yet out-of-pocket spending for ICU hospitalizations remains poorly understood, particularly among the nearly half of the US population with commercial health insurance. Using 2008–19 MarketScan data, we compared 1,441,810 hospitalizations involving ICU services with 13,011,208 hospitalizations that did not involve ICU services.
    • “Average cost sharing, adjusted for patient and admission factors, increased from $1,137 per hospitalization in 2008 to $1,539 in 2019, or a 34 percent increase. This was driven by increasing deductibles, which rose by 163 percent.
    • “Across twenty clinical conditions whose hospitalizations commonly occurred in both ICU and non-ICU settings, ICU admission was associated with $155 higher cost-sharing (13.0 percent higher) relative to cost sharing in non-ICU hospitalizations.
    • “Patients with high-deductible plans faced the highest cost-sharing relative to those with other plan types.
    • “Patients who received out-of-network hospital care encountered higher cost-sharing relative to those admitted to in-network hospitals with in-network clinicians.”

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

From Washington DC,

  • Govexec.com offers an interview with OPM’s Deputy Director Rob Shriver.
  • The American Hospital Association informs us
    • “The Centers for Medicare & Medicaid Services will select up to eight states to participate in a new voluntary all-payer model that aims to curb health care cost growth, improve population health, and advance health equity by reducing disparities in health outcomes. CMS plans to detail requirements for the States Advancing All-Payer Health Equity Approaches and Development Model in a funding opportunity notice this fall. Participating states will receive up to $12 million each to implement the model during one of three start dates, with the model concluding in December 2034. CMS expects to begin the pre-implementation period for the first cohort next summer. The model will build on best practices from the Maryland Total Cost of Care model, the Pennsylvania Rural Health Model, and the Vermont All-Payer ACO Model.

From Harrisburg, PA,

  • The Pennsylvania Department of State announced,
    • “Starting Sept. 5, 2023, registered nurses and licensed practical nurses from other states who hold multistate licenses through the Nurse Licensure Compact m(NLC) will be able to provide in-person and telehealth services to PA patients. * * * Pennsylvania nurses will be able to apply for a multistate license once the compact has been fully implemented.”
  • Here is a link to nurse.org’s “Compact Nursing States List 2023,” which now includes forty states, Guam, and the Virgin Islands.
  • This type of licensing flexibility should help with nursing shortages.

From the Affordable Care Act front, Beyond the Basics provides an updated guide to minimum essential coverage.

From the generative AI front, STAT News now provides a tracking service that serves as a guide to health systems and companies driving the adoption of this important new technology.

Speaking of technology,

  • BioPharma Dive reports
    • Beam Therapeutics has begun human testing in the U.S. of a first-of-its-kind gene editing medicine for cancer, the company said Tuesday.
    • “Beam, a pioneering developer of a precise gene editing technique known as base editing, said in a short statement that it’s dosed its first patient in a study of the treatment, called BEAM-201. The trial involves patients with an aggressive form of blood cancer known as T-cell acute lymphoblastic leukemia/T-cell lymphoblastic lymphoma, or T-ALL/T-LL. It will eventually enroll about 100 participants, according to a federal database.
    • “The study’s start makes BEAM-201 the first base editing therapy to enter clinical testing in the U.S., and marks the first time patients have received a cell therapy made by “multiplex editing,” in which several genes are edited. The edits are designed to eliminate expression of four genes known as CD7, TRAC, PDCD1 and CD52.
    • “Beam claims this approach could lead to a more powerful and durable treatment. In its statement, the company noted BEAM-201’s potential to sidestep a variety of issues associated with cell therapies, like propensity for the modified cells to kill one another, or become weaker as time goes on.
    • “Beam also believes the simultaneous edits could yield a more potent donor-derived, or “off the shelf,” cell therapy. Such allogeneic treatments would be more convenient than the personalized CAR-T therapies on the market, but results to date haven’t proven they’re more powerful at killing cancer cells.”
  • Very Buck Rogers.

From the telehealth front,

  • Per Healthcare Dive,
    • “Approximately one-third of behavioral health patients seeking therapy or medication visits said their clinicians did not offer both telehealth and in-person care, according to a study from nonprofit research organization Rand.
    • “The study, published on Tuesday in Health Affairs, revealed that 45% of behavioral health patients did not believe their clinicians considered their preferences for virtual or in-person care. In addition, 32% of respondents said they did not receive their preferred method of treatment.
    • “Despite the lack of choice offered by providers, many patients undergoing behavioral health therapy preferred in-person visits due to the personal nature of the treatment, the ability to build a rapport with providers, and fears around data security and privacy, the report found.”
  • Such reports explain why hub and spoke telemental services are not a solution for mental health parity.

From the human resources front,

  • The Society for Human Resource Management advises,
    • Even though [last week’s] proposed overtime rule is likely to be challenged in court after it is finalized, employers should start examining how it will affect their workplaces, legal experts say.
    • “I don’t think businesses should act now and make concrete changes,” said Jeff Ruzal, an attorney with Epstein Becker Green in New York City. “A preliminary injunction is likely” after the rule is finalized, he said, but employers “should study and audit the workplace” and prepare for the rule to possibly take effect. They should analyze who is exempt and nonexempt and plan for complying “without jeopardizing the business or payroll.” 

Monday Roundup

Photo by Sven Read on Unsplash

From the public health front —

  • The Wall Street Journal explains why the new Covid variant BA 2.86 nicknamed Pirola is worth watching.
    • “BA.2.86—dubbed “pirola” by a group of scientists on social media who name notable variants—has been detected in only about a dozen people but it has surfaced in all corners of the world. What’s troubling about this variant, scientists say, is that it contains more than 30 mutations on the spike protein, which is what helps the virus enter cells and cause an infection. This means it might be able to evade current vaccines and previous infections more easily, and it likely won’t be a great match with the fall booster expected to be approved soon.
    • “[Reassuringly,] Scientists say treatments such as the antiviral Paxlovid should still remain effective even with such a highly mutated virus because they target a different part of the virus, not the spike. Rapid antigen tests, often used to test for Covid-19 at home, also should be able to detect the new variant, the CDC said last week.”
  • The Wall Street Journal reports,
    • “Dr. Shoshana Ungerleider knew what her father’s pancreatic cancer diagnosis meant for his future. She didn’t realize what it meant for her own cancer risk. 
    • “Steven Ungerleider’s doctors ordered genetic testing in 2022 to see if his cancer might respond to a new treatment. They found he had a mutation in the BRCA2 gene, which raises risks for cancers including pancreatic, breast and ovarian—and can be passed from parents to children
    • “Ungerleider and her sister got tested and discovered they had the same mutation
    • “I had no idea that this was possible for me,” said Ungerleider, 43, an internal medicine doctor and founder of End Well, a nonprofit focused on end-of-life care. 
    • “Doctors are recommending genetic tests to more cancer patients and their families. Testing costs have droppedand the results are helping doctors choose newer targeted drugs and encourage relatives to confront their own cancer risk. 
    • “We can test you for dozens of genes at the same time, and it’s going to influence your treatment,” said Dr. Jewel Samadder, co-leader of the Office of Precision Medicine at the Mayo Clinic Comprehensive Cancer Center in Phoenix.
    • “But few patients or their relatives get testedGenetic counselors are scarce, and some doctors aren’t up-to-date on genetics training or guidance. After a cancer diagnosis, inherited risk isn’t a priority for many patients. 
    • “It’s an implementation fail,” said Dr. Deborah Schrag, chair of the department of medicine at Memorial Sloan Kettering Cancer Center in New York.”
  • This week, “Oncologist and epidemiologist Vinay Prasad of the University of California, San Francisco, talks to EconTalk’s Russ Roberts about why many tests to detect cancer do little or nothing to extend lifespan.”  The bottom line in 2023 is a point that Russ Roberts makes
    • “I think one of the reasons people screen, even when it’s, quote, “not rational,” or the expected value is zero, is they want to be proactive. They don’t want to have to regret later. They’re afraid that if they don’t screen and then they get terminal cancer, they’ll feel like they were foolish and they made a mistake.”
  • HealthDay informs us,
    • “New research shows that four gut conditions (gastroparesis, dysphagia, constipation and irritable bowel syndrome without diarrhea) are associated with a higher risk of Parkinson’s disease up to five years before diagnosis.
    • “Study findings also suggested that appendix removal may be protective against Parkinson’s.
    • “Researchers noted that the gut conditions implicated are also more prevalent before the onset of Alzheimer’s or cerebrovascular disease.”
  • The American Medical Association tells us what doctors want their patients to know about rheumatoid arthritis.

From the telehealth front,

  • Per Healthcare Dive,
    • In-person and telehealth mental healthcare utilization increased during the COVID-19 pandemic, according to a study of insurance claims published on Friday in JAMA Health Forum.
    • Spending on mental health services increased by 54%, and utilization soared by nearly 40% among commercially insured adults between January 2019 and August 2022.
    • Whether the “disproportionate increase in spending” will remain is an open question, the authors note. Now that the public health emergency has ended, economists are eyeing insurers’ next move to determine whether they will continue or stop coverage for telehealth mental health visits. 
  • As hub-and-spoke-telehealth visits are per se in-network, and only one fifth of mental health providers are in-network, it would be nuts for an insurer to curb telemental visits.
  • mHealth Intelligence reports,
    • “While the majority of telehealth visits do not result in in-person follow-ups within a week, the fraction [11%] of virtual visits that do are for behavioral health and chronic condition issues, new research shows.
    • “Conducted by market research firm Trilliant Health, the analysis aimed to examine the extent to which virtual care is disrupting the patient care journey. The researchers assessed data from the firm’s national all-payer claims database. They determined the percentage of patients who utilized telehealth and had a follow-up visit in person for the same clinical reason within one week.”

From the U.S. healthcare business front,

  • According to Beckers Hospital Review,
    • Rite Aid is preparing to file for Chapter 11 bankruptcy this fall as it faces numerous lawsuits over its alleged role in the opioid epidemic, people familiar with the matter told The Wall Street Journal
    • A Chapter 11 bankruptcy filing could alleviate the pharmacy chain’s $3.3 billion debt and legal costs for ongoing opioid lawsuits from private plaintiffs, states and the federal government, according to the Aug. 25 report. Chapter 11 bankruptcies are commonly used to reorganize a company’s structure to continue its business while paying creditors, such as plaintiffs, over time. 
  • The FEHBlog recalls that other large pharmacy chains, including CVS Health, Walgreens and Walmart, settled these class action claims late last year.
  • Becker’s also notes,
    • “Alaska tops the charts when it comes to healthcare costs, with an average yearly expenditure of $13,188 per resident. [Utah comes in at number 50 with an AYE of $7,241 per resident.]
    • “That number comes from Forbes Advisor, which updated its “cost of living by state” analysis on Aug. 23. To determine each state’s average annual healthcare cost, the publication referred to KFF.org’s available healthcare expenditure data, which it averaged from 2018 to 2020. Annual costs refer to the combined price of one’s insurance premium, deductible, copayments, coinsurance and out-of-pocket expenses.” 
  • STAT News points
    • “Over the past year, weight loss drugs have captured the public’s imagination but also raised existential questions about the future of bariatric surgery.
    • “For obesity, surgery has long been — and continues to be — the most effective treatment, reducing patients’ risk of sleep apnea, diabetes, cancer, cardiovascular disease, and death. However, the gap between weight loss drugs and bariatric surgery is starting to narrow after Wegovy cut the risk of major heart complications by 20% in Novo Nordisk’s SELECT trial.
    • “Personally, I would have taken a 5% reduction,” said Angela Fitch, president of the Obesity Medicine Association, emphasizing that these results symbolize a paradigm shift in obesity medicine. With even more effective weight loss drugs already emerging and other clinical trial evidence on the horizon, the hope is that, with medication, “we would see similar sorts of outcomes that we see with surgery,” said Fitch.”
  • Per Fierce Healthcare,
    • “Nationwide hospital finances hit a rough patch in July as reduced patient volumes, a bump in bad debt and charity care whittled operating margins.
    • “That’s the latest from healthcare consulting firm Kaufman Hall, which reported a -1.6% median single-month operating margin index for the industry in July. The decline drove a slight dip in hospitals’ median year-to-date operating margin index to 1.3%.
    • “Still, the firm was quick to note that the hospital industry’s tough month is still a “slight improvement” over the operating margins of 2022.
    • “It’s clear that today’s challenging financial environment is here to stay, and hospital leaders must be proactive in seeking out opportunities to refine their operations and remain competitive,” Erik Swanson, senior vice president of data and analytics with Kaufman Hall and an author of the report, said in a release.
    • “Hospitals’ daily net operating revenues declined 9% from June to July but remain up 7% compared to July 2022. Month-over-month declines to daily inpatient revenue (-3%) paled in comparison to those of daily outpatient revenue (-8%) and were mirrored by reductions in daily adjusted discharges (-7%) and daily operating room minutes (-3%).”
  • BioPharma Dive relates,
    • Danaher plans to buy Cambridge, England-based Abcam for about $5.7 billion in cash, the companies announced on Monday.
    • The acquisition would bring together two firms that make equipment and supplies for life sciences companies. Abcam, with a market capitalization of $5.2 billion, would operate as a standalone company under Washington, D.C.-based Danaher, which has a market cap of $191.7 billion. 
    • Danaher reportedly outbid other companies including Agilent Technologies, Reuters wrote on Friday, citing people familiar with the matter.

In Postal Service news,

  • Govexec reports,
    • “The U.S. Postal Service has begun insourcing some of its trucking operations, opening the possibility of bringing back in-house thousands of jobs that are currently contracted out. 
    • “The pilot program started in Oklahoma City with 125 insourced jobs late last year and has since expanded to the larger Richmond, Virginia, area, including Charlottesville, according to officials involved in the initiative and public job postings. The Postal Service is actively looking for areas to expand the program, though it is so far relaying few details about its long-term plans to stakeholders or the public. 
    • “The Oklahoma City pilot was set to last at least six months, but is still in effect nine months later. USPS signed a memorandum of understanding with the American Postal Workers Union to create a new job series—postal vehicle operator—as part of the initiative. The Richmond expansion coincided with the Postal Service revamping its mail transportation in that metro area, as the city will host one of the agency’s first new, all-inclusive Regional Processing and Distribution Centers. 
    • “It also coincides with Postmaster General Louis DeJoy’s plan to significantly reduce the agency’s reliance on air transportation. USPS has saved $1 billion by slashing its chartered mail flights by 90% over the last two years. and it now ships 95% of its mail and packages on the ground.”

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Healio informs us,
    • “An FDA panel voted that for adults with uncontrolled hypertension, the benefits of an ultrasound renal denervation device outweigh its risks.
    • Concerns about long-term durability of effect were expressed.”
  • The Department of Health and Human Services announced
    • “award[ing] more than $1.4 billion for Project NextGen to support the development of a new generation of tools and technologies to protect against COVID-19 for years to come.
    • “The awards announced today follow extensive coordination with industry partners and include support for clinical trials that will enable the rapid development of even more effective and longer-lasting coronavirus vaccines, a new monoclonal antibody, and transformative technologies to streamline manufacturing processes.”
  • The U.S. Preventive Services Task Force reaffirmed its 2019 Grade A recommendation that “clinicians prescribe preexposure prophylaxis using effective antiretroviral therapy to persons who are at increased risk of HIV acquisition to decrease the risk of acquiring HIV.”
  • The Centers for Disease Control lets us know, based on a survey,
    • About 20% of women reported mistreatment while receiving maternity care.
    • About 30% of Black, Hispanic, and multiracial women reported mistreatment. 
    • Almost half (45%) of women held back from asking questions or sharing concerns during their maternity. * * *
    • Mistreatment was reported most often by Black, Hispanic, and multiracial moms and those with public insurance or no insurance.
  • That’s a big bowl of wrong. The CDC observes,
    • Respectful maternity care is free from harm and mistreatment, maintains privacy, confidentiality, and dignity, and allows for shared decision-making and continuous support.
  • The Department of Justice announced yesterday,
    • [“D]eferred prosecution agreements resolving criminal antitrust charges against Teva Pharmaceuticals USA, Inc. and Glenmark Pharmaceuticals Inc., USA. As part of those agreements, both companies will divest a key business line involved in the misconduct, and as an additional remedial measure, Teva will make a $50 million drug donation to humanitarian organizations. Teva will pay a $225 million criminal penalty — the largest to date for a domestic antitrust cartel — and Glenmark will pay a $30 million criminal penalty. Both companies will face prosecution if they violate the terms of the agreements, and if convicted, would likely face mandatory debarment from federal health care programs.
    • “The agreements each require the companies to undertake remedial measures, including the timely divestiture of their respective drug lines for pravastatin, a widely used cholesterol medicine that was a core part of the companies’ price-fixing conspiracy. This extraordinary remedy forces the companies to divest a business line that was central to the misconduct. Teva must also donate $50 million worth of clotrimazole and tobramycin, two additional drugs with prices affected by Teva’s criminal schemes, to humanitarian organizations that provide medication to Americans in need. Both Teva and Glenmark have agreed, among other things, to cooperate with the department in the ongoing criminal investigations and resulting prosecutions, report to the department on their compliance programs, and modify those compliance programs where necessary and appropriate.” 
  • Federal New Network reports that OPM released guidance for hybrid teleworkers who are covered under the Fair Labor Standards Act.
  • The Equal Employment Opportunity Commission released its new strategic plan for fiscal years 2022 through 2026
    • “The new Strategic Plan reflects our thoughtful assessment of the agency’s mission, goals, and objectives in light of current conditions and what we expect in the next few years,” said EEOC Chair Charlotte A Burrows. “It emphasizes expanding the EEOC’s capacity to eliminate systemic barriers to equal opportunity in the workplace, using technology and other tools to improve our services to the public, and achieving organizational excellence with a culture of accountability, inclusivity, and accessibility. I am grateful for the hard work of our staff across the agency who assisted in developing this plan and look forward to its successful implementation.”.

From the public health front,

  • The Washington Post explains
    • how to address the factors that may underlie the growing number of women under age 40 who are afflicted with breast cancer,
  • and
    • how to guard against germs in leafy green salads.

From the U.S. healthcare business front,

  • The FEHBlog was surprised to read in the Wall Street Journal that
    • “America’s nursing homes are fading away.
    • “The U.S. has at least 600 fewer nursing homes than it did six years ago, according to a Wall Street Journal analysis of federal data. More senior care is happening at home, and the Covid-19 pandemic caused many families to shun nursing homes while draining workers from an already short-staffed industry.
    • “The result? Frail elderly patients are stuck in hospitals, a dangerous place for seniors, waiting for somewhere to go—sometimes for months. Beds are disappearing while the need for senior care is growing. The American population 65 and older is expected to swell from 56 million in 2020 to 81 million by 2040.
  • MedPage Today notes.
    • “States that recently adopted less-restrictive policies surrounding the use of telepharmacy had fewer pharmacy deserts in the following year, a cohort study involving a dozen states showed.
    • “Compared with nearby states that made no changes, states that formally implemented or updated pro-telepharmacy policies had a 4.5% relative decrease (95% CI 1.6-7.4) in the percentage of regions defined as pharmacy deserts (P=0.001) and an 11.1% relative decrease (95% CI 2.4-22.6) in the proportion of people living in one of these deserts (P=0.03).
    • “And in general, telepharmacies tended to serve areas of high medical need, reported Jessica Adams, PharmD, of TelePharm in Iowa City, Iowa, and colleagues.
    • “As pharmacy closures and socioeconomic factors persist, pharmacy deserts are likely to expand unless policies are implemented to ensure continued access to pharmacy services,” the researchers wrote in JAMA Network Open
  • The Business Group on Health points out,
    • “Mental health needs among workforces continued to climb this year, with 77% of large employers reporting an increase and another 16% anticipating one in the future, according to Business Group on Health’s 2024 Large Employer Health Care Strategy Survey.
    • “This represents a 33 percentage-point surge over last year, when 44% of employers saw an increase in employee mental health concerns.
    • “The Business Group survey, released today in Washington, DC, also showed that cancer was still the top driver of large companies’ health care costs while rising prescription drug costs also proved to be a leading concern. Cancer overtook musculoskeletal conditions last year as the top driver of large companies’ healthcare costs and shows no sign of abating in the coming years.
    • “Yet as businesses respond to the increase in mental health needs, grapple with soaring health care costs and address issues of health equity and affordability, they will continue to invest strategically in diverse health and well-being offerings for the upcoming year, the survey also showed.”
  • Axios reports that “Middle-class Americans [who earn $50,000 to $100,000 annually] are the most likely to be saddled with medical debt, with nearly 1 in 4 — or roughly 17 million people — having unpaid medical bills, according to a report shared first with Axios from center-left think tank Third Way.”
  • Per Healthcare Dive,
    • “Epic and Microsoft announced on Tuesday an expanded collaboration focused on integrating generative artificial intelligence tools in the vendor’s electronic health records system. 
    • “The partners are working to “rapidly deploy dozens” of AI technologies, including clinical note summarization, medical coding suggestions and data exploration tools that aim to fill gaps in clinical evidence by using real-world data. 
    • “The expanded partnership is intended to speed the development of AI tools in healthcare, bringing the technology as “quickly as possible, responsibly and in partnership with providers,” according to a blog post by Eric Boyd, corporate vice president of AI platform at Microsoft.”

Monday Roundup

Photo by Sven Read on Unsplash

From Washington DC,

  • The Department of Health and Human Services “announced two awards totaling $2 million under “the Leading Edge Acceleration Projects in Health Information Technology (LEAP in Health IT) funding opportunity. LEAP in Health IT awardees seek to create methods and tools to improve care delivery, advance research capabilities, and address emerging challenges related to interoperable health IT.”

From the public health front,

  • Medscape takes a look at the current state of Covid.
    • Cautious optimism and a call to remain vigilant seem like the consensus at the moment. While the numbers remain low so far, and the uptick in new cases and hospitalizations are relatively small compared to past scenarios, “It makes sense to boost our anti-Omicron antibody levels with immunizations before fall and winter,” Anne Liu, MD, an allergy, immunology, and infectious disease specialist at Stanford University, said.
    • “It’s just advisable for everyone — especially those who are at higher risk for hospitalization or death — to be aware,” Bernard Camins, MD, an infectious disease specialist at Mount Sinai Hospital in New York City, said, “so they can form their own decisions to participate in activities that may put them at risk for contracting COVID-19.”
  • MedPage Today says,
    • “Reassuringly, a history of oral contraceptive use had no deleterious effects on cardiovascular disease (CVD) and survival over long-term follow-up, a U.K. Biobank study showed. * * *
    • “These findings provide significant public health insights and may facilitate a shift in public perception because OC [oral contraceptive] use is common in women of reproductive age, and previously negative publicity exists about the safety of OC use,” Huijie Zhang, MD, Ph.D, of Nanfang Hospital, Southern Medical University, in Guangdong, China, and colleagues wrote in the Journal of the American Heart Association.”
  • Fierce Healthcare says,
    • “CareFirst BlueCross BlueShield is joining forces with Ryse Health, a company that specializes in providing in-person and virtual care for patients with uncontrolled Type 2 diabetes, in hopes of driving better long-term outcomes.”
    • “CareFirst officials said they believe the effort will help improve care by better pinpointing what they need most.”
    • “This partnership with Ryse is unique from our perspective because it’s one of the first ways in which we’ve been able to create a longitudinal value-based program that is complementing the broader value-based program efforts that the organization has,” Nathan Coffey, CareFirst’s manager of payment transformation, told Fierce Healthcare.
    • “But there’s been a gap, not just with us, but across the industry where you have a lot of discrete care programs for specialists, but having that longitudinal tie that amplifies the impact of those larger population health programs—that’s harder to create,” Coffey said.”

From the telehealth front —

  • mHealth Intelligence reports
    • “Despite the boom in telehealth use during the COVID-19 pandemic, Americans and healthcare workers largely agree that in-person care is higher quality, more efficient, and more affordable than virtual care, a new survey shows.
    • “Conducted by Morning Consult, the survey polled 1,006 healthcare workers from May 5 to May 18 and 2,202 United States adults from July 21 to July 23.
    • “But patient perceptions regarding telehealth may be changing. The survey shows that only 6 percent of US adults prefer virtual care versus 53 percent who prefer in-person care.
    • “This preference for in-person care was evident across all age groups. Generation Z displayed the highest preference for virtual care, with 9 percent of survey respondents in this group saying they preferred virtual care. However, 49 percent of Gen Z patients preferred in-person care. Similarly, while only 8 percent of Millennials said they preferred virtual care, 43 percent preferred in-person care. * * *
    • “On the other hand, hybrid care proved relatively popular across age groups. About 30 percent of Gen Z patients, 40 percent of Millennials, 37 percent of Gen X patients, and 31 percent of Baby Boomers said they preferred a hybrid healthcare model that includes both in-person and virtual care.”

From the U.S healthcare business front,

  • Healthcare Dive informs us,
    • Religiously affiliated hospital giant AdventHealth is suing cost management firm MultiPlan, alleging the company works with health insurers to systematically underpay for out-of-network medical claims.
    • AdventHealth alleges providers have lost at least $19 billion per year as a direct result of MultiPlan’s anticompetitive agreements with major payers, including UnitedHealth, Aetna, Elevance, Centene, Cigna, Humana and a number of Blue Cross Blue Shield insurers.
    • MultiPlan called the lawsuit, which was filed last week in the U.S. District Court for the Southern District of New York, meritless in a statement.
  • From what the FEHBlog knows about Multiplan arrangements, he agrees with Multiplan’s take.

Following up on yesterday’s lede article, the FEHBlog tracked down the American Society of Anesthesiologist’s warning about the relationship between the use of GLP-1 drugs and aspiration while under anesthesia.

“ASA’s Task Force on Preoperative Fasting suggests the following for patients taking GLP-1 agonists for type 2 diabetes or weight loss who are having elective procedures. It is also calling for further research to be done regarding GLP-1 agonist medications and anesthesia.

Day or week prior to the procedure:

  • Hold GLP-1 agonists on the day of the procedure/surgery for patients who take the medication daily.
  • Hold GLP-1 agonists a week prior to the procedure/surgery for patients who take the medication weekly.
  • Consider consulting with an endocrinologist for guidance in patients who are taking GLP-1 agonists for diabetes management to help control their condition and prevent hyperglycemia (high blood sugar).

Day of the procedure:

  • Consider delaying the procedure if the patient is experiencing GI symptoms such as severe nausea/vomiting/retching, abdominal bloating or abdominal pain and discuss the concerns of potential risk of regurgitation and aspiration with the proceduralist or surgeon and the patient.
  • Continue with the procedure if the patient has no GI symptoms and the GLP-1 agonist medications have been held as advised. 
  • If the patient has no GI symptoms, but the GLP-1 agonist medications were not held, use precautions based on the assumption the patient has a “full stomach” or consider using ultrasound to evaluate the stomach contents. If the stomach is empty, proceed as usual. If the stomach is full or if the gastric ultrasound is inconclusive or not possible, consider delaying the procedure or proceed using full stomach precautions. Discuss the potential risk of regurgitation and aspiration of gastric contents with the proceduralist or surgeon and the patient.

“Full stomach precautions also should be used in patients who need urgent or emergency surgery.”

https://www.asahq.org/about-asa/newsroom/news-releases/2023/06/patients-taking-popular-medications-for-diabetes-and-weight-loss-should-stop-before-elective-surgery