Thursday Miscellany

Thursday Miscellany

Photo by Josh Mills on Unsplash

From Washington, DC, —

  • The New York Times reports
    • “Top White House officials and Republican lawmakers were closing in on Thursday on a deal that would raise the debt limit for two years while capping federal spending on everything but the military and veterans for the same period. Officials were racing to cement an agreement in time to avert a federal default that is projected in just one week.
    • “The deal taking shape would allow Republicans to say that they were reducing some federal spending — even as spending on the military and veterans’ programs would continue to grow — and allow Democrats to say they had spared most domestic programs from significant cuts.
    • “Negotiators from both sides were talking into the evening and beginning to draft legislative text, though some details remained in flux.”
  • The Wall Street Journal adds
    • “The Treasury Department is preparing to change how the U.S. processes federal agencies’ payments if the debt ceiling is breached, dusting off a contingency plan crafted after the 2011 borrowing-limit standoff, people familiar with the matter said.
    • “Just days away from becoming unable to pay all of the government’s bills on time unless Congress raises the debt limit, Treasury officials have been quietly laying the groundwork for potentially delaying some payments after June 1.
    • “Under the backup plan created for a debt-limit breach, federal agencies would submit payments to the Treasury Department no sooner than the day before they are due, the people familiar with the talks said. That would represent a change from the current system, in which agencies may submit payment files well before their due dates. The Treasury Department processes them on a rolling basis, often ahead of the deadlines. Some payments are already sent to the department one day early, one person said. 
    • “The plan would enable the Treasury to make daily decisions about whether it can pay all of the government’s bills the next day.”
  • Back to the New York Times,
    • “The [U.S.] House of Representatives passed legislation on Thursday that would make permanent harsh criminal penalties and strict controls on fentanyl-related drugs, with scores of Democrats joining nearly all Republicans in a vote that reflected the political challenges of tackling what both parties consider America’s most pressing drug crisis.
    • “The bill, approved by a vote of 289 to 133, would permanently list fentanyl-related drugs as Schedule I controlled substances, a designation that mandates severe prison sentences for highly addictive, nonmedicinal chemicals, and which is now set to expire at the end of 2024.
    • “The bipartisan vote reflected agreement among Republicans and a solid bloc of Democrats that stiffening penalties for fentanyl-related drugs is a necessary component of the federal response to the crisis. According to the Centers for Disease Control and Prevention, there were roughly 75,000 synthetic opioid overdose deaths in 2022, with fentanyl being a main culprit.”
  • Federal News Network informs us
    • “With many agencies’ return-to-office plans still uncertain, Republicans on the House Oversight and Accountability Committee want to take matters into their own hands.
    • “GOP committee leaders changed their strategy for trying to get more federal telework data, now reaching out directly to agency heads. In a series of 25 letters, the lawmakers asked for up-to-date  numbers of teleworking federal employees, after saying the Biden administration was “not adequately tracking the specific levels of telework.”
    • “The Biden administration “has not provided current data about the specific amount of telework occurring within federal agencies or across the entire federal workforce. Furthermore, it has provided no objective evidence concerning the impact of elevated telework on agency performance — including any deleterious impacts,” lawmakers said in the letters, published May 18.”

From the Rx coverage front —

  • Today the Food and Drug Administration granted full marketing approval to Paxlovid, the Covid treatment pill, which in the FEHBlog’s opinion, brought us to the end of the pandemic. Here’s a link to a MedPage Today report on this FDA action
  • The Institute for Clinical and Economic Research released “a Final Evidence Report assessing the comparative clinical effectiveness and value of resmetirom (Madrigal Pharmaceuticals, Inc.) and obeticholic acid (Ocaliva®, Intercept Pharmaceuticals, Inc.) for non-alcoholic steatohepatitis (NASH).”
    • “Independent appraisal committee narrowly voted that currently available evidence for resmetirom is adequate to demonstrate a net health benefit over lifestyle management, whereas current evidence for obeticholic acid was deemed inadequate to demonstrate a net health benefit —
    • “ICER analyses suggest resmetirom would achieve common thresholds for cost-effectiveness if priced between $39,600 – $50,100 per year assuming that short-term effects on liver fibrosis translate into longer-term reductions in cirrhosis; under the same assumptions, obeticholic acid would achieve common thresholds for cost-effectiveness if priced between $32,600 – $40,400 per year.
    • “Payers should develop coverage criteria based on non-invasive testing to foster equitable access to early detection and treatment across diverse communities.
  • BioPharma Dive tells us
    • “Apellis Pharmaceuticals on Thursday became the latest drugmaker to give up on a potential treatment for amyotrophic lateral sclerosis, a neurodegenerative disorder that has frustrated researchers for decades.
    • “The decision came after a Phase 2 trial showed no benefit for the drug, known as systemic pegcetacoplan, compared with a placebo. It failed to meet the primary endpoint, measured by a statistical tool called the Combined Assessment of Function and Survival, as well as secondary goals assessing overall function, survival, lung function and muscle strength.
    • “The final results weren’t a total surprise; an independent board monitoring the study had already advised the company not to start a second, “open-label” part of the trial that would have offered the medicine to all participants after the initial 52-week research period. Apellis executives had also signaled to analysts that the trial had a low chance of success.”

From the miscellany department —

  • The National Institutes of Health announced
    • “Initial findings from a study of nearly 10,000 Americans, many of whom had COVID-19, have uncovered new details about long COVID, the post-infection set of conditions that can affect nearly every tissue and organ in the body. Clinical symptoms can vary and include fatigue, brain fog, and dizziness, and last for months or years after a person has COVID-19. The research team, funded by the National Institutes of Health, also found that long COVID was more common and severe in study participants infected before the 2021 Omicron variant.
    • The study, published in JAMA, is coordinated through the NIH’s Researching COVID to Enhance Recovery initiative, a nationwide effort dedicated to understanding why some people develop long-term symptoms following COVID-19, and most importantly, how to detect, treat, and prevent long COVID. The researchers hope this study is the next step toward potential treatments for long COVID, which affects the health and well-being of millions of Americans.
  • The New York Times discusses the miraculous case of a paralyzed man who has begun to walk again thanks to brain and spine “implants that provided a “digital bridge” between his brain and his spinal cord, bypassing injured sections” of his body.
  • HealthDay relates
    • “Older Americans are increasingly likely to log into “patient portals” to access their health care information — but confidence levels vary. 
    • “About 78% of people aged 50 to 80 now use at least one patient portal, according to the new University of Michigan (U-M) National Poll on Healthy Aging. 
    • “Five years ago, just 51% in this age range used patient portals, the researchers said. 
    • “The poll also found that 55% of those who used patient portals had done so in the past month. About 49% had accounts on more than one portal. 
    • “This surge is partly due to the increase in use of telehealth visits, said Denise Anthony, the U-M School of Public Health professor who worked on the poll.
    • “This change makes access to secure portals even more important for older adults who want to see their doctors and other health care providers virtually. It also makes the disparities we found in our poll even more troubling,” Anthony said in a Michigan Medicine news release. 
    • “Older adults with annual household incomes below $60,000, and those who were Black or Hispanic, had lower rates of portal use. These groups were also less likely to say they’re comfortable using a portal.”
  • The Washington Post reports
    • “U.S. authorities have seized increasing quantities of illegal ketamine, according to new research, a trend that coincides with the psychedelic drug’s rising popularity as a treatment for mental health ailments.
    • “The number of ketamine seizures by federal, state and local law enforcement in the United States increased from 55 in 2017 to 247 in 2022, while the total weight increased by more than 1,000 percent over that time, according to a letter published Wednesday in JAMA Psychiatry. Most of the ketamine was in powder form, which could raise the risk of being adulterated with deadly drugs such as fentanyl.”

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From Washington, DC, the Wall Street Journal explains,

“President Biden and Democratic leaders in Congress approached this year’s debt-ceiling drama with a consistent mantra: They would absolutely never, ever, under any circumstances, negotiate over raising the country’s borrowing level.

“But now they are very much negotiating on the debt limit, just about a week before the June 1 date when the Treasury Department estimates the U.S. could run out of measures to avoid default. Talks are underway about how to find a package of spending cuts and other measures acceptable to enough Republicans and Democrats to clear Congress, with House Speaker Kevin McCarthy (R., Calif.) and Biden meeting Monday and planning further talks to craft a deal framework in coming days.

“We’re not there yet” on a deal, said McCarthy on Tuesday. White House press secretary Karine Jean-Pierre said: “While areas of disagreement remain, the president, the speaker and their teams will continue to discuss the path forward.”

Govexec adds,

“Most non-defense federal agencies appear headed for at least a spending freeze next fiscal year—if not an outright cut—as President Biden has offered to back down from his proposed spending increases in exchange for an increase to the government’s debt ceiling. 

House Republicans, who are spearheading negotiations with the White House to avoid a debt default that could occur as soon as June 1, have rejected that proposal, holding out for cuts compared to current spending levels. The two sides have been locked in marathon negotiations for the last week, agreeing to some costccc-cutting measures but remaining far from an overall agreement.”

 From the public health front —

  • Roll Call reports,
    • New HIV infections dropped 12 percent in 2021 compared to 2017, according to new Centers for Disease Control and Prevention estimates released Tuesday, with the biggest drops among young gay and bisexual men.
    • But the agency warned that HIV prevention efforts need to be accelerated to reach the national goals.
    • The data Tuesday credited the overall decrease to a 34 percent drop in infections among 13-24 year olds, with the largest declines among young gay and bisexual men. Annual HIV infections among young people decreased from 9,300 to 6,100, but among young LGBTQ men new infections dropped from 7,400 to 4,900.
  • McKinsey Health Institute released a survey shedding “light on the health perceptions and priorities of people aged 55 and older.”
    • “Among the results, unsurprisingly, is that older adults who have financial stability—no matter their country—are more likely than their peers to be able to adhere to healthy habits, including those that boost cognitive health.3 And contrary to the perception that older adults are tech laggards compared with their younger peers, the results find widespread technology adoption, especially in smartphone use, among the older adult population.”
  • The U.S. Preventive Services Task Force issued draft recommendations and evidence reviews for the following projects: Oral Health in Adults: Screening and Preventive Interventions and Oral Health in Children and Adolescents Ages 5 to 17 Years: Screening and Preventive Interventions. Both recommendations are “I” for inconclusive. The public comment submission deadline is June 30, 2023.
  • The U.S. Surgeon General Dr. Vivel Murthy circulated “a new Surgeon General’s Advisory on Social Media and Youth Mental Health – PDF. While social media may offer some benefits, there are ample indicators that social media can also pose a risk of harm to the mental health and well-being of children and adolescents. Social media use by young people is nearly universal, with up to 95% of young people ages 13-17 reporting using a social media platform and more than a third saying they use social media “almost constantly.”

From the medical research front —

  • The New York Times reports, “Researchers have for the first time recorded the brain’s firing patterns while a person is feeling chronic pain, paving the way for implanted devices to one day predict pain signals or even short-circuit them.”
  • The NIH Director’s Blog tells us, “Basic Researchers Discover Possible Target for Treating Brain Cancer.”

From the Rx coverage front —

  • The Drug Channels blog points out “The Top Pharmacy Benefit Managers of 2022: Market Share and Trends for the Biggest Companies.”
    • “We estimate that for 2022, about 80% of all equivalent prescription claims were processed by three companies: the Caremark business of CVS Health, the Express Scripts business of Cigna, and the OptumRx business of UnitedHealth Group. 
    • “This concentration reflects the significant transactions and business relationships among the largest PBMs that have further concentrated market share. Five of the six largest PBMs are now jointly owned by organizations that also own a health insurer, as illustrated in Mapping the Vertical Integration of Insurers, PBMs, Specialty Pharmacies, and Providers: A May 2023 Update
      • “The big three PBMs’ aggregate share of claims was similar to the 2021 figure. Compared with 2021, however, Cigna’s share declined due to customer losses, while OptumRx’s share grew slightly. Two other notable market changes affected the 2022 figures:
      • “In January 2022, Caremark added the specialty business back to its Federal Employee Program (FEP) mail and clinical pharmacy services contract. The specialty portion of the FEP had transitioned to Prime Therapeutics in 2018. 
      • “In late 2022, Prime Therapeutics completed its acquisition of Magellan Rx from Centene. For 2022, Magellan Rx managed $22.9 billion in drug spend and had annual claims volume of 220.9 million. Magellan Rx annualized claims are included with Prime’s figures above.
    • “Beginning in 2024, Express Scripts will begin a five-year agreement to manage pharmacy benefits for more than 20 million Centene beneficiaries. We estimate that the Centene business will bring $35 to $40 billion in total gross pharmacy spend and more than 550 million prescriptions. This forthcoming shift of Centene’s PBM business from CVS Health’s Caremark to Cigna’s Express Scripts will significantly alter the relative position of these companies. 
  • MedPage Today informs us,
    • “The first nalmefene hydrochloride nasal spray (Opvee) won FDA approval for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and up, the agency announced.
    • “If administered quickly, the opioid receptor antagonist provides fast onset and long duration reversal of opioid-induced respiratory depression. It will be available for use by prescription in healthcare and community settings.”
  • The FDA announced
    • “approving Xacduro (sulbactam for injection; durlobactam for injection), a new treatment for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex, for patients 18 years of age and older. 
    • “According to the World Health Organization, Acinetobacter species top the list of critical bacterial pathogens that pose the greatest threat to human health, highlighting the high level of need for additional treatment options amid growing global resistance to antimicrobial medicines.”

From the generative artificial intelligence front, STAT News provides expert perspectives and answers readers’ common questions about AI and healthcare.

From the U.S. healthcare business front —

  • Healthcare Dive relates,
    • “The newly rebranded Intermountain Health reported $549 million in net income for the first three months of 2023, an increase from the prior-year period when the health system posted a $298 million net loss. 
    • “The Salt Lake City-based system brought in $4 billion in revenue compared with $2.8 billion in the period ended March 31 last year. 
    • “Intermountain’s expenses still climbed 44% to $3.7 billion, with a large portion coming from employee compensation and benefits at $1.7 billion. But supply costs grew too, reaching $703 million during the quarter, an increase of 46% from a year earlier.”
  • Fierce Healthcare notes,
    • “Cleveland Clinic is starting 2023 on the right side of zero, reporting Tuesday a Q1 operating income of $32.3 million (0.9% operating margin) and a net income of $335.5 million.
    • “Though the nonprofit system had reported a $1.2 billion net loss across 2022, the first quarter’s numbers continue the upward momentum Cleveland Clinic enjoyed at the end of last year.
    • “Like many health systems have reported in recent weeks, the performance is also a substantial bounce back from Q1 2022when the omicron wave dragged Cleveland Clinic to a $104.5 million operating loss (-3.4% operating margin) and a $282.5 million net loss.
    • “On a year-over-year basis, total unrestricted revenues grew 15.7% by way of a 13.3% rise in net patient revenue, to $3.1 billion, and a 37.3% increase in other restricted revenues, to $425.3 million.”

Weekend update

Photo by Thought Catalog on Unsplash

The House of Representatives will be in session for Committee business and floor voting, while the Senate will be on a State work week this week. The Senate press gallery informs us, “In today’s (5/18/23) wrap-up, Schumer reiterated that as discussions concerning the debt ceiling continue over the next week, Senators should be able to return to the Senate within a 24-hour period.”

The Wall Street Journal reports

“President Biden and House Speaker Kevin McCarthy agreed to meet Monday afternoon in a last-ditch effort to reach a deal to avoid a default on U.S. sovereign debt after negotiations to raise the federal borrowing limit reached an impasse.

“Talks between White House and House Republican negotiators largely ground to a halt this weekend, with both sides blaming the other for a failure to bridge their differences over spending levels. But Biden and McCarthy instructed their negotiating teams to resume their discussions, starting with a 6 p.m. meeting on Sunday. * * *

“There’s no agreement. We’re still apart,” McCarthy, a California Republican, told reporters at the Capitol, though he said the call with Biden was productive.” * * *

“Leaders in Washington are rushing to come up with a deal to lift the country’s borrowing limit. If they are unable to do so, the country might be unable to pay all of its bills as soon as June 1, according to an assessment by the U.S. Treasury Department.  

“Appearing Sunday on NBC, Treasury Secretary Janet Yellen said the “odds of reaching June 15th, while being able to pay all of our bills, is quite low.”

“Economists say that failure to lift the debt ceiling, and a subsequent default, would tip the economy into a recession. Moody’s Analytics predicts that a default would cost more than seven million jobs and cause the unemployment rate to move above 8%. The ratings company also predicts that the stock market would lose a fifth of its value.”


From the plan design front, the Wall Street Journal reports

“The Internal Revenue Service on Tuesday announced the largest-ever increase to the amount Americans can set aside in health-savings accounts each year.

“For 2024, the maximum HSA contribution will be $8,300 for a family and $4,150 for an individual. That is up from $7,750 for a family and $3,850 for an individual for 2023.

“Participants age 55 and older can contribute an extra $1,000, which means an older married couple could sock away $10,300 a year, up from $9,750 this year. In the last ten years leading up to retirement, a couple could accumulate more than $100,000 in these accounts. * * *

While workers can tap 401(k)s and individual retirement accounts for medical costs, health savings accounts offer more tax savings than both traditional or Roth retirement accounts. There is no tax going in, tax-free growth and tax-free withdrawals if used for eligible healthcare expenses.”

The FEHBlog came to love the high-deductible health plan/health savings account arrangement. The Wall Street Journal endorses the FEHBlog’s viewpoint. The FEHBlog was cut off from the arrangement when he became Medicare primary in late 2019. Because the FEHBlog’s law firm has less than 20 employees, the FEHBlog found it necessary to drop his employer-sponsored coverage in favor of Medicare. Medicare coverage has been fine, but the FEHBlog misses contributing to his HSA. Younger employees should give the HDHP / HSA arrangement a close look.

The Wall Street Journal adds

“Remember one important caveat, however: If you’re sure to spend over the deductible, other plans may be more appropriate for you, such as the PPO plan that will cost you an additional $800. (You forgo the ability to save, but you also face a lower out-of-pocket maximum.) For instance, if you know with reasonable certainty that you need access to a more-expensive provider for a one-time procedure, then you should pick a plan that gives you this access, such as a PPO plan, and switch back to an HMO plan with an HDHP-and-HSA option during next year’s open-enrollment period.

“If you do end up choosing an HDHP, please remember: Do not cut back on care haphazardly, as many people do. Following a doctor’s recommendations is much more important than saving a bit of money.”

While the FEHBlog is not yet retired, he is intrigued by the Fortune Well article on cognitive decline following retirement. The article offers four ways to avoid this otherwise “universal trend.”

  1. Keep or get connected.
  2. Keep active.
  3. Keep stress to a minimum
  4. Keep working, regardless of pay.

Next stop, Walmart greeter??

From the U.S. healthcare business front, Healthcare Dive tells us

“Physician staffing firm Envision Healthcare has filed for Chapter 11 bankruptcy, citing its $7.7 billion in debt obligations, declining patient volumes, “flawed” implementation of the No Surprises Act and exclusionary health insurers as reasons for its financial decline in a restructuring announcement on Monday.

“The bankruptcy wipes out private equity firm KKR’s investment in Envision. In 2018, the PE firm shelled out over $5 billion in 2018 to take Envision private in a deal valued at $9.9 billion, including debt. Last week, The Wall Street Journal reported that an Envision bankruptcy filing would be one of the steepest losses in KKR’s history.”

From the miscellany department, NPR Shots offers articles evaluating experimental cancer treatments and looking into a new NIH study:

There’s plenty of one-size-fits-all nutrition advice. But there’s mounting evidence that people respond differently to food, given differences in biology, lifestyle and gut microbiome.

“The National Institutes of Health wants to learn more about these individual responses through a Nutrition for Precision Health study, and this week researchers began enrolling participants to take part in the study at 14 sites across the U.S.

“It’s part of the All of Us research initiative that aims to use data from a million participants to understand how differences in our biology, lifestyle and environment can affect our health.

Holly Nicastro of the NIH Office of Nutrition Research says the goal of the precision nutrition study is to help develop tailored approaches for people. “We’ll use machine learning and artificial intelligence to develop algorithms that can predict how individuals will respond to a given food or dietary pattern,” Nicastro says.

“The study will take into account a person’s genetics, gut microbes, and other lifestyle, environmental and social factors “to help each individual develop eating recommendations that improve overall health,” Nicastro says.”

Midweek Update

Photo by Michele Orallo on Unsplash

From Capitol Hill —

Roll Call reports

  • “The White House and congressional leaders are discussing the duration of appropriations caps and a debt limit raise as staff talks get underway in advance of the next principals meeting on Friday.
  • “A two-year appropriations deal is under consideration, according to sources familiar with the talks, along the lines of three separate laws since 2015 that were paired with suspensions of the debt limit. 
  • “The White House and top Democrats are pushing for two years of debt limit breathing room, as in the 2019 deal cut with former President Donald Trump. That law contained two years of spending caps, which Speaker Kevin McCarthy pointed out as far back as January.
  • “Such an arrangement would, in theory, remove the threat of fiscal cliffs facing lawmakers and the economy until after the 2024 elections.”

Fierce Healthcare tells us,

  • “The Senate Health, Education, Labor and Pensions (HELP) Committee convened the heads of three big pharmas—Eli Lilly CEO David Ricks, Novo Nordisk CEO Lars Fruergaard Jørgensen and Sanofi CEO Paul Hudson—as well as the top brass at the three largest PBMs—CVS Health Executive Vice President and President of Pharmacy Services David Joyner, Express Scripts President Adam Kautzner and OptumRx CEO Heather Cianfrocco.
  • “The legislation on the docket for the HELP Committee aims to inject transparency into the pharmaceutical supply chain as well as increase access to generics. PBM reforms on the table include eliminating spread pricing models as well as clawbacks from pharmacies. * * *
  • “The HELP Committee will convene Thursday to mark up four bills that target drug pricing. Sanders said that while these measures are a priority, there’s more work to be done in addressing this issue. He added that issues with affording drugs are a broader part of the ongoing challenges around affordability in healthcare.”

Tomorrow is the last day of the Covid public health emergency, and today the Department of Health and Human Services posted a fact sheet on how the end of the PHE affects telehealth.

From the Rx coverage front, the Wall Street Journal points out

  • “Advisers to the Food and Drug Administration recommended making an oral contraceptive available without a prescription for the first time, potentially widening access to birth control for women across the country. 
  • “The panel of FDA advisers voted 17 to 0 on Wednesday that there was enough evidence for the agency to approve the medication’s sale over-the-counter. The FDA, which is expected to make a final decision this summer, doesn’t have to follow the expert panel’s advice, though it often does.
  • “The FDA approved the pill, called Opill, for prescription use in 1973. HRA Pharma, owned by Perrigo, a Dublin-based generic drugmaker, submitted its application to make Opill available over-the-counter last July. 
  • “The advisory panel said the benefits of making oral contraceptives available over-the-counter outweighed the risks.”

The cost curve is pointing down.

From the medical research front, the National Institutes of Health updates us on multiple mRNA vaccines that show promise for treating HPV-Related cancers.

From the healthcare quality front, NCQA informs us

  • “We launched our Race and Ethnicity Stratification Learning Network.
  • “The network is a free, interactive, online tool that offers data and best practices to help health plans improve how they collect race and ethnicity data on enrollees.
  • Improving data collection of race and ethnicity data is vital to improving health equity.
  • “The data available in this new resource summarize the care of 20 million people enrolled in 14 health plans that reported results on 5 HEDIS measuresstratified by race and ethnicity.
  • “Best practices we identify come from NCQA’s qualitative interviews of key staff at plans in the learning network.
  • “A report groups our findings in three areas.”

Check it out.

From the federal employment front, the Office of Personnel Management announced

  • released proposed regulations that would prohibit the use of previous salary history in setting pay for federal employment offers. Under the new proposed regulations, federal agencies would not be able to consider an applicant’s salary history when setting pay for new federal employees in the General Schedule pay system, Prevailing Rate pay system, Administrative Appeals Judge pay system, and Administrative Law Judge pay system.  
  • “These proposed regulations are a major step forward that will help make the federal government a national leader in pay equity,” said OPM Director Kiran Ahuja. “Relying on a candidate’s previous salary history can exacerbate preexisting inequality and disproportionally impact women and workers of color. With these proposed regulations, the Biden-Harris Administration is setting the standard and demonstrating to the nation that we mean business when it comes to equality, fairness, and attracting the best talent.” 

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From Capitol Hill —

Roll Call tells us, “Senators are so far standing firm on letting Speaker Kevin McCarthy and President Joe Biden work out how to address the debt limit.” The President’s meeting with Congressional leaders will be held on May 9.

Fierce Healthcare informs us,

  • “A key Senate panel has postponed a markup hearing on several bills aimed at drug pricing until after the heads of three major drug companies and three pharmacy benefit managers appear before legislators.
  • “The Senate Health, Education, Labor and Pensions Committee convened Tuesday morning to discuss four pieces of legislation aimed at tackling the rising costs of drugs in the U.S., including a bill that would push significant reforms to the PBM industry.
  • “Instead, the committee will markup the bills on May 11, one day after hosting a blockbuster hearing on insulin and other drug pricing issues. The hearing will include testimony from Eli Lilly CEO David Ricks, Novo Nordisk CEO Lars Fruergaard Jorgensen, Sanofi CEO Paul Hudson, CVS Health President of Pharmacy Services David Joyner, Express Scripts President Adam Kautzner and OptumRx CEO Heather Cianfrocco.”

From the public health front —

  • The National Institutes of Health announced
    • Women aged 55 years and younger have nearly double the risk of rehospitalization in the year immediately after a heart attack compared to men of similar age, according to a study supported by the National Institutes of Health. Higher rates of risk factors such as obesity, heart failure, and depression among women most likely contributed to the disparity.
    • “The findings suggest a need for closer health monitoring of the approximately 40,000 American women aged 18 to 55 years who have heart attacks each year following hospital discharge, and a better understanding of the reasons behind the different outcomes. The study, funded by the National Heart, Lung, and Blood Institute (NHLBI), part of NIH, was published today in the Journal of the American College of Cardiology.”
  • The U.S. Preventive Services Task Force updated its recommendation for screeening asymptomatic adults at increased risk of latent tuberculosis infection (LTBI) with the same grade B that it last gave in 2017. The FEHBlog is impressed by the USPSTF’s routine re-evaluation of its decisions.
  • The Department of Health and Human Services announced
    • “awarding the 15 winners for Phase 1 of the HHS Endocrine-Disrupting Chemicals (EDC) Innovator Award Competition. This competition was developed to identify gaps in knowledge and innovative solutions to improving women’s health by reducing EDC exposure risk.  
    • “For far too long, Black women have been overexposed to harmful endocrine-disrupting chemicals in personal care products. We created this competition to help find innovative solutions to meet this challenge, and I want to congratulate all the winners for their incredible ideas,” said HHS Secretary Xavier Becerra. “We will continue to prioritize the health of Black women by addressing the exposure risks caused by this environmental justice issue.”
  • Kaiser Family Foundation discusses community paramedic programs.
    • Most community paramedicine programs rely on paramedics, but some also use emergency medicine technicians, nurses, social workers, and other professionals, according to the 2017 survey. Programs can offer home visits, phone check-ins, or transportation to nonemergency destinations, such as urgent care clinics and mental health centers.
    • Many programs support people with chronic illnesses, patients recovering from surgeries or hospital stays, or frequent users of 911 and the ER. Other programs focus on public health, behavioral health, hospice care, or post-overdose response.
    • Community paramedics can provide in-home vaccinations, wound care, ultrasounds, and blood tests.

From the mental health care front

  • CVS Health calls our attention to
    • “A recent CVS Health® (NYSE: CVS)/Harris Poll survey found that young adults and physicians continue to see the country struggling with mental health, but most Americans aren’t seeking care.
      • “Six in 10 (60%) respondents aged 18-32 say they are concerned about their mental health, and two thirds (67%) say they know a lot of people in their community that are struggling with mental health issues.
      • “Most physicians (56%) also report declining mental health among their patients.
      • “However, only 1 in 10 (12%) Americans regularly see a mental health professional like a psychiatrist, psychologist, psychotherapist, or well-being therapist.” * *
    • “The survey also found that generations have different views of how to access mental health care.
      • “Ninety-five percent of respondents age 57+ agreed that mental health and illnesses should be taken more seriously by society, compared to 8 in 10 respondents aged 18-32 (83%).
      • “About six in 10 (58%) respondents aged 18-32 report that social media has negatively impacted their mental health, compared to just 22% of respondents age 57+.
      • “A higher number of respondents aged 33-40 believe in using technology to access care, with 85% agreeing that digital health services have made mental health more accessible.
  • The U.S. Surgeon General issued an advisory on the healing effects of social connection.
    • “Connection plays a critical role in individual, community, and societal health. This advisory calls attention to that role and offers a framework for how we can all contribute to improving social connection.”

From the U.S. healthcare business front —

  • BioPharma Dive relates
    • “Pfizer on Tuesday reported first quarter revenue that beat Wall Street forecasts despite declining by more than one-fourth compared to the same period in 2022 due to plummeting sales of the company’s COVID-19 vaccine.
    • “Sales of the COVID antiviral Paxlovid, at $4 billion for the quarter, were substantially higher than analysts expected, although the total was tied to the timing of the final delivery under a U.S. supply contract. CFO David Denton told investors that 2023 will be a “transitional” year as Paxlovid distribution shifts from government purchasing to commercial insurance.
    • “Executives affirmed guidance of 7% growth in non-COVID revenues for the full year, higher than the 5% growth in the first quarter. Hitting that target will require successful new drug launches, such as for a respiratory syncytial virus vaccine now under regulatory review and an experimental multiple myeloma treatment. Investors are also looking for better performance from drugs bought via dealmaking, such as the migraine pill Nurtec.”
  • and
    • “Johnson & Johnson has acquired rights to two experimental cell therapies for blood cancer in a move meant to build on the success it’s had developing a CAR-T treatment for multiple myeloma.
    • “The deal, announced Tuesday with the Maryland-based Cellular Biomedicine Group, has J&J paying $245 million upfront to gain access to two CAR-T therapies that have shown positive early-phase results in patients with recurrent diffuse large B cell lymphoma, or DLBCL, the most common form of non-Hodgkin lymphoma.
    • “The agreement increases J&J’s presence in the field of cell therapy. The big drugmaker already sells one treatment, known as Carvykti. The newly added therapies are in early testing or soon will be.  
  • Healthcare Dive reports
    • CVS has closed its acquisition of Oak Street Health for $10.6 billion in cash, pushing the retail health giant further into direct care delivery, CVS announced on Tuesday.
    • With the deal’s completion, CVS adds a multi-state chain of doctor-staffed medical clinics for seniors to its primary care roster.
    • CVS first announced the acquisition, which values Oak Street at $39 a share, in February.
  • On Monday,  “Blue Cross Blue Shield of Michigan and Blue Cross and Blue Shield of Vermont announced an agreement to formally affiliate and work together across both companies. The affiliation will enable the organizations to broaden the range of health plan and service solutions that will further benefit members and customer groups, while remaining within and committed to local communities in both states. The agreement is pending approval of state regulators.”

From the healthcare spending front —

  • Buck Consultants announced
    • “The impact of inflation is not yet fully reflected in medical trend factors, according to Buck, an integrated HR, pensions, and employee benefits consulting, technology, and administration services firm. The findings were released today in Buck’s 44th National Healthcare Trend Survey, a report that identifies trend factors that are used to project employers’ healthcare costs for 2023-2024.
    • “Buck’s annual survey of nearly 100 health insurers and health plan administrators covering more than 100 million plan participants found that while medical trend factors have yet to fully adjust for recent inflationary increases, they continue to increase at a rate consistent with trends reported in the prior survey, which will likely drive healthcare premiums higher in the coming year.
  • Health Payer Intelligence informs us,
    • “Payers with larger market shares tend to have lower prices nationally, a study published in Health Affairs confirmed.
    • “The researchers used data from Turquoise Health, a company that collects hospital price data from the hospitals’ websites, to determine the impact that payer market share can have on prices. The study covered prices for 14 potentially shoppable services with data from 1,446 acute care hospitals. The data was collected through the end of 2021.
    • “Prices were stable within hospitals but not across different payers. And the pricing was dependent, at least in part, on the payers’ market shares. * * *
    • “just as payers can use their market share to negotiate lower prices, the Congressional Budget Office (CBO) found that providers with higher market shares can use their market position to get higher reimbursement out of payers. Hospital consolidation was a key factor in price increases, the CBO report found.”

Midweek Update

Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

From Capitol Hill, Roll Call reports, “House Republicans narrowly passed legislation Wednesday pairing nearly $4.8 trillion in deficit reduction measures with a debt limit increase into next year — a move they argue should force Democrats to finally negotiate conditions for raising the nation’s borrowing limit.” Time will tell.

Politico explains why and how prescription benefit managers are playing defense on Capitol Hill.

From the U.S. healthcare business front, Healthcare Dive informs us

  • “Kaiser Permanente is acquiring Geisinger Health and forming a new nonprofit to buy and operate other value-oriented nonprofit systems, the organizations announced Wednesday.
  • “The new nonprofit, Risant Health, will operate separately from Kaiser Permanente. Geisinger will become part of Risant but maintain its own name and mission, according to a press release.
  • “Geisinger president and CEO Jaewon Ryu will be CEO of Risant as the transaction closes, subject to regulatory review. Risant will have its headquarters in Washington, D.C.

Both Kaiser and Geisinger are FEHB plan carriers. Kaiser is the third largest carrier in the FEHB Program. Healthcare Dive adds

  • “Kaiser, which reported $95 billion in revenue in 2022, plans to spend $5 billion on Risant over the next five years and add five or six health systems to Risant over that period, according to reports.
  • “Kaufman Hall said recently it expects a “new wave of transaction activity” and a growing number of cross-regional partnerships.
  • “Pennsylvania-based Geisinger has ten hospital campuses and a health plan that covers more than 500,000 members. It has more than 25,000 employees. Both Geisinger and Kaiser reported operating losses last year, as supply and labor expenses rose.

Beckers Payer Issues tells us,

  • “Humana posted a 33 percent increase in profits year over year and added more than 500,000 Medicare Advantage members in the past year, according to its first-quarter earnings posted April 26. 
  • “We’ve had a strong start to the year, with our outperformance underpinned by strong membership growth and favorable inpatient utilization trends in our individual Medicare Advantage business,” CEO Bruce Broussard said. 
  • “The company posted $1.3 billion in net income in the first quarter of 2023, up from $930 million in the first quarter of 2022.”

From the public health front,

  • The National Cancer Institute released a bevy of research articles.
  • The FEHBlog ran across this helpful Johns Hopkins article about U.S infertility statistics,
    • “For the new study, Snow and Trent analyzed data on 53,764 women who participated in the federally supported National Survey of Family Growth (NSFG). While the survey did not ask explicitly about infertility, it contained questions about sexual activity, contraception and pregnancy that were not used in previous studies to estimate infertility rates. It also collected information about sociodemographic and healthcare factors.
    • “Based on the responses, the researchers concluded that the rate of infertility varied slightly from year to year, with a low from 2006 to 2010 of 5.8% and a high between 2017 to 2019 of 8.1%. However, these fluctuations are not considered statistically significant, and the team concluded that overall fertility rates did not significantly change during the study period.
    • “In particular populations, however, infertility rates were significantly higher than average compared with the general population. Women aged 40 to 44 were about 11 times more likely to be infertile than younger women, women who did not complete high school were twice as likely to be infertile as those with higher levels of education, non-Hispanic Black women were 44% more likely to be infertile than women of other races and women who had not recently received sexual health care were 61% more likely to be infertile. Unlike previous studies, the new data did not show a higher rate of infertility for Hispanic women.
  • MedPage Today offers an interview with Dr. Atul Gawande about the importance of palliative care.
  • Medscape identifies emerging cardiovascular disease risk factors.

From the Rx coverage front

Biopharma Dive reports

  • “The Food and Drug Administration has conditionally approved a new ALS medicine in a decision likely to influence how other experimental treatments for the nerve-destroying disease are tested and reviewed.
  • “The medicine, known until now as tofersen, is only for ALS patients who have a specific genetic mutation. Estimates cited by the FDA hold that this group accounts for less than 500 of the roughly 30,000 people in the U.S. with the disease.
  • “Until Tuesday, the few therapies that had secured FDA approval did so because they were shown to help patients live a bit better or a bit longer. Tofersen, which will be sold as Qalsody, is different. It failed the key clinical trial meant to demonstrate it can slow the functional decline associated with ALS, or amyotrophic lateral sclerosis.
  • “Rather, tofersen’s approval hinged on its ability to lower levels of “neurofilament light chain,” a protein that’s drawn increasing interest from ALS researchers. It’s the first ALS drug approved based on so-called “biomarker” data, setting a precedent that could provide another, perhaps faster path to market for some developers.

Biopharma Dive adds

  • “Roche’s new eye drug Vabysmo brought in nearly $500 million during the first quarter, the company said Wednesday. The more than 500% year-over-year sales increase outpaced all other of Roche’s medicines, surpassing top-sellers like the multiple sclerosis treatment Ocrevus and hemophilia therapy Hemlibra.
  • “Vabysmo’s market launch for age-related vision loss comes as one of the first treatments for the condition, Roche’s own Lucentis, faces copycat rivals, and another, Regeneron’s Eylea, could soon.
  • “The strong growth from Vabysmo helped propel a 9% increase in pharmaceutical division sales, which contrasted with a 3% decline in first quarter revenue for the overall business due to lower COVID-19 test sales.”

From the miscellany front —

  • Per the American Hospital Association, “The Centers for Medicare & Medicaid Services today announced changes to its enforcement process for the hospital price transparency rule. CMS said it will now automatically impose a civil monetary penalty if hospitals fail to submit a corrective action plan on time or fail to complete the CAP within 45 days. In addition, the agency will no longer issue a warning notice to hospitals that have not posted any machine-readable file or shoppable services list/price estimator tool, but will immediately ask the hospital to submit a CAP.”
  • The Office of Personnel Management announced
    • its OPM Data Strategy Fiscal Years 2023-2026, which lays out a vision to fully leverage OPM and agency human capital data, and to provide federal agencies, federal employees, and public users seamless access to OPM data products and services. In addition to the overarching strategy, OPM released a set of initial data dashboards to the updated OPM Data Portal at, including FedScope datasets which can now be accessed at The OPM Data Portal is a redesigned OPM webpage providing increased access to OPM data products and services.
  • HIMSS posted a wrap-up page from last week’s conference.

Tuesday’s Tidbits

Happy Pi Day!

Photo by Patrick Fore on Unsplash

From the Omicron and siblings front —

  • The Wall Street Journal reports
    • In the three years since Covid-19 surfaced in the U.S., most Americans have been infected and are largely back to their prepandemic routines and workaday lives. 
    • Scientists, still in the dark about what the virus will do in the long term, warn it is too early to sound the all clear. Despite the success of a global effort to decode the SARS-CoV-2 virus and create vaccines and treatments to combat it, there remains uncertainty about how the virus will behave, the path of its mutations and Covid-19’s long-term effects. 
    • Covid-19 vaccines are widely available, but researchers don’t yet know enough about how the virus might change or how long immunity lasts to be certain who should get future boosters or how often. The unknowns could have public-health consequences in the years ahead, virus experts said.
    •  “A big question is how will that play out over time?” Bronwyn MacInnis said of the virus’s mutations. She is director of pathogen genomic surveillance at the Broad Institute of MIT and Harvard, a biomedical research center in Cambridge, Mass. “Are there other tricks we have yet to see?” she said. * * *
    • “Any time someone talks about Covid, I think it’s good to start with a lot of humility,” Moderna Chief Executive Officer Stéphane Bancel said. “It’s still a new virus. So we don’t know everything.”
  • The Food and Drug Administration (FDA) announced amending “the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide for a single booster dose of the vaccine in children 6 months through 4 years of age at least 2 months after completion of primary vaccination with three doses of the monovalent (single strain) Pfizer-BioNTech COVID-19 Vaccine.”
  • Yesterday, The FDA took the following steps concerning the Johnson and Johnson (Jannsen) vaccine.
    • The Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to include a Warning conveying that reports of adverse events following use of the vaccine under emergency use authorization suggest increased risks of myocarditis and pericarditis, particularly within the period 0 through 7 days following vaccination. The Fact Sheet for Recipients and Caregivers was also revised to include information about myocarditis and pericarditis following the administration of the Janssen COVID‑19 Vaccine. An additional revision to the Fact Sheets was made to include that facial paralysis (including Bell’s Palsy) has been reported during post-authorization use. Also, the scope of authorization for a booster dose of the Janssen COVID-19 Vaccine has been revised to reflect that the vaccine may be administered as a first booster dose at least 2 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine. The FDA reissued the letter of authorization for the Janssen COVID-19 Vaccine to revise the scope of authorization related to the administration of a booster dose and the conditions of authorization related to the Vaccine Adverse Event Reporting System (VAERS) reporting requirements for vaccination providers and Janssen Biotech, Inc. to include myocarditis and pericarditis.  
    • The Janssen COVID-19 Vaccine is authorized for emergency use for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older for whom other FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate and in individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. The letter of authorization and revised fact sheets are available on the FDA’s website.

From the Rx coverage front —

  • Fierce Healthcare offers its insights into why the Veterans Administration decided to offer the new Alzheimer’s Disease drug Leqembi to its patients who are eligible for the drug under the FDA’s guidance. Fierce Healthcare does not expect to CMS to follow this approach later this year. Currently, Medicare covers the drug when offered in a clinical trial, while the FDA’s approach is much broader.
  • The Wall Street Journal reports,
    • Novo Nordisk A/S is set to cut the U.S. list prices for several insulin drugs by up to 75%, the latest big drugmaker to make steep price reductions amid pressure to curb diabetes treatment costs.

    • Novo, one of the biggest sellers of insulin in the U.S. and around the world, said Tuesday it would cut the list price of its NovoLog insulin by 75% and the prices for Novolin and Levemir by 65% starting in January 2024. 

    • In addition, Novo plans to cut prices for its unbranded insulin products to match the reduced price of Novo’s corresponding brands.

  • The Centers for Disease Control issued a Vital Signs report titled “Progress Toward Eliminating HIV as a Global Public Health Threat Through Scale-Up of Antiretroviral Therapy and Health System” over the period 2004 through 2022.
    • What is already known about this topic?
    • The U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) began providing HIV antiretroviral therapy (ART) worldwide in 2004. [At that time, George W. Bush was President.} Through viral load suppression, effective ART improves health outcomes and prevents transmission.
    • What is added by this report?
    • By 2022, approximately 20 million persons with HIV infection in 54 countries received PEPFAR-supported ART (62% CDC-supported); this number represents an increase of 300-fold from 66,6550 in 2004. During 2015–2022, viral load suppression rates increased from 80% to 95% among those who received testing.
    • What are the implications for public health practice?
    • To eliminate HIV as a global public health threat, achievements must be sustained and expanded to reach all subpopulations. PEPFAR remains committed to tackling HIV while strengthening public health systems and global health security.

In recognition of Patient Safety Awareness Week, Beckers Hospital Review highlights

Healthgrades recognized 864 hospitals with its 2023 Patient Safety Excellence Awards and Outstanding Patient Experience Award. Only 83 of those hospitals received both awards. 

The dual recipients spanned 28 states. Texas had the most dual recipients with 12 honorees — including three Baylor Scott and White Health hospitals. 

From the medical research front,

  • NIH researchers compared a new genetic animal model of Down syndrome to the standard model and found the updated version to be more similar to the changes seen in humans. The new mouse model shows milder cognitive traits compared to a previously studied Down syndrome mouse model. The results of this study, published in Biological Psychiatry, may help researchers develop more precise treatments to improve learning and memory in people with Down syndrome.
  • The NIH DIrectors in his blog, explains
    • “The human brain is profoundly complex, consisting of tens of billions of neurons that form trillions of interconnections. This complex neural wiring that allows us to think, feel, move, and act is surrounded by the blood-brain barrier (BBB), a dense sheet of cells and blood vessels. The BBB blocks dangerous toxins and infectious agents from entering the brain, while allowing nutrients and other essential small molecules to pass right through.
    • “This gatekeeping function helps to keep the brain healthy, but not when the barrier prevents potentially life-saving drugs from reaching aggressive, inoperable brain tumors. Now, an NIH-funded team reporting in the journal Nature Materials describes a promising new way to ferry cancer drugs across the BBB and reach disease sites [1]. While the researchers have not yet tried this new approach in people, they have some encouraging evidence from studies in mouse models of medulloblastoma, an aggressive brain cancer that’s diagnosed in hundreds of children each year.” 

Thanks, research mice.

From the healthcare costs front, the New York Times reports, “Most older cancer patients received invasive care in the last month of their lives, a new study finds. That may not be what they wanted.”

The health care system could improve end-of-life care. When palliative care is introduced soon after a diagnosis, patients have a better quality of life and less depression, a study of people with metastatic lung cancer found. Though they were less likely to undergo aggressive treatment, they survived longer.

Palliative care doctors, skilled in discussions of serious illness, are scarce in some parts of the country, however, and in outpatient practices.

Nomi Health announced today that “Diabetes costs U.S. employers approximately $245 billion a year — more than double what the entire American automotive industry is worth. * * *Employers spend more than $175 billion annually on direct medical and pharmacy costs for diabetic members, in addition to nearly $70 billion on indirect costs from employee absenteeism, reduced productivity and diabetes-related disability, the research showed.”

Additional findings from Nomi Health’s Trends in Spend Tracker research include:

  • Cost of care for diabetics is increasing twice as fast as for non-diabetics, and it’s growing at a staggering clip of nearly 20% year over year, reaching more than $20,000 average per member per year (PMPY) for employers in 2020-21.
  • A diabetes diagnosis means higher costs for patients, too, who spend about 240% more annually on medical bills and nearly 450% more on pharmacy expenses than non-diabetics.
  • The high cost of diabetes extends to the chronic conditions associated with the disease, which often cost more than the diabetes itself. Care for diabetics with ketoacidosis or kidney disease in 2020-21 cost employers 252% above the average, or $68,325 average PMPY.

This retrospective cohort analysis was conducted by Artemis — a leading benefits analytics platform acquired by Nomi Health last year

From the post-Dobbs front, Healthcare Dive relates

Senate Democrats are urging the largest retail pharmacies in the U.S. to ensure access to the abortion pill mifepristone amid ongoing confusion over legal access to the pill.

On Monday, 18 Democrats sent letters to seven of the biggest pharmacy chains in the country requesting more information about their plans to provide customers access to mifepristone — currently an open question for some chains as pressure from anti-abortion lawmakers and lawsuits target the legality of medication abortion.

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From our Nation’s Capital, Roll Call fills us in on the debt ceiling negotiations. Significantly,

​Economists at Moody’s Analytics estimate that the Treasury Department will run out of borrowing room by mid-August if Congress doesn’t act to raise or suspend the statutory debt limit by then.

The “x date” after which Treasury may not be able to pay all of the federal government’s bills appears to be Aug. 18, specifically, according to Moody’s economists Mark Zandi, Christian deRitis and Bernard Yaros. 

The trio laid out various scenarios and potential consequences of failure to lift the $31.4 trillion debt ceiling in a new paper this week, on a topic that was examined more closely Tuesday afternoon in a Senate Banking subcommittee hearing led by Sen. Elizabeth Warren, D-Mass. Zandi is among those slated to testify.

The propspect of a mid-August explosion may encourage Congress to suspend the debt ceiling suspension until the end of the federal fiscal year, September 30, and focus on negotiating the interrelated 2024 appropriations and the debt ceiling topics.

The President provided highlights of the Medicare proposals in his 2024 fiscal year budget. The American Hospital Association explains

The president’s fiscal year 2024 budget will propose policies to keep Medicare’s Hospital Insurance Trust Fund solvent for at least an additional 25 years by directing additional Medicare taxes and savings from prescription drug reforms to the HI Trust Fund, the White House announced today. According to the latest annual report by the Medicare Trustees, the fund currently has sufficient funds to pay full benefits until 2028. 

Among other Medicare provisions, the president’s budget will propose to eliminate cost-sharing for three behavioral health visits per year; require parity between physical health and mental health coverage; lower out-of-pocket costs for drugs subject to price negotiation; and cap Part D cost-sharing for certain generic drugs, the White House said.

The president’s FY 2024 budget is expected to be publicly released on March 9, with additional detail on March 13. AHA members will receive additional information on the president’s budget as those details are released.

Congress shared the budget with the Congressional Budget Office to analyze whether this plan will work.

Federal News Network reports on a recent GAO report about OPM.

The Office of Personnel Management is at “significant risk” of being unable to help agencies address governmentwide skills gaps, if it can’t first do a better job of addressing its internal skills gaps, GAO said in a report published last week.

Persistent internal skills gaps “could compromise OPM’s ability to implement its strategic objectives related to closing governmentwide skills gaps,” GAO said in the Feb. 27 report.

Although OPM has made progress in some areas of workforce management, such as creating an internal committee to hire and train new staff members, the agency is struggling to clearly identify and address several skills gaps within its own staff. * * *

Ron Sanders, former chairman of the Federal Salary Council and former associate director for HR policy at OPM, said the results of the GAO report were “unsurprising,” but that the reason behind the challenges may be difficult to measure.

“I think the skills gaps and have more to do with intangibles than they do with specific functional specializations,” Sanders, current president and CEO of Publica Virtu LLC, said in an interview with Federal News Network. 

Hang in there, OPM, which has a lot on its plate, as we all do.

Healthcare Dive tells us

  • The Federal Trade Commission will give the public an additional 30 days to comment on a sweeping proposal to ban employers from imposing noncompete contracts on their workers. 
  • The agency said interested parties have requested an extension, though acknowledged others oppose the delay. The public now has until April 19 to comment on the proposed rule, the FTC said on Monday.  
  • FTC Commissioner Christine Wilson said in a separate statement that she would have supported an even longer extension since the proposal is “a departure from hundreds of years of precedent.” 

MedCity News writes about the state of No Surprises Act rulemaking. Of note,

What the industry really needs from the government agencies at this point is a road map, or, as the Workgroup for Electronic Data and Interchange (WEDI) said in a recent letter to the secretary of HHS, a “glide path” that explains how the industry and the government will develop standards and operating rules together. In the letter, WEDI asked for the government’s expectations on vetting and testing standards and an estimate on timelines for implementing NSA regulations.

The FEHBlog heartily agrees with WEDI. Congress should consider amending certain provisions, particularly the good faith estimate and advance explanation of benefit provisions which should be amendments to the HIPAA electronic transaction standards and narrowed in scope.

From the Food and Drug Administration front —

  • STAT News provides an interview with Food and Drug Commissioner Dr. Robert Califf. For example

FDA Commissioner Robert Califf said on Monday that it “bothers” him that Novo Nordisk, which makes an obesity medication, funded the development of obesity coursework for medical schools. But he also said he saw it as an example of a drug company filling the void left by health systems that aren’t teaching doctors and trainees how to use new medicines.

“I think it’s a shame that you would need to depend on a pharmaceutical company for an educational program about something that’s affecting half of Americans,” Califf said during a meeting with STAT reporters and editors.

But, he said, “we also live in a practical real world. You might argue that if health systems did their jobs, you would have no need for educational programs from drug companies. But talk to people who practice medicine who are part of these big health systems and ask them how much help they get and guidance on what to do from the health systems they work for. I say this being a card-carrying lover of academic health systems, but that’s not where the money goes in academic health systems.”

  • Beckers Hospital Review informs us,

The FDA is set to decide whether to fully approve Leqembi, Eisai and Biogen’s Alzheimer’s treatment by July 6, CNBC reported March 6.

Leqembi is an antibody treatment that targets brain plaque associated with Alzheimer’s. The drug is administered intravenously twice a month and in clinical trials has shown it can slow early Alzheimer’s disease by 27 percent; however, the deaths of three trial participants may be tied to brain swelling caused by the drug.

The FDA approved the drug on an expedited basis in January, but CMS has made it accessible to patients only in clinical trials. CMS plans to provide broader coverage if Leqembi is fully approved, according to CNBC.

Covis Pharma Group said it will stop selling its drug to prevent preterm births, after a study couldn’t confirm the medicine worked and U.S. health regulators were taking steps that could have it pulled.

Makena was the only drug approved by the Food and Drug Administration to reduce the risk of preterm birth in women with a history of early deliveries.

Covis said Tuesday it wants to work with the FDA to set a wind-down period for the drug so that patients aren’t abruptly taken off of it. The company said it was acting after experts advising the agency recommended it pursue Makena’s withdrawal from the market.

Eli Lilly and Company (NYSE: LLY) today [March 3] announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for Verzenio® (abemaciclib), in combination with endocrine therapy (ET), for the adjuvant treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) at a high risk of recurrence. High risk patients eligible for Verzenio can now be identified solely based on nodal status, tumor size, and tumor grade (4+ positive nodes, or 1-3 positive nodes and at least one of the following: tumors that are ≥5 cm or Grade 3).1 This expanded adjuvant indication removes the Ki-67 score requirement for patient selection.

From the U.S. Healthcare business front —

  • Beckers Hospital Review tells us,
    • “The first hospitals seeking CMS’ new rural emergency hospital designation have submitted their applications, Kaiser Health News reported March 6. 
    • “Hospitals that convert receive a 5 percent increase in Medicare payments as well an average annual facility fee payment of about $3.2 million, according to the report. In return, the hospitals must close their inpatient beds and focus solely on outpatient and emergency care.”
  • Healthcare Dive informs us
    • “Regional health system Atrium Health [headquartered in Charlotte, NC] is partnering with tech retailer Best Buy to co-design hospital-at-home programming, bolster Atrium’s existing hospital-at-home program and sell to other hospital clients down the line.
    • The partnership, announced Tuesday, aims to combine Atrium’s hospital-at-home program and existing telemedicine infrastructure with Best Buy Health, the retailer’s healthcare vertical that includes care-at-home business Current Health, along with its home installation and supply chain capabilities.
    • “The Atrium and Best Buy partnership seeks to improve some aspects of hospital-at-home programs that can be particularly tricky for operators, like patient education and technology installation in the home.
  • Beckers Hospital Review tells us, “Mark Cuban Cost Plus Drug Co. has entered into an agreement with IBSA Pharma to sell Tirosint, a medication for hypothyroidism. It will be the first brand-name drug offered by Mr. Cuban’s pharmacy.”

From the medical and pharmaceutical research and studies front —

  • The Wall Street Journal relates
    • “Some doctors are urging patients to cut back their consumption of sugar substitutes as questions mount about their health effects. 
    • “In the latest study, published February in the journal Nature Medicine, Cleveland Clinic researchers found that the commonly used zero-calorie sweetener erythritol was associated with an increased risk of heart attacks, strokes and death within three years.
    • “Erythritol, a sugar alcohol produced naturally in the body, is used as a sugar substitute in low-calorie and low-carb products, often in those marketed as keto-friendly, such as ice cream, baked goods and condiments. It is also often mixed with other sweeteners. 
    • “As low-carb and ketogenic diets have grown popular, people have turned to nonsugar-sweetened products for a hit of sweetness with less sugar and carbs. Yet, researchers are warning that sugar substitutes might pose their own health concerns.”
  • Medscape considers whether Vitamin D is a viable prevention strategy for dementia.
  • The NIH Director’s Blog discusses the importance of dental/oral health care to overall health and well-being.
  • Securian Financial announced
    • “Fully 73% of Generation Z employees and 74% of Millennial employees have utilized mental health benefits offered by their employers, while 58% of Generation X employees and 49% of Baby Boomer employees have used the benefits.
    • Additionally, while 65% of Generation Z and 60% of Millennial workers say it’s “very important” for their employers to provide mental wellness benefits, just 49% of Generation X and 45% of Baby Boomer workers say the same.”
  • BioPharma Dive points out
    • “An experimental medicine for a rare blood vessel disorder [pulmonary arterial hypertension, or PAH, which is caused by a thickening of the blood vessels around the lungs] improved patients’ exercise capacity and potentially slowed the disease’s progression, according to detailed results from a late-stage clinical trial that were revealed on Monday.
    • “The drug, called sotatercept and owned by Merck & Co., was the principal prize of an $11.5 billion acquisition the pharmaceutical company negotiated more than a year ago.
    • “Data from the trial were presented at a medical conference and published in The New England Journal of Medicine. They have been highly anticipated since October when Merck said the study, dubbed STELLAR, was a success.”
  • The National Institutes of Health (NIH) announced
    • “Researchers at the National Institutes of Health show the benefits of screening adult patients in remission from acute myeloid leukemia (AML) for the residual disease before receiving a bone marrow transplant. The findings, published in JAMA(link is external), support ongoing research aimed at developing precision medicine and personalized post-transplant care for these patients.
    • About 20,000 adults in the United States are diagnosed each year with AML, a deadly blood cancer, and about one in three live past five years. A bone marrow transplant, which replaces unhealthy blood-forming cells with healthy cells from a donor, often improves these chances. However, research has shown that lingering traces of leukemia can make a transplant less effective. 
    • “Researchers in the current study wanted to show that screening patients in remission for evidence of low levels of leukemia using standardized genetic testing could better predict their three-year risks for relapse and survival. To do that, they used ultra-deep DNA sequencing technology to screen blood samples from 1,075 adults in remission from AML. All were preparing to have a bone marrow transplant. The study samples were provided through donations to the Center for International Blood and Marrow Transplant Research.

Midweek update

From our Nation’s capital, HHS Secretary Xavier Becerra made a statement honoring Black History Month which began today.

The Wall Street Journal reports

President Biden and House Speaker Kevin McCarthy began face-to-face debt-ceiling discussions [today], with the latter expressing cautious optimism that they can come to a deal to avoid the first-ever default of the country’s debt.

The Hill tells us

  • Senate Minority Leader Mitch McConnell (R-Ky.) has pulled Sen. Rick Scott (R-Fla.), who tried to oust him as the Senate’s top Republican in a bruising leadership race, off the powerful Commerce Committee.  
  • McConnell also removed Sen. Mike Lee (R-Utah), who supported Scott’s bid to replace McConnell as leader, from the Commerce panel, which has broad jurisdiction over a swath of federal agencies.  

Speaking of federal agencies, Healthcare Dive informs us

The Federal Trade Commission is penalizing GoodRx for sharing users’ sensitive health information with advertisers, in the agency’s first enforcement action under the Health Breach Notification Rule.

The FTC filed an order with the Department of Justice on Wednesday that would prohibit GoodRx from sharing user health data with third parties for advertising purposes, among other guardrails. GoodRx has also agreed to pay a $1.5 million fine, though the company admitted no wrongdoing. The order needs to be approved by a federal court in order to go into effect.

Also, the President issued a Statement of Administration Policy objecting to Republican legislative efforts to end the national and public health emergencies for the Covid pandemic without further delay. The Statement explains why the White House has opted to end those emergencies on May 11.

In that regard, Health Payer Intelligence notes

CMS announced that there will be a special enrollment period on the Affordable Care Act marketplace for individuals who lose their Medicaid coverage due to the public health emergency unwinding.

“Today, CMS is announcing a Marketplace Special Enrollment Period (SEP) for qualified individuals and their families who lose Medicaid or CHIP coverage due to the end of the continuous enrollment condition, also known as ‘unwinding,’” the FAQ sheet explained.

The special enrollment period will stretch from March 31, 2023 to July 31, 2024. In order to be eligible for the special enrollment period, individuals must be eligible for Affordable Care Act marketplace coverage and must have lost their Medicaid, Children’s Health Insurance Program (CHIP), or Basic Health Program (BHP) coverage.

From the Omicron and siblings front, Beckers Hospital Review points out

The FDA altered its emergency use authorizations on Paxlovid and Lagevrio, two COVID-19 treatments, on Feb. 1 to revoke a requirement for a positive COVID-19 test before a provider can prescribe them. 

“The agency continues to recommend that providers use direct SARS-CoV-2 viral testing to help diagnose COVID-19,” the FDA said in an emailed statement. But, “in rare instances, individuals with a recent known exposure (e.g., a household contact) who develop signs and symptoms consistent with COVID-19 may be diagnosed by their healthcare provider as having COVID-19” even if they test negative.

From the public health front —

  • The Commonwealth Fund issued a report titled “U.S. Health Care from a Global Perspective, 2022: Accelerating Spending, Worsening Outcomes.” The FEHBlog’s perception is quite sunny compared to this gloomy report.
  • The National Institutes of Health is celebrating American Heart Month.
  • The National Cancer Institute offers an interesting newsletter on its work.
  • The Wall Street considers dangerous fungi that are infecting people as a result of climate change.

From the No Surprises Act front, according to Healthcare Dive, the Texas Medical Association has filed a fourth lawsuit concerning the law. This time the TMA objects to the regulators’ entirely appropriate decision to increase the arbitration administration fee from $100 split between the parties to $700 similarly split. The arbitration or IDRE process was being bombarded with arbitration requests from providers. The fee increase will focus more provider attention on the open negotiation period that precedes the arbitration. “The suit also challenges the laws’ restrictions on batching claims, which allows arbitration processes only on claims with the same service code, requiring providers to go through a separate payment dispute process for each claim related to an individual’s care episode, according to the suit.” Quelle domage.

From the U.S. healthcare business front

  • Beckers Payer Issues reports, “Humana posted revenues of nearly $93 billion in 2022 and a net loss of $15 million in the most recent quarter, according to its year-end earnings report published Feb. 1.  The company also appointed Steward Health Care President Sanjay Shetty, MD, to lead its healthcare services business, CenterWell, which includes pharmacy dispensing, provider and home health services. Dr. Shetty will start April 1. In addition, the company promoted its Medicare president, George Renaudin, to president of Medicare and Medicaid, effective immediately.”
  • Beckers Hospital Review examines whether Amazon can disrupt the pharmacy industry.

From the Medicare front, the Centers for Medicare and Medicaid Services released

the Calendar Year (CY) 2024 Advance Notice of Methodological Changes for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (the Advance Notice). CMS will accept comments on the CY 2024 Advance Notice through Friday, March 3, 2023. CMS will carefully consider timely comments received before publishing the final Rate Announcement by April 3, 2023.

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From Capitol Hill, Roll Call reports

The Biden administration will send its budget for the next fiscal year up to Capitol Hill on March 9, according to a memo from top White House aides.

That’s about a month later than the statutory deadline, which is the first Monday in February, though that target is often missed and there’s no penalty for doing so.

National Econonic Council Director Brian Deese and Office of Management and Budget Director Shalanda Young laid out the timing in a memo to “interested parties” that also discussed agenda topics for Wednesday’s scheduled meeting between President Joe Biden and Speaker Kevin McCarthy, R-Calif.

The memo, first reported by ABC News, said Biden will ask McCarthy to “commit to the bedrock principle that the United States will never default on its financial obligations,” a reference to the upcoming fight over the statutory debt ceiling. Treasury Secretary Janet L. Yellen has warned that the U.S. could be in danger of missed payments by early June if Congress doesn’t act to raise or suspend the $31.4 trillion debt limit.

The memo also says Biden will urge McCarthy and House Republicans to release their own fiscal 2024 budget blueprint that spells out the spending cuts they want to attach to any debt limit deal and how their budget will balance if they plan to extend expiring tax cuts.

Senator Tina Smith (D MN) and a bipartisan group of colleagues sent several large health insurers a letter requesting answers to questions about ghost networks. It turns out the ghost networks are online provider directories with errors. The FEHBlog thinks that the Senators should be pressuring the No Surprises Act regulators to implement the provider directory accuracy provision in that law.

From the Omicron and siblings front, the New York Times explores why Paxlovid, a reliable treatment, is underprescribed by doctors.

Doctors prescribed it in about 45 percent of recorded Covid cases nationwide during the first two weeks of January, according to White House data. In some states, Paxlovid is given in less than 25 or even 20 percent of recorded cases. (Those are likely overestimates because cases are underreported.)

Why is Paxlovid still relatively untapped? Part of the answer lies in a lack of public awareness. Some Covid patients also may decide that they don’t need Paxlovid because they are already vaccinated, have had Covid before or are younger. (My colleagues explained why even mild cases often still warrant a dose of Paxlovid.) * * *

Experts have increasingly pointed to another explanation for Paxlovid’s underuse: Doctors still resist prescribing it. Today’s newsletter will focus on that cause.

Some doctors have concerns that are rooted in real issues with Paxlovid and inform their reluctance to prescribe it. But experts are unconvinced that those fears are enough to avoid prescribing Paxlovid altogether, especially to older and higher-risk patients.

“What I’m doing for a living is weighing the benefits and the risks for everything,” said Dr. Robert Wachter, the chair of the medicine department at the University of California, San Francisco. In deciding whether to prescribe Paxlovid, he said, the benefits significantly outweigh the risks.

This isn’t very encouraging.

From the U.S. healthcare business front —

Beckers Hospital Review reports

Six years after regulators approved Amjevita, a biosimilar to the nation’s most lucrative drug, Humira, Amgen’s drug jumped on the U.S. market Jan. 31 with two list prices.

The biosimilar to AbbVie’s most profitable drug will either cost 5 percent or 55 percent less than Humira’s price, according to Amgen. Humira costs $6,922 for a month’s supply, meaning Amjevita’s price — depending on the buyer — will be $6,576 or $3,115. The higher price is designed to entice pharmacy benefit managers, and the lower one is for payers, according to Bloomberg

As Humira’s 20-year, $114 billion, 247-patent-strong monopoly ends with the first biosimilar, more copycat versions are set to premiere in the next few months.

STAT News dives deeper into the implications of Amgen’s pricing approach.

AHIP responded yesterday to CMS’s final Medicare Advantage plan audit rule.

“Our view remains unchanged: This rule is unlawful and fatally flawed, and it should have been withdrawn instead of finalized. The rule will hurt seniors, reduce health equity, and discriminate against those who need care the most. Further, the rule would raise prices for seniors and taxpayers, reduce benefits for those who choose MA, and yield fewer plan options in the future. 

“We encourage CMS to work with us, continuing our shared public-private partnership for the health and financial stability of the American people. Together, we can identify solutions that are fair, are legally sound, and ensure uninterrupted access to care and benefits for MA enrollees.” 

Is the next step the courthouse?

Money Magazine offers a list of hospitals that provide bariatric surgery with Leapfrog safety grades.

From the mental healthcare front, Fierce Healthcare tells us

Parents can now be added alongside providers, health insurers and employers to the list of stakeholders with growing concerns about mental health, according to a study by the Pew Research Center.

The study found that 40% of parents call the fact that their children might be struggling with anxiety and depression their No. 1 concern—something they’re extremely or very worried about—followed by 35% of parents who put the fear that their children are being bullied into that category.

From the tidbits department —

  • The NY Times lists ten nutrition myths that experts wish would be forgotten.
  • The NIH Directors blog explains why a “New 3D Atlas of Colorectal Cancer Promises Improved Diagnosis, Treatment.”
  • The National Association of Plan Advisors points out that “Despite a rebound in out-of-pocket health care spending in 2021, health savings account (HSA) balances increased on average over the course of the year, the Employee Benefit Research Institute (EBRI) recently found. Its analysis of HSA balances, contributions, and distributions also found, “patients sought health care services more frequently in 2021—and spent more out of pocket, as well—than they did in 2020, yet the average end-of-year balance was higher than the average beginning-of-year balance.”