Happy Flag Day!

Rx coverage

Happy Flag Day!

David Ermer–ACA, CMS, Congress, FDA, No Surprises Act, Rx coverage, U.S. Healthcare–
Thanks to Aaron Burden for sharing their work on Unsplash.

From Washington DC —

  • The Senate Finance Committee announced
    • “Senate Finance Chairman Ron Wyden (D-Ore.), Senate Finance Ranking Member Mike Crapo (R-Idaho) alongside U.S. Senators Bob Menendez (D-N.J.), Marsha Blackburn (R-Tenn.), Jon Tester (D-Mont.), Roger Marshall (R-Kan.), today introduced the Patients Before Middlemen (PBM) Act to delink the compensation of pharmacy benefit managers (PBMs) from drug price and utilization in order to better align incentives that will help lower prescription drugs costs for Medicare Part D beneficiaries.”
  • Fierce Healthcare informs us
    • “While national health spending growth slowed in 2022, that trend isn’t likely to stick around.
    • “Experts at the Centers for Medicare & Medicaid Services’ Office of the Actuary predict that health spending growth will outstrip growth in the economy over the next decade, according to a study published in Health Affairs. Between 2022 and 2031, the actuaries predict spending will increase by 5.4% on average each year, faster than the estimated annual gross domestic product growth of 4.6%.”
  • As the French say, Plus ça change, plus c’est la même chose (literally the more it changes, the more it’s the same thing”.
  • CMS made its No Surprises Act website more consumer friendly.

In conference news, MedPage Today fills us in on the American Medical Association conference and Smartbrief does the same for the AHIP conference.

From the Rx coverage front —

  • Beckers Hospital Review tells us,
    • “Mark Cuban Cost Plus Drug Co. considered selling insulin but found the price doubled with shipping costs, CEO and co-founder Alex Oshmyansky, MD, PhD, said June 13 at the AHIP conference. * * *
    • “We were working on bringing in an insulin product to the market for quite some time,” he said at the conference. “We did actually bring one to the market, we did it as sort of a closed beta pilot to see what consumer response would be. But ultimately, direct to consumer mail-order it was $35 for a month’s supply but $65 for the shipping and handling. It didn’t quite make sense within our model. We almost viewed it as a solved problem from the consumer perspective at this point. You know, almost everyone has access to $35 insulin in one form or another now.”
  • Reuters reports,
    • “Pfizer (PFE.N) has warned that a drug used to treat syphilis and other bacterial infections in children could run out by the end of June because it has had to prioritize versions made for adults due to a spike in syphilis infections in that population.
    • “Supply of the pediatric version of the drug, Bicillin L-A, is expected to be exhausted by the end of this quarter, the company said in a letter to the U.S. health regulator dated Monday. Pfizer said in an email on Tuesday that the pediatric formulations of the antibiotic are not widely used.”
  • Medscape informs us
    • The US Food and Drug Administration (FDA) has expanded the indication for linaclotide (Linzess) to children as young as age six years with functional constipation, making it the first approved treatment for pediatric functional constipation.
    • The recommended dosage in pediatric patients is 72 mcg orally once daily.
    • Functional constipation is common in children and adolescents. Symptoms include infrequent bowel movements with hard stools that can be difficult or painful to pass.
    • There is no known underlying organic cause, and there are typically multiple contributing factors, the FDA notes in a statement announcing the approval.

From the U.S. healthcare business front —

  • Healthcare Dive notes,
    • “Pent-up demand for delayed healthcare during the COVID-19 pandemic is pressuring medical costs for health insurers that had a financial windfall during the pandemic amid low utilization.
    • “UnitedHealth, the parent company of the largest private payer in the U.S., expects its medical loss ratio — the share of premiums spent on member’s healthcare costs — to be higher than previously expected in the second quarter of 2023, due to a surge in outpatient care utilization among seniors,” CFO John Rex said Tuesday during Goldman Sachs’ investor conference.”
  • Fierce Healthcare relates,
    • “Cerner brought in $1.5 billion in revenue in the latest quarter, boosting strong growth for enterprise software giant Oracle. The health IT company also generated $5.9 billion in revenue for Oracle’s 2023 fiscal year, which ended May 31.
    • “Oracle’s revenue reached an all-time high of $50 billion last year, driven by growing demand for its cloud offerings from companies deploying AI.”

In litigation news —

  • Health Payer Intelligence points out,
    • On June 13, “A federal appeals court approved an agreement between parties in Braidwood Management v Becerra, preserving the mandate requiring health plans to cover preventive care services based on recommendations from the US Preventive Services Task Force (USPSTF). * * *
    • “While the federal government works to appeal Judge O’Connor’s ruling, it cannot penalize Braidwood Management for refusing to cover USPSTF-recommended preventive care services. Additionally, if the court upholds the mandate in the appeal, the Biden administration cannot retroactively penalize the plaintiff.”

Monday Roundup

David Ermer–Congress, COVID-19, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC —

  • Roll Call tells us “A disagreement between Speaker Kevin McCarthy and House conservatives that jammed up legislative business last week eased Monday evening, but members of the rebel bloc made clear it may not be the end of trouble for their leadership.”
  • Govexec informs us
    • “After multiple years of significant spending increases at non-defense agencies, Congress has reverted to austerity by demanding an overall freeze of discretionary funding for domestic agencies. 
    • “The pullback, agreed to as part of a deal struck by President Biden and House Republicans to meet GOP demands for raising the debt ceiling, will force agencies to make difficult decisions as they abandon some efforts to launch new programs and grow existing ones. The 2023 Fiscal Responsibility Act set only a top-level cap for non-defense spending, leaving it to Congress to establish line-by-line funding levels across government. 
    • “The impacts will look different agency to agency,” said Rachel Snyderman, a senior associate director at the Bipartisan Policy Center and former Office of Management and Budget official.”
  • Federal News Network helpfully reviews the 71 public comments submitted to OPM in response to its April 6, 2023, interim final rule implementing the Postal Service Health Benefits Program.
  • Health Payer Intelligence relates, “AHIP offered four recommendations to the Senate Finance Committee on Consolidation and Competition (the Committee) [last week] to support healthy competition and lower healthcare spending in the healthcare industry.”

From the litigation front —

  • Yahoo News reports,
    • “The Biden administration on Monday finalized a deal to preserve the federal mandate requiring U.S. health insurers to cover preventive care like cancer screenings and HIV-preventing medication at no extra cost to patients while a legal challenge continues.
    • “The agreement, first disclosed on Friday and now finalized in a filing in the New Orleans-based 5th U.S. Circuit Court of Appeals, leaves the mandate in place nationwide while the administration appeals a court order striking it down.
    • “It does allow Texas-based Braidwood Management, one of a group of businesses and individuals that sued to challenge the mandate, to stop covering pre-exposure prophylaxis (PrEP) against HIV and other preventive services for its employees for now. The administration agreed not to take any retroactive enforcement action against the company, which operates an alternative health center if the mandate is restored on appeal.”
  • STAT News adds,
    • “The U.S. Chamber of Commerce sued the federal government over its new Medicare drug-price negotiation program on Friday, arguing that Congress tried to take too much power away from the courts.
    • “The lawsuit is the second to challenge the new program, enacted by Democrats last August in the Inflation Reduction Act, within a week’s time, but relies on different legal reasoning. Merck, which makes a diabetes drug that could be subject to negotiation, sued on Tuesday.
    • “Medicare is supposed to choose the first ten drugs to be negotiated by the program by Sept. 1. The goal of the lawsuits is to slow down or stop the process from going into effect.”

From the public health front —

  • Politico relates,
    • “The FDA’s independent advisers will discuss and recommend this week which strain of SARS-CoV-2 should be included in the newest Covid booster to be rolled out ahead of fall and winter. The FDA doesn’t have to follow its advisers’ recommendations, but it often does.
    • “Since the beginning of the year, the regulatory agency has made it clear that it will shift gears to prepare for annual Covid-19 shots as the virus becomes endemic. Now that we’re four months out from the intended rollout, the FDA must select a strain that will most likely be prevalent so manufacturers can start developing vaccines.
    • “Novavax, Pfizer-BioNTech and Moderna, the companies that manufacture the three vaccines available in the U.S., need the FDA’s recommendations to begin tweaking their existing platforms. They must also conduct clinical trials to show that the updated formulas generate a similar immune response to their existing products.”
  • MedPage Today reports,
    • “Oseltamivir (Tamiflu) has not panned out for reducing the risk of influenza hospitalization, according to a large meta-analysis.
    • “Among over 6,000 flu patients across 15 studies, the 0.14-percentage point difference in hospitalization rate between those who took oseltamivir and those who did not was not significant (RR 0.77, 95% CI 0.47-1.27), Emily McDonald, MD, MSc, of McGill University Health Centre in Montreal, and colleagues reported in JAMA Internal Medicine.
    • “I wouldn’t prescribe it to an otherwise healthy person,” McDonald told MedPage Today. “There was little evidence that it would prevent you from going to the hospital.”
    • “What’s more, she added, “it’s not completely benign. It does cause uncomfortable side effects.”
  • The Wall Street Journal reports,
    • “During the pandemic, Carl Prudhomme of Alpine, Texas, got his cancer drugs mailed directly to him from his oncologist.
    • “No longer. With the end of the Covid-19 public-health emergency, independent cancer doctors can no longer send prescriptions directly to their Medicare patients—creating hurdles for some people in rural areas who say they have to travel to get their medications. Prudhomme plans to drive the 569 miles each way to his oncologist’s office in Houston every three months to pick up his drugs in person.
    • “The Centers for Medicare and Medicaid Services in September 2021 posted a list of frequently asked questions that said independent oncologists can dispense prescriptions only to a patient who is physically in the doctor’s office at the time. 
    • “Sending oral chemotherapy drugs by mail violates the Stark law, the agency said. The law bans doctors from making referrals of Medicare and Medicaid patients to other organizations or medical businesses where they have a financial stake. The restriction also applies to other independent practices, such as urology, that have an on-site dispensing pharmacy.
    • “Roughly 30% of the more than 5,000 independent oncologists in the U.S. have on-site pharmacies in their practices, according to an analysis led by the University of Pennsylvania’s Perelman School of Medicine. 
    • “The restriction was suspended during the pandemic public-health emergency. Its return has alarmed cancer doctors who are lobbying Congress and CMS to rescind the restriction, even if that means undergoing new rule-making to do so.”

From the U.S. healthcare business front —

  • Fierce Healthcare tells us,
    • “Prior authorization has been a flashpoint for providers, and, while insurers have taken steps to ease these utilization management protocols, they still play a key role as the industry shifts to value-based care.
    • “David Brailer, M.D., executive vice president and chief health officer at the Cigna Group, told Fierce Healthcare in an interview that ultimately the goal is to ensure patients are receiving the best treatment option for them.
    • “And the insurer has seen that in more advanced value-based arrangments, it can relax prior authorization and other utilization management tools, Brailer said. 
    • “That’s going to be a few years before the market shifts,” he said. “We’ve already announced that we’re starting to step down the number of prior auths that we have.”
  • STAT News relates,
    • “Novartis said on Monday it would purchase Chinook Therapeutics for $3.2 billion upfront, picking up two drugs for a chronic kidney disease that are in late-stage clinical trials.
    • “The transaction values Seattle-based Chinook at $40 a share, compared to Friday’s closing price of under $24. The agreement includes another $300 million if certain regulatory milestones are reached.”
  • Healthcare Dive points out
    • CVS Health’s decision to shut down its two-year-old clinical trials unit means less competition for the growing group of retailers in research, but the area is still nascent and potentially challenging for new entrants, experts said.
    • “It may sort of spook some pharma companies who may think that if CVS exited, maybe these other companies will also exit, and it may make them a little bit more hesitant to partner up with the retailers,” said Sari Kaganoff, general manager of consulting at Rock Health. “At the same time, there’s a lot of opportunity, we believe, for pharma companies to use retailers for clinical trials.”
    • CVS will fully exit the clinical trials business by the end of 2024, winding down the business in phases and working with trial sponsors to ensure patients continue to receive care. 

From the Rx coverage front —

  • The Wall Street Journal informs us,
    • Kristen Ireland struggled with bulimia nervosa for years, working with a therapist and taking medications for anxiety and depression.
    • It wasn’t until her psychiatrist prescribed Victoza, a diabetes medication that works much like Ozempic, Wegovy and Mounjaro, that her binges and purges faded away.
    • “I feel free now,” said Ireland, 27 years old, who manages sports-merchandise stores in Jackson Hole, Wyo. 
    • Treating eating disorders is another potential application for a class of drugs that has taken the weight-loss world by storm. The drugs, synthetic versions of the GLP-1 hormone that act on appetite centers in the brain and gut, have helped patients lose 15% of their body weight on average
    • Some studies and the experience of doctors in the field suggest they could also help people stop binge eating.
  • CBS News discusses the side effects of these new weight loss drugs.

Weekend update

David Ermer–Congress, Rx coverage, SCOTUS, U.S. Healthcare–

From Washington, DC —

  • The House of Representatives and the Senate are in session this week for floor voting and Committee business.
  • The Supreme Court has over 20 opinions to issue before it can end its October 2022 term.
  • Fierce Healthcare reports,
    • The Federal Trade Commission is building out its deep dive into the pharmacy benefit management industry yet again.
    • The agency said Thursday that it has sent an order to the group purchasing organization Emisar Pharma Services, requiring it to provide information and records pertaining to its business practices. The order follows similar missives sent to two other GPOs, Zinc Health Services and Ascent Health Services, last month.
    • Emisar negotiates rebates with drugmakers on behalf of Optum Rx, a UnitedHealth Group subsidiary and one of the three largest PBMs.
    • The FTC said its order to Emisar is “substantially similar” to those issued to Zinc and Ascent.

Fortune Well offers us advice on the following topics:

McKinsey and Company explains how to improve children’s developmental trajectories.

Washington Post columnist discusses her recent experience taking Ozempic at length.

  • “I cannot claim to have done this for my health — certainly, appearance was my primary motivation — but the health impact has been impressive. My sleep apnea had been so severe that tests showed I was waking up an alarming 54 times every hour; new testing put it in the mild range, and my sleep apnea machine has been stashed in the closet. In November 2020, my LDL cholesterol — the “bad” kind, which raises your risk of heart disease and stroke — was at 146; it was down to 133 by March 2022 and, a year later, to 120. My A1c levels, measuring blood sugar, have fallen from on the cusp of prediabetes to safely in the normal range. My blood pressure is lower, and my C-reactive protein, an indicator of cardiovascular disease, has plummeted. * * *
  • “There are two things that are important for readers to know: My response to the medication has been extraordinary, and my experience with insurance coverage has also been unusually positive. Most insurers do not currently cover medications for obesity alone. But my doctor was able to point to my risk of developing diabetes, and my insurer, thankfully, did not question the need for coverage. “Ozempic, $24.99,” the Walgreens website informs me when I look back at my prescription records. “Insurance saved you: $1,046.10.”

Thursday Miscellany

David Ermer–CMS, Congress, COVID-19 vaccine, FDA, HSA, Medical / Rx research, Medicare, Rx coverage, Telehealth–
Photo by Josh Mills on Unsplash

From Washington, DC —

  • The Senate Finance Committee held a hearing today about “Consolidation and Corporate Ownership in Health Care: Trends and Impacts on Access, Quality, and Costs.”
  • Mercer Consulting informs us
    • “Two key House committees voted this week to send a series of health care bills to the House floor, including legislation to make permanent the ability of health savings account-qualifying high-deductible health plans (HSA-qualifying HDHPs) to cover telehealth and other remote care services on a predeductible basis. Originally enacted as part of the 2020 Coronavirus Aid, Relief and Economic Security (CARES) Act, this flexibility was most recently extended as part of the 2023 Consolidated Appropriations Act, and now is set to expire on Dec. 31, 2024, for calendar-year plans (later for noncalendar-year plans).”
  • “The U.S. Department of Health and Human Services (HHS) released the STI Federal Implementation Plan to detail how various agencies and departments across the federal government are taking a comprehensive approach to making meaningful and substantive progress in improving public health. This new plan builds on other key HHS actions to protect the public’s health by addressing the growing threat of sexually transmitted infections (STIs) in America.”
    • Roll Call identifies potential obstacles to implementing this plan.
  • Govexec reports
    • “As smoke from Canadian wildfires moves into the Northeast and Mid-Atlantic regions of the United States, triggering air quality warnings in several cities, the Office of Personnel Management on Thursday reminded agencies to protect the health of federal workers who ordinarily may work or commute to work amid the hazardous haze.”
      • Healthcare Dive discusses health system reactions to this problem.
        • “Hospitals in the northeastern U.S. are keeping an eye on air quality as smoke from Canadian wildfires envelops the region. Most health systems contacted by Healthcare Dive did not report significant spikes in patient volumes yet, but they said they’re continuing to monitor the situation.
        • “Millions of people live in areas currently under air quality alerts, and meteorologists say conditions may not significantly improve for a few more days.
        • “Health systems in the region are urging residents to stay indoors and use masks — particularly snug-fitting N95s — when traveling outside. Though everyone should limit their time outdoors, it’s especially important for older people, children and pregnant women as well as those with conditions like heart or lung disease or asthma, according to Kristin Fless, a pulmonologist at RWJBarnabas Health Medical Group.”
  • The Wall Street Journal relates
    • “Ashish Jha, the White House Covid-19 czar, will be leaving his post next week in the latest sign the Biden administration is confident the country is on stronger footing in its fight against the virus.
    • “Jha plans to leave June 15 and return July 1 to his previous position as dean of Brown University’s School of Public Health. He will be the last of the administration’s rotating Covid-19 czars. Instead, the director of the White House’s nascent Office of Pandemic Preparedness and Response Policy, who hasn’t been named, will advise the president and coordinate federal responses to various biological and pandemic threats.”

From the  public health front —

  • Mercer Consulting tells us
    • Our research over the past few years has tracked the ways employers are working to align employee benefit programs with their organizations’ overarching DEI goals. For Pride month, here’s a round-up of survey results relating to health and well-being benefits of particular importance to the LGBTQ+ community.
    • Here’s a link to the article.
  • The American Hospital Association reports
    • “The first data on the safety of a third mRNA COVID-19 vaccine dose among young children show that a third dose is safe for children ages 6 months to 5 years old, similar to findings for doses one and two, the Centers for Disease Control and Prevention reportedtoday, based on reports to the Vaccine Adverse Event Reporting System and v-safe voluntary smartphone health checker for use after vaccination.
    • “This study’s findings can reassure health care professionals, parents, and caregivers that a third dose of COVID-19 vaccine is safe for children ages 6 months to 5 years and can protect them from severe illness,” CDC said.
    • “While CDC recommends that all children ages 6 months through 5 years old receive at least 1 bivalent mRNA COVID-19 vaccine dose, vaccination rates among this age group have been low.”
  • Health Payer Intelligence informs us
    • “Group health insurance plan members with high healthcare spending often have one or more of the same five chronic diseases, according to a fast facts sheet from the EBRI Center for Research on Health Benefits Innovation (EBRI CRHBI).
    • “The study covered healthcare claims from 8.6 million group insurance health plan members using 2021 data from the Merative MarketScan Commercial Database. Members were 65 years of age or younger and the health plans covered a variety of types.
    • “Five conditions were very common among the group health insurance plan members with the highest healthcare spending: heart disease, respiratory conditions, musculoskeletal conditions, nervous system conditions, and skin disorders. A couple of these are among the most expensive chronic diseases in the US. They are also some of the most common comorbidities.”

From the Rx coverage front —

  • BioPharma Dive notes that tomorrow a Food and Drug Administration advisory committee will consider recommending that the FDA give full marketing approval to the Alzheimer’s drug Leqembi.
    • “A closely watched Alzheimer’s disease medicine appears to be heading toward broader approval, as documents released Wednesday show the Food and Drug Administration appears to have few concerns with it.”
  • BioPharm Dive also tells us that “After years of disappointment, cancer vaccines show new promise. Moderna presented new data at ASCO for its melanoma shot, highlighting progress with a personalized approach that’s also being pursued by BioNTech and Gritstone.”
    • “Moderna is testing its shot, mRNA-4157, together with Merck’s immunotherapy Keytruda in people with melanoma who have had their primary tumors removed. The goal of such “adjuvant” treatment is to prevent cancer from returning.
    • “In December, the company reported the two drugs reduced the relative risk of death or recurrence by 44% over Keytruda alone. The new data came from an analysis of the risk of cancer spreading to distant organs or tissues, or “distant metastasis free survival.”
    • “One-third of patients who receive Keytruda in this setting experience such spread, driving researchers’ work to come up with better options. “We know that patients with distant metastases experience more morbidity and mortality,” said Adnan Khattak, a clinical professor at Edith Cowan University in Australia, who presented the Moderna data at ASCO.
    • “In the combination trial, mRNA-4157 and Keytruda reduced the risk of distant spread or death by 65% compared to Keytruda alone.”
  • The Associated Press reports
    • “A growing shortage of common cancer treatments is forcing doctors to switch medications and delaying some care, prominent U.S. cancer centers say.
    • “The National Comprehensive Cancer Network said Wednesday that nearly all the centers it surveyed late last month were dealing with shortages of carboplatin and cisplatin, a pair of drugs used to treat a range of cancers. Some are no longer able to treat patients receiving carboplatin at the intended dose or schedule. 
    • “Dr. Kari Wisinski has had to turn to other treatments for some patients or switch the order in which people receive their drug combinations. She said she’s done that “hoping that within three months there will be a better carboplatin supply.” * * *
    • “The U.S. Food and Drug Administration has taken some steps to try to ease the chemotherapy shortage. The agency is allowing the temporary importation of some foreign-approved versions of cisplatin from factories registered with the FDA.”
  • Beckers Hospital Review adds “Seventy percent of the 20 most commonly prescribed medications from GoodRx are in shortage, according to databases from the FDA and the American Society of Health-System Pharmacists.” The article goes on to list the drugs subject to shortages.

From the Medicare front —

  • Beckers Payer Issues informs us
    • “The FDA and CMS are discussing how to handle obesity drugs in Medicare, Bloomberg Law reported June 7. 
    • “The two agencies are in talks over “what to do about obesity drugs,” FDA Commissioner Robert Califf said at the Biotechnology Innovation Organization convention in Boston. Mr. Califf’s comments indicate CMS could expand weight loss benefits, according to Bloomberg Law’s report. 
    • “New GLP-1 drugs to treat obesity and diabetes can be expensive, costing upward of $10,000 a year without insurance coverage. GLP-1 drugs, including Ozempic, Trulicity, Victoza and Mounjaro, are used to treat Type 2 diabetes. Wegovy and Saxenda are approved for weight loss.  
    • “Under current law, Medicare is prohibited from covering weight loss drugs. Drug manufacturers are lobbying Congress to require the program to pay for the drugs. Proposed legislation to pay for the drugs has stalled. 
    • “The drugs could have a big effect on Medicare Part D spending. If 10 percent of people with obesity covered by Medicare were prescribed a brand-name semaglutide, a type of GLP-1, the drug would cost Medicare $26.8 billion annually, according to a study published in the New England Journal of Medicine in March.”
  • and
    • “Medicare spending per person grew by an average of 4.6 percent annually between 2000 and 2022, according to a June 6 analysis from KFF. 
    • “KFF analyzed data from the 2023 Annual Report of the Boards of Trustees of the Federal Hospital Insurance and Federal Supplementary Medical Insurance Trust Funds. 
    • “KFF said the “influx of the Baby Boomer Generation added many relatively younger, healthier people to the Medicare beginning in 2011,” while the share of adults aged 80 and older enrolled in the program also continues to grow. Growth in healthcare spending is attributed to this increased volume and use of services, along with the availability of new technologies and rising prices.”
      • 2018: $13,579
      • 2019: $14,189
      • 2020: $14,373
      • 2021: $15,139
      • 2022: $15,727

Monday Roundup

David Ermer–HSA, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the public health front —

  • The Wall Street Journal reports
    • “Doctors are coalescing around the ironic idea that for some cancer treatment, less can be better. 
    • Some patients with cervical and pancreatic cancer can do as well with less invasive surgery, according to research presented at the American Society of Clinical Oncology conference in Chicago over the weekend. Other studies at the annual meeting showed some patients with rectal cancer or Hodgkin lymphoma can safely get less radiation. 
    • “The findings expand a body of evidence doctors are using to design treatment plans that aim to reduce side effects and costs. They call the strategy de-escalation: cutting back on some therapies to improve a patient’s quality of life without hurting their odds of survival.
    • “Newer treatments and tests are extending patients’ lives and moving cancer care away from a blunt, one-size-fits-all approach. On the strength of studies like those presented in Chicago, doctors are getting better at determining who needs the most aggressive care and who can get away with less treatment and less collateral damage.
  • The Journal also reminds readers that
    • “The approach of summer means warmer days, more time outside—and nagging worries about ticks. What to do if you find one on yourself?
    • “Get it off, pronto. To infect you with Lyme disease, a tick must bite and attach to your skin, typically for at least 24 hours. Take care as you remove it. In some cases, you should call your doctor after you take it off.
    • “Lyme disease is especially common in the Northeast and Midwest, transmitted by blacklegged ticks. They can transmit other pathogens that cause different diseases, too. And other types of ticks can transmit other diseases.
    • “This year, parts of the Northeast should expect a particularly bad season for tick-borne diseases, says Richard S. Ostfeld, a senior scientist at the Cary Institute of Ecosystem Studies in Millbrook, N.Y., who has been monitoring local tick populations and their hosts for 30 years.”
  • Fierce Healthcare tells us,
    • “Self-insured employers face myriad challenges in trying to manage growing healthcare costs, and one of those results from recent history, according to a survey by the National Alliance of Healthcare Purchaser Coalitions (NAHPC).
    • “Employers are seeing a rise in high-cost claims for younger plan members, with $1 million+ claims disproportionately weighted toward this demographic,” the NAHPC survey said. “The top conditions for these claims include cancer, prenatal/neonatal care, and treatment for COVID-19/long COVID.”
    • “The NAHPC survey is based on input from the Alabama Employer Health Consortium, the Dallas Fort-Worth Business Group on Health, HealthCareTN and the Nevada Business Group on Health. NAHPC and affiliated organizations represent 45 million Americans who spend over $400 billion annually on healthcare. 
    • “The employers’ concerns come from a pre-survey of 39 firms that was conducted in October and November 2022 and a series of roundtables that NAHPC held with 50 employers conducted in November 2022.

From the Rx coverage front —

  • BioPharma Dive informs us,
    • “Johnson & Johnson expects its cancer cell therapy Carvykti to become a go-to option for treating multiple myeloma earlier, presenting Monday a fuller look at clinical trial results that show the therapy substantially outperformed the current standard.
    • “In the trial, Carvykti reduced the risk of disease progression or death by 74% versus one of two commonly used drug combinations in patients for whom a mainstay medicine called Revlimid no longer works. According to J&J, it’s the largest relative risk reduction to be reported in a Phase 3 study of a treatment for the blood cancer.”
  • Medscape relates,
    • “Patients with a certain type of brain tumor could soon be treated with an oral targeted drug instead of undergoing more toxic chemotherapy and radiation, say researchers reporting new results that could potentially change the treatment landscape.
    • “The investigational drug vorasidenib (Servier) is awaiting approval for use in gliomas bearing mutations in isocitrate dehydrogenase 1 and 2 (IDH1, IDH2).
    • “Results from the pivotal phase 3 INDIGO trial show that the drug was associated with a significant delay in time to disease progression when compared with placebo.  
    • “The median progression-free survival (PFS) was 27.7 months for patients on vorasidenib, compared with 11.1 months for patients assigned to placebo (hazard ratio (HR) for progression or death with vorasidenib of 0.39 (P < .0001).”
  • BioPharma Dive adds,
    • “Wedged into the surface of a tumor cell, the protein called HER2 acts as a homing beacon for some of the most potent cancer medicines developed. Its discovery decades ago, and abnormal abundance in some breast cancers, led to the development of targeted drugs like Herceptin that have greatly improved patient care.
    • “Results from an exploratory clinical trial unveiled Monday suggest targeting HER2 could also be a useful strategy against other cancers that are not as widely associated with the protein.
    • “The findings, which will be presented at the American Society of Clinical Oncology’s annual meeting in Chicago, show that a newer HER2-targeting drug called Enhertu shrank tumors of the uterus, cervix, ovaries, bladder and, to a lesser extent, bile duct. In this way, they’re another data point in a yearslong shift toward describing cancers by their genetics, rather than only by their location in the body.
    • “Developed by AstraZeneca and Daiichi Sankyo, Enhertu is different from drugs like Herceptin, which interfere with how HER2 incites tumor growth. Instead, Enhertu combines a targeting molecule aimed at HER2 with a cell-killing toxin in a biochemical assemblage known as an antibody-drug conjugate.
    • “The reason why this [result] is exciting is that the tumor doesn’t have to be addicted to HER2 to respond to this therapy,” said Angela DeMichele, a medical oncologist at Penn Medicine. “The HER2 in this case is acting as a docking station for delivery of the chemotherapy.”
  • The Institute for Clinical and Economic Research proposed today
    • “a set of changes to its methods and processes for conducting value assessments, beginning in 2024. These proposals are based on ICER’s experience in methods development for health technology assessment (HTA) reports in the US, benchmarking with HTA agencies around the world, and input from stakeholders across the US health system. ICER is accepting public comment on these proposals through June 30, 2023.
    • “Areas with proposed changes include:
      • “Clinical trial diversity ratings and other methods adaptations related to health equity.
      • “Cost-effectiveness scenarios related to potential effects of Medicare drug price negotiation.
      • “New methods to ensure that cost-effectiveness analyses done according to a modified societal perspective have “non-zero” inputs for impacts on productivity for the patient and caregivers, even when direct data are lacking.”

From the U.S. healthcare business front —

  • Fierce Healthcare reports
    • “The home health bidding wars are heating up as UnitedHealth Group’s Optum unit is making a big play for home health and hospice firm Amedisys.
    • “Just one month ago, Amedisys agreed to be bought by another healthcare company, Option Care Health, a provider of post-acute care and infusion services. That deal valued Amedisys at $3.6 billion. That deal was expected to close in the second half of 2023.
    • “Optum has made an all-cash offer of $100 per share to Amedisys’ board of directors, the healthcare behemoth announced Monday morning. The deal represents a “superior proposal for Amedisys shareholders, with price certainty at a 26% premium over most recent share price,” Optum executives said. According to news reports, the deal is valued at $3.26 billion
    • “Option Care Health proposed last month to buy the company for roughly $97.38 per share.
    • “On May 27, 2023, the Board determined that the unsolicited proposal received from Optum could reasonably be expected to result in an ‘Amedisys Superior Proposal’ as defined in Amedisys’ merger agreement with Option Care Health,” Amedisys wrote in a filing with the Securities and Exchange Commission (SEC). “As permitted by the terms of Amedisys’ merger agreement with Option Care Health, Amedisys entered into a confidentiality agreement with Optum on May 30, 2023, and is currently engaging in exploratory discussions with Optum with respect to Optum’s proposal.”

From the plan design front —

  • Govexec encourages federal and postal employees to consider a high deductible health plan with a health savings account for 2024. Although the Govexec headline is directed at federal and postal employees under age 65 also can take advantage of health savings accounts.
    • “Once you turn 55, you’ll be able to contribute an additional $1,000 per year as a “catch-up” contribution on top of the normal contribution maximum.
    • “Once you turn 65, a big change with your HSA takes place: You’re allowed to make non-medical distributions and only pay your regular tax obligations. Prior to age 65, non-medical distributions would create a 20% income-tax penalty on top of your normal taxes. This change gives you more flexibility on how to use your HSA funds, including as supplemental retirement income.
    • “There are other healthcare-related qualified expenses that you can choose to use your HSA for in retirement and pay no taxes on. The premium for long-term care insurance, which pays for nursing homes and assisted living centers, is a qualified expense, as are Medicare Part B and D premiums both for you and a spouse.”

 

Thursday Miscellany

David Ermer–CDC, CMS, Congress, COVID vaccine mandate, FDA, Medicare, Rx coverage, U.S. Healthcare–

From Washington, DC –The Wall Street Journal reports

  • “The Senate passed wide-ranging legislation Thursday [night] that suspends the $31.4 trillion debt ceiling [until January 1, 2025] while cutting federal spending, backing a bipartisan deal struck by President Biden and House Speaker Kevin McCarthy to avert an unprecedented U.S. default.
  • “The 63-36 vote reflected support from both Democrats and Republicans, with backers saying the need to raise the nation’s borrowing limit outweighed concern about provisions related to military and domestic spending and energy policy, among other contentious issues.
  • “The measure now goes to the president for his signature with several days to spare before Monday, when the Treasury Department has said that the government will run out of money to pay all of its bills.”
  • The Journal further informs us,
    • “President Biden plans to pick former North Carolina Health Secretary Dr. Mandy Cohen to lead the Centers for Disease Control and Prevention, according to people familiar with the planning. * * *
    • “Cohen, a medical doctor like Walensky, served in the Obama administration as chief of staff at the Centers for Medicare and Medicaid Services. She helped implement the Affordable Care Act and new payment models at the agency.
    • “She also served as North Carolina’s health secretary for nearly five years into 2021, helping lead the state through the Covid-19 pandemic. She is an executive at Aledade, a network of independent primary-care practices. * * *
    • “The White House and the CDC declined to comment. Cohen’s selection for the role was earlier reported by The Washington Post. The role doesn’t require Senate confirmation.”
  • Healthcare Dive tells us,
    • “The CMS on Wednesday issued a final rule lifting the COVID-19 vaccine mandate for workers in healthcare facilities that receive federal funding as soon as early August. The rule, which will go into effect 60 days after being published in the Federal Register, would withdraw regulations requiring the vaccines for healthcare workers that went into effect last year following a number of legal challenges.
    • “The CMS said it will not be enforcing the provisions between now and August.”

From the public health front —

  • The Wall Street Journal reports,
    • “There is a test that could diminish the toll of the nation’s top cancer killer—if people would use it. Doctors are pushing harder to make that happen.
    • “Lung cancer kills upward of 127,000 people in the U.S. each year. The toll has waned in recent years thanks to declining smoking rates and new treatments, but it remains the deadliest cancer for Americans by far. 
    • “A CT scan can catch the disease early to help save lives. The five-year survival rate when lung cancer is caught early is about 60%, compared with around 7% if it is caught after disease has spread, according to the American Lung Association. Medical groups recommend annual, low-dose scans starting at 50 for people who smoke heavily or recently quit. Insurers often cover the test. 
    • “It’s low-hanging fruit for the country,” said Dr. Patrick Hwu, president and chief executive of the Moffitt Cancer Center in Tampa, Fla. “It would save the most lives immediately.”
  • The Journal also lets us know,
    • “About 3.66 million babies were born in the U.S. in 2022, essentially unchanged from 2021 and 15% below the peak hit in 2007, according to new federal figures released Thursday.
    • “The provisional total—3,661,220 births—is about 3,000 below 2021’s final count, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics. Final government data expected later this year could turn that small deficit positive. * * *
    • “Absent increases in immigration, fewer births combined with ongoing baby boomer retirements will likely weigh on the labor force supply within the next 10 years, said Kathy Bostjancic, chief economist at Nationwide, an insurance and financial-services company.
    • “You’re going to have a real shortage of workers unless we have technology somehow to fill the gap,” Bostjancic said.”
  • The U.S. Preventive Services Task Force released a final research plan for its Perinatal Depression: Preventive Interventions project.
  • The Department of Labor points out,
    • [Last week,] “the White House released the first-ever U.S. National Plan to End Gender-Based Violence. The plan lays out a roadmap for a whole-of-government effort to prevent and address gender-based violence in the United States. One of the groundbreaking aspects of this plan is that it reflects principles from the International Labor Organization’s Convention on Violence and Harassment in the World of Work, recognizing gender-based violence and harassment in the “world of work,” which includes not only traditional workplaces but anywhere workers are paid, in places workers take rest breaks, in work-related training, and through work-related communications.” 
  • HR Dive reports,
    • “The percentage of employees in the general U.S. workforce who tested positive for marijuana after a job accident reached a 25-year high in 2022, according to data released May 18 by Quest Diagnostics.
    • “In 2022, 7.3% of the general workforce (private sector employees in non-safety-sensitive jobs) tested positive for marijuana in a post-accident urine test, up from 6.7% in 2021, according to Quest’s latest Drug Testing Index. After rising steadily each year for the past 10 years, the 2022 positivity rate reflected a 204% jump since 2012, Quest said. 
    • “The increase in post-accident marijuana positivity rates corresponds with the legalization of marijuana for recreational use in certain states, starting in 2012 with Colorado and Washington, Quest noted in a news release. The DTI data “provide compelling evidence that increased use of cannabis products can contribute to greater risk for injuries in the workplace,” Katie Mueller, a National Safety Council senior program manager, stated.”

From the U.S. healthcare business front —

  • Beckers Hospital Review shares Newsweek’s list of top-ranked maternity hospitals in the U.S.
  • The American Hospital Association reports
    • “Following discussions between the American Hospital Association (AHA) and United Healthcare (UHC), the insurer late yesterday announced a refocused gastroenterology (GI) policy that relies on additional provider education rather than prior authorizations to address the insurer’s concerns about possible overutilization. The refocused policy avoids potential care denials for patients, particularly vulnerable patients, and will not impact the coverage and payment of claims for these services. The GI policy, which pertains to certain non-screening endoscopy and colonoscopy services, goes into effect today, June 1.
    • “UHC will instead implement a 7-month, or potentially longer, pilot program to collect data that substitutes notification and submission of standard clinical data when services are delivered for prior authorization, removing the risk of potential care delays and claim denials. This data will be applied to UHC’s gold-carding program, beginning sometime in 2024, in order to exempt physicians that are routinely aligned with the insurer’s guidelines. The insurer has yet to determine any additional controls that will be placed on non-gold-carded clinicians at the end of the pilot.”
  • Healthcare Dive tells us
    • “BJC HealthCare and Saint Luke’s Health System announced Wednesday they had signed a non-binding agreement to merge, creating a $10 billion health system serving patients in Missouri, Kansas and Illinois. 
    • “The 28-hospital system would keep their current brands and operate from two headquarters, with the St. Louis base focusing on eastern Missouri and southern Illinois, while the Kansas City, Missouri, headquarters serves western Missouri and parts of Kansas. 
    • “BJC and Saint Luke’s said they’re planning to reach a definitive agreement “in the coming months,” assuming no regulatory hurdles. They expect the deal to close by the end of the year.”
  • and
    • “Oak Street Health plans to enter Arkansas, Iowa, Kansas and Virginia beginning this summer, the value-based primary care chain for seniors announced Tuesday.
    • “The expansion will grow the footprint of Chicago-based Oak Street, which was acquired by CVS for $10.6 billion, to 25 states.
    • “Oak Street also plans to open additional centers in Arizona, Colorado, Georgia, Illinois, Indiana, Louisiana, New York, Ohio and Pennsylvania this year, according to a release.”

From the Rx coverage front —

  • STAT News reports,
    • “In a bold move, Coherus BioSciences plans to sell a biosimilar version of Humira — one of the world’s best-selling medicines — at a steep discount, and will work with Mark Cuban’s generic drug company to make the medicine available directly to consumers for even less.
    • “Specifically, the Coherus medicine will carry a $995 list price for a carton of two autoinjectors, an 85% discount from the $6,922 that AbbVie charges for Humira, which is used to treat rheumatoid arthritis and other conditions. At the same time, Coherus will sell its drug at a discount to the Mark Cuban Cost Plus Drug Company, which will market the treatment for about $579.
    • “The lowball pricing for the drug, which will become available in July, has the potential to alter one of the most closely watched product rollouts by pharmaceutical companies in many years. After enjoying a monopoly that yielded billions of dollars in annual sales, AbbVie is expected to face at least eight biosimilar rivals to Humira by the end of the year.”
  • BioPharma Dive relates,
    • “Medicare on Thursday affirmed plans to limit coverage for certain Alzheimer’s disease drugs, but signaled it’s taking steps to ensure broader access should one of the medicines receive full Food and Drug Administration approval.
    • “In a statement, the Centers for Medicare and Medicaid Services said they would cover drugs like Eisai and Biogen’s Leqembi when patients and their doctors participate in a registry for collecting data on how the treatments work in the real world. The stance is in line with the agency’s current policy, but describes a process that analysts viewed as relatively straightforward to fulfill.
    • “However, the nonprofit Alzheimer’s Association, which has previously attacked Medicare’s policy, criticized the registry requirement and said it “will create unnecessary hurdles to coverage.” The agency’s plan will soon be tested as Leqembi — currently cleared on a conditional basis in the U.S. — is up for full FDA approval, with a decision expected by July.”

Midweek update

David Ermer–CDC, Congress, COVID-19, FDA, Medical / Rx research, NIH, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC —

  • The Wall Street Journal reports,
    • “The House passed a sweeping bill that suspends the federal government’s $31.4 trillion debt ceiling in exchange for spending cuts, as Republican Speaker Kevin McCarthy muscled through a deal struck with President Biden to avert a looming government default.
    • “The 314-117 vote relied on support from both Republicans and Democrats. Passage of the deal sends the measure to the Senate, where leaders have promised quick action, and Biden has said he is eager to sign the measure into law. Treasury Secretary Janet Yellen has said the government could run out of the cash it needs on June 5 to pay its bills on time and warned of severe economic damage and market disruptions unless Congress acts.
    • “The House vote marks the culmination of a hard-fought debate in the chamber, where Republicans were intent on using the debt ceiling as leverage to deeply cut deficit spending and roll back many of Biden’s signature initiatives—but ended up settling for more modest changes.
    • “The outcome showed, for now, that McCarthy has the power to deliver high-stakes deals with Democrats while still keeping his job, and bolstered Biden’s reputation as a deal maker who was willing to find a middle ground with Republicans.”
  • Healthcare Dive provides details on the healthcare provisions in the bill (HR 3746).
  • STAT News tells us
    • “As Congress considers wide-ranging reforms to pharmacy benefit managers, a top executive at CVS Health, which owns one of the largest PBMs in the country, said the company would find ways to maintain its level of profit if those reforms to things like drug rebates went into effect.
    • “There’s other ways in the economic model that we can adjust to if one of those things changes,” Shawn Guertin, CVS’ chief financial officer, said at an industry conference Wednesday. “The other important part of this, if some of these things change, it could lead to higher costs for employers and health plans.”
  • If the FEHBP’s experience with transparent prescription drug pricing is any guide, the reforms under consideration will not lower costs for employers and health plans. For example, OPM mandated full transparency of manufacturer rebates and 100% distribution of those rebates to the health plans, causing higher administrative expenses for FEHB plans. Presumably, the larger rebates and higher administrative expenses wash. OPM also mandates triennial RFP processes for PBM contracts which do produce savings.

Speaking of FEHBP, Govexec brings us up to date on Postal Service Health Benefits Program implementation. The article illustrates the support that carriers and the Postal Services, among other agencies, are providing OPM with this project. All of the major Postal unions are FEHB carriers.

Today is the deadline for FEHB carriers to submit their 2024 benefit and rate proposals to OPM. Fierce Healthcare discusses a Mercer survey of employer expectations for 2024 premiums.

From the public health front —

  • Kaiser Family Foundation News points out that medical debt is materially higher in the Diabetes Belt found in the southeastern U.S. “The CDC says the Diabetes Belt consists of 644 mostly Southern counties where rates of the disease are high. NPR found that more than half of the counties have high levels of medical debt in collections — meaning at least 1 in 5 people are affected.”
  • Healio relates
    • Compared with reoffering colonoscopy and fecal immunochemical test alone, offering a blood test as a secondary option resulted in a nearly twofold increase in colorectal cancer screening in veterans who had declined first-line screening. 
    • “We know screening prevents colorectal cancer, but participation in screening is suboptimal,” Peter S. Liang, MD, MPH, assistant professor of medicine and population health at NYU Langone Health, told Healio. “Compared to widely used screening modalities such as colonoscopy and stool-based testing, a blood test has certain advantages: It is noninvasive, can be done at point of care and does not require self-collection.”
  • Leapfrog Group calls attention to its newly released 2023 maternity care report.
  • STAT News explains why new cancer patients need navigation support
    • [P]eople * * * in this suspected peri-diagnostic period (the time between a positive finding on a screening test and leading up to a formal diagnosis and treatment) are not looking for specific answers so much as they are seeking general support.
    • Patients want a trusted person to help provide a general overview of the journey ahead. They want someone to help them through the structural and logistical challenges of our cumbersome and sometimes unresponsive health systems. They would like triage on whether their case is common enough that they can access high-quality, convenient, and accessible community care, or whether their diagnosis warrants the specialized care available at large academic medical centers. They want guidance on what sorts of questions to ask their care team. They want to know if they should pursue second opinions, and if so, how to go about getting insurance approval or the mechanics of how to actually secure an appointment.
  • Medscape reports
    • “About 10% of people infected with Omicron reported having long COVID, a lower percentage than estimated for people infected with earlier strains of the coronavirus, says a study published in The Journal of the American Medical Association.”

From the Rx coverage front —

  • The Hill reports
    • “The Food and Drug Administration (FDA) on Wednesday approved Pfizer’s vaccine to prevent the respiratory disease RSV in older adults, the company announced.
    • The approval of Pfizer’s Abrysvo marks the second authorized RSV shot for older adults in the U.S. this month, after GlaxoSmithKline won approval for its rival shot, Arexvy. “
  • Medscape informs us
    • Sotagliflozin, a novel agent that inhibits sodium-glucose cotransporter (SGLT) 1 as well as SGLT2, received marketing approval from the US Food and Drug Administration (FDA) on May 26 for reducing the risk for cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in patients with heart failure, and also for preventing these same events in patients with type 2 diabetes, chronic kidney disease (CKD), and other cardiovascular disease risk factors.
    • This puts sotagliflozin in direct competition with two SGLT2 inhibitors, dapagliflozin (Farxiga) and empagliflozin (Jardiance), that already have indications for preventing heart failure hospitalizations in patients with heart failure as well as approvals for type 2 diabetes and preservation of renal function.
    • Officials at Lexicon Pharmaceuticals, the company that developed and will market sotagliflozin under the trade name Inpefa, said in a press release that they expect US sales of the agent to begin before the end of June 2023. The release also highlighted that the approval broadly covered use in patients with heart failure across the full range of both reduced and preserved left ventricular ejection fractions.
    • Lexicon officials also said that the company will focus on marketing sotagliflozin for preventing near-term rehospitalizations of patients discharged after an episode of acute heart failure decompensation.

From the U.S. healthcare business front —

  • Beckers Hospital Review reports
    • “The median year-to-date operating margin index for hospitals slightly improved in April to 0 percent, according to Kaufman Hall. 
    • “The neutral margin marks a slight improvement from the -0.3 percent recorded in March, according to Kaufman Hall’s latest “National Flash Hospital Report” — based on data from more than 900 hospitals.
    • “Hospitals saw increased bad debt and charity care and decreased inpatient and outpatient volumes in April, which Kaufman Hall experts correlate to the winding down of the COVID-19 Public Health Emergency, which ended May 11.” 
  • Healthcare Dive tells us
    • “Nonprofit hospital and health plan operator Kaiser Permanente announced Tuesday that it was committing $10 million to safety-net hospital and regional operator Denver Health, as the facility struggles with “unprecedented financial challenges” including increased expenses and a rise in uninsured patients.
    • “Denver Health provides care for around 30% of the city’s population — including the largest percentage of uninsured patients. The system has struggled with a rise in costs and a surge in sicker patients, with expenses totaling $1.3 billion for Denver Health in fiscal year 2022.
    • “The announcement comes as both nonprofit and for-profit hospitals across the country struggle with negative margins and pent-up financial challenges stemming from the COVID-19 pandemic, including persistent heightened contract labor costs, inflationary pressures and unfavorable payer mixes.”

From the miscellany department —

  • Bloomberg updates us on the promising hunt for a breast cancer vaccine.
  • MedCity News relates
    • About 65% of Americans believe that employer-sponsored insurance provides them with “financial peace of mind,” a new survey shows.
    • The AHIP report, published Wednesday, was conducted by Locust Street Group from April 17 to April 25 as part of AHIP’s Coverage@Work campaign, which aims to gather insights on Americans’ thoughts on employer-sponsored coverage. It included responses from 1,000 U.S. consumers with employer-sponsored coverage.
  • Beckers Payer Issues ranks the States by Medicare Advantage enrollment.
  • The Society for Human Resource Management reports
    • “In a memo released May 30, National Labor Relations Board (NLRB) General Counsel Jennifer Abruzzo announced that noncompete agreements violate the National Labor Relations Act (NLRA). The announcement, which applies to nonunionized and unionized employers, may result in unfair labor practice charges for any employer that uses noncompetes, said Thomas Payne, an attorney with Barnes & Thornburg in Indianapolis.
    • “However, a manager’s or supervisor’s noncompete would seemingly be unaffected by the memo because the NLRA applies only to nonmanagerial, nonsupervisory staff, said James Redeker, an attorney with Duane Morris in Philadelphia.  Managers and supervisors are the most likely to have noncompetes, he noted.”

Tuesday’s Tidbits

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

From Washington, DC, the House Rules Committee held a four-hour hearing on the debt ceiling compromise bill (HR 3746) this afternoon. The Wall Street Journal adds

“House Republican leaders projected confidence Tuesday that the debt-ceiling deal struck with President Biden would draw enough support to pass, while some conservative lawmakers angrily denounced the agreement.

“The bill advanced (7-6 vote) past a closely watched procedural hurdle in the Rules Committee late Tuesday, and a final House vote is expected as soon as Wednesday night. While the bill appears on track to gain sufficient Republican and Democratic votes to pass the House and then the Senate by the June 5 deadline, it could still run into procedural obstacles, complicating the race to avoid an unprecedented default.”

From the public health front —

  • The University of Minnesota informs us
    • “[As of last Friday] the two main metrics that the Centers for Disease Control and Prevention (CDC) uses to track US COVID-19 activity—hospitalizations and deaths—continue to decline, according to the latest data. Hospitalizations for COVID are down 11% compared to a week ago, and deaths from the virus are down 13.3%.
    • “The hospitalization map, which reflects activity by county, replaces the CDC’s earlier community levels, and there are currently only a few hot spots, some in Texas and in small portions of Nebraska and Louisiana.
    • “Early indicators—regional test positivity and emergency department (ED) visits—also show no signs of increase. Test positivity at the national level is 4.3%, down 0.7% from a week ago. The only region showing a slight increase is the part of the Southwest that includes California, Nevada, and Arizona. Only 0.5% of ED visits last week were due to COVID, down 10.8% from the previous week. There are no major rises in COVID positivity in wastewater surveillance.”
  • HHS’s Agency for Healthcare Quality and Research issued a report on “Treated Prevalence of Commonly Reported Health Conditions, 2016 to 2020.”
  • PBS informs us,
    • “The United States grew older, faster, last decade.
    • “The share of residents 65 or older grew by more than a third from 2010 to 2020 and at the fastest rate of any decade in 130 years, while the share of children declined, according to new figures from the most recent census.
    • “The declining percentage of children under age 5 was particularly noteworthy in the figures from the 2020 headcount released Thursday. Combined, the trends mean the median age in the U.S. jumped from 37.2 to 38.8 over the decade.
    • “America’s two largest age groups propelled the changes: more baby boomers turning 65 or older and millennials who became adults or pushed further into their 20s and early 30s. Also, fewer children were born between 2010 and 2020, according to numbers from the once-a-decade head count of every U.S. resident. The decline stems from women delaying having babies until later in life, in many cases to focus on education and careers, according to experts, who noted that birth rates never recovered following the Great Recession of 2007-2009.”

From the Rx coverage front —

  • Fierce Healthcare updates us on the soaring employee demand for anti-obesity drugs.
  • Also, Fierce Healthcare relates,
    • “Optum Rx is rolling out new programs aimed at supporting independent and rural pharmacies in closing care gaps beginning in June.
    • “The pharmacy benefit manager said Tuesday that the new initiatives will focus on three key areas: helping patients in underserved areas connect to community resources, improving maternal and fetal health by boosting access to key supplies and deploying community pharmacies to address healthcare deserts.
    • :The new initiatives kick off what Optum said is a “broader, industry-leading commitment to bridge resource gaps in the community.”
    • “These initiatives provide opportunities not only to help patients but also to offer appropriate compensation that recognizes the clinical expertise and unique capabilities our community and independent pharmacy partners have to meet the needs of their patients,” said Heather Cianfrocco, CEO of Optum Rx, in the release.”

From the medical and prescription drug research front

  • The NIH Director’s blog tells us,
    • “Biomedical breakthroughs most often involve slow and steady research in studies involving large numbers of people. But sometimes careful study of even just one truly remarkable person can lead the way to fascinating discoveries with far-reaching implications.
    • “An NIH-funded case study published recently in the journal Nature Medicine falls into this far-reaching category [1]. The report highlights the world’s second person known to have an extreme resilience to a rare genetic form of early-onset Alzheimer’s disease. These latest findings in a single man follow a 2019 report of a woman with similar resilience to developing symptoms of Alzheimer’s despite having the same strong genetic predisposition for the disease [2].
    • “The new findings raise important new ideas about the series of steps that may lead to Alzheimer’s and its dementia. They’re also pointing the way to key parts of the brain for cognitive resilience—and potentially new treatment targets—that may one day help to delay or even stop the progression of Alzheimer’s.”
  • BioPharma Dive reports
    • “An experimental hemophilia drug developed by Pfizer significantly reduced bleeding frequency compared to on-demand or preventive clotting factor proteins, the drugmaker said Tuesday. Called marstacimab, the drug was not associated with the kind of dangerous blood clotting that has delayed or sidelined similarly acting drugs from Novo Nordisk and Bayer.
    • “If approved, marstacimab would compete with established medicines like Roche’s Hemlibra as well as newer treatments like CSL Behring’s gene therapy Hemgenix and Sanofi’s long-acting drug Altuviiio. These therapies offer options for patients beyond regular infusions of engineered clotting factor proteins.
    • “Marstacimab requires a weekly subcutaneous shot, while Hemlibra can be administered subcutaneously as infrequently as once every four weeks after an initial dosing phase. Gene therapies like Hemgenix, or another from BioMarin Pharmaceutical that’s now under review, are intended to be a one-and-done treatment, although their long-term durability has not been proven.”

From the U.S. healthcare business front

  • Per Healthcare Dive
    • “Nonprofit hospital operator Ascension Healthcare reported a loss from operations of $1.8 billion on revenue of $21.3 billion for the nine months ending March 31, as it struggled with higher operating costs and sustained revenue challenges driven by continued impacts of the COVID-19 pandemic and inflationary pressures.
    • “An improvement in total surgical volumes, especially outpatient surgeries and emergency room visits, didn’t outpace growing expenses for Ascension, which increased by $804 million year over year in the nine-month period.”
  • Per Fierce Healthcare
    • “Advocate Health, the newly formed marriage of major nonprofits Advocate Aurora Health and Atrium Health, reported a $10.4 million operating income (0.1% operating margin) and $578.7 million net gain in its first-ever Q1 earnings report, released Tuesday.
    • “The 67-hospital entity tallied more than $7.54 billion in total revenue during the three months ended March 1 thanks to year-over-year increases across each of its major divisions—Advocate Aurora Health, Atrium Health’s Charlotte-Mecklenburg Hospital Authority and Atrium Health Wake Forest Baptist.”

From the litigation front, STAT News reports, “A federal appeals court ruled Tuesday Purdue Pharma can shield its owners — members of the wealthy Sackler family — from thousands of lawsuits over the role the company played in the opioid crisis in exchange for a contribution of up to $6 billion to a proposed bankruptcy settlement. * * * The U.S. Court of Appeals for Second Circuit, though, ruled a U.S. bankruptcy court was correct in approving the immunity and, moreover, that it was “equitable and appropriate under the specific factual circumstances of this case.” The decision reverses a ruling made last December by a federal judge had sided with the U.S. Trustee. The case now goes back to U.S. bankruptcy court to approve the settlement, although the U.S. Trustee could ask the U.S. Supreme Court to review the appeals court ruling.”

Thursday Miscellany

David Ermer–Congress, COVID treatment, COVID-19, Electronic health records, FDA, Medical / Rx research, NIH, Rx coverage–
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

David Ermer–Congress, Generative AI, Medical / Rx research, Mental health care, NIH, Rx coverage, U.S. Healthcare, Uncategorized–
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.”