Midweek update

End of the PHE, NE

Midweek update

David Ermer–Congress, Electronic health records, End of the PHE, NE, Generative AI, Medical / Rx research–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The Wall Street Journal reports
    • “Negotiators worked Wednesday to reach an agreement on reining in government spending, which has emerged as the central hurdle to a deal to raise the debt ceiling, with a possible government default just a week away.
    • “U.S. stocks extended declines Wednesday, reflecting rising anxieties about the debt ceiling, with the Dow Jones Industrial Average posting a fourth-straight session of losses.
    • “The White House has offered a spending freeze for next year, while GOP negotiators have insisted that any deal must result in lower discretionary spending, calling it a critical step in starting to address the country’s growing debt, which now stands at $31.4 trillion.”

Healthcare Dive, MedPage Today, and Fierce Healthcare discuss a House Oversight and Accountability Committee hearing on prescription benefit managers held yesterday.

The House Energy and Commerce Committee cleared a bunch of healthcare-related bills for floor consideration today.

STAT News tells us, “Matt Eyles, CEO of America’s Health Insurance Plans, is leaving by this October, the lobbying group said Wednesday.” Good luck, Mr. Eyles.

From the public health front —

  • Helen Branswell, writing in STAT News, points out
    • :An impressive number of vaccines and monoclonal antibody products are racing toward the end of the development pipeline, with two products aimed at protecting children expected to receive approval from the Food and Drug Administration by autumn. One, a maternal vaccine developed by Pfizer, received a recommendation last week from FDA’s vaccine advisory committee.
    • “But there are sizable hurdles standing in the way of the implementation of these products, hurdles that could see the promise they offer squandered because of bureaucracy, health systems that don’t interact with one another, and steep price tags.”
  • Ms. Branswell discusses the hurdles with experts on the matter.
  • Forbes reports
    • This week, Achieve Life Sciences announced that its drug, cytisinicline, saw strong results in its latest phase III trial. While the drug has been used for decades in eastern Europe, it’s not yet been approved by the FDA. The drug works by targeting the nicotine receptors in the brain, CEO John Bencich tells Forbes. “It works to reduce the satisfaction you get while smoking, but also helps with the cravings and withdrawal symptoms.” 
    • The study, which followed 792 patients, had patients take the drug for either 6 weeks or 12 weeks. Both patients who received the drug and those who got a placebo also went through a behavioral program about quitting smoking. The company says that over 30% of those who took the drug for 12 weeks stopped smoking completely in the last four weeks of the study, compared to less than 10% in the placebo group. For six weeks of treatment, the drug had a nearly 15% success rate compared to 6% in the placebo group. The company saw similar success in a smaller study it reported in the spring on the success of the drug in helping patients quit vaping. Patients will be monitored for 24 weeks after completing the cessation program, and the company expects to file a new drug application with the FDA in the first half of 2024. 
  • This week’s Econtalk podcast offers an interview between host Russ Roberts and University of Chicago economist Casey Mulligan about the macroeconomic angles of public health issues, like the Covid pandemic. Check it out.

From the interoperability front,

  • Fierce Healthcare relates
    • The total number of Epic customers pledging to join the electronic medical record provider in its participation in the Trusted Exchange Framework and the Common Agreement (TEFCA) has jumped to 27. 
    • After announcing the participation of 20 health systems plus health tech company KeyCare and health information exchange OCHIN on Monday, five more organizations have joined the pledge including Kaiser Permanente.
    • According to Matt Doyle, interoperability software development lead at Epic, the EMR company is optimistic that nearly all of the 2,000 hospitals and 600,000 clinicians that use Epic across the country will participate. 
  • Let’s go.

From the generative AI front,

  • Patient Engagement HIT tells us
    • Can ChatGPT really replace doctors? Probably not, at least for right now, as surveying shows that patient trust in chatbots and generative AI in healthcare is relatively low.
    • The report from The University of Arizona Health Sciences showed that around half of patients don’t fully trust AI-powered medical advice, like the information issued from chatbots like ChatGPT. Instead, patients still trust and prefer their traditional healthcare providers.
    • However, patients may be more receptive to chatbot medical advice if the AI is guided by a doctor’s or human’s touch.

Thursday Miscellany

David Ermer–Congress, End of the PHE, NE, FDA, Medical / Rx research, OPM, SCOTUS, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC, Roll Call reports

“Lawmakers from both parties suggested negotiators were making progress Thursday toward a bipartisan deal that would raise the $31.4 trillion debt limit, though days of talks still lie ahead.

“Scrambling to avert a debt limit breach that Treasury Secretary Janet L. Yellen said could hit as early as June 1, negotiators are attempting to reach a framework for a deal by Sunday, when President Joe Biden returns from a trip to the G-7 summit in Japan.

“Speaker Kevin McCarthy, who is negotiating with Biden through proxies, said he is hopeful that a deal could come as soon as this weekend. In a sign of progress, the two parties have begun to exchange offers, said House Rules Chairman Tom Cole, R-Okla.

“We’ve made good progress this week, but the work continues,” said Senate Majority Leader Charles E. Schumer. “ No one will get everything they want.”

“If a deal is reached by Monday, the House would vote next week, with 72 hours notice after the text is posted. While the Senate is scheduled to be in recess next week, Schumer said his chamber would be prepared to reconvene with 24 hours’ notice to schedule a vote.”

Per STAT News

“Pharmacy benefit managers would be subject to new transparency rules under a bill that cleared a key House subcommittee, Modern Healthcare says. The Transparent PRICE Act of 2023, which received a unanimous vote in the House Energy and Commerce Committee’s Health Subcommittee, would require pharmacy benefit managers to annually provide employers with detailed data on drug spending, including acquisition costs, out-of-pocket spending, formulary-placement rationale, and aggregate rebate information. The bill also would order the Government Accountability Office to report on group health plan pharmacy networks, including those owned by health insurers.”

Fierce Healthcare discusses other healthcare actions taken by this subcommittee yesterday.

BioPharma Dive tells us

“The U.S. Supreme Court on Thursday ruled against Amgen in its decade-long battle with Sanofi and Regeneron, affirming a lower court’s decision that Amgen’s rivals did not infringe on patents the biotechnology company held on a cholesterol-lowering medicine.

“In a unanimous decision authored by Justice Neil Gorsuch, the court said two Amgen patents on its PCSK9 inhibitor Repatha fell short of a legal standard known as enablement, which requires the claimed invention be described well enough to allow a skilled person in the field to use it. * * *

“The court’s ruling could open the door for challenges to older classes of antibody therapies, [University of Illinois law professor Jacob]Sherkow said. “This decision is probably going to give challengers solace. They’re going to have good options when working with the enablement requirements to challenge competitors’ patents out there.”

From the public health front —

  • The Robert Wood Johnson Foundation released its 2023 U.S. county health rankings while the UnitedHealthFoundation issued its 2023 Seniors Report from its America’s Health Rankings Services.
  • MedPage Today informs us
    • “The CDC encouraged populations at risk of contracting mpox, formerly known as monkeypox, to get fully vaccinated against the disease as part of preparations for summer during a briefing Thursday morning.
    • “Demetre Daskalakis, MD, the White House National Mpox Response Deputy Coordinator, noted that with summer gatherings on the horizon, mpox vaccination should be considered, as should overall sexual health and wellness.
    • “Getting ‘summer ready’ means mpox vaccination, but that’s not all it means — it also means to be up to date on all of your sexual health, and that includes HIV and STIs [sexually transmitted infections] like syphilis, gonorrhea, and chlamydia,” he said.”
  • The Department of Health and Human Services posted a fact sheet with “Resources on Ways Communities Can Stay Protected from Mpox in Advance of Summer Months.”
  • The Wall Street Journal points out the important medical tests that Americans should consider undergoing over the decades of life.
  • The U.S. Preventive Services Task Force notified the public about a draft research plan concerning “Weight Loss to Prevent Obesity-Related Morbidity and Mortality in Adults: Interventions” that is open for comment until June 14, 2023.

From the Food and Drug Administration front, the Wall Street Journal reports

“The Food and Drug Administration for the first time cleared a test to gauge a mother’s risk of severe preeclampsia, a leading cause of pregnancy-related illness and death in the U.S.  

“Thermo Fisher Scientific said Thursday that the blood test it already sells in Europe could be available in the U.S. soon. Its introduction could transform prenatal care in the U.S., doctors and maternal-health advocates said.”

Bravo.

From the U.S. healthcare business front —

  • Beckers Hospital Review notes five new details about Kaiser Permanente’s Risant Health deal.
  • Fierce Healthcare discusses provider objections to what appears to the FEHBlog to be a reasonable new prior authorization program that UnitedHealthcare is introducing. No good deed goes unpunished.

From the miscellany department —

  • STAT News relates that
    • “A multibillion-dollar science agency tasked with slashing through research bureaucracy will start its work with a plan to help people regenerate bone.
    • “The Advanced Research Projects Agency for Health, launched a little more than a year ago, announced Thursday that its first official program would target bone and joint damage from osteoarthritis, a condition affecting more than 32 million Americans.”
  • Govexec discusses FEHB coverage of Covid tests and vaccines following the end of the PHE.
  • The Equal Employment Opportunity Commission weighs in on the Title VII compliance implications of employer use of artificial intelligence to make employment decisions.

Midweek update

David Ermer–Congress, End of the PHE, NE, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington DC, Roll Call informs us,

“Negotiators tapped by President Joe Biden and Speaker Kevin McCarthy to hash out a debt limit compromise were racing against the clock Wednesday to get some principles down on paper that could be written into legislative text in time for votes as early as next week.

“Both the president and his chief GOP counterpart on Capitol Hill said they thought a deal was possible. Biden is scheduled to return Sunday from his trip to Japan for the G-7 summit, telling reporters at the White House on Wednesday he’d be back for “final negotiations” and that he’d hold a press conference upon his return.

“I’m confident that we will get the agreement on the budget, that America will not default,” Biden said. “Every leader in the room understands the consequences if we fail to pay our bills.”

The FEHBlog offers less encouraging news from the public health front —

  • The Wall Street Journal reports
    • “For decades, advances in healthcare and safety steadily drove down death rates among American children. In an alarming reversal, rates have now risen to the highest level in nearly 15 years, particularly driven by homicides, drug overdoses, car accidents and suicides.
    • “The uptick among younger Americans accelerated in 2020. Though Covid-19 itself wasn’t a major cause of death for young people, researchers say social disruption caused by the pandemic exacerbated public-health problems, including worsening anxiety and depression. Greater access to firearms, dangerous driving and more lethal narcotics also helped push up death rates.
    • “Between 2019 and 2020, the overall mortality rate for ages 1 to 19 rose by 10.7%, and increased by an additional 8.3% the following year, according to an analysis of federal death statistics led by Steven Woolf, director emeritus of the Center on Society and Health at Virginia Commonwealth University, published in JAMA in March. That’s the highest increase for two consecutive years in the half-century that the government has publicly tracked such figures, according to Woolf’s analysis. * * *
    • “Many public-health experts say they don’t think the end of the pandemic will reverse the rise in death rates among young people. Rivara predicts these problems will continue due to persistent issues around mental health and the accessibility of guns.
    • “[Dr. Elizabeth] Wolf said demand for child and adolescent psychiatric services still outstrips supply in her Richmond, Va., office. Patients are on months long waiting lists to see a psychiatrist that accepts insurance.”  
  • Digging deeper, the Journal informs us,
    • “Overdose deaths in the U.S. edged higher in 2022, a federal estimate showed, marking only the second time drugs killed more than 100,000 people in a year. 
    • “The Centers for Disease Control and Prevention on Wednesday released a provisional count of overdose deaths last year that indicated the toll of the fentanyl crisis leveling off after two years of surges during the Covid-19 pandemic. The CDC counted 109,680 overdose deaths in 2022 compared with 109,179 deaths from a similar 2021 projection. For overdose deaths to hover at such a high level demonstrates how fentanyl’s ubiquity and potency continue to threaten the lives of illicit drug users. 
    • “I’m glad to see us not get worse, but it’s hard to celebrate,” said Dr. Chad Brummett, an anesthesiologist and co-director of the Opioid Research Institute at the University of Michigan.”
  • STAT News adds
    • “More than a quarter of American adults are depressed, a 10% surge from nearly a decade ago, according to the latest Gallup survey.
    • “The data come as the Biden administration tries to overhaul mental health care costs and boost the number of health care workers licensed to practice behavioral health care. Congress in this year’s budget also allotted hundreds of millions of dollars to mental health care grants and programs, many of them trained on children or substance misuse.”
  • On a related note
    • McKinsey Consulting explores how virtual hospitals could offer respites to overwhelmed health systems.
    • Health Affairs Forefront discusses approaches to integrating behavioral health with primary care.
    • Employee Benefits News identifies three coverage categories that can reduce healthcare disparities and lower costs — 1) Colon cancer screening (Hey OPM, the article suggests giving a free day off to employees who undergo screening colonoscopies); 2) Basic dental care, and 3) fertility coverage.

From the Rx coverage front, the New York Times reports,

“Thousands of patients are facing delays in getting treatments for cancer and other life-threatening diseases, with drug shortages in the United States approaching record levels.

“Hospitals are scouring shelves for supplies of a drug that reverses lead poisoning and for a sterile fluid needed to stop the heart for bypass surgery. Some antibiotics are still scarce following the winter flu season when doctors and patients frantically chased medicines for ailments like strep throat. Even children’s Tylenol was hard to find.

“Hundreds of drugs are on the list of medications in short supply in the United States, as officials grapple with an opaque and sometimes interrupted supply chain, quality and financial issues that are leading to manufacturing shutdowns.

“The shortages are so acute that they are commanding the attention of the White House and Congress, which are examining the underlying causes of the faltering generic drug market, which accounts for about 90 percent of domestic prescriptions.”

No bueno.

From the human resources front, HR Dive relates,

  • “Employers cannot automatically revoke reasonable accommodations related to COVID-19, despite the dissolution of the “public health emergency” status for the pandemic, the U.S. Equal Employment Opportunity Commission cautioned employers Monday. “Employers may evaluate accommodations granted during the public health emergency, and, in consultation with the employee, assess whether there continues to be a need for reasonable accommodation based on individualized circumstances,” the agency said. 
  • “The warning came as EEOC announced updates to its technical guidance, “What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws,” including additional accommodation examples and tips for preventing COVID-related harassment.
  • “The EEOC highlighted that accommodations include low-cost or free measures, such as uninterrupted work time, a quiet workspace or noise-canceling headphones to facilitate that.”

Friday Factoids

David Ermer–CDC, COVID-19, End of the PHE, NE, Federal employment benefits, OPM, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

Today marks the final issue of the CDC’s weekly interpretative review of its Covid statistics. The final issue advises

“The latest updates to CDC’s COVID Data Tracker reflect these changes. The homepage has a new look, and there are also new landing pages for hospitalizations, emergency department (ED) visits, and death data, as well as visualizations of trends and maps. Several pages have also been retired, but COVID Data Tracker has a page with links to archived data and visualizations.

“These are the most notable changes to COVID Data Tracker:

  • Hospital admission rates and the percentage of COVID-19 deaths among all deaths are now the primary surveillance metrics.
  • COVID-19 hospital admission levels replace COVID-19 Community Levels (CCLs) as the main indicator of county trends. COVID-19 hospital admission levels are comparable with CCLs.
  • Provisional death certificate data from the National Vital Statistics System (NVSS) will become the primary source for mortality surveillance, replacing aggregate death counts.
  • Aggregate case and death count reporting has been discontinued.
  • ED visit data will serve as an early indicator of COVID-19 activity.”

The Wall Street Journal reports on the ongoing struggles of people afflicted with long Covid.

From the public health front –

  • In recognition of Mothers’ Day this weekend, the CDC encourages pregnant women to get a flu shot (not the nasal flu vaccine spray).
  • MedPage Today tells us that “The CDC reported that the nation’s first-ever cases of treatment-resistant ringworm were identified in New York City. (Morbidity and Mortality Weekly Report)
  • The Department of Health and Human Services celebrated “the first anniversary of the National Maternal Mental Health Hotline. Since being launched on Mother’s Day 2022 by the Health Resources and Services Administration (HRSA), the hotline’s professional counselors have provided emotional support, resources, and referrals to almost 12,000 pregnant and postpartum individuals struggling with mental health concerns, and their loved ones.  Additionally, HRSA is introducing an updated, more user-friendly toll-free number for the Hotline: 1-833-TLC-MAMA (1-833-852-6262).”

From the Rx coverage front —

  • The Food and Drug Administration announced “approving Veozah (fezolinetant), an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause. Veozah is the first neurokinin 3 (NK3) receptor antagonist approved by the FDA to treat moderate to severe hot flashes from menopause. It works by binding to and blocking the activities of the NK3 receptor, which plays a role in the brain’s regulation of body temperature.”
  • Mercer Consulting offers advice to employers and health plans on how to help employees and members address drug shortages.
  • Biopharma Dive reports
    • “A group of Food and Drug Administration advisers narrowly supported approving what could be the first gene therapy for Duchenne muscular dystrophy in a meeting Friday, clearing the way for the agency to make a closely watched decision later this month.
    • “By an 8-6 vote, the panel recommended that the treatment, developed by biotechnology company Sarepta Therapeutics, be granted an “accelerated” approval. The close vote reflected a daylong back-and-forth over the treatment, and whether the protein it’s designed to produce in the body — called microdystrophin — is reasonably likely to benefit people with Duchenne who can still walk. * * *
    • “The FDA usually follows the advice of its advisory committees, but isn’t required to do so. The agency is set to make its decision by May 29.
    • “While far from unanimous, the panel’s recommendation could make that decision easier, and marks an important moment for a Duchenne patient community that has long advocated for gene therapy.”

From the federal employee benefits front, NARFE informs us that.

  • “Effective May 1, 2023, the US Office of Personnel Management (OPM) extended its contract with John Hancock to provide insurance coverage to all Federal Long Term Care Insurance Program (FLTCIP) enrollees. Although OPM solicited multiple bids, John Hancock remained the sole bidder. The program administrator, Long Term Care Partners LLC, has mailed notice of this action to enrollees.  
  • “Per the extended contract, most enrollees should expect to face a premium increase effective January 1, 2024. In September 2023, each enrollee will be offered personalized options that will include accepting the premium rate increase to maintain current coverage or to reduce coverage to reduce the impact of any increase. OPM indicated that premium increases would be phased in over three years for some options.  
  • No additional information on the premium increases or personalized options is available currently.” 

From the bravery department, Govexec points out that the National Association of Letter Carriers named two dozen letter carriers were named as heroes of the year for taking life-saving actions on the job. Bravo!

From the healthcare spending front, Fierce Healthcare informs us

  • “The anti-dementia medication lecanemab will come with an extraordinarily high price tag if the Centers for Medicare & Medicaid Services (CMS) decides to cover it, according to a research letter in JAMA Internal Medicine.
  • “Researchers at RAND estimate that covering the drug and other associated services could add between $2 billion and $5 billion in annual Medicare costs. This could also lead to “substantial out-of-pocket costs for beneficiaries lacking supplemental coverage,” the researchers said.
  • :Those out-of-pocket costs could be as much as one-fifth of the annual income for a Medicare beneficiary, according to the study. The medication, developed by Eisai and Biogen, costs $26,500 a year, including treatment add-ons such as imaging.”

Whoa, Nelly. Thank heavens OPM is allowing FEHB carrier to offer Medicare Part D EGWPs next year.

Thursday Miscellany

David Ermer–Congress, COVID-19, End of the PHE, NE, FDA, Medical / Rx research, Rx coverage–

From Washington DC —

Photo by Josh Mills on Unsplash
  • The Secretary of Health and Human Services issued a statement on the end of the Covid health emergency which occurred today.
    • Govexec and the Society for Human Resource Management respectively discuss the impact of this event on federal agencies and employers generally.
      • SHRM notes, “President Biden in April ended the pandemic national emergency weeks earlier than expected—but the premature ending won’t shift the deadlines spelled out in the administration’s guidance from March, including the extended deadline for special enrollment in health plans. * * * July 10 will also mark the end of some COBRA-related relief, under which employees were allowed extra time to pay their COBRA premiums or to decide whether they wanted to use the coverage.”
  • The Wall Street Journal reports
    • “A highly anticipated meeting scheduled for Friday between President Biden and congressional leaders to chart a path forward on lifting the debt ceiling was postponed until next week, officials said.
    • “The delay will give White House and congressional staff more time to make progress in their closed-door spending talks, the officials said, adding that one of the lawmakers was unable to attend the meeting Friday because of a scheduling conflict.
  • STAT News informs us
    • “The Senate health committee on Thursday passed a package of bills aimed at speeding generic drug competition and reining in drug middlemen business practices. But they failed to pass an ambitious reform to the pharmacy benefit manager sector, despite strong bipartisan support for it.
    • “Chairman Bernie Sanders (I-Vt.) is pursuing the drug pricing reforms at the behest of Senate Majority Leader Chuck Schumer (D-N.Y.), who wants to hold a floor vote on an even bigger package of health bills later this year. The markup came just a day after the same panel held a major hearing on PBM and drugmakers’ role in high insulin prices.
    • “It’s not clear when the Senate would take up that package, and while the package is bipartisan, it’s not clear whether it has enough support among House Republicans to pass in that chamber. There are a few, tamer PBM bills that the House Energy and Commerce Committee is expected to mark up on May 17, but there is no indication that Senate and House lawmakers are coordinating on PBM legislation.
    • “The committee passed 18 to 3 a bill that would ban PBMs from using so-called spread pricing. It would also require that the middlemen disclose rebates, fees, and other payments they receive and to pass them on to the insurers for whom they negotiate those concessions. * * * The committee included an amendment from Sen. Tina Smith (D-Minn.), that would let patients appeal insurer decisions to make them try cheaper drugs before getting more expensive drugs.”

From the public health front, Healio tells us that “Overweight and obese BMI during adulthood appeared associated with increased risk for colorectal cancer and non colorectal gastrointestinal cancers, according to study results published in JAMA Network Open.” The FEHBlog does not think that the new generation of obesity-reduction drugs needs publicity, but there you go.

From the Rx coverage and more front, the FDA announced

  • “the supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease. This is the first FDA-approved treatment option for this indication.”
    • Medpage Today adds, “Brexpiprazole’s labelopens in a new tab or window will continue to carry a boxed warning about the risk of increased mortality in elderly patients with dementia-related psychosis treated with antipsychotic drugs. The warning further stipulates that the drug is not approved for patients with dementia-related psychosis who are not experiencing agitation associated with Alzheimer’s dementia.”
  • and “finalized recommendations for assessing blood donor eligibility using a set of individual risk-based questions to reduce the risk of transfusion-transmitted HIV. These questions will be the same for every donor, regardless of sexual orientation, sex or gender. Blood establishments may now implement these recommendations by revising their donor history questionnaires and procedures.”
  • Beckers Hospital Review points out “The Biden administration has been taking action to address the prescription drug supply shortage, which has caused upheaval both for patients and providers, according to a May 10 Bloomberg report.”

From the medical research front —

  • STAT News reports
    • “Home to billions of cells that form trillions of connections, the human brain isn’t just the body’s most important organ; it’s also the hardest to study. But an international team of scientists using cutting-edge stem cell technology has devised a new way to better understand the brain’s cellular cleanup crew — and its connection to neurological disease.
    • “Researchers coaxed stem cells to grow into microglia, immune cells that roam the brain searching for signs of damage and that monitor and maintain neuronal connections. They then added microglia to brain organoids, tiny 3D structures of neurons that mimic some aspects of brain function, and transplanted these microglia-containing “mini-brains” into mice. Doing so caused microglia to look and behave much more like they would in a human brain compared to previous lab experiments conducted in a dish.
    • “The authors also found early hints that they could use these transplanted organoids to study disease, including the role that microglia might play in autism. Microglia in brain organoids derived from people with autism had larger cell bodies than cells from controls and had an overabundance of small cellular extensions associated with an active, inflammatory state researchers believe may contribute to the disorder.”
    • “The findings, published on Thursday in the journal Cell, are the result of a collaboration between scientists from San Diego to Germany to Israel. The study raises the possibility of using transplanted organoids to understand the complex crosstalk between neurons and immune cells across a range of diseases, and to perhaps one day use this system to test potential treatments.”
  • The Washington Post adds
    • “A skin patch being developed by a French pharmaceutical company to treat peanut allergy is showing promise in toddlers, according to a peer-reviewed study published Wednesday.
    • “The “peanut patch” outperformed a placebo in “desensitizing children to peanuts and increasing the peanut dose that triggered allergic symptoms,” said the study, which was funded by the company DBV Technologies and published in the New England Journal of Medicine.”

Midweek Update

David Ermer–Congress, End of the PHE, NE, NCQA, NIH, OPM, Rx coverage, Telehealth, Uncategorized–
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 measures, stratified 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

David Ermer–ACA, COVID-19, End of the PHE, NE, FDA, Federal employment benefits, OPM, Telehealth–
Photo by Patrick Fore on Unsplash

From Washington DC, the Wall Street Journal reports

  • “President Biden and House Speaker Kevin McCarthy remained at loggerheads after a meeting Tuesday at the White House, appearing to make little progress in averting the first-ever default by the federal government as soon as next month.
  • “House Republicans have demanded deep spending cuts in exchange for raising the debt ceiling and criticized Mr. Biden for not starting talks earlier. But Mr. Biden and Democrats in Congress maintain that the federal borrowing limit should be raised without preconditions and have called the GOP stance irresponsible. Neither side has presented a path forward that could win enough support to pass both chambers of Congress.
  • ”I didn’t see any new movement,” Mr. McCarthy said after leaving the meeting. He said he thought negotiators only had about two weeks to reach an agreement. He said there were staff-level meetings planned and the key leaders would meet again on Friday.”

From the end of the public health emergency front —

  • The Department of Health and Human Services released a fact sheet on the end of the Covid public health emergency, which ends on Thursday, May 11.
  • The Washington Post tells us,
    • “The federal government will allow doctors to keep using telemedicine to prescribe certain medications for anxiety, pain and opioid addiction, extending for six months emergency flexibilities established during the coronavirus pandemic.
    • “The Drug Enforcement Administration and Substance Abuse and Mental Health Services Administration made the announcement Tuesday, two days before the telemedicine flexibilities were set to expire along with the coronavirus public health emergency.
    • “The ability to prescribe controlled medications remotely will run through Nov. 11, 2023. And that deadline will be longer still if doctors have already established a telemedicine relationship with patients. In that circumstance, physicians can keep prescribing the medications virtually through Nov. 11, 2024.”
  • Govexec informs us
    • “President Biden on Tuesday officially revoked the COVID-19 vaccine mandates for federal employees and contractors that had already been mired in lawsuits that prevented them from being enforced. 
    • “The mandates–issued in September 2021–will end on May 12, Biden said in an executive order. The move had been expected following an announcement from the White House earlier this month, and will coincide with the end of the COVID public health emergency on May 11.”
  • STAT News adds
    • “The White House isn’t quite ready to launch its new pandemic response office for a neat handoff at the end of the Covid-19 public health emergency, White House Covid-19 Response Coordinator Ashish Jha told reporters Tuesday.
    • “Jha said White House officials are in the middle of setting up an Office of Pandemic Preparedness and Response Policy that Congress mandated them to create in December, but it won’t be ready in time for a clean transfer at the end of the public health emergency on May 11.
    • “He deflected questions about whether he will stay on after the transition.

From the substance abuse disorder front, Google tells us that this is National Fentanyl Awareness Day, and Shatterproof addresses four myths about fentanyl.

From the preventive services front, the U.S. Preventive Services Task Force posted

  • “a draft recommendation statement on screening for breast cancer. The Task Force now recommends that all women get screened for breast cancer every other year starting at age 40. This is a B grade. More research is needed on whether or not women with dense breasts should have additional screening with breast ultrasound or MRI, and on the benefits and harms of screening in women older than 75. These are I statements.”
  • The public comment period ends on June 5, 2023.

From the litigation front, STAT News reports

  • “A federal jury handed a major win to Gilead Sciences on Tuesday in a closely watched battle with the U.S. government over the rights to groundbreaking HIV prevention pills.
  • “The jury decided Gilead did not infringe on patents held by the Centers for Disease Control and Prevention and, in fact, that the agency’s patents were invalid. The CDC helped fund academic research into HIV prevention that later formed the basis for the pills. The Department of Health and Human Services contended that Gilead refused to reach a licensing agreement despite several attempts to reach a deal.
  • “For its part, the company argued that it invented the pills — an older one called Truvada and a newer, upgraded version called Descovy — and that the concept of using Truvada to prevent HIV was well-known by the time the government tried to obtain its patents. Moreover, Gilead maintained that it acted in good faith during its negotiations with the government.”

From the tidbits front —

  • Federal News Network relates
    • “The Postal Service is falling short of its goal to start turning around its financial losses this year, but Postmaster General Louis DeJoy says the agency is taking “aggressive actions” to get the agency back on track to break even by the end of the decade.
    • “USPS reported a $2.5 billion net loss for the second quarter of fiscal 2023, and is expected to see a net loss for the entire fiscal year.
    • The agency saw more than an 8% decline in first-class mail volume and a 5% decline in package volume, compared to the same period last year.”
  • OPM announced
    • “U.S. Office of Personnel Management (OPM) Director Kiran Ahuja will deliver the commencement address to the 2023 graduating class of the University of Georgia’s (UGA) School of Public and International Affairs at the Ramsey Auditorium on the UGA campus.  
    • “Director Ahuja, an alumna of the University of Georgia School of Law, will speak to the Class of 2023 on the opportunities that a career in federal service offers. As federal agencies seek to fill the positions necessary to implement legislation such as the 2021 Bipartisan Infrastructure Law, OPM is leading the federal government’s recruitment efforts. Director Ahuja’s message to graduates will be simple: if you want a career with impact, the federal government is hiring.”
  • HUB International points out that
    • “The IRS recently released a Chief Counsel Memo confirming its long-standing position that all flexible spending account (“FSA”) expenses must be substantiated. This means that, no matter how small, each expense must have some kind of third-party verification. While Chief Counsel Memos are not official, binding IRS guidance, they are informative of the IRS’s views in a particular area.”
  • Last Wednesday, “the FDA published a new web page with details about over-the-counter (OTC) Hearing Aids: What You Should Know before and after buying an OTC hearing aid.”

 

  

Friday Factoids

David Ermer–CDC, COVID-19, End of the PHE, NE, Mental health care, U.S. Healthcare, Uncategorized–
Photo by Sincerely Media on Unsplash

From Washington DC —

  • The Wall Street Journal reports
    • “Rochelle Walensky will be stepping down as director of the Centers for Disease Control and Prevention in June, the agency said Friday.
    • “Dr. Walensky decided to step aside, after more than two years in the job, as the Biden administration prepares to end the national health emergency around Covid-19 next week and just hours after the World Health Organization declared the crisis was over.
    • “Her departure is another indication the U.S. is moving into a new phase of its response to the virus, which health experts say is still a threat but not spreading like it had, and hospitalizations and deaths are nearing new lows.”
  • The Washington Post adds
    • “Neera Tanden will replace Susan Rice as head of President Biden’s Domestic Policy Council, the White House announced Friday, becoming the first Asian American to serve in the role.
    • “I am pleased to announce that Neera Tanden will continue to drive the formulation and implementation of my domestic policy, from economic mobility and racial equity to health care, immigration and education,” Biden said in a statement.
    • “Tanden, 52, has served as senior adviser and staff secretary to Biden since 2021, overseeing aspects of the president’s domestic, economic and national security teams. Tanden also held policy advising positions in the Clinton and Obama administrations, and was the former president of the Center for American Progress, a liberal think tank.”

From the public health front —

  • The Wall Street Journal informs us,
    • “The World Health Organization declared an end to the Covid-19 emergency, signaling that one of the most deadly and economically devastating pandemics in modern history is receding as the disease that caused it becomes a routine illness. 
    • “Covid-19 is here to stay, but the pandemic has been in a downward trend for more than a year because people around the world have built up immunity to the virus, the WHO said on Friday. Mortality has decreased, and there is less pressure on health systems. The trends have enabled most countries to return to prepandemic life, even as Covid-19 continues to spread.
    • “It’s therefore with great hope that I declare Covid-19 over as a global health emergency,” said WHO Director-General Tedros Adhanom Ghebreyesus.
  • Here are links to the CDC’s Covid Data Tracker and Weekly Fluview which continue to support the ending of U.S. Covid public health emergency next Thursday, May 11.
  • U.S. News and World Report ranks U.S. states by mental health depression rates.
    • “Around 1 in 5 American adults have dealt with a form of depression, with data also indicating symptoms are most prevalent among young adults and women.
    • “According to the most recent survey data collected through the Behavior Risk Factor Surveillance System, which is administered by the Centers for Disease Control and Prevention, a median of about 21% of the U.S. adult population in 2021 had ever been told they have a form of depression. That’s the highest the share has been in comparative data collected since 2011.”
  • NBC News points out that
    • “Prolonged and unexplained bouts of diarrhea, stomachaches and spots of blood during bowel movements may be signs of early-onset colorectal cancer — a disease that’s increasingly found in young adults not old enough to qualify for colonoscopies.
    • “The most troubling early symptom is rectal bleeding, a possible sign of colon cancer that’s not comfortably discussed beyond the bathroom.
    • “It can be difficult or embarrassing to talk about,” said Dr. Matthew Kalady, the director of the division of colon and rectal surgery at the Ohio State University Comprehensive Cancer Center. “But the reality is everybody deals with something like this,” and it’s important to understand what’s normal and what’s not, he said.
    • “The new research from Washington University School of Medicine in St. Louis, published Thursday in the Journal of the National Cancer Institute, included 5,075 people with early-onset colorectal cancer.”

From the U.S. healthcare business front —

  • Healthcare Dive tells us,
    • “Cigna Group raised its full-year guidance for adjusted earnings per share, revenue and customer growth as it reported first-quarter results Friday, including total revenue up 6% year over year at $46.5 billion. The insurer’s net income, at $1.3 billion, increased from $1.2 billion in the year-ago period. 
    • “Cigna posted a medical loss ratio of 81.3%, down from 81.5% in the prior-year quarter and better than internal expectations. This was partly based on lower COVID-19 costs. Claims for COVID, flu and respiratory syncytial virus were lower than expected in the quarter while non-viral care needs were more normalized, executives said on a call with investors Friday. * * *
    • “In discussing pharmacy benefit management arm Express Scripts, executives said they are aware of public and political pressure to lower drug costs, but are prepared to adapt as needed. “We are confident in our ability to earn sustainable and attractive margins for our services under a variety of legislative scenarios,” [CEO David] Cordani said.”
  • Fierce Healthcare relates that
    • “Option Care Health, a provider of post-acute care and infusion services, will shell out $3.6 billion to acquire home health and hospice firm Amedisys.
    • “The deal will create a massive provider of post-acute care services encompassing more than 16,500 employees and 674 care centers in 46 U.S. states, with a projected $6.2 billion in annual revenue. The combination of the two will enable the companies to beef up capabilities and expand their footprints as care options increasingly move into patients’ homes.
    • “Combining Amedisys’ home health, hospice, palliative and high-acuity care services with Option Care Health’s home and alternate site infusion services will create a leading independent platform for home and alternate site care, according to the executives in a press release.”

Monday Roundup

David Ermer–CMS, Congress, End of the PHE, NE, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC, The Wall Street Journal reports

  • “Treasury Secretary Janet Yellen said the U.S. government could become unable to pay all of its bills on time as soon as June 1 if Congress doesn’t first raise the debt limit.
  • “President Biden on Monday invited the top Republicans and Democrats on Capitol Hill to meet next week to discuss raising the country’s roughly $31.4 trillion borrowing limit, the White House said soon after Ms. Yellen’s warning. 
  • “The new estimate released Monday sets a shorter timeline than forecasters had previously expected, putting the U.S. potentially just weeks away from the first default on the U.S. debt. Republicans and Democrats have been debating how to raise the debt ceiling for months, but they have so far made little progress toward reaching an agreement.  * * *
  • “Ms. Yellen said the Treasury’s latest projection was still uncertain. The Treasury could ultimately be able to pay the nation’s bills for several weeks beyond early June, she said. The Treasury tends to be conservative when communicating projected deadlines for possible default.
  • “It is impossible to predict with certainty the exact date when Treasury will be unable to pay the government’s bills,” Ms. Yellen wrote in a letter to House Speaker Kevin McCarthy (R., Calif.).” 

In public health emergency (PHE) news,

  • Govexec informs us “The White House announced on Monday it’s officially ending the COVID-19 vaccine mandates for federal employees and contractors when the public health emergency ends on May 11.”
  • The Centers for Disease Control issued public fact sheets on post-PHE coverage for over-the-counter Covid tests. OPM’s end of PHE guidance requires carriers to continue coverage of these items but allows cost sharing.

From the public health front —

  • The National Institutes of Health announced
    • “Researchers have found the “Eat, Sleep, Console” (ESC) care approach to be more effective than using the Finnegan Neonatal Abstinence Scoring Tool (FNAST) to assess and manage opioid-exposed newborns, according to a national, randomized controlled clinical trial funded by the National Institutes of Health. Newborns cared for with ESC were medically ready for discharge approximately 6.7 days earlier and 63% less likely to receive medication as part of their treatment, compared to newborns cared for with FNAST. ESC prioritizes non-pharmacologic approaches to care, such as a low-stimulation environment, swaddling, skin-to-skin contact and breastfeeding. ESC also encourages parental involvement in the care and assessment of their infants. These findings are based on the hospital outcomes of a large and geographically diverse group of opioid-exposed infants. A two-year follow-up study of a subset of infants is ongoing. The current findings are published in the New England Journal of Medicine.
    • “Medical care for newborns who were exposed to opioids during pregnancy varies widely across hospitals,” said Diana W. Bianchi, M.D., director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which co-led the study with the NIH Environmental Influences on Child Health Outcomes (ECHO) Program. “These findings are an important step toward standard, evidence-based guidance for the care of these infants.”
  • The McKinsey Health Institute evaluates the impact of tech and social media on Gen Z mental health.
    • “Much like many relationships a person might have between ages 18 and 24, the relationship a young person has with social media can be complicated. No matter where they live, respondents in a new global survey said social media usage can lead to a fear of missing out (FOMO) or poor body image, but it also can help with social connections and self-expression.”

From the Rx coverage front, STAT News tells us,

  • “It’s hard to imagine now, but there was a time when obesity was a desert for drug development. Now that drugs originally conceived to control diabetes appear to be such sweeping successes in weight loss, competitors may soon crowd the field. Some candidates may move beyond the current class of GLP-1-based drugs, which mimic the hormone that helps regulate insulin and hunger. 
  • “STAT’s Elaine Chen and Allison DeAngelis explore novel approaches still in development, including some that don’t induce muscle loss, unlike the GLP-1 drugs, and some that mirror the effect of bariatric surgery. Still, among roughly 80 obesity treatments in development, more than half are GLP-1-based, according to tallies by STAT and analysts at TD Cowen. And combination treatments may be the future. Read more.“

From the U.S. healthcare business front,

  • Beckers Hospital Review points out that “Nursing shortages are easing for some hospitals after falling pay from temp agencies and new hospital perks drive more nurses back into permanent positions, The Wall Street Journal reported May 1.”
  • Beckers Payer Issues relates “Molina Healthcare reported double-digit growth in net income since the same period last year and raised its year-end earnings guidance, according to the company’s first-quarter earnings posted April 26.”
  • According to BioPharma Dive
    • “Japanese drugmaker Astellas Pharma on Sunday agreed to acquire Iveric Bio for about $5.9 billion, betting that a medicine the biotechnology company has developed for a common type of vision loss can help it build an eye drug business. * * *
    • “The deal hands Astellas a drug called Zimura that Iveric is studying as a treatment for a form of vision loss known as geographic atrophy. Iveric’s drug already succeeded in a pair of Phase 3 trials and is currently being reviewed by U.S. regulators. A decision is expected by Aug. 19.
    • “Pharmaceutical companies have increasingly turned to dealmaking to help offset patent losses that are soon expected for many of the industry’s top-selling drugs. Over the last two months, drugmakers have spent roughly $65 billion in total on buyouts, led by Pfizer’s $43 billion acquisition of cancer biotech Seagen, according to BioPharma Dive data.”

Friday Factoids

David Ermer–CDC, Congress, COVID-19, End of the PHE, NE, Federal employment benefits, SCOTUS, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From the end of the PHE front, the CDC’s daily Covid tracker continues to point down; flu activity remains low nationally, and OPM released its end of PHE guidance for FEHB carriers yesterday.

From the post-Dobbs front, the Wall Street Journal reports,

  • “The Supreme Court on Friday allowed the widely used abortion pill mifepristone to remain on the market indefinitely, granting emergency requests from the Biden administration and the brand-name manufacturer of the drug.
  • “The high court blocked the effect of a lower-court order that was poised to limit access to the pill, which is used in more than half of U.S. abortions. The Supreme Court’s action wasn’t a decision on the merits of the case; instead, the justices were deciding whether the pill could remain available during a continuing legal challenge brought by antiabortion groups.
  • “The court’s order was unsigned and provided no reasoning, as is typical in emergency actions. But it indicated that FDA-approved access to mifepristone would remain until litigation concludes in the lower courts and the Supreme Court itself has an opportunity to review those decisions—a timeline that likely will take many months.”

From the U.S. healthcare business front —

  • STAT News informs us,
    • Patient volumes are back in a big way, at least for the country’s largest for-profit hospital operator.
    • HCA Healthcare beat Wall Street’s expectations of profitability in the first quarter of 2023, as more people flocked to HCA’s hospitals, surgery centers, and physician clinics. Inpatient admissions, all types of surgeries, and emergency room visits were each up significantly in the first quarter of this year, compared with the same period last year, when the Omicron variant of the coronavirus stymied a lot of patient care.
  • The American Hospital Association adds,
    • Financial reserves play an important role for not-for-profit hospitals and health systems in ensuring that they can continue to serve their communities in the face of challenging operational and financial headwinds, according to a new report prepared for the AHA by Kaufman Hall. The report explains how financial reserves enable struggling not-for-profit hospitals and health systems to make needed investments, borrow at affordable interest rates, cover operating expenses and remain available to their communities as surging labor and supply costs, investment losses and other challenges persist. 

From Capitol Hill, STAT News reports,

  • Amid a scramble to assemble a health care policy package in the Senate, a pair of key senators have significantly changed a proposal to cap insulin costs.
  • The new legislation by Senate Diabetes Caucus co-chairs Sens. Jeanne Shaheen (D-N.H.) and Susan Collins (R-Maine) would cap insured patients’ insulin costs at $35 per month for at least one insulin of each type and dosage form, and require pharmacy benefit managers to pass through rebates they collect from insulin manufacturers to the insurance plans that employ them.
  • The legislation also includes several provisions related to biosimilar policy. The bill would create a new, expedited pathway for the Food and Drug Administration to consider biosimilars that would be alternatives to biologics without adequate competition and would allow Medicare drug plans to put biosimilars on their formularies as soon as they come on the market.
  • That is a major shift from the version of the bill that the senators released last year, which was structured differently around offering incentives to get drug manufacturers to voluntarily lower the prices of insulin.

Politico discusses a bipartisan bill to shift some Medicare coverage to home.

From the miscellany front, Healthcare Dive offers a potpourri of wrap-up stories on the HIMSS conference that ended yesterday.