FEHBlog

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.”

 

  

Monday roundup

David Ermer–Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the public health front

  • The Washington Post reports
    • “In 2022, 8,300 cases of tuberculosis were identified in the United States, marking a 5 percent increase from the year before, according to a report from the Centers for Disease Control and Prevention.
    • “The 2022 rebound in TB cases included a 26 percent increase in TB diagnoses in children 4 or younger — from 160 cases in 2021 to 202 last year. That increase is concerning, CDC officials said in a news release, because cases in that age group are usually the result of recent transmission rather than reactivation of a long-standing latent infection.
    • “Still, the overall 2022 tally did not reach the pre-pandemic count of 8,895 TB cases in 2019. That number fell by 20 percent in 2020, which health officials generally attributed to delayed or missed diagnoses during the pandemic, as well as changes in people’s travel and movement that limited their potential exposure to the disease.”
  • STAT News informs us
    • “Only about one in 5,000 people in the United States is a centenarian. (About 1,900 centenarians live in Massachusetts, according to 2021 federal records.) And the odds of reaching 110 are rarer still: just one in 5 million.
    • “But it’s not just longevity that makes [centerarian Heldra] Senhouse exceptional. Her clear memory and sharp thinking are hallmarks of super agers, as these ancients are known; so is her generally good health. Major age-related illnesses hit most centenarians about 20 to 30 years later than everyone else. And few ever develop Alzheimer’s disease.
    • “Increasingly, scientists believe that genes, and not necessarily good habits, determine who lives past 100. Many people who exercise regularly, eat healthy diets, and refrain from smoking will make it to 90. Beyond that is when researchers say genetics plays a much larger role.
    • FEHBlog note — the researchers are trying to identify the super ager genes.
  • JAMA Online offers a discussion of the role of pediatricians in resolving the maternal mortality problem.

From the substance use disorder front —

  • The Washington Post discusses community efforts to create “overdose prevention centers [that] allow people to take illegal drugs like fentanyl under the watch of staff trained to reverse overdoses.”
  • STAT News tells us
    • “Ever since fentanyl came to dominate the U.S. illicit drug supply, doctors and patients have found buprenorphine, a key addiction-treatment medication, increasingly difficult to use.
    • “All too often, fentanyl’s potency has meant that patients transitioning to buprenorphine, a far weaker drug, experience excruciating symptoms known as “precipitated withdrawal.” Often, the discomfort is so severe that patients give up on buprenorphine altogether.
    • “But a trio of West Coast doctors is reporting a buprenorphine breakthrough thanks to an unlikely-seeming medication: ketamine, an anesthetic used both medicinally and recreationally and that has hallucinogenic effects at high doses. Giving tiny doses of ketamine as patients begin buprenorphine treatment, they say, has all but eliminated their withdrawal symptoms.”

From the U.S. healthcare business front, Healthcare Dive reports, “Nonprofit Kaiser Permanente posted net income of $1.2 billion for the first quarter this year, as higher care volumes and a more generous financial market boosted quarterly profit. The operator reported a $961 net loss in the first quarter of last year.”

From the telehealth front, Healthcare IT News shares a sneak peek at a new Ernst & Young survey. “The firm’s global health leader speaks with Healthcare IT News about hybrid care, digital transformation, big data, generative AI and smart technology.”

Weekend update

David Ermer–Congress, FDA, Telehealth, U.S. Healthcare–
Photo by Thought Catalog on Unsplash

The Senate will be on a State work period this week, while the House of Representatives will hold a DC work week. This means that Committee business will occur.

The Wall Street Journal reports

“Top Democrats and Republicans are racing to try to find a politically acceptable way to raise the nation’s borrowing limit in the coming weeks, diving into talks that President Biden has avoided during months of impasse. 

“Mr. Biden will host House Speaker Kevin McCarthy (R., Calif.) and other congressional leaders at the White House on Tuesday, the first direct contact in months as officials grapple with the prospect of the first-ever U.S. default as soon as June 1. 

“While the two parties are publicly standing by their negotiating stances, officials on both sides of the aisle have started to quietly search for a way out of a potential crisis.”

From the Rx coverage front —

  • Fortune Well tells us,
    • “U.S. health regulators are weighing the first-ever request to make a birth control pill available without a prescription.
    • “Advisers to the Food and Drug Administration meet [this] week to review drugmaker Perrigo’s application to sell a decades-old pill over the counter. The two-day public meeting is one of the last steps before an FDA decision.
    • “If the FDA grants the company’s request, Opill would become the first contraceptive pill to be moved out from behind the pharmacy counter onto store shelves or online.
    • “In an initial review posted Friday, the FDA raised several concerns about studies of Opill, citing problems with the reliability of some of the company’s data and raising questions about whether women with certain other medical conditions would correctly opt out of taking it. It also noted signs that study participants had trouble understanding the labeling instructions.
    • “The agency will ask the panel to consider whether younger teenagers will be able to understand and follow the instructions.
    • “At the end of the meeting, the FDA panel will vote on whether the benefits of making the pill more widely available outweigh the potential risks. However, the panel vote is not binding, and the FDA is expected to make its final decision this summer.
  • Healthcare Dive reports,
    • “U.S. supply of Novo Nordisk’s weight loss drug Wegovy will be “reduced temporarily,” the company said Thursday, revealing the latest setback to a launch that’s been slowed by manufacturing issues over the last year and a half. 
    • “Availability of the lower three of Wegovy’s five doses, used as weekly starter shots to gradually increase patients’ tolerance to the drug, will be limited to ensure people who now get maintenance treatment can maintain “continuity of care,” the company said. Novo indicated the problem will be eased once it gets a new contract manufacturer up and running. * * *
    • “Despite the production hurdles, Wegovy sales continued to grow. Sales rose to 4.6 billion Danish kroner, or about $676 million, in the first quarter, up from 2.4 billion kroner the previous quarter and 1.4 billion over the first three months of 2022.”

From the health plan design front, Fierce Healthcare points out

“The first step to living healthier is choosing that lifestyle, and CareFirst BlueCross BlueShield has tapped Noom for Work to help many of its approximately 3.2 million members make that decision.

“The partnership, announced this week, will focus on CareFirst members who struggle with obesity as well as those with prediabetes, according to an announcement.

“In what Noom called a “mind-first approach,” the program will include a curriculum for those struggling with weight control that will focus on the “why” behind the behaviors that have led to problems, and then get to work on changing those behaviors.

“Included are daily lessons tailored to each person’s weight-loss goals, such as continuous education, food intake tracking and advice on how to connect to devices, such as scales and wearables, that offer not only immediate feedback but also encouragement.

From the U.S. healthcare business front, NPR Shots notes

“The Biden administration on Thursday cautioned Americans about the growing risks of medical credit cards and other loans for medical bills, warning in a new report that high-interest rates can deepen patients’ debts and threaten their financial security.

“In its new report, the Consumer Financial Protection Bureau estimated that people in the U.S. paid $1 billion in deferred interest on medical credit cards and other medical financing in just three years, from 2018 to 2020.

“The interest payments can inflate medical bills by almost 25%, the agency found by analyzing financial data that lenders submitted to regulators.”

From the fraud, waste, and abuse front, Fierce Healthcare reports

“Just as the long off-ramp from the COVID-19 public health emergency (PHE) ends and telepsychiatry providers breathe a sigh of relief with a temporary extension of virtual prescribing flexibilities, a report dropped showing an estimated $348 million in telehealth psychotherapy Medicare payments were noncompliant.

“This week, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released the findings of an audit (PDF) of Medicare payments from March 2020 through February 2021. During the audit period, Medicare Part B paid $1 billion for more than 13.5 million psychotherapy services, including telehealth services.

“Of the $1 billion in Medicare Part B payments, approximately $591 million was for psychotherapy services that were billed as telehealth services, and approximately $439 million was in payments for in-person psychotherapy services, according to the report.

“The federal watchdog estimates $580 million in improper payments for services that did not comply with Medicare requirements during the audit period, including $348 million for telehealth services, or about 60% of the payments, and $232 million for non-telehealth services.”

 

Cybersecurity Saturday

David Ermer–Cybersecurity, Uncategorized–

From the cyber breaches front, Health IT Security reports on the latest healthcare breaches.

From the cybersecurity justice front —

The Washington Post informs us,

  • “Former Uber chief security officer Joe Sullivan avoided prison Thursday as he was sentenced for covering up the 2016 theft of company data on 50 million Uber customers while the company was being investigated by the Federal Trade Commission over a previous breach.
  • “Sullivan had been convicted in October of obstruction of justice and hiding a felony, making him the first corporate executive to be found guilty of crimes related to a data breach by outsiders.
  • “U.S. District Judge William Orrick sentenced Sullivan to three years of probation, noting his significant past work in protecting people from the sort of crime he later concealed. He also said that Sullivan’s steps had succeeded in keeping the stolen data from being exposed.
  • “Orrick said he felt former Uber chief executive Travis Kalanick was equally responsible for what he considered a serious offense, and he wondered aloud why Kalanick had not been charged. The judge also said he was influenced by the unprecedented nature of the case, warning that future offenders would be jailed, even if they were the pope.”

Cybersecurity Dive tells us,

  • “A New Jersey appellate court upheld a prior ruling in favor of Merck, a major pharmaceutical company embroiled in a closely watched case involving $1.4 billion in claims stemming from the 2017 NotPetyacyberattack.
  • “The court agreed Monday that insurers could not deny coverage under war exclusion language contained in the policies, saying the circumstances didn’t apply in the Merck case. 
  • “The decision is considered a major victory for companies seeking claims for cyberattacks at a time when hackers linked to rogue nation-states have stepped up threat activity through supply chain attacks, ransomware and other malicious threats.”

From the cyber vulnerabilities front, the Cybersecurity and Infrastructure Security Administration added three more known exploited vulnerabilities to its catalog.

Cybersecurity Dive points out “three areas of generative AI the NSA is watching in cybersecurity.
Generative AI is a “technological explosion,” NSA Cybersecurity Director Rob Joyce said. While it is a game-changing technology, it hasn’t delivered quite yet.”

From the ransomware front —

Cyberscoop relates that “Victims’ reluctance to report ransomware stymies efforts to curb cyberattacks, say federal officials. Federal officials say they need more victims to report when they’ve been hit by ransomware in order to better defend against the problem.”

Here is a link to Bleeping Computer’s latest Week in Ransomware.

  • “This week’s ransomware news has been dominated by a Royal ransomware attack on the City of Dallas that took down part of the IT infrastructure.
  • “The attack occurred early Monday, affecting the Dallas Police dispatch system and the public library’s computer network. Additional systems, including the City’s website, were shut down as time passed.
  • “On Wednesday, the City’s network printers began printing ransom notes from the attack. BleepingComputer obtained a screenshot of this note, allowing us to identify that the Royal ransomware operation was behind the attack.”

From the cyber defenses front, Cybersecurity Dive notes

  • “Google rolled out a feature Wednesday that allows account holders to create passkeys, part of a wider move to phase out passwords across the industry.
  • “Passkeys are stored on local computers or mobile devices, reducing the risk of credentials being hacked through a phishing attack. Passkeys allow users to sign into apps and sites the same way as they would access their devices, such as a face scan or fingerprint. 
  • “Dashlane separately announced a feature called passwordless login on Wednesday, which means users of the password manager will no longer need to create a master password to access the service.”

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.”

Thursday Miscellany

David Ermer–CDC, COVID-19, Mental health care, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From the public health front —

  • MedPage Today tells us
    • “COVID-19 dropped to the fourth leading cause of death in 2022, down from third place in 2020 and 2021, according to provisional mortality data from the CDC.
    • “Taking its place was “unintentional injury,” which followed heart disease and cancer as the longstanding top killers, reported Farida B. Ahmad, MPH, and colleagues in Morbidity and Mortality Weekly Report (MMWR).”
  • The New York Time reports
    • “Births and pregnancies in the United States have been on a long-term decline. A new data analysis provides one reason: It’s becoming less common for women to get pregnant when they don’t want to be.
    • “The analysis, released Thursday in the journal Demography by researchers at the Guttmacher Institute, estimates the number of pregnancies in the United States — there is no single official count — and examines women’s feelings about the timing of their pregnancies.” 
  • The New York Times Morning column points out that state legislatures are embracing harm avoidance approaches to drug addiction. ” The approach focuses on mitigating the potential dangers of drugs, not necessarily encouraging users to abstain, e.g., legalizing fentanyl testing strips.”

From the mental healthcare front —

  • The Department of Health and Human Service recognizes “this Mental Health Awareness Month, [by] bringing attention to mental health and how essential it is to overall health and wellbeing [via] a fact sheet providing a snapshot of various efforts made by HHS over the past year.
  • Per Govexec,
    • “The Office of Personnel Management encouraged agencies to highlight the variety of mental health resources available to federal employees, and highlighted a new interagency effort to connect feds with mental health-related tools and events.
    • “In a memo to agency heads marking the start of Mental Health Awareness Month, OPM Director Kiran Ahuja said protecting the physical and mental well-being of federal workers is a “top priority” for the administration.
    • “We encourage agency leaders to remind employees about the importance of cultivating healthy wellness habits, which include caring for one’s mental health on a proactive rather than reactive basis,” she wrote. “Initiating regular conversations surrounding mental and emotional well-being is instrumental in normalizing and destigmatizing receiving mental health treatment and fostering a healthier workforce.”
    • “Ahuja said a new interagency listserv called Mindful Fed will offer tools and activities that federal employees can use to maintain their mental health. * * *
    • “Federal workers seeking to join the new listserv can email Mindful-FED-subscribe-request@listserv.gsa.gov, Ahuja wrote.”

From the U.S healthcare business front —

Healthcare Dive informs us,

  • Hospital margins continued to stabilize in March, but remained razor thin as inflation drove up supply and drug costs, according to Kaufman Hall’s national hospital flash report.
  • Hospitals reported flat median year-to-date operating margins, an improvement from almost a year of negative margins, according to the report.
  • “While it appears that hospital finances are stabilizing, that doesn’t mean that all is well,” said Erik Swanson, senior vice president of Data and Analytics with Kaufman Hall, in a statement.
  • Expenses, driven by economic inflation, hampered hospitals and outpaced a 24% month-over-month increase in profitability and a 12% increase in revenue.

and

  • “U.S. telehealth use totaled 5.5% of medical claim lines in February, a drop of 6.8% from January, according to Fair Health’s monthly telehealth tracker.
  • “In February, telehealth use declined in the four U.S. census regions: It dropHelaped by 8.7% in the Midwest, 8.3% in the South, 6.2% in the West and 1.5% in the Northeast.
  • “COVID-19 dropped out of the top five telehealth diagnoses nationally. The top diagnosis on telehealth claim lines was mental health conditions.”

From the miscellany front —

  • Fierce Healthcare relates, “It’s official: Medicare Advantage (MA) enrollment accounts for just over half of all Medicare beneficiaries, according to a new analysis from the Kaiser Family Foundation.”
  • Healthcare Innovation tells us,
    • “A year ago, officials from the Center for Medicare and Medicaid Services unveiled a National Quality Strategy. In a May 1 update on the strategy, CMS officials discussed several goals, including annually increasing the percentage of digital measures used in CMS quality programs. CMS officials also said the organization would build one or more quality data systems that can receive data using the FHIR data standard by 2027.”
  • The Segal consulting firm offers a five step strategy for improving wellness programs.
  • Mercer Consulting delves into employer health benefit planning ideas for 2024.

Midweek Update

David Ermer–Congress, Medical / Rx research, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC, the Wall Street Journal reports

  • “The Biden administration and Capitol Hill leaders are scrambling to avoid a first-ever government default that could arrive as soon as June 1, taking potential alternative strategies more seriously after months of deadlock over raising the country’s borrowing limit.  
  • “Publicly, both Republicans and Democrats are still sticking to their demands as the clock ticks. GOP lawmakers are seeking to force cuts to federal spending in exchange for supporting raising the debt limit, while Democrats continue to call for a debt-limit increase without any other policy conditions.
  • “Privately, though, Biden administration officials and lawmakers have started to weigh potential alternatives to their negotiating position, including a short-term increase in the borrowing limit that would buy them time to find a compromise, according to people familiar with the matter. Biden administration officials are also taking a fresh look at experimental ways the U.S. could potentially keep paying the government’s bills even if Congress doesn’t raise the debt limit, the people said.” 

From the Rx coverage front —

MedPage Today informs us,

  • “The FDA has approved the first-ever vaccine for respiratory syncytial virus (RSV), the agency announced on Wednesday.
  • “Marketed under the trade name of Arexvy, the adjuvanted RSV prefusion F protein-based vaccine is specifically indicated for preventing lower respiratory tract infections in adults 60 and over.
  • “Until now, no vaccine has existed to protect against RSV infection, a common scourge both for young children and older adults.  * * *
  • “GSK said the vaccine would be available ahead of the 2023/2024 RSV season, and that the CDC’s Advisory Committee on Immunization Practices will weigh in on the RSV vaccine’s appropriate use in June.”

Beckers Pay Issues points out,

  • “Payers are anticipating the cost of expensive new gene therapy drugs to be a significant issue in the coming years, according to a survey from the Pharmaceutical Strategy Group. 
  • “The survey, published May 1, asked 182 benefits leaders at employers and health plans about their organization’s specialty drug benefit design. 
  • “Read the full report here. “

From the drug research front, the Wall Street Journal reports

  • “An experimental Eli Lilly drug slowed cognitive and functional decline for people with early-stage Alzheimer’s disease in a new study that signals drugmakers are turning a corner in long-running efforts to find meaningful treatments for the memory-robbing disease.
  • “Based on the new data, Lilly said Wednesday it plans to apply this quarter to the U.S. Food and Drug Administration for approval to market the drug, setting up a potential agency decision later in 2023 or in 2024. * * *
  • “Researchers designed Lilly’s drug donanemab and Leqembi, from Eisai and Biogen, to work by targeting and reducing amyloid, a substance that forms plaque in the brain and is a prime suspect in fueling the worsening of Alzheimer’s. * * *
  • “In the study of more than 1,730 patients, the [intravenously administered] drug slowed patients’ decline by 35% compared with people who received a placebo over 18 months of treatment, Lilly said. Researchers gave the drug to elderly people who testing indicated were in the early stages of Alzheimer’s. * * *
  • “The findings could bolster donanemab’s appeal to some doctors and patients when compared with Eisai and Biogen’s Leqembi, according to analysts.
  • “Leqembi slowed Alzheimer’s patients’ decline by 27% versus a placebo over 18 months in a separate study, though there were differences in the studies that make direct comparisons difficult.
  • “Yet Leqembi’s safety profile might give it an advantage over donanemab with other doctors and patients, analysts said.”

From the U.S. healthcare business front, Healthcare Dive informs us that “CVS [Health] lowers 2023 earnings outlook on Oak Street, Signify deal costs.”

  • “Despite lowering 2023 earnings guidance by 20 cents to a range of $8.50 to $8.70 per share, “we remain committed to achieving the $9 and $10 targets for 2024 and 2025,” CFO Shawn Guertin said on a Wednesday earnings call.”

From the patient safety front, the Leapfrog Group released

  • “the spring 2023 Leapfrog Hospital Safety Grade. An analysis found the average risk of three healthcare-associated infections (HAIs)— including Methicillin-resistant Staphylococcus aureus (MRSA), central line-associated bloodstream infections (CLABSI) and catheter-associated urinary tract infections (CAUTI)—spiked to a 5-year high in hospitals during the COVID-19 pandemic.” 
  • “Additional highlights from the spring 2023 Safety Grades include:
  • “Twenty-nine percent of hospitals received an “A,” 26% received a “B,” 39% received a “C,” 6% received a “D,” and less than 1% received an “F.”
  • “The top ten states with the highest percentages of “A” hospitals are: New Jersey, Idaho, Utah, Pennsylvania, Connecticut, North Carolina, South Carolina, Colorado, Virginia and Massachusetts.
  • “There were no “A” hospitals in Delaware, the District of Columbia or North Dakota.

Tuesday’s Tidbits

David Ermer–Congress, Mental health care, NIH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill —

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

Fierce Healthcare informs us,

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

From the public health front —

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

From the mental health care front

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

From the U.S. healthcare business front —

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

From the healthcare spending front —

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

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.”