MedPage Today reminds us about “the Top Supreme Court Health Cases to Watch [this month]. — A slew of cases this term could reshape health policy.” The Supreme Court now hands down its opinions on Thursdays.
Last week, the U.S. Office of Personnel Management’s (OPM) Office of Inspector General posted its Semi-annual report to Congress for the period ended March 31, 2024, and OPM posted its response to that report. These reports are always worth a gander.
From the public health and medical research front.
The American Medical Association offers “the top health tips your cardiologist wants you to know.”
Fortune Wells points out “five lifestyle changes improved brain function for those with early Alzheimer’s.”
NPR notes “eight mistakes to avoid if you’re going out in the heat.”
The Washington Post advises folks that “‘The first step before you take inventory of your body is to decide that you care about living a long, healthy life,’ one expert says.”
“Doctors couldn’t help. [Parents and patients] turned to a shadow system of DIY medical tests.”Doctors couldn’t help. [Parents and patients] turned to a shadow system of DIY medical tests.
“Buoyed by regulatory vacuums, Silicon Valley is building a booming online wellness market that aims to leave the doctor’s office behind.
“Many investors and entrepreneurs endorse self-testing with similar urgency. Tiny Health founder Cheryl Sew Hoy said she raced to develop her baby microbiome testing start-up because of her experience giving birth to a C-section baby with gastrointestinal issues that doctors could not address. Though she and her business partners were aware that the benefits of gut bacteria testing have often been overhyped, they found cutting-edge research showing that the simplicity of a baby’s gut makes it highly responsive to interventions.
“To them, it did not seem fair to wait for years — possibly decades — until that research could become standard pediatric advice.
“It will eventually get to the point where you get screened with a stool test every time you go to the hospital, but that’s not going to happen next year or the next couple of years,” said Ruben Mars, a microbiologist at the Gut Microbiome Laboratory at the Mayo Clinic, and a scientific adviser to Tiny Health. “But these kids are getting chronic disease now. … They shouldn’t have to wait until it becomes standard of care.”
“As long as the medical system remains slow there is going to be a market for people who take matters into their own hands, said Anarghya Vardhana, a Silicon Valley investor. “If you don’t give patients the tools, they will go figure it out themselves,” she added.”
“A personalized screening technique predicts preeclampsia more accurately than current guidelines relying on risk factors, recent research in the journal Hypertension suggests.
“A pregnancy complication marked by high blood pressure and signs of organ failure,” preeclampsia develops in about 1 in 25 U.S. pregnancies, according to the Centers for Disease Control and Prevention. Worldwide, it accounts for more than 70,000 maternal deaths and 500,000 fetal deaths each year.
“The new screening approach, which relies on blood biomarkers and ultrasound data in addition to information about maternal health, can accurately predict up to two-thirds of preterm preeclampsia cases, the study’s authors say.”
The Wall Street Journal tells us “Influencers Are Saying Sunscreen Causes Cancer. They Are Wrong.” That’s a big bowl of wrong.
STAT News alerts us that while wearables generate powerful data but it’s [often?] not useful to doctors, yet.
“Just because the Food and Drug Administration has given the Apple Watch and other wearable devices the OK to market the health benefits of their tracking and algorithms doesn’t mean that the data they generate are useful for either patients or their doctors, experts said Thursday at the STAT Breakthrough Summit West in San Francisco.
“Yesterday, I saw a patient with type 2 diabetes who has a continuous glucose monitor, and so she’s been tracking her blood sugar every five minutes,” said Ida Sim, a primary care physician and chief research informatics officer at the University of California, San Francisco. “[I] sat with her for almost an hour yesterday. I couldn’t get to her CGM data — she had it on her phone, but the report goes into a website that I didn’t have the login to, and it hadn’t been downloaded into my electronic medical record. So all this tracking data, I didn’t have it.”
“Not only do clinicians not have the ability to access data that their patients want to use to guide their care, but primary care doctors often don’t know how to interpret that firehose of data, said Sim. She asked some of her endocrinology research colleagues how they use that data and they explained the calculations needed to create biomarker metrics from them. That made the data largely useless to her as a doctor, and it was frustrating.
“I think the motto right now is, ‘We just give you the data, tell us what to do with it,’” but doctors don’t know what to do with it, said Sim. “But it does tell a good story sometimes. And I think we need to boil that data down into biomarkers that help us tell the story that fit the picture together, and I think we’re just not there yet because we just need to have different people in the room.”
“Renton, Wash.-based Providence is back in the black after reporting a $176 million operating gain (2.3% margin) in the first quarter, a significant improvement on the $345 million operating loss (-5.1% margin) reported in the first quarter of 2023. “Renton, Wash.-based Providence is back in the black after reporting a $176 million operating gain (2.3% margin) in the first quarter, a significant improvement on the $345 million operating loss (-5.1% margin) reported in the first quarter of 2023.
“The 51-hospital system saw first-quarter patient revenues increase 11% year over year to $7.8 billion while expenses rose 6.4% to $7.6 billion, according to financial documents. Salaries and benefits costs grew by 4% year over year to $3.9 billion as wage increases were offset by lower premium labor expenses. Contract labor declined by 42% year over year for the quarter.
“We are navigating the headwinds facing healthcare by focusing on our strategies for recovery and renewal,” CFO Greg Hoffman said in a May 17 news release shared with Becker’s. “We expect the positive momentum to continue throughout the year and are excited for a strong 2024.”
“With the Federal Trade Commission (FTC) issuing a final rule last month that bans noncompete agreements nationwide, the graphic below is our attempt to categorize the current status of complex state noncompete laws that affect physicians. Except in the event of a business sale, five states—California, North Dakota, Minnesota, Nebraska, and Oklahoma—ban all noncompete agreements for all employees, and at least 19 states either ban them for physicians or place varying limits on them for physicians. * * *
“Should the new FTC ban survive the mounting legal challenges it faces, its effect on the physician labor market may be limited, as not-for-profit organizations fall outside the FTC’s traditional enforcement jurisdiction. However, the agency has indicated a willingness to reevaluate an entity’s not-for-profit status and stated that “some portion” of tax-exempt hospitals could fall under the final rule’s purview.“
“Can’t focus on the task at hand or feeling sluggish beyond the afternoon slump? One possible cause: iron-deficiency anemia (IDA).
“About 3 million Americans have anemia, according to the U.S. Centers for Disease and Prevention Disease and Prevention (CDC), and those are just the people who’ve been diagnosed. Many others live with the condition for years without realizing it. * * *
“After figuring out the underlying cause, the next plan of action is treatment. For many, iron supplements are the answer. Your doctor may recommend over-the-counter iron pills to replenish the iron stores in your body. However, these tablets are not a one-size-fits-all solution.”
“Amid the many demands of practicing medicine, doctors can have less time and energy for their patients, and those relationships can suffer. Yet research has shownthat when physicians show empathy, that can generally lead to better clinical outcomes, at least over the near-term. Now, a new study, published Thursday in JAMA Network Open, demonstrates that those benefits can extend longer and be even more effective than some clinical therapies in dealing with lower back pain, which affects half of the U.S. population in any given year.
“Researchers at the University of North Texas Health Science Center at Fort Worth, observing patients with lower back pain over the course of 12 months, found that treatment by a “very empathic” physician was associated with better outcomes at the end of that year than treatment by a “slightly empathic” physician. And those positive outcomes were greater than those associated with nonpharmacological treatments (exercise therapy, yoga, massage therapy, spinal manipulation, acupuncture, cognitive behavioral therapy), opioid therapy, and lumbar spine surgery.”
From the U.S. healthcare business front,
Beckers Hospital Review lists “27 critical access hospitals to know for 2024.”
“These hospitals are vital components of the overall healthcare delivery system, providing quality care to the residents and visitors of rural areas. The small but mighty organizations are working to expand access to specialty care, cut down on patient travel times, and improve community health.
“Critical access hospitals are those that offer 24/7 emergency care and have no more than 25 inpatient beds. While compiling this list, the editorial team examined rankings and awards from several respected organizations, including Healthgrades, the National Rural Health Association and the Chartis Center for Rural Health.”
“A year ago, Blue Shield of California joined forces with Accolade and TeleMed2U to launch Virtual Blue, a new plan that centers on virtual care for members with the goal of boosting access.
“And with that first year on the books, the insurer is seeing positive results in Virtual Blue, it revealed Friday. Members were more likely to visit their primary care doctors compared to those in a more traditional PPO plan. Blue Shield saw primary care claims increase by 31% in 2023 compared to 2022.
“People who enroll in Virtual Blue are able to secure virtual visits with a $0 copayment and can schedule appointments online with their clinician, making it easier to fit critical visits into their daily lives. In-person care is available whenever appropriate or when the member prefers, Blue Shield said.”
The FEHBlog was tied up with family business yesterday so Cybersecurity Saturday appears below the Weekend Update
From Washington, DC,
Congress is back to work on Capitol Hill. The Wall Street Journal describes the situation as “Battered Congress Has Two Weeks to Fix Three Big Problems: Talks to stop a government shutdown, fix the border and fund Ukraine converge on Capitol Hill.”
“Congressional leaders reached a bipartisan deal on Sunday setting a roughly $1.6 trillion federal spending level for the year, but the pact drew quick criticism from some conservatives, and it remained unclear whether lawmakers would be able to quickly pass legislation averting a government shutdown.”
Congress does not have any hearings scheduled for this week.
“The Supreme Court said Friday it will review a case (No. 23-727) challenging Idaho’s strict abortion ban, which the Biden administration says conflicts with a federal law [EMTALA] requiring emergency room doctors to perform the procedure in some circumstances.”
Federal News Network provides more background to reduce retirement program overpayments.
“For OPM, many of the improper payments that the agency makes through retirement services may stem from limited data, on account of not using enough analytics to identify beneficiaries who have died and therefore are no longer entitled to the benefits, [Linda] Miller, [Audient Group CEO] said.
“There is more than one way of identifying people who have passed away — looking at Social Security, obituary data and more accurate information on deaths,” Miller said. “OPM doesn’t use much of that data, so the reports are likely less accurate.”
From the public health and medical research front,
Fortune Well offers us four strategies for older folks to get good quality sleep and an approach to adding beneficial thirty-second-long micro-workouts to your day.
“The Veterans Affairs Department will soon begin funding research into the use of psychedelics such as MDMA and mushrooms to treat PTSD and depression, the first time the agency has done so since the 1960s.
“The announcement answers the call from some veterans and researchers who have long advocated for the potential medical benefits of MDMA and psilocybin, or psychoactive mushrooms. VA on Friday issued a request for applications to its network of researchers, collaborating with academic institutions to solicit proposals to study the impact of using the compounds to treat post-traumatic stress disorder and depression in veterans.”
From the U.S. healthcare front,
STAT News reminds us that the JP Morgan Healthcare Conference will be held this week in San Fransico.
“Nonprofit hospitals often get overshadowed at the J.P. Morgan Healthcare Conference, the health care industry’s swankiest investor meeting whose agenda is dominated by drugmakers and biotech companies.
“But hospitals are still the largest part of America’s health care economy, commanding nearly a third of the country’s $4.7 billion health care tab. And similar to last year, when hospitals touted their plans for expansion and hiking prices, they will have a rosy picture to sell to financiers as patients flock to their facilities.”
The American Medical Association informs us, “What doctors wish patients knew about scope of practice.”
“Despite efforts to reduce drug costs through Medicare negotiation for 10 common medications, the US still pays more for these drugs than almost any other nation, even after factoring in discounts and rebates, according to a Commonwealth Fund chart pack.
“The researchers used 2021 data from IQVIA and the Medicare Payment Advisory Commission (MedPAC) to assess how US drug prices differed from international trends. With this information, the researchers compiled 12 charts that situate the drug prices in the United States compared to other countries.”
“Duluth, Minnesota-based Essentia Health and Marshfield, Wisconsin-based Marshfield Clinic Health System have scrapped their plan to merge into a 25-hospital Midwest system.
“The two nonprofit health systems said in a statement that they have “engaged in meaningful discussion” over the last two years about how the organizations could combine their unique strengths.
“We have decided that a combination at this time is not the right path forward for our respective organizations, colleagues and patients,” the health systems said in a statement posted to Essentia Health’s website Friday.”
“Metagenomi, a biotechnology startup working to identify new CRISPR enzymes for editing genes, has filed to go public.
“Backed by healthcare investors and pharmaceutical firms including Novo Nordisk’s parent company and Bayer’s venture arm, Metagenomi most recently raised a $275 million Series B round. The startup is also partnered with Moderna and Ionis Pharmaceuticals.
“The Emeryville, California-based biotech is one of at least three life sciences companies to publicly plan for an initial public offering so far this year. Should it successfully price an IPO, its performance could serve as an early barometer for the sector in 2024.”
The Society for Human Resource Management notes HR trends for which we should be prepared in 2024
Cybersecurity Saturday
HealthcareIT Today offers a boatload of cybersecurity predictions for 2024.
From the cybersecurity vulnerabilities front,
HHS’s Health Sector Cybersecurity Coordination Center (HC3) released its December 2023 monthly vulnerabilities report on January 4:
In December 2023, vulnerabilities to the health sector have been released that require attention. This includes the monthly Patch Tuesday vulnerabilities released by several vendors on the second Tuesday of each month, along with mitigation steps and patches. Vulnerabilities for December are from Microsoft, Google/Android, Apple, Mozilla, Cisco, SAP, VMWare, Adobe, Fortinet, and Atlassian. A vulnerability is given the classification of a zero-day when it is actively exploited with no fix available or if it is publicly disclosed. HC3 recommends patching all vulnerabilities with special consideration to the risk management posture of the organization.”
The Cybersecurity and Infrastructure Security Agency added two more known exploited vulnerabilities to the catalog on January 2.
“A critical vulnerability in Apache OFBiz was hit with a surge in exploitation attempts in recent weeks, which could allow attackers to take control of affected systems and launch supply chain attacks, according to researchers from SonicWall.
“Apache OFBiz is an open source enterprise resource system that is used in a wide range of software, including Atlassian Jira, which is used by more than 120,000 companies. “Jira uses a customized OFBiz Entity Engine that does not implement the vulnerable framework module,” a spokesperson for Atlassian told Cybersecurity Dive via email.
“The authentication bypass vulnerability, listed as CVE-2023-51467, has a CVSS score of 9.8 and could expose sensitive data or allow an unauthenticated attacker to execute arbitrary code.”
From the ransomware front,
Here’s a link to the Bleeping Computer’s Week in Ransomware.
From the cyber defenses front,
The Wall Street Journal offers tips for security computers for personal and small business use.
“As the digital realm continues to expand, it is axiomatic that cybersecurity threats are escalating concurrently. The fight against cybercrime has transformed from an optional frontline battle to a mandatory survival skill for businesses and individuals. Unfortunately, humans have now surpassed machines as the most favored targets for cybercriminals. An effective approach that merges change management methodology with cybersecurity procedures is needed to combat this.”
Security Intelligence offers a wholisitc approach to information and operational technology.
The Hill discusses four ways the Fiscal Year 2024 appropriations issues can play out in January.
The Chief Justice, Hon. John Roberts, released his year-end report on the federal judiciary. The report focuses on generative artificial intelligence.
From the public health and medical research front,
Fortune Well considers the reigning Omicron subvariant JN.1 or Pirola.
“As always, it’s impossible to distinguish COVID from the flu, RSV, and other common winter illnesses like rhinoviruses, enteroviruses, and parainfluenza viruses by symptoms alone. Even with the new, highly mutated COVID variant “Pirola” JN.1, now globally dominant, this remains true. What’s more, it’s possible to have two or more infections at the same time.
“As always, testing—at a health care facility or at home, in the case of COVID—is the only true way to determine the source of your illness. And while you should consult your health care provider, if your symptoms are mild and you don’t have other health conditions, the cause may not matter.”
The article wades into Pirola specifics.
The Washington Post shares what’s known about long Covid.
“An analysis of nearly 5 million U.S. patients who had covid, based on a collaboration between The Washington Post and research partners, showed that people infected with the coronavirus’s omicron variant are less likely to develop symptoms typical of long covid than those who had covid earlier in the pandemic. Patients exposed to the coronavirus during the first wave of pandemic illness — from early 2020 to late spring 2021 — were most prone to develop long covid, with 1 in 12 suffering persistent symptoms, the study showed.”
“Although HDL helps remove cholesterol from people’s arteries, the researchers wrote that, at very high levels, HDL’s structure and actions change, and it “may become deleterious to health” in various ways.
“For more than six years, they tracked 18,668 study participants, all 65 or older and all physically and cognitively healthy at the start of the study. In those years, cognitive dementia was diagnosed in 850 participants (4.6 percent).
“Those with very high HDL levels were more likely to have developed dementia than were those with more optimal HDL levels. For instance, the oldest participants with high HDL levels (those 75 or older) were 42 percent more likely to have developed dementia than those with normal HDL levels, and overall, anyone with high HDL levels had a 27 percent increased risk for dementia.”
and also offers exercise-based strategies for people experiencing trouble standing up or lying down.
“Researchers made important gains in 2023 in the fight against cardiovascular disease (CVD), according to the American Heart Association’s (AHA’s) annual list of key scientific developments in the field.
“Every year, we compile an overview of scientific research that advances our understanding of how to prevent, treat, and manage heart disease and stroke,” Mariell Jessup, MD, AHA chief science and medical officer, said in a news release.
“Whether the science points to new ways to treat long-known health conditions, disparities in care, or how to prevent some of our most pressing problems, such as high blood pressure, diabetes, or obesity, the findings help people, healthcare professionals, policymakers, and others make better informed healthcare decisions,” Jessup added.
“[The article provides] a brief summary of some of the year’s most noteworthy developments, according to the AHA.”
“Sugar sneaks into our diet in surprising ways, from coffee drinks you don’t realize are sugar bombs to small amounts that add up in bread or sauces. Looking more closely at nutrition labels and little tricks like putting a few cookies onto a plate rather than eating them straight from the bag can help.
“It’s worth the effort, nutrition researchers say. Studies have found that diets high in added sugars are linked to a higher risk of obesity and Type 2 diabetes.
“U.S. guidelines recommend that Americans limit their consumption of added sugars to 10% of daily calories. The American Heart Association recommends a limit of 6% of calories. While overall sugar consumption has decreased in recent years, Americans still get an average of about 13% of their daily calories from added sugars, according to federal data.
“Still, there’s an important distinction between added sugars—which are found in processed foods such as soda, cereal and yogurt, as well as honey and sugar itself—and sugar that occurs naturally in foods like fruit and dairy products. Foods that naturally contain sugar provide nutrients that people need and most Americans aren’t eating enough of them, nutrition researchers say.”
“Drugmakers including Pfizer, Sanofi and Takeda Pharmaceutical plan to raise prices in the United States on more than 500 drugs in early January, according to data analyzed by healthcare research firm 3 Axis Advisors.
“Excluding different doses and formulations, more than 140 brands of drugs will have their prices raised next month, the data showed. * * *
“More drug prices are likely to be announced over the course of January – historically the biggest month for drugmakers to raise prices.
“In 2023, drugmakers raised prices on 1,425 drugs, down from 2022, when they raised prices on 1,460 drugs, according to data published by 46brooklyn.
“While drugmakers have pared back their price increases for established drugs, prices for newly launched drugs have hit record levels.
“In 2022, the price of newly launched drugs topped $220,000 from around $180,000 in the first six months of 2021 suggesting a more than 20% increase. That’s in line with a JAMA-published study on drug prices which showed that between 2008 and 2021 U.S. drug launch prices grew 20% annually.”
The U.S. Supreme Court granted the federal government’s request to direct three U.S. Courts of Appeals to vacate decisions they made in cases involving the federal government employee Covid vaccine mandate on the ground that the President had withdrawn the mandate. In short, the Court held that the cases are moot.
“Employer groups are lining up behind legislation headed to the House floor that would prevent medical groups owned by hospitals from charging more for services than private providers.
“The Lower Costs, More Transparency Act (H.R. 5378) includes provisions that would require “site-neutral” payments for drug administration in off-campus hospital outpatient departments. The measure, which has bipartisan support, could come to a vote in the House as early as Monday.
“Although the measure only applies to Medicare, employers say site-neutral payments could spill over to reduce costs for commercial plans. They argue the additional fees hospital-owned practices are charging aren’t necessary for services that can be safely performed in a doctor’s office, while hospitals counter that the legislation will lead to reduced oversight and lower quality of care.” * * *
The American Hospital Association blasted site neutral proposals.
P.S. The House of Representatives passed H.R. 5378 by a bipartisan 320-71 vote.
According to a press release, “AHIP is pleased to announce the appointment of Mike Tuffin as its next President and CEO, effective January 8, 2024. Tuffin returns to AHIP having served as its Executive Vice President for Public Affairs from 2003 to 2012. He succeeds Julie Simon Miller, AHIP’s General Counsel, who has served as Interim CEO since September 2023.” Good luck.
The Sequoia Project is releasing five new TEFCA resources. TEFCA will be the long-overdue backbone for connecting the country’s various electronic health record networks.
Mercer Consulting discusses Rx legislative activity to watch in 2024.
“Data from the CDC and anecdotal reports form hospital officials suggest respiratory syncytial virus infections have peaked in the U.S., allaying concerns that the nation could see simultaneous surges of COVID-19, flu and RSV.
“We think we’re near the peak of RSV season or will be in the next week or so,” CDC Director Mandy Cohen, MD, told NBC News in a Dec. 1 report.
“National data aligns with that forecast. Weekly emergency department visits for RSV had been on the rise since September. Now, they may be coming down again, CDC data indicates. There were 22,321 ED visits for RSV for the week ending Dec. 2, the latest for which data are available. That’s down from 23,500 in the previous week. PCR test positivity rates also fell slightly to 11.7 from 12.7 in the previous week.”
“As flu season progresses, usually peaking between December and February, the CDC plans to update its tally of flu-related cases weekly. The flu, or influenza, is a highly contagious respiratory infection caused by viruses that spread from person to person, often via droplets expelled through coughing or sneezing.
“The flu, like colds and other respiratory illnesses, is more common in cold weather as people tend to spend more time indoors, where viruses can pass more easily from person to person. Also, health experts believe the flu virus survives better in cold weather and cold, dry air weakens people’s resistance.”
“Health officials on Friday released the first nationally representative estimate of how many U.S. adults have chronic fatigue syndrome: 3.3 million.
“The Centers for Disease Control and Prevention’s number is larger than previous studies have suggested, and is likely boosted by some of the patients with long COVID. The condition clearly “is not a rare illness,” said the CDC’s Dr. Elizabeth Unger, one of the report’s co-authors.
“Chronic fatigue is characterized by at least six months of severe exhaustion not helped by bed rest. Patients also report pain, brain fog and other symptoms that can get worse after exercise, work or other activity. There is no cure, and no blood test or scan to enable a quick diagnosis.”
“Patients taking Novo Nordisk’s weight loss drug Wegovy in 2021 and 2022 were three times more likely to continue taking the medication a year later compared to older weight loss therapies, according to a study published Dec. 6 in Obesity.
“Researchers from Cleveland Clinic evaluated about 1,000 EHRs between January 2015 and July 2023 among patients who were taking anti-obesity medications. The EHRs were collected from a large health system in Ohio and Florida.
“The weight loss drug with the highest adherence was Wegovy (semaglutide), with 40% of Wegovy patients still filling prescriptions after a year. In comparison, the adherence of orlistat, liraglutide, naltrexone-bupropion and phentermine-topiramate after 12 months ranged between 0% and 19%.”
The American Medical Association lets us know what doctors wish their patients knew about pickleball injuries.
From the U.S. healthcare business front,
MedCity News identifies five trends shaping healthcare business strategies for 2024.
M&A
Generative AI
Workforce Challenges
Outsourcing
Affordability
Per Fierce Healthcare and because many FEHB plans offer global coverage
“More than half of global health insurers are expecting significant increases in healthcare costs over the next several years, according to a new report.
“Analysts at advisory firm WTW surveyed 266 insurers across 66 countries and found that 58% are bracing for “higher or significantly higher” cost increases in the three upcoming years. The report found that global medical costs increased by 10.7% in 2023, a record high and up from a 7.4% increase in 2022.
“The average cost trend insurers expect is 9.9% next year, which accounts for variations in rates between regions. For example, the estimated rate of cost increases decreased from 10.9% in 2023 to 9.3% in 2024, while it’s projected to rise from 11.3% in 2023 to 12.1% in 2024 in the Middle East and Africa, according to the report.”
“Healthcare technology giant Epic is leveraging its massive clinical research database, with data on 226 million patients, to develop a next-generation decision support tool for clinicians.
“Elevance Health, formerly Anthem and the nation’s second-largest insurer, leverages its clinical data platform, called Health OS, and artificial intelligence to help providers close gaps in care and reduce burdensome paperwork, according to CEO Gail Boudreaux.
“The insurer’s goal is to break down data silos and integrate data on patients’ physical, mental and social health into a longitudinal patient record within electronic health record (EHR) systems, Boudreaux said during the Forbes Healthcare Summit this week in New York City.”
Beckers Hospital Review identifies the eight most influential drugs approved by the FDA this year, according to GoodRx, while the Institute for Clinical and Economic Review (ICER)
“published its latest report on Unsupported Price Increases (UPI) of prescription drugs in the United States. Among the top 10 drugs with net price increases in 2022 that had substantial effects on US spending, ICER determined that eight lacked adequate new evidence to support any price increase. The analysis also found that one of three Medicare Part B drugs with high list price increases in 2021 lacked adequate supporting new evidence, directly raising annual out-of-pocket expenses for Medicare patients by up to $680 per year.”
Beckers Hospital Review identifies nine hospitals already cleared to administer the new CRISPR treatment for sickle cell anemia that FDA approved last week. Also, “[re]ad more about the treatment and experts’ reactions here.”
Republican speaker nominee Rep. Jim Jordan was weighing whether to embark on a third-floor vote after a plan to temporarily put caretaker speaker Rep. Patrick McHenry in charge of the House ran into sharp objections from conservatives.
“I am still running for speaker, and I plan to go to the floor and get the votes and win this race,” Jordan said initially after leaving a heated closed-door meeting of House Republicans. The Ohio conservative said the plan to elect a temporary speaker didn’t have the support of the conference.
In the evening, Jordan met in a House office with detractors. As some trickled out, there was no sign he had managed to change their minds, and Jordan wouldn’t say after the meeting whether he still intended to hold another floor vote.
The New York Times adds, “Mr. Jordan said he would push for another vote to become speaker, scheduled for Friday at 10 a.m., even though he was bleeding support and calls were increasing for him to step aside.”
The Society for Human Resource Management informs us,
“The U.S. Supreme Court has agreed to hear two cases that will impact the power of federal agencies to implement regulations on employers.
“On Oct. 13, the court decided to hear Relentless v. Department of Commerce, in which the owners of three fishing companies in Rhode Island and Massachusetts sued to challenge the federal government’s authority to require them to partially pay for federal monitors on their boats. The justices willconsider that case in tandem with a similar case, Loper Bright Enterprises v. Raimondo, which involves the same requirement for fishing companies in New Jersey.
“In both cases, the justices will decide whether to overturn the long-standing Chevron precedent, which holds that when Congress wrote a statute without a clear meaning, courts should defer to the federal agency applying the law, unless its directives were unreasonable. Federal departments and agencies that enforce employment laws could be impacted.”
In yesterday’s post, the FEHBlog called attention to AHIP’s public comments on the proposed rule, making changes to the current mental health parity rules. AHIP asked the regulators to try again. Per Fierce Healthcare,
“The Blue Cross Blue Shield Association (BCBSA) echoed AHIP in its comments, arguing that additional clarity around the changes is necessary. The organization said it could lead patients to care that is not recommended, worsening outcomes.
“We share the administration’s goal of expanding access to affordable mental health support, but we’re concerned it could become harder—not easier—for patients to get the care they need,” said David Merritt, BCBSA’s senior vice president of policy and advocacy, in a statement.
“This rule could push us in the wrong direction by forcing health plans to remove important protections that ensure patients are receiving safe, medically necessary, effective care,” Merritt added. “We’ll continue to work with our partners, the administration and Congress to improve both access and quality for Americans.”
“The Alliance for Community Health Plans said the updates create “an entirely new regulatory schema” that would actually impede insurers looking to address mental health parity.
“The ERISA Industry Committee, or ERIC, said many of the proposals “reflect an overreach of agency authority under the statute” and that they would be burdensome for employer-sponsored health plans. The changes, ERIC said, could drive up costs for families and force significant changes to benefit designs.
“Unfortunately, the proposed regulations are so unworkable, it is unclear how compliance could ever be achieved while continuing to offer these important benefits,” said James Gelfand, CEO of ERIC, in a statement. “The Departments’ proposals are written in a way that sets plans up to fail.”
“The U.S. health regulator [the Food and Drug Administration] has approved Hyloris Pharmaceuticals’ drug for post-operative pain, the Belgium-based company said on Wednesday, adding that it expects to launch the non-opioid treatment in the United States by early next year.
“The injectable drug, branded as Maxigesic IV, was approved as a post-operative drug in hospitals or when patients cannot take medicine orally.
“Maxigesic IV, a combination of paracetamol with ibuprofen solution for infusion, helps reduce pain and inflammation without the risk of opioid addiction that resulted in more than half a million deaths in the U.S. during 1999 to 2020.”
From the public health front,
HHS’s Agency for Healthcare Research and Quality posted for public comment an Effective Health Programs abstract on caring for Long Covid. The comment period ends on November 17, 2023.
“Data show CMS’ Million Hearts CVD Risk Reduction Model, which provided payments for CVD risk assessment and reduction, reduced incidence of first-time MIs and strokes over 5 years without significant changes in Medicare spending.
“The results support clinical guidelines for CVD preventive care,” G. Greg Peterson, PhD, MPA, a principal researcher with Mathmatica, told Healio. “Current guidelines in the U.S., similar to those in other countries, recommend that health care practitioners calculate CVD risk scores and use the scores to engage patients in discussions about CVD prevention. Although previous studies of CVD risk scoring interventions have shown improvement in CVD risk factor control, this is the first study of a CVD risk score-focused intervention to demonstrate declines in CVD events.”
“Fluctuating blood pressure can be a harbinger for both dementia and heart disease, a new study finds.
“Ups and downs within 24 hours or even over several days or weeks were linked with impaired thinking, researchers from Australia reported.
“Higher variations in systolic blood pressure, the top number, were linked with stiffening of the arteries, which is associated with heart disease.
“Clinical treatments focus on hypertension while ignoring the variability of blood pressure,” said lead author Daria Gutteridge, a PhD candidate at the University of South Australia’s Cognitive Aging and Impairment Neuroscience Laboratory.”
“A research team funded by the National Institutes of Health has developed a smartphone app that can track and analyze a person’s ability to move from one place to another, known as locomotion and other types of movements. Human motion analysis is used to evaluate patients with movement difficulties, to help clinicians plan surgery, and to assess the results of treatment procedures. The research team believes that using the app costs about 1% of conventional motion analysis techniques and works 25 times faster. The study appears in PLOS Computational Biology.
“Researchers tested their app, called OpenCap, with 100 participants. Using two or more smartphones, the app recorded sufficient quality videos to allow for web-based, artificial intelligence analysis of muscle activations, joint loads and joint movements. Data collection took 10 hours for the 100 participants, and computation of results took 31 hours. Traditionally, locomotion analysis requires fixed lab space and more than $150,000 worth of equipment, including eight or more specialized cameras to capture three-dimensional images. The captured data also takes several days to analyze by a trained expert.
“While current technology is too expensive for routine clinical use, according to the investigators, the app could potentially be used to help screen for disease risk, inform rehabilitation decisions, and track improvements in motion following treatment.”
CVS Health is pulling some of the most common decongestants from its shelves and will no longer sell them, after advisers to U.S. health regulators recently determined that an ingredient doesn’t work.
The products contain [as the only active ingredient] oral phenylephrine, an almost-century-old ingredient in versions of decongestants and over-the-counter pills, syrups and liquids to clear up congested noses.
An advisory panel to the Food and Drug Administration last month declared that the ingredient was ineffective when taken orally. The FDA had said in its own analysis that the oral phenylephrine formulations are safe but ineffective at standard or even higher doses.
The FDA hasn’t made a decision yet nor asked manufacturers or retailers to remove products from store shelves. CVS is removing phenylephrine products voluntarily.
“In a bankruptcy court filing Oct. 18, Rite Aid said it will close 154 stores in more than 10 states to save on rent costs, according to The New York Times. Details on the round of store closures came just days after the retail pharmacy chain filed for Chapter 11 bankruptcy protection. “In a bankruptcy court filing Oct. 18, Rite Aid said it will close 154 stores in more than 10 states to save on rent costs, according to The New York Times. Details on the round of store closures came just days after the retail pharmacy chain filed for Chapter 11 bankruptcy protection.
“Rite Aid has more than 2,000 stores in 17 states. Of the 154 planned closures, about 40 are Pennsylvania locations. Many stores in California and New York will also close, and additional store closings may be forthcoming as Rite Aid looks to shed about $4 billion in debt.
“The Philadelphia-based company previously said it secured $3.45 billion from lenders to fund operations through the bankruptcy restructuring, with McKesson Corp. as the largest creditor. Alongside the bankruptcy filing, Rite Aid announced Jeffrey Stein as its new CEO and chief restructuring officer.”
“President Joe Biden signed a short-term spending bill to avert a partial government shutdown starting Sunday after a dramatic turn of events Saturday that saw the House quickly pivot to bipartisanship.
“Hours before the midnight deadline, the Senate voted 88-9 to clear the House-passed, 48-day funding patch, which generally mirrors the Senate version except for one major omission: There’s no military or economic aid for Ukraine, unlike the Senate bill, which had $6 billion.
“Democrats grumbled about that and called on the House to bring a separate Ukraine aid bill to the floor. But ultimately, there was no stomach to allow a government shutdown over the lack of Ukraine money, which lawmakers on both sides of the aisle said would be forthcoming in a separate package.”
The new deadline is November 17, the Friday before Thanksgiving. Bear in mind that the debt ceiling act incentivizes passing all twelve appropriations bills by the end of the calendar year.
Rep. Matt Gaetz (R-Fla.) wants to remove House Speaker Kevin McCarthy (R-Calif.) for working across the aisle to stop a government shutdown — but some Democrats are not on board.
Why it matters: As Axios has previously reported, Gaetz will likely need the vast majority of Democrats to vote with him, barring an unprecedented GOP uprising against McCarthy.
Driving the news: Gaetz said during an appearance on CNN’s “State of the Union” on Sunday that he planned to file a motion to vacate against McCarthy this week.
McCarthy responded in a CBS News interview that he will “survive,” calling Gaetz’s effort “personal.”
What they’re saying: “I’m not going to follow Matt Gaetz to Peter Luger’s Steakhouse,” said Rep. Steve Cohen (D-Tenn.), a member of the Progressive Caucus.
Cohen said McCarthy “shouldn’t be put out” for putting a bipartisan stopgap funding bill on the floor: “He did the right thing … and I’ll definitely vote not to vacate. I expect a good number of Democrats will as well.”
“Every time we work together, he loses his mind,” Rep. Greg Landsman (D-Ohio) said of Gaetz in a statement, adding: “This is all about TV appearances for him … just let us govern.”
“I see almost no way that Matt gets most of the Dems,” said one senior House Democrat, speaking on the condition of anonymity. “Many will vote present if they don’t vote No on [House Minority Leader Hakeem Jeffries’] recommendation.”
“Hundreds of children die or are left severely injured around the country each year after they are rushed to hospital emergency rooms that are poorly prepared to treat them.
“Only about 14% of emergency departments nationwide have been certified as ready to treat kids, or are children’s hospitals specializing in treating young patients, The Wall Street Journal found.
“Many emergency doctors don’t treat enough children to be able to spot life-threatening illnesses obscured by run-of-the-mill symptoms, or conditions more common in kids. Some E.R. staff default to drug doses and protocols meant for adults and either don’t have or don’t know where to find child-size gear in a crisis.
“Doctors, health authorities and policy makers have known—and warned—of these failures for decades. Research in recent years has quantified the lack of readiness and number of child deaths that could have been avoided, and pointed to basic steps for solving the problem.
“Yet most hospitals haven’t taken action, according to the Journal’s investigation of certification levels in all 50 states, reviews of medical records and interviews with doctors, health officials and researchers.”
The Journal helpfully “put together the first comprehensive list of hospitals nationwide that have received state certification of some level of readiness for pediatric emergencies. The tally also includes certain children’s hospitals and certain pediatric trauma centers, which specialize in caring for kids.”
“Congress heads into a make-or-break week for avoiding a government shutdown, with leaders of the Republican-controlled House hoping they can persuade GOP holdouts to get on board with four full-year bills and a short-term funding patch.
“With a shutdown set for Oct. 1, unless Congress acts, the plan marks a last-ditch effort by Republicans to find a way forward. If no deal is reached, hundreds of thousands of federal workers are set to be furloughed.
“When it gets crunch time, people that have been holding off all this time blaming everybody else will finally hopefully move,” House Speaker Kevin McCarthy (R., Calif.) told reporters Saturday.
“McCarthy laid out the path forward in a GOP conference call. The House is expected on Tuesday to vote on a rule establishing the parameters for debate on a defense-spending bill, a bill funding the Homeland Security Department, one funding the State Department and another funding agricultural priorities.
“After that, McCarthy is expected to focus on a short-term spending deal ranging from two weeks to two months to keep the government funded while negotiations continue.”
The U.S. Supreme Court has posted its October 2023 Term calendar. The opening conference will be held on Tuesday, September 26. The first oral arguments will be held on October 2, 2023.
If history can be a guide, OPM will announce the 2024 FEHB premiums this week, along with the government contribution change.
“The drug colchicine has been used for more than 2,000 years to treat the fiery joint-pain ailment called gout. It also is a remedy for a genetic disorder called familial Mediterranean fever and for pericarditis, an inflammation of the sac around the heart.
“Now, colchicine may be set for a surprising new role. In June, the Food and Drug Administration approved a new low-dose version of the drug as the first-ever medicine to treat cardiovascular inflammation, marking a new approach to heart attack prevention.
“Several things could limit the adoption of colchicine by cardiologists, at least at first, including side-effect concerns and the emergence of several other new options for reducing the risk of heart attacks. But the drug’s approval provides fresh validation for a concept that has been gaining momentum in cardiology over the past 25 years—that inflammation is a key culprit in atherosclerosis, the artery-clogging disease, and that treating it can reduce the risk of a heart attack.
T”he bedrock strategy for heart-attack prevention has long been lowering LDL cholesterol with drugs called statins. Adding low-dose colchicine—which in one study reduced cardiovascular risk by 31% in patients already treated with statins and other preventive medicines—would enable doctors to simultaneously hit two biological targets that cause heart attacks.
“This is about combining therapies” that are both effective ways to reduce risk, says Dr. Paul Ridker, director of the Center for Cardiovascular Disease Prevention at Harvard-affiliated Brigham and Women’s Hospital, Boston. “They’re not in conflict; they’re synergistic.”
Cardiovascular Business identifies the best heart hospitals using a Newsweek survey. The top five are the following:
NPR Shots considers whether Ozempic causes mental health side effects.
The NY Times discusses the synthetic opioid epidemic plaguing many of the Nation’s large cities, like New York. This article focuses on “collateral damage.”
“The rising death toll comes as the city and the state have turned away from the aggressive law enforcement of low-level street drug activity that was common in the late 1990s. The shift has happened gradually over time, as a broader movement has pushed to reframe drug use as a public health crisis rather than as primarily a criminal issue.”
In Medicare news, Fortune Well tells us about 2024 Medicare changes and other relevant matters as we approach the Medicare open enrollment period, which begins on October 15, 2023.
In business news,
HR Dive points out, “Employers have 44 days on average to “make or break” a new hire, and first impressions make a lasting impression, according to a Sept. 20 report from BambooHR, a cloud-based human resources platform.”
“Creating a “buddy system” to pair new hires with experienced employees can make the onboarding experience stronger, according to a McLean & Co. report. The tenured employee can personalize the onboarding experience, serve as a contact person and provide advice about team processes or organizational culture.”
From Washington DC, where the air quality index was code red today —
The Supreme Court is down to its final four pending decisions from the October 2022 term. The final decision day is tomorrow morning
The EEOC Chair made the following noteworthy comment on today’s Supreme Court decision on affirmation action in college admissions:
“Today’s Supreme Court decision effectively turns away from decades of precedent and will undoubtedly hamper the efforts of some colleges and universities to ensure diverse student bodies. That’s a problem for our economy because businesses often rely on colleges and universities to provide a diverse pipeline of talent for recruitment and hiring. Diversity helps companies attract top talent, sparks innovation, improves employee satisfaction, and enables companies to better serve their customers”.
“However, the decision in Students for Fair Admissions, Inc. v. President & Fellows of Harvard College and Students for Fair Admissions, Inc. v. University of North Carolina does not address employer efforts to foster diverse and inclusive workforces or to engage the talents of all qualified workers, regardless of their background. It remains lawful for employers to implement diversity, equity, inclusion, and accessibility programs that seek to ensure workers of all backgrounds are afforded equal opportunity in the workplace.”
“The Supreme Court on Thursday ruled against the U.S. Postal Service in its attempts to require any employee to work on Sundays, even when it conflicted with their religious observances.
“In a unanimous decision [interpreting Title VII of the Civil Rights Act of 1964], the top court reversed decades of precedent in determining that employers like USPS have to demonstrate more than a de minimis burden to avoid their otherwise mandated obligations to provide reasonable religious accommodations. The justices sent the case back to a lower court to determine whether, given the specifics of the case, the Postal Service could come up with other means to keep a letter carrier on the payroll without requiring him to work on Sundays.”
“As proposed by its Advisory Committee on Immunization Practices, the Centers for Disease Control and Prevention [(CDC)] today recommended a single dose of the GSK or Pfizer Respiratory Syncytial Virus vaccine for people aged 60 and older who decide with their health care provider that the vaccine would benefit them. The Food and Drug Administration last month approved the vaccines for use in individuals 60 and older. The first U.S.-licensed vaccines to protect against RSV, they are expected to be available this fall.”
“CDC Director Rochelle P. Walensky, M.D., M.P.H. adopted the 2023-2024 Advisory Committee on Immunization Practices’ (ACIP) recommendations on annual influenza (flu) vaccination for everyone 6 months and older in the United States on June 27, 2023. There were small changes to the annual recommendations around flu vaccination, including an acknowledgement of the updated flu vaccine composition for the 2023-2024 flu season and a change in the recommendations for vaccination of people with egg allergies. Dr. Walensky’s adoption of the ACIP recommendations makes them official CDC policy. * * *
The recommended timing of flu vaccination has not changed. September and October are the best times for most people to get vaccinated.
The Department of Health and Human Services announced
“[Its] Office of the Assistant Secretary for Health (OASH) is releasing a draft framework to support and accelerate smoking cessation, building on supports that are already in place for people who want to quit. This framework will be a roadmap to enhance collaboration and coordination across HHS—and with federal and nonfederal stakeholders—to drive further progress toward smoking cessation and to deliver equitable outcomes for all persons in America. HHS is seeking public input on the framework before it is finalized.
“The public comment period will be open for 30 days starting June 30, 2023, through July 30 at 11:59 PM ET. HHS is committed to transparency and providing opportunities for public participation during the development of the Framework.
“Anyone can comment. Each responding entity (person or organization) is requested to submit only one response via email to HHSSmokingCessationFramework2023@hhs.gov as a Word document, Portable Document Format (PDF), or in the body of an email. Please include “Request for Information: Draft HHS 2023 Framework to Support and Accelerate Smoking Cessation” in the subject line of the email message.”
The Society for Human Resource Management offers employers strategies for reducing record-level employee stress.
“Only one-third of individuals diagnosed with hepatitis C have been cured in the decade since cures for the disease became available, according to a study published Thursday from the Centers for Disease Control and Prevention.
“Hepatitis C is a viral inflammation of the liver that can be asymptomatic yet spread through blood or other bodily fluids. Without treatment, hepatitis C is a chronic condition that can lead to liver cancer, liver failure or other comorbidities.
“The Food and Drug Administration approved the first highly effective direct-acting antiviral drugs to cure hepatitis C in 2013. Treatment occurs over the course of 8 to 12 weeks and has a 95 percent success rate.
“But almost 15,000 Americans still die from hepatitis C annually. * * *
“Francis Collins, the former longtime NIH director who leads the White House National Hepatitis C Elimination Program, said the data “highlights an urgency for a bold response to hepatitis C.”
“Following the COVID-19 pandemic, the rising tide of mental health concerns—particularly among children and adolescents—has been a major focus in the industry.
“But it’s not a new problem. Behavioral health needs have been on the rise for some time, and that’s why in 2018 the team at Elevance Health’s Carelon established the Suicide Prevention Program, which deploys data and predictive models to identify people at risk sooner and avoid potential self-harm or suicide events.
“Suicide is the second-leading cause of death for young people, and rates have increased by 56% in the last 20 years. Through the prevention program, Carelon saw a reduction of more than 20% in suicidal events among adolescents and young adults with commercial coverage.
I”n addition, this corresponded to a 30% decrease in per member per month behavioral health spending.”
The Society for Human Resource Management identifies four ways to boost employee satisfaction with high deductible plans connected with health savings accounts.
“Johnson City, Tenn.-based Ballad Health is using artificial intelligence to identify potential medication errors and improve pharmacy workflows, the health system said June 29.
“Ballad is using a medication safety monitoring platform from MedAware for this effort. The platform monitors drug prescriptions in real-time and compares this information against patient data from the health system’s EHR to flag potentially dangerous or fatal drug interactions.
“The Ballad Health Innovation Center and Ballad Ventures, the system’s venture capital subsidiary, is funding the project with MedAware.
“Healthcare costs are expected to rise 7% next year as inflation drives providers to seek rate increases from insurers and pharmaceutical costs rise, according to PwC’s annual report.
“The consultancy, which surveyed actuaries at insurers that offer group and individual plans, said the increase outstrips its predictions for 2022 and 2023, which were 5.5% and 6% respectively.
“Some trends are pushing costs down, like the availability of more biosimilar drugs and a shift toward cheaper outpatient care. A number of other factors are expected to be cost neutral but key to watch, including health plans’ investment in value-based care, COVID-19 impacts, behavioral healthcare utilization, health equity initiatives, price transparency rules and Medicaid redeterminations, PwC said.
“Primary care physicians saw their compensation rise faster than other medical and surgical specialties in 2022, as significant E/M coding changes enacted by the CMS kicked into gear and volume stabilized coming out of the pandemic.
“Medical groups and healthcare organizations reported a 6.1% increase in primary care compensation in 2022 compared to 2021 in the AMGA’s most recent compensation survey published on Wednesday. That’s compared to 1.5% and 1.6% increases for medical and surgical specialties, respectively.
“Medical groups’ revenue increased faster than compensation gains for physicians, a trend the AMGA said could be due to groups using more revenue to address higher expenses as supply and labor costs soared.”
“Individuals with depression, anxiety, or both who are enrolled in large employer-sponsored health plans have higher out-of-pocket spending than individuals without such diagnoses, according to an issue brief from the Peterson-KFF Health System Tracker.
“These findings of higher health spending among privately insured individuals receiving treatment for depression and/or anxiety come at a time of rising health costs. Health insurance is already expensive for enrollees with private insurance, and treatment for mental health conditions can further escalate these costs,” the brief noted.
“The researchers used large employer health plan claims from the 2021 MerativeMarketScan Commercial Database. Nine percent of adult, large employer-sponsored health plan enrollees had a depression or anxiety diagnosis or both.
“Members with a generalized anxiety disorder (anxiety) diagnosis, a depression diagnosis, or both spent, on average, $1,501 per year in out-of-pocket costs. This was nearly double the $863 in average annual out-of-pocket healthcare spending that individuals without one of these diagnoses spent.
“Moreover, total annual spending, including out-of-pocket healthcare costs, was 1.9 times higher for individuals with one of these diagnoses than those without one. Utilization was also twice as high for those diagnosed, who typically visited a provider’s office 7.4 times per year, while those without a diagnosis visited 3.2 times per year on average.
From the Food and Drug Administration (FDA) front —
“The promise of gene therapy has arrived for thousands of Americans with the most common and severe form of hemophilia.
“The U.S. Food and Drug Administration approved the first gene therapy for hemophilia A on Thursday, giving patients a long-awaited option for avoiding the burden of regular infusions and injections.
“That’s a complete game-changer for quality of life,” said Mike Reutershan, a 38-year-old medicinal chemist with hemophilia who lives in suburban Boston. “You don’t have to carry a bag of medicine around with you.”
“The FDA approved the new gene therapy, called Roctavian and made by BioMarin Pharmaceutical, for adults with a severe form of the disease. Roctavian is infused just once.
“The agency announced Wednesday, June 29, that it has approved donislecel, a new pancreatic islet cellular therapy made from the pancreatic cells of deceased donors, for the treatment of type 1 diabetes among adult patients with severe hypoglycemia. Donislecel is marketed and sold by Chicago-based CellTrans under the brand name Lantidra.
“This represents the first time the FDA has approved a cellular therapy for type 1 diabetes.”
Biopharma Dive calls attention to ten clinical trials to watch in the second half of this year.
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