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Oral Arguments for the Court of Appeals for the Eighth Circuit
Jefferson County v. Express Scripts, Inc.
Ralph speaks to Washington Post columnist Dana Milbank about the Trump Administration's path of destruction in our federal government. Then, Ralph welcomes legendary public interest lawyer Alan Morrison to discuss the President's authority to impose tariffs and other constitutional questions.Dana Milbank is a nationally syndicated op-ed columnist for the Washington Post. He also provides political commentary for various TV outlets, and he is the author of five books on politics, including the New York Times bestseller The Destructionists and the national bestseller Homo Politicus. His latest book is Fools on the Hill: The Hooligans, Saboteurs, Conspiracy Theories and Dunces who Burned Down the House.I shouldn't be amazed, but Mike Johnson never ceases to amaze me with the rapidity with which he'll just drop to his knees whenever Trump says something.Dana MilbankWe're going to know this shortly, but it does appear that Trump's honeymoon may be over in the House as the conservatives finally seem to be finding their backbones. But I've thought that might happen before and then only to find out that they, in fact, they could not locate their backbones. So I don't want to be premature.Dana MilbankTrump seems to be gambling (and the administration seems to be gambling) that ultimately the Supreme Court is going to a wholesale reinterpretation of the Constitution to grant these never-before-seen executive powers, and it's possible that he's right about that. We're not going to know that. There have been a couple of preliminary rulings that seem friendly to Trump, but none of those is final, so we can't really be sure of it.Dana MilbankMy guess is that Chief Justice Roberts is seeing his legacy heading toward the ditch after his decision of Trump v. United States, where he said that Presidents cannot be criminally prosecuted….My guess is he's going to unpleasantly surprise Trump in the coming months.Ralph NaderAlan Morrison is the Lerner Family Associate Dean for Public Interest & Public Service at George Washington Law School. He currently teaches civil procedure and constitutional law, and previously taught at Harvard, NYU, Stanford, Hawaii, and American University law schools. He has argued 20 cases in the Supreme Court and co-founded the Public Citizen Litigation Group in 1972, which he directed for more than 25 years.It's inevitable that even for a non-economist like myself to understand that [the costs of tariffs] are going to be passed on. Other than Donald Trump, I don't think there's anybody who believes that these taxes are not going to be passed on and that they're going to be borne by the country from which the company did the exporting.Alan MorrisonIt's an uphill battle on both the statutory interpretation and the undue delegation grounds, but our position is rather simple: If the Congress doesn't write a statute so that there's something that the government can't order or do, then it's gone too far. In effect, it has surrendered to the President its power to set policy and do the legislative function. Interestingly, Trump has trumpeted the breadth of what he's doing here. He calls it a revolution. Well, if we have revolutions in this country, my copy of the Constitution says that the Congress has to enact revolution and the President can't do it on its own. So we think we've got a pretty strong case if we can get it to court.Alan MorrisonOne of the things that I've been struck by is that laws alone cannot make this country governable. That we can't write laws to cover every situation and every quirk that any person has, especially the President. We depend on the norms of government—that people will do things not exactly the way everybody did them before, but along the same general lines, and that when we make change, we make them in moderation, because that's what the people expect. Trump has shed all norms.Alan MorrisonNews 4/9/251. Our top story this week is the killing of Omar Mohammed Rabea, an American citizen in Gaza. Known as Amer, the BBC reports the 14-year-old was shot by the Israeli military along with two other 14-year-old boys “on the outskirts of Turmus Ayya” on Sunday evening. Predictably, the IDF called these children “terrorists.” According to NJ.com – Rabea formerly resided in Saddle Brook, New Jersey – Rabea's uncle sits on the board of a local Palestinian American Community Center which told the press “The ambulance was not allowed to pass the checkpoint for 30 minutes, a denial in medical treatment that ultimately resulted in Amer's death…[his] death was entirely preventable and horrifically unjust. He was a child, a 14-year-old boy, with an entire life ahead of him.” The Rachel Corrie Foundation, founded in honor of the American peace activist killed by an Israeli bulldozer while protesting the demolition of a Palestinian home, issued a statement reading “Rabea's death…was perpetuated by Israeli settlers who act with impunity…We believe that if our own government demanded accountability…Rabea would still be alive.” The Council on American-Islamic Relations (CAIR) has sent a letter to Attorney General Bondi demanding an investigation, but chances of the Trump administration pursuing justice in this case are slim.2. Meanwhile, President Trump seems to be driving the U.S. economy into a deep recession. Following his much-publicized tariff announcement last week – which included 10% tariffs on uninhabited Heard and McDonald Islands – the S&P dipped by 10.5%, among the largest drops in history, per the New York Times. Far from making Trump back off however, he appears dead set on pushing this as far as it will go. After the People's Republic of China responded to the threat of a 54% tariff with a reciprocal 34% tariff, Trump announced the U.S. will retaliate by upping the tariff to a whopping 104% on Chinese imports, according to the BBC. Reuters reports that JP Morgan forecasts a 60% chance of a recession as a result of these tariffs.3. In more foreign affairs news, on Friday April 4th, South Korea's President Yoon Suk Yeol was officially removed from office by that country's Constitutional Court, “ending months of uncertainty and legal wrangling after he briefly declared martial law in December,” per CNN. The South Korean parliament had already voted to impeach Yoon in December of 2024. The court's decision was unanimous and characterized the leader's actions as a “grave betrayal of the people's trust.” Upon this ruling being handed down, Yoon was forced to immediately vacate the presidential residence. A new election is scheduled for June 3rd. Incredible what a political and judicial class unafraid to stand up to lawlessness can accomplish.4. Speaking of ineffectual opposition parties, one need look no further than Texas' 18th congressional district. This safe Democratic district – including most of central Houston – was held by Congresswoman Sheila Jackson Lee from 1995 until her death in 2024. According to the Texas Tribune, Lee planned to run yet again in 2024, triumphing over her 43-year-old former aide Amanda Edwards in the primary. However, Lee passed in July of 2024. Edwards again sought the nomination, but the Harris County Democratic Party instead opted for 69-year-old former Houston Mayor Sylvester Turner, per the Texas Tribune. Turner made it to March of 2025 before he too passed away. This seat now sits vacant – depriving the residents of central Houston of congressional representation and the Democrats of a vote in the House. Governor Gregg Abbot has announced that he will not allow a special election before November 2025, the Texas Tribune reports. This is a stunning Democratic own-goal and indicative of the literal death grip the gerontocratic old guard continue to have on the party.5. One ray of hope is that Democratic voters appear to be waking up the ineffectual nature of the party leadership. A new Data for Progress poll of the 2028 New York Senate primary posed a hypothetical matchup between incumbent Senator Chuck Schumer and Democratic Socialist firebrand Congresswoman Alexandria Ocasio-Cortez – and found AOC with a staggering lead of 19 points. This poll showed AOC winning voters under 45 by 50 points, over 45s by eight points, non-college educated by 16 points, college educated by 23 points, Black and white voters by 16 points, and Latinos by 28. Schumer led among self-described “Moderates” by 15 and no other group. It remains to be seen whether the congresswoman from Queens will challenge the Senate Minority Leader, but this poll clearly shows her popularity in the state of New York, and Schumer's abysmal reputation catching up with him.6. Another bright spot from New York, is Zohran Mamdani's mayoral candidacy and specifically his unprecedented field operation. According to the campaign, between April 1st and April 6th, volunteers knocked on 41,591 doors. No mayoral campaign in the history of the city has generated a grassroots movement of this intensity, with politicians traditionally relying on political machines or enormous war chests to carry them to victory. Mamdani has already reached the public financing campaign donation cap, so he can focus all of his time and energy on grassroots outreach. He remains the underdog against former Governor Andrew Cuomo, but his campaign appears stronger every day.7. Turning to the turmoil in the federal regulatory apparatus, POLITICO reports Secretary of Health and Human Services Robert F. Kennedy Jr. has eliminated the Freedom of Information Act offices at the Centers for Disease Control, and other HHS agencies. An anonymous source told the publication that HHS will consolidate its FOIA requests into one HHS-wide office, but “Next steps are still in flux.” In the meantime, there will be no one to fulfill FOIA requests at these agencies. This piece quotes Scott Amey, general counsel at the Project on Government Oversight, who said this “sends a wrong message to the public on the administration's commitment to transparency.” Amey added, “I often say that FOIA officers are like librarians in knowing the interactions of the agency…If you don't have FOIA officers with that specific knowledge, it will slow down the process tremendously.”8. At the Federal Trade Commission, Axios reports the Trump administration has “paused” the FTC's lawsuit against major pharmacy benefit managers, or PBMs, related to “the drug middlemen…inflating the price of insulin and driving up costs to diabetes patients.” The case, filed against CVS Caremark, OptumRx and Express Scripts was halted by the FTC in light of “the fact that there are currently no sitting Commissioners able to participate in this matter.” That is because Trump unlawfully fired the two remaining Democratic commissioners Alvaro Bedoya and Rebecca Slaughter. In a statement, former FTC Chair Lina Khan called this move “A gift to the PBMs.”9. One federal regulatory agency that seems to be at least trying to do their job is the Federal Aviation Administration. According to the American Prospect, the FAA has “[has] proposed [a] rule that would mandate Boeing update a critical communications malfunction in their 787 Dreamliner plane that could lead to disastrous accidents.” As this piece explains, “very high frequency (VHF) radio channels are transferring between the active and standby settings without flight crew input.” The FAA's recommendation in is that Boeing address the issue with an update to the radio software. Yet disturbingly, in one of the comments on this proposed rule Qatar Airways claims that, “[they have] already modified all affected…airplanes with … [the recommended software updates] …However … flight crew are still reporting similar issues.” This comment ends with Qatar Airways stating that they believe, “the unsafe condition still exists.” Boeing planes have been plagued by critical safety malfunctions in recent years, most notably the 2018 and 2019 crashes that killed nearly 350 people.10. Finally, on a somewhat lighter note, you may have heard about Bryan Johnson, the tech entrepreneur dubbed “The Man Who Wants to Live Forever.” Johnson has attracted substantial media attention for his unorthodox anti-aging methods, including regular transfusions of plasma from his own son. But this story is not about Johnson's bizarre immortality obsession, but rather his unsavory corporate practices. A new piece in New York Magazine focuses on the lawsuits filed against Johnson by his all-too-mortal workers, represented by eminent labor lawyer Matt Bruenig. This piece relays how Johnson “required his staffers to sign 20-page NDAs,” and an “opt-in” document which informed his employees they had to be comfortable “being around Johnson while he has very little clothing on” and “discussions for media production including erotica (for example, fan fiction including but not limited to story lines/ideas informed by the Twilight series and-or 50 Shades of Grey.)” Bruenig says, “That stuff is weird,” but his main interest is in the nondisparagement agreements, including the one Johnson's former employee and former fiancée Taylor Southern entered into which has further complicated an already thorny legal dispute between Johnson and herself. Now Bruenig is fighting for Southern and against these blanket nondisparagement agreements in a case that could help define the limits of employer's power to control their workers' speech. Hopefully, Bruenig will prevail in showing that Johnson, whatever his pretensions, truly is a mere mortal.This has been Francesco DeSantis, with In Case You Haven't Heard. Get full access to Ralph Nader Radio Hour at www.ralphnaderradiohour.com/subscribe
Hello Listeners! Join us for the inaugural episode of our new Get Plugged In podcast series, AI Insights, which explores the intersection of Artificial Intelligence and Actuarial Science.
Erin DaSilva has joined Rovertown. Kroger Co. has entered a new agreement with Express Scripts. And Global Partners has made Fortune's most admired companies list.
Join us for an engaging conversation with Navy CAPT(Ret) Ed Norton, the Chief of the Defense Health Agency's Pharmacy Operations Division, as we explore the intricate world of military pharmacy. With a wealth of experience in both the Navy and DHA, Ed shares his journey and the significant responsibilities he shoulders in managing the TRICARE pharmacy benefit for over 7 million users. Discover how his team collaborates with service pharmacy consultants and Military Treatment Facility representatives to ensure an informed and effective service. Ed provides insights into the expansive TRICARE Pharmacy Benefit, serving a large number of DOD eligible beneficiaries with a net government cost of around $9 billion annually, and how these operations are critical in maintaining a ready medical force through programs like the deployed prescription program. In this episode, we also shed light on the vital role of Pharmacy Benefit Managers, focusing on the partnership between the Department of Defense and Express Scripts in managing the TRICARE pharmacy benefit. Listen as we discuss how Express Scripts ensures seamless claim processing, maintains a network of pharmacies, and provides essential mail-order services to deployed service members. We address the challenges and opportunities facing the TRICARE benefit, including rising pharmacy costs and shifts away from Military Treatment Facilities. Ed highlights initiatives aimed at enhancing patient experience and cost-efficiency through improved communication and technology. This episode offers a comprehensive view of the operations that keep our service members medically ready and the strategies in place to optimize this essential benefit. Chapters: (00:05) TRICARE Pharmacy Benefit and Operations Navy CAPT(Ret) Ed Norton discusses the TRICARE pharmacy benefit, supporting operational forces and maintaining medical readiness for 7 million users. (08:18) TRICARE Pharmacy Benefit and Management Express Scripts collaborates with DOD to manage TRICARE pharmacy benefit, optimizing costs and convenience for patients and taxpayers. Take Home Messages: Understanding TRICARE's Pharmacy Benefit: The episode provides an in-depth exploration of the TRICARE pharmacy benefit, detailing its role in supporting over 7 million service members. Listeners will gain insights into how the system ensures medical readiness through programs like the deployed prescription program, highlighting the extensive responsibilities involved in managing this critical aspect of military healthcare. Role of Pharmacy Benefit Managers (PBMs): The discussion sheds light on the partnership between the Department of Defense and Express Scripts, the PBM responsible for TRICARE. The episode explains how this collaboration facilitates seamless claim processing, mail-order services, and the establishment of a robust pharmacy network, which collectively optimize costs and enhance convenience for service members. Challenges and Opportunities in Military Pharmacy: Rising pharmacy costs and the gradual shift away from Military Treatment Facilities (MTFs) are identified as significant challenges. However, these also present opportunities to enhance patient experience and cost-efficiency through improved communication and the adoption of innovative technology solutions. Enhancing Patient Experience through Technology: The episode highlights initiatives aimed at improving patient experience within military pharmacies. This includes leveraging technology like electronic health records and queue management systems to streamline operations and reduce waiting times, thereby making pharmacy services more efficient and user-friendly. Military Medicine as a Career Path: The episode emphasizes the rewarding nature of a career in military medicine, underscoring the sense of purpose and camaraderie that comes with serving America's patriots. It encourages those considering this path to appreciate the unique opportunities and meaningful impact they can have within the military healthcare system. Episode Keywords: Military Pharmacy, TRICARE, Pharmacy Benefit, Defense Health Agency, Express Scripts, Medical Readiness, Pharmacy Operations, Military Treatment Facility, Prescription Services, Pharmacy Network, Pharmacy Costs, Technology Solutions, Patient Experience, Cost-Efficiency, Pharmacy Benefit Managers, Direct Delivery, Deployed Service Members, Contract Requirements, Civilian Pharmacy Plans, Taxpayers Hashtags: #MilitaryMedicine #TRICAREPharmacy #EdNortonInsights #PharmacyBenefit #DefenseHealth #ExpressScripts #MilitaryReadiness #HealthcareInnovation #WarDocsPodcast #VeteransHealthcare Honoring the Legacy and Preserving the History of Military Medicine The WarDocs Mission is to honor the legacy, preserve the oral history, and showcase career opportunities, unique expeditionary experiences, and achievements of Military Medicine. We foster patriotism and pride in Who we are, What we do, and, most importantly, How we serve Our Patients, the DoD, and Our Nation. Find out more and join Team WarDocs at https://www.wardocspodcast.com/ Check our list of previous guest episodes at https://www.wardocspodcast.com/our-guests Subscribe and Like our Videos on our YouTube Channel: https://www.youtube.com/@wardocspodcast Listen to the “What We Are For” Episode 47. https://bit.ly/3r87Afm WarDocs- The Military Medicine Podcast is a Non-Profit, Tax-exempt-501(c)(3) Veteran Run Organization run by volunteers. All donations are tax-deductible and go to honoring and preserving the history, experiences, successes, and lessons learned in Military Medicine. A tax receipt will be sent to you. WARDOCS documents the experiences, contributions, and innovations of all military medicine Services, ranks, and Corps who are affectionately called "Docs" as a sign of respect, trust, and confidence on and off the battlefield,demonstrating dedication to the medical care of fellow comrades in arms. Follow Us on Social Media Twitter: @wardocspodcast Facebook: WarDocs Podcast Instagram: @wardocspodcast LinkedIn: WarDocs-The Military Medicine Podcast YouTube Channel: https://www.youtube.com/@wardocspodcast
American healthcare is well known for its extreme cost and worst outcomes among industrialized (such as the 38 OECD member) countries, and beyond that to be remarkably opaque. The high cost of prescription drugs contributes, and little has been done to change that except for the government passing the Affordable Insulin Now Act at the end of 2022, enacted in 2023. But in January 2022 Mark Cuban launched Cost Plus Drugs that has transformed how many Americans can get their prescriptions filled at a fraction of the prevailing prices, bypassing pharmacy benefit managers (PBMs) that control 80% of US prescriptions. That was just the beginning of a path of creative destruction (disruptive innovation, after Schumpeter) of many key components American healthcare that Cuban is leading, with Cost Plus Marketplace, Cost Plus Wellness and much more to come. He certainly qualifies as a master disrupter: “someone who is a leader in innovation and is not afraid to challenge the status quo.” Below is a video clip from our conversation dealing with insurance companies. Full videos of all Ground Truths podcasts can be seen on YouTube here. The current one is here. If you like the YouTube format, please subscribe! The audios are also available on Apple and Spotify.Transcript with External links to Audio (00:07):Hello, it's Eric Topol with Ground Truths, and I have our special phenomenal guest today, Mark Cuban, who I think you know him from his tech world contributions and Dallas Mavericks, and the last few years he's been shaking up healthcare with Cost Plus Drugs. So Mark, welcome.Mark Cuban (00:25):Thanks for having me, Eric.Eric Topol (00:27):Yeah, I mean, what you're doing, you've become a hero to millions of Americans getting them their medications at a fraction of the cost they're used to. And you are really challenging the PBM industry, which I've delved into more than ever, just in prep for our conversation. It's just amazing what this group of companies, namely the three big three CVS Caremark, Optum of UnitedHealth and Express Scripts of Cigna with a market of almost $600 billion this year, what they're doing, how can they get away with all this stuff?Inner Workings of Pharmacy Benefit ManagersMark Cuban (01:03):I mean, they're just doing business. I really don't blame them. I blame the people who contract with them. All the companies, particularly the bigger companies, the self-insured companies, where the CEO really doesn't have an understanding of their healthcare or pharmacy benefits. And so, the big PBMs paid them rebates, which they think is great if you're a CEO, when in reality it's really just a loan against the money spent by your sickest employees, and they just don't understand that. So a big part of my time these days is going to CEOs and sitting with them and explaining to them that you're getting ripped off on both your pharmacy and your healthcare side.Eric Topol (01:47):Yeah, it's amazing to me the many ways that they get away with this. I mean, they make companies sign NDAs. They're addicted to rebates. They have all sorts of ways a channel of funds to themselves. I mean, all the things you could think of whereby they even have these GPOs. Each of these companies has a group purchasing organization (I summarized in the Table below).Mark Cuban (02:12):Yeah, which gives them, it's crazy because with those GPOs. The GPO does the deal with the pharmacy manufacturer. Then the GPO also does the deal with the PBM, and then the PBM goes to the self-insured employer in particular and says, hey, we're going to pass through all the rebates. But what they don't say is they've already skimmed off 5%, 10%, 20% or more off the top through their GPO. But that's not even the worst of it. That's just money, right? I mean, that's important, but I mean, even the biggest companies rarely own their own claims data.Mark Cuban (02:45):Now think about what that means. It means you can't get smarter about the wellness of your employees and their families. You want to figure out the best way to do GLP-1s and figure out how to reduce diabetes, whatever it may be. You don't have that claims data. And then they don't allow the companies to control their own formularies. So we've seen Humira biosimilars come out and the big PBMs have done their own version of the biosimilar where we have a product called Yusimry, which is only $594 a month, which is cheaper than the cheapest biosimilar that the big three are selling. And so, you would think in a normal relationship, they would want to bring on this new product to help the employer. No, they won't do it. If the employer asks, can I just add Cost Plus Drugs to my network? They'll say no, every single time.Mark Cuban (03:45):Their job is not to save the employer money, particularly after they've given a rebate. Because once they give that loan, that rebate to the employer, they need to get that money back. It's not a gift. It's a loan and they need to have the rebates, and we don't do rebates with them at all. And I can go down the list. They don't control the formula. They don't control, you mentioned the NDAs. They can't talk to manufacturers, so they can't go to Novo or to Lilly and say, let's put together a GLP-1 wellness program. All these different things that just are common sense. It's not happening. And so, the good news is when I walk into these companies that self-insured and talk to the CEO or CFO, I'm not asking them to do something that's not in their best interest or not in the best interest of the lives they cover. I'm saying, we can save you money and you can improve the wellness of your employees and their families. Where's the downside?Eric Topol (04:40):Oh, yeah. Yeah. And the reason they can't see the claims is because of the privacy issues?Mark Cuban (04:46):No, no. That's just a business decision in the contract that the PBMs have made. You can go and ask. I mean, you have every right to your own claims. You don't need to have it personally identified. You want to find out how many people have GLP-1s or what are the trends, or God forbid there's another Purdue Pharma thing going on, and someone prescribing lots of opioids. You want to be able to see those things, but they won't do it. And that's only on the sponsor side. It's almost as bad if not worse on the manufacturer side.Eric Topol (05:20):Oh, yeah. Well, some of the work of PBMs that you've been talking about were well chronicled in the New York Times, a couple of major articles by Reed Abelson and Rebecca Robbins: The Opaque Industry Secretly Inflating Prices for Prescription Drugs and The Powerful Companies Driving Local Drugstores Out of Business. We'll link those because I think some people are not aware of all the things that are going on in the background.Mark Cuban (05:39):You see in their study and what they reported on the big PBMs, it's crazy the way it works. And literally if there was transparency, like Cost Plus offers, the cost of medications across the country could come down 20%, 30% or more.Cost Plus DrugsEric Topol (05:55):Oh, I mean, it is amazing, really. And now let's get into Cost Plus. I know that a radiologist, Alex Oshmyansky contacted you with a cold email a little over three years ago, and you formed Cost Plus Drugs on the basis of that, right?Mark Cuban (06:12):Yep, that's exactly what happened.Eric Topol (06:15):I give you credit for responding to cold emails and coming up with a brilliant idea with this and getting behind it and putting your name behind it. And what you've done, so you started out with something like 110 generics and now you're up well over 1,200 or 2,500 or something like that?Mark Cuban (06:30):And adding brands. And so, started with 111. Now we're around 2,500 and trying to grow it every single day. And not only that, just to give people an overview. When you go to www.costplusdrugs.com and you put in the name of your medication, let's just say it's tadalafil, and if it comes up. In this case, it will. It'll show you our actual cost, and then we just mark it up 15%. It's the same markup for everybody, and if you want it, we'll have a pharmacist check it. And so, that's a $5 fee. And then if you want ship to mail order, it's $5 for shipping. And if you want to use our pharmacy network, then we can connect you there and you can just pick it up at a local pharmacy.Eric Topol (07:10):Yeah, no, it's transparency. We don't have a lot of that in healthcare in America, right?Mark Cuban (07:15):No. And literally, Eric, the smartest thing that we did, and we didn't expect this, it's always the law of unintended consequences. The smartest thing we did was publish our entire price list because that allowed any company, any sponsor, CMS, researchers to compare our prices to what others were already paying. And we've seen studies come out saying, for this X number of urology drugs, CMS would save $3.6 billion a year. For this number of heart drugs at this amount per year, for chemotherapy drugs or MS drugs this amount. And so, it's really brought attention to the fact that for what PBMs call specialty drugs, whether there's nothing special about them, we can save people a lot of money.Eric Topol (08:01):It's phenomenal. As a cardiologist, I looked up a couple of the drugs that I'm most frequently prescribed, just like Rosuvastatin what went down from $134 to $5.67 cents or Valsartan it went down from $69 to $7.40 cents. But of course, there's some that are much more dramatic, like as you mentioned, whether it's drugs for multiple sclerosis, the prostate cancer. I mean, some of these are just thousands and thousands of dollars per month that are saved, brought down to levels that you wouldn't think would even be conceivable. And this has been zero marketing, right?Mark Cuban (08:42):Yeah, none. It's all been word of mouth and my big mouth, of course. Going out there and doing interviews like this and going to major media, but it's amazing. We get emails and letters and people coming up to us almost single day saying, you saved my grandma's life. You saved my life. We weren't going to be able to afford our imatinib or our MS medication. And it went from being quoted $2,000 a month to $33 a month. It's just insane things like that that are still happening.Eric Topol (09:11):Well, this is certainly one of the biggest shakeups to occur in US healthcare in years. And what you've done in three years is just extraordinary. This healthcare in this country is with its over 4 trillion, pushing $5 trillion a year of expenditure.[New CMS report this week pegs the number at $4.867 trillion for 2023]Mark Cuban (09:30):It's interesting. I think it's really fixable. This has been the easiest industry to the disrupt I've ever been involved in. And it's not even close because all it took was transparency and not jacking up margins to market. We choose to use a fixed margin markup. Some choose to price to market, the Martin Shkreli approach, if you will. And just by being transparent, we've had an impact. And the other side of it is, it's the same concept on the healthcare side. Transparency helps, but to go a little field of pharmacy if you want. The insane part, and this applies to care and pharmacy, whatever plan we have, whether it's for health or whether it's for pharmaceuticals, there's typically a deductible, typically a copay, and typically a co-insurance.Insurance CompaniesMark Cuban (10:20):The crazy part of all that is that people taking the default risk, the credit risk are the providers. It's you, it's the hospital, it's the clinics that you work for. Which makes no sense whatsoever that the decisions that you or I make for our personal insurance or for the companies we run, or if we work for the government, what we do with Medicare or Medicare Advantage, the decisions we all make impacts the viability of providers starting with the biggest hospital systems. And so, as a result, they become subprime lenders without a car or a house to go after if they can't collect. And so, now you see a bunch of people, particularly those under the ACA with the $9,000, the bronze plans or $18,000 out-of-pocket limits go into debt, significant medical debt. And it's unfortunate. We look at the people who are facing these problems and think, well, it must be the insurance companies.Mark Cuban (11:23):It's actually not even the insurance companies. It's the overall design of the system. But underneath that, it's still whoever picks the insurance companies and sets plans that allow those deductibles, that's the core of the problem. And until we get to a system where the providers aren't responsible for the credit for defaults and dealing with all that credit risk, it's almost going to be impossible to change. Because when you see stories like we've all seen in news of a big healthcare, a BUCA healthcare (Blue Cross Blue Shield (BCBS), UnitedHealth, Cigna, and Aetna/CVS) plan with all the pre-authorizations and denials, typically they're not even taking the insurance risk. They're acting as the TPA (third party administrator) as the claims processor effectively for whoever hired them. And it goes back again, just like I talked about before. And as long as CMS hires or allows or accepts these BUCAs with these plans for Medicare for the ACA (Affordable care Act), whatever it may be, it's not going to work. As long as self-insured employers and the 50 million lives they cover hire these BUCAs to act as the TPAs, not as insurance companies and give them leeway on what to approve and what to authorize and what not to authorize. The system's going to be a mess, and that's where we are today.Academic Health System PartnershipsEric Topol (12:41):Yeah. Well, you've been talking of course to employers and enlightening them, and you're also enlightening the public, of course. That's why you have millions of people that are saving their cost of medications, but recently you struck a partnership with Penn Medicine. That's amazing. So is that your first academic health system that you approached?Cost Plus MarketplaceMark Cuban (13:00):I don't know if it was the first we approached, but it was certainly one of the biggest that we signed. We've got Cost Plus Marketplace (CPM) where we make everything from injectables to you name it, anything a hospital might buy. But again, at a finite markup, we make eight and a half percent I think when it's all said and done. And that saves hospital systems millions of dollars a year.Eric Topol (13:24):Yeah. So that's a big change in the way you're proceeding because what it was just pills that you were buying from the pharma companies, now you're actually going to make injectables and you're going to have a manufacturing capability. Is that already up and going?Mark Cuban (13:39):That's all up and going as of March. We're taking sterile injectables that are on the shortage list, generic and manufacturing them in Dallas using a whole robotics manufacturing plant that really Alex created. He's the rocket scientist behind it. And we're limited in capacity now, we're limited about 2 million vials, but we'll sell those to Cost Plus Marketplace, and we'll also sell those direct. So Cost Plus Marketplace isn't just the things we manufacture. It's a wide variety of products that hospitals buy that we then have a minimal markup, and then for the stuff we manufacture, we'll sell those to direct to like CHS was our first customer.Eric Topol (14:20):Yeah, that's a big expansion from going from the pills to this. Wow.Mark Cuban (14:24):It's a big, big expansion, but it goes to the heart of being transparent and not being greedy, selling on a markup. And ourselves as a company, being able to remain lean and mean. The only way we can sell at such a low markup. We have 20 employees on the Cost Plus side and 40 employees involved with the factories, and that's it.Eric Topol (14:46):Wow. So with respect to, you had this phenomenal article and interview with WIRED Magazine just this past week. I know Lauren Goode interviewed you, and she said, Mark, is this really altruistic and I love your response. You said, “how much f*****g money do I need? I'm not trying to land on Mars.” And then you said, “at this point in my life, it's just like more money, or f**k up the healthcare industry.” This was the greatest, Mark. I mean, I got to tell you, it was really something.Mark Cuban (15:18):Yeah.Eric Topol (15:19):Well, in speaking of that, of course, the allusion to a person we know well, Elon. He posted on X/Twitter in recent days , I think just three or four days ago, shouldn't the American people be getting their money's worth? About this high healthcare administration costs where the US is completely away from any other OECD country. And as you and I know, we have the worst outcomes and the most costs of all the rich countries in the world. There's just nothing new here. Maybe it's new to him, but you had a fabulous response on both X and Bluesky where you went over all these things point by point. And of course, the whole efforts that you've been working on now for three years. You also mentioned something that was really interesting that I didn't know about were these ERISA lawsuits[Employee Retirement Income Security Act (ERISA) of 1974.] Can you tell us about that?ERISA LawsuitsMark Cuban (16:13):Yeah, that's a great question, Eric. So for self-insured companies in particular, we have a fiduciary responsibility on a wellness and on a financial basis to offer the members, your employees and their families the best outcomes at the best price. Now, you can't guarantee best outcomes, but you have to be able to explain the choices you made. You don't have to pick the cheapest, but again, you have to be able to explain why you made the choices that you did. And because a lot of companies have been doing, just like we discussed earlier, doing deals on the pharmacy side with just these big PBMs, without accounting for best practices, best price, best outcomes, a couple companies got sued. Johnson and Johnson and Wells Fargo were the first to get sued. And I think that's just the beginning. That's just the writing on the wall. I think they'll lose because they just dealt with the big pharmacy PBMs. And I think that's one of the reasons why we're so busy at Cost Plus and why I'm so busy because we're having conversation after conversation with companies and plenty of enough lawyers for that matter who want to see a price list and be able to compare what they're paying to what we sell for to see if they're truly living up to that responsibility.Eric Topol (17:28):Yeah, no, that's a really important thing that's going on right now that I think a lot of people don't know about. Now, the government of the US think because it's the only government of any rich country in the world, if not any country that doesn't negotiate prices, i.e., CMS or whatever. And only with the recent work of insulin, which is a single one drug, was there reduction of price. And of course, it's years before we'll see other drugs. How could this country not negotiate drugs all these years where every other place in the world they do negotiate with pharma?Mark Cuban (18:05):Because as we alluded to earlier, the first line in every single pharmaceutical and healthcare contract says, you can't talk about this contract. It's like fight club. The number one rule of fight club is you can't talk about fight club, and it's really difficult to negotiate prices when it's opaque and everything's obfuscated where you can't really get into the details. So it's not that we're not capable of it, but it's just when there's no data there, it's really difficult because look, up until we started publishing our prices, how would anybody know?Mark Cuban (18:39):I mean, how was anybody going to compare numbers? And so, when the government or whoever started to negotiate, they tried to protect themselves and they tried to get data, but those big PBMs certainly have not been forthcoming. We've come along and publish our price list and all that starts to change. Now in terms of the bigger picture, there is a solution there, as I said earlier, but it really comes down to talking to the people who make the decisions to hire the big insurance companies and the big PBMs and telling them, no, you're not acting in your own best interest. Here's anybody watching out there. Ask your PBM if they can audit. If you can audit rather your PBM contract. What they'll tell you is, yeah, you can, but you have to use our people. It's insane. And that's from top to bottom. And so, I'm a big believer that if we can get starting with self-insured employers to act in their own best interest, and instead of working with a big PBM work with a pass-through PBM. A pass-through PBM will allow you to keep your own claims, own all your own data, allow you to control your own formulary.Mark Cuban (19:54):You make changes where necessary, no NDA, so you can't talk to manufacturers. All these different abilities that just seem to make perfect sense are available to all self-insured employers. And if the government, same thing. If the government requires pass-through PBMs, the price of medications will drop like a rock.Eric Topol (20:16):Is that possible? You think that could happen?Mark Cuban (20:19):Yes. Somebody's got to understand it and do it. I'm out there screaming, but we will see what happens with the new administration. There's nothing hard about it. And it's the same thing with Medicare and Medicare Advantage healthcare plans. There's nothing that says you have to use the biggest companies. Now, the insurance companies have to apply and get approved, but again, there's a path there to work with companies that can reduce costs and improve outcomes. The biggest challenge in my mind, and I'm still trying to work through this to fully understand it. I think where we really get turned upside down as a country is we try to avoid fraud from the provider perspective and the patient perspective. We're terrified that patients are going to use too much healthcare, and like everybody's got Munchausen disease.Mark Cuban (21:11):And we're terrified that the providers are going to charge too much or turn into Purdue Pharma and over-prescribe or one of these surgery mills that just is having somebody get surgery just so they can make money. So in an effort to avoid those things, we ask the insurance companies and the PBMs to do pre-authorizations, and that's the catch 22. How do we find a better way to deal with fraud at the patient and provider level? Because once we can do that, and maybe it's AI, maybe it's accepting fraud, maybe it's imposing criminal penalties if somebody does those things. But once we can overcome that, then it becomes very transactional. Because the reality is most insurance companies aren't insurance companies. 50 million lives are covered by self-insured employers that use the BUCAs, the big insurance companies, but not as insurance companies.Eric Topol (22:07):Yeah, I was going to ask you about that because if you look at these three big PBMs that control about 80% of the market, not the pass-throughs that you just mentioned, but the big ones, they each are owned by an insurance company. And so, when the employer says, okay, we're going to cover your healthcare stuff here, we're going to cover your prescriptions there.Mark Cuban (22:28):Yeah, it's all vertically integrated.Mark Cuban (22:36):And it gets even worse than that, Eric. So they also own specialty pharmacies, “specialty pharmacies” that will require you to buy from. And as I alluded to earlier, a lot of these medications like Imatinib, they'll list as being a specialty medication, but it's a pill. There's nothing special about it, but it allows them to charge a premium. And that's a big part of how the PBMs make a lot of their money, the GPO stuff we talked about, but also forcing an employer to go through the specialty mail order company that charges an arm and the leg.Impact on Hospitals and ProceduresEric Topol (23:09):Yeah. Well, and the point you made about transparency, we've seen this of course across US healthcare. So for example, as you know, if you were to look at what does it cost to have an operation like let's say a knee replacement at various hospitals, you can find that it could range fivefold. Of course, you actually get the cost, and it could be the hospital cost, and then there's the professional cost. And the same thing occurs for if you're having a scan, if you're having an MRI here or there. So these are also this lack of transparency and it's hard to get to the numbers, of course. There seems to be so many other parallels to the PBM story. Would you go to these other areas you think in the future?Mark Cuban (23:53):Yeah, we're doing it now. I'm doing it. So we have this thing called project dog food, and what it is, it's for my companies and what we've done is say, look, let's understand how the money works in healthcare.Mark Cuban (24:05):And when you think about it, when you go to get that knee done, what happens? Well, they go to your insurance company to get a pre-authorization. Your doctor says you need a knee replacement. I got both my hips replaced. Let's use that. Doctor says, Mark, you need your hips replaced. Great, right? Let's set up an appointment. Well, first the insurance company has to authorize it, okay, they do or they don't, but the doctor eats their time up trying to deal with the pre-authorization. And if it's denied, the doctor's time is eaten up and an assistance's time is eaten up. Some other administrator's time is eaten up, the employer's time is eaten up. So that's one significant cost. And then from there, there's a deductible. Now I can afford my deductible, but if there is an individual getting that hip replacement who can't afford the deductible, now all of a sudden you're still going to be required to do that hip replacement, most likely.Mark Cuban (25:00):Because in most of these contracts that self-insured employers sign, Medicare Advantage has, Medicare has, it says that between the insurance company and the provider, in this case, the hospital, you have to do the operation even if the deductibles not paid. So now the point of all this is you have the hospital in this case potentially accumulating who knows how much bad debt. And it's not just the lost amount of millions and millions and billions across the entire healthcare spectrum that's there. It's all the incremental administrative costs. The lawyers, the benefits for those people, the real estate, the desk, the office space, all that stuff adds up to $10 billion plus just because the hospitals take on that credit default risk. But wait, there's more. So now the surgery happens, you send the bill to the insurance company. The insurance company says, well, we're not going to pay you. Well, we have a contract. This is what it says, hip replacement's $34,000. Well, we don't care first, we're going to wait. So we get the time value of money, and then we're going to short pay you.Mark Cuban (26:11):So the hospital gets short paid. So what do they have to do? They have to sue them or send letters or whatever it is to try to get their money. When we talk to the big hospital systems, they say that's 2%. That's 2% of their revenue. So you have all these associated credit loss dollars, you've got the 2% of, in a lot of cases, billions and billions of dollars. And so, when you add all those things up, what happens? Well, what happens is because the providers are losing all that money and having to spend all those incremental dollars for the administration of all that, they have to jack up prices.Eric Topol (26:51):Yeah. Right.Mark Cuban (26:53):So what we have done, we've said, look for my companies, we're going to pay you cash. We're going to pay you cash day one. When Mark gets that hip replacement, that checks in the bank before the operation starts, if that's the way you want it. Great, they're not going to have pre-authorizations. We're going to trust you until you give us a reason not to trust you. We're not short paying, obviously, because we're paying cash right there then.Mark Cuban (27:19):But in a response for all that, because we're cutting out all those ancillary costs and credit risk, I want Medicare pricing. Now the initial response is, well, Medicare prices, that's awful. We can't do it. Well, when you really think about the cost and operating costs of a hospital, it's not the doctors, it's not the facilities, it's all the administration that cost all the money. It's all the credit risks that cost all the money. And so, if you remove that credit risk and all the administration, all those people, all that real estate, all those benefits and overhead associated with them, now all of a sudden selling at a Medicare price for that hip replacement is really profitable.Eric Topol (28:03):Now, is that a new entity Cost Plus healthcare?Mark Cuban (28:07):Well, it's called Cost Plus Wellness. It's not an entity. What we're going to do, so the part I didn't mention is all the direct contracts that we do that have all these pieces, as part of them that I just mentioned, we're going to publish them.Eric Topol (28:22):Ah, okay.Mark Cuban (28:23):And you can see exactly what we've done. And if you think about the real role of the big insurances companies for hospitals, it's a sales funnel.Getting Rid of Insurance CompaniesEric Topol (28:33):Yeah, yeah. Well, in fact, I really was intrigued because you did a podcast interview with Andrew Beam and the New England Journal of Medicine AI, and in that they talked about getting rid of the insurers, the insurance industry, just getting rid of it and just make it a means test for people. So it's not universal healthcare, it's a different model that you described. Can you go over that? I thought it was fantastic.Mark Cuban (29:00):Two pieces there. Let's talk about universal healthcare first. So for my companies, for our project dog food for the Mark Cuban companies, if for any employee or any of the lives we cover, if they work within network, anybody we have the direct contract with its single-payer. They pay their premiums, but they pay nothing else out of pocket. That's the definition of single-payer.Eric Topol (29:24):Yeah.Mark Cuban (29:25):So if we can get all this done, then the initial single-payers will be self-insured employers because it'll be more cost effective to them to do this approach. We hope, we still have to play it all through. So that's part one. In terms of everybody else, then you can say, why do we need insurance companies if they're not even truly acting as insurance companies? You're not taking full risk because even if it's Medicare Advantage, they're getting a capitated amount per month. And then that's getting risk adjusted because of the population you have, and then there's also an index depending on the location, so there's more or less money that occurs then. So let's just do what we need to do in this particular case, because the government is effectively eliminating the risk for the insurance company for the most part. And if you look at the margins for Medicare Advantage, I was just reading yesterday, it's like $1,700 a year for the average Medicare Advantage plan. So it's not like they're taking a lot of risk. All they're doing is trying to deny as many claims as they can.Eric Topol (30:35):Deny, Deny. Yeah.Mark Cuban (30:37):So instead, let's just get somebody who's a TPA, somebody who does the transaction, the claims processing, and whoever's in charge. It could be CMS, can set the terms for what's accepted and what's denied, and you can have a procedure for people that get denied that want to challenge it. And that's great, there's one in place now, but you make it a little simpler. But you take out the economics for the insurance company to just deny, deny, deny. There's no capitation. There's no nothing.Mark Cuban (31:10):The government just says, okay, we're hiring this TPA to handle the claims processing. It is your job. We're paying you per transaction.Mark Cuban (31:18):You don't get paid more if you deny. You don't get paid less if you deny. There's no bonuses if you keep it under a certain amount, there's no penalties If you go above a certain amount. We want you just to make sure that the patient involved is getting the best care, end of story. And if there's fraud involved as the government, because we have access to all that claims data, we're going to introduce AI that reviews that continuously.Mark Cuban (31:44):So that we can see things that are outliers or things that we question, and there's going to mean mistakes, but the bet was, if you will, where we save more and get better outcomes that way versus the current system and I think we will. Now, what ends up happening on top of that, once you have all that claims data and all that information and everybody's interest is aligned, best care at the best price, no denials unless it's necessary, reduce and eliminate fraud. Once everybody's in alignment, then as long as that's transparent. If the city of Dallas decides for all the lives they cover the 300,000 lives they cover between pharmacy and healthcare, we can usually in actuarial tables and some statistical analysis, we can say, you know what, even with a 15% tolerance, it's cheaper for us just to pay upfront and do this single-pay program, all our employees in the lives we cover, because we know what it's going to take.Mark Cuban (32:45):If the government decides, well, instead of Medicare Advantage the way it was, we know all the costs. Now we can say for all Medicare patients, we'll do Medicare for all, simply because we have definitive and deterministic pricing. Great. Now, there's still going to be outlier issues like all the therapies that cost a million dollars or whatever. But my attitude there is if CMS goes to Lilly, Novo, whoever for their cure for blindness that's $3.4 million. Well, that's great, but what we'll say is, okay, give us access to your books. We want to know what your breakeven point is. What is that breakeven point annually? We'll write you a check for that.Eric Topol (33:26):Yeah.Mark Cuban (33:27):If we have fewer patients than need that, okay, you win. If we have more patients than need that, it's like a Netflix subscription with unlimited subscribers, then we will have whatever it is, because then the manufacturer doesn't lose money, so they can't complain about R&D and not being able to make money. And that's for the CMS covered population. You can do a Netflix type subscription for self-insured employers. Hey, it's 25 cents per month per employee or per life covered for the life of the patent, and we'll commit to that. And so, now all of a sudden you get to a point where healthcare starts becoming not only transparent but deterministic.Eric Topol (34:08):Yeah. What you outline here in these themes are extraordinary. And one of the other issues that you are really advocating is patient empowerment, but one of the problems we have in the US is that people don't own their data. They don't even have all their data. I expect you'd be a champion of that as well.Mark Cuban (34:27):Well, of course. Yeah. I mean, look, I've got into arguments with doctors and public health officials about things like getting your own blood tested. I've been an advocate of getting my own blood tested for 15 years, and it helped me find out that I needed thyroid medication and all of these things. So I'm a big advocate. There's some people that think that too much data gives you a lot of false positives, and people get excited in this day and age to get more care when it should only be done if there are symptoms. I'm not a believer in that at all. I think now, particularly as AI becomes more applicable and available, you'll be able to be smarter about the data you capture. And that was always my final argument. Either you trust doctors, or you don't. Because even if there's an aberrational TSH reading and minus 4.4 and it's a little bit high, well the doctor's going to say, well, let's do another blood test in a month or two. The doctor is still the one that has to write the prescription. There's no downside to trusting your doctor in my mind.Eric Topol (35:32):And what you're bringing up is that we're already seeing how AI can pick up things even in the normal range, the trends long before a clinician physician would pick it up. Now, last thing I want to say is you are re-imagining healthcare like no one. I mean, there's what you're doing here. It started with some pills and it's going in a lot of different directions. You are rocking it here. I didn't even know some of the latest things that you're up to. This seems to be the biggest thing you've ever done.Mark Cuban (36:00):I hope so.Mark Cuban (36:01):I mean, like we said earlier, what could be better than people saying our healthcare system is good. What changed? That Cuban guy.Eric Topol (36:10):Well, did you give up Shark Tank so you could put more energy into this?Mark Cuban (36:16):Not really. It was more for my kids.Eric Topol (36:19):Okay, okay.Mark Cuban (36:20):They go hand in hand, obviously. I can do this stuff at home as opposed to sitting on a set wondering if I should invest in Dude Wipes again.Eric Topol (36:28):Well, look, we're cheering for you. This is, I've not seen a shakeup in my life in American healthcare like this. You are just rocking. It's fantastic.Mark Cuban (36:37):Everybody out there that's watching, check out www.costplusdrugs.com, check out Cost Plus Marketplace, which is business.costplusdrugs.com and just audit everything. What I'm trying to do is say, okay, if it's 1955 and we're starting healthcare all over again, how would we do it? And really just keep it simple. Look to where the risk is and remove the risk where possible. And then it comes down to who do you trust and make sure you trust but verify. Making sure there aren't doctors or systems that are outliers and making sure that there aren't companies that are outliers or patients rather that are outliers. And so, I think there's a path there. It's not nearly as difficult, it's just starting them with corporations, getting those CEOs to get educated and act in their own best interest.Eric Topol (37:32):Well, you're showing us the way. No question. So thanks so much for joining, and we'll be following this with really deep interest because you're moving at high velocity, and thank you.**************************************************Thank you for reading, listening and subscribing to Ground Truths.If you found this fun and informative please share it!All content on Ground Truths—its newsletters, analyses, and podcasts, are free, open-access.Paid subscriptions are voluntary. All proceeds from them go to support Scripps Research. Many thanks to those who have contributed—they have greatly helped fund our summer internship programs for the past two years. I welcome all comments from paid subscribers and will do my best to respond to each of them and any questions.Thanks to my producer Jessica Nguyen and to Sinjun Balabanoff for audio and video support at Scripps Research.FootnoteThe PBMS (finally) are under fire—2 articles from the past week Get full access to Ground Truths at erictopol.substack.com/subscribe
December 10, 2024 - Dale Colee joined Byers & Co to talk about Express Scripts' in-network status, GLP-1 medications insurance changes, holiday shopping, and storewide discounts. Listen to the podcast now!See omnystudio.com/listener for privacy information.
Oral Arguments for the Court of Appeals for the Ninth Circuit
Kelley-Ross & Associates Inc v. Express Scripts, Inc.
November 19, 2024 - Dale Colee joined Byers & Co to talk about the Pharmacists Fight Back Act event in Washington DC, Express Scripts, Medicare Part D, and Clear Springs Health plans. Listen to the podcast now!See omnystudio.com/listener for privacy information.
It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Hurricane aid for people with diabetes, Medtronic safety warning, stem cell updates for type 1, new study about teens and young adults with type 1, and Ryan Reed returns to racing. Find out more about Moms' Night Out Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom Edgepark Medical Supplies Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com Reach out with questions or comments: info@diabetes-connections.com Episode transcription with links: Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX Hurricane Insulin efforts XX Medtronic has notified customers that battery issues with its Minimed 600 and 700 series insulin pumps could cause the devices to stop delivering insulin significantly sooner than expected. A “low battery pump” alert, intended to signal up to 10 hours of remaining battery life, may be displayed on the device even if much less time is left. Medtronic told customers they could contact the company to determine the need for a replacement pump. Medtronic said it received 170 reports of hyperglycemia and 11 reports of diabetic ketoacidosis in the U.S., from January 2023 to September 2024, potentially related to the issue. Pump models including the Minimed 630G, 670G, 770G and 780G systems are affected by the notice. https://www.medtechdive.com/news/Medtronic-Minimed-insulin-pumps-recall-battery-life/729019/ XX A woman has undergone a stem-cell therapy made from her own cells, to treat her type 1 diabetes. Researchers in China discovered the woman did not need to use insulin 75 days after the procedure, and that the stem-cell derived islet cells she was injected with had been engrafted inside her abdomen. the case is the first of its kind, and two more people have been enrolled in the clinical trial in China since, researchers involved in the study told Medical News Today. Other stem-cell based therapies for type 1 and type 2 diabetes are also currently in development and in trials. For this case study, researchers based in Tianjin First Central Hospital, Nankai University, Tianjin, China took fat cells from a 25 year-old woman with type 1 diabetes, and chemically induced them to behave as pluripotent stem cells, a type of cell that can develop into other types of cell. They then used these to create islet cells, which typically exist in the pancreas and create insulin, a hormone that regulates levels of glucose (sugar) in the bloodstream. The patient in this case study had previously had two liver transplants and a failed pancreas transplant due to complications that had arisen due to her diabetes. The induced islet cells made from the patient's own cells were then injected between the skin and abdominal muscles. Researchers discovered that these successfully engrafted in the patient, including growing their own vasculature. Before the procedure she produced enough insulin to reach her target glycemic range 43.18% of the time, and 4 months later this increased to 96.2% of the time. She was also shown to have lower glycated hemoglobin, which indicated long-term systemic glucose levels at a non-diabetic level. https://www.medicalnewstoday.com/articles/stem-cell-therapy-reverses-type-1-diabetes-in-groundbreaking-case-study XX The state of Texas is accusing major pharmacy benefit managers and drug companies of colluding to raise the cost of insulin. Texas alleged drug manufacturers Eli Lilly, Novo Nordisk and Sanofi raise the price of insulin and then pay an undisclosed amount back to PBMs Optum Rx, Express Scripts and CVS Caremark through a quid pro quo agreement. PBMs then give preferred status on its standard formularies to drugs with the highest list prices, the state said. Insulin costs $2 to produce and could be purchased for $20 in the 1990s but now costs up to $700, the Office of the Attorney General of Texas wrote in a news release. The filing goes so far as to describe a LinkedIn group these executives would use to discuss insulin pricing tactics. The Federal Trade Commission (FTC) recently sued Optum Rx, Express Scripts and Caremark for rising insulin prices and anticompetitive practices. The PBMs reject the FTC's findings. Drug manufacturers were not included in the lawsuit. Texas' lawsuit also noted the consolidation in the PBM market, arguing it gives PBMs a “disproportionate amount of market power.” Nearly 40 PBM entities have now been consumed by UnitedHealth Group, Cigna and CVS Caremark. https://www.fiercehealthcare.com/payers/texas-sues-pbms-manufacturers-over-insulin-conspiracy XX Canadian teens and young adults living with diabetes face double the risk of hospitalizations and emergency room visits compared with younger children with the condition, say doctors suggesting changes to how care is organized for affected families. In the October issue of the journal The Lancet Diabetes and Endocrinology, Dr. Meranda Nakhla, a pediatric endocrinologist at the Montreal Children's Hospital, and her team used Quebec health administrative data to estimate the risk of gaps in regular diabetes care for complications in children under 10, and adults up to age 23. "With adolescents and young adults, [the complication] tends to be more related to an insulin omission and maybe just feeling burnt out from having diabetes and just not wanting to deal with it," Nakhla said. "They may stop taking insulin and a day later end up in the emergency room with diabetic ketoacidosis." Part of the challenge, Nakhla said, is for parents to take a step back from managing all aspects of their child's diabetes to a more supportive role that allows the child to have more autonomy. What's new about the Quebec findings is they highlight how gaps in diabetes care visits start at a younger age than previously looked at, said Dr. Rayzel Shulman, a pediatric endocrinologist at Toronto's Hospital for Sick Children. Since the brains of adolescents and young adults aren't fully developed, planning ahead, thinking about the consequences of their actions and controlling impulses differs from their parents. As part of an ongoing study, Shulman's team uses text messages to send adolescents and young adults appointment reminders as well as monthly diabetes messages. They recently added an artificial intelligence chat bot programmed with answers from trusted sources. https://www.cbc.ca/news/health/diabetes-pediatric-1.7345526 XX A trade organization representing compounding pharmacies that make unbranded versions of the weight loss drugs Mounjaro and Zepbound has filed a lawsuit against the Food and Drug Administration (FDA) for declaring an end to the shortage, effectively halting the sale of “copycat” versions of these drugs. On Oct. 2, the FDA announced that the nearly two-year-long shortage of tirzepatide, the active ingredient in Mounjaro and Zepbound, had ended. This was after the agency said it had confirmed the manufacturer, Eli Lily, had a manufacturing capacity that “can meet the present and projected national demand.” With the shortage over, the ability of compounding pharmacies to sell unbranded, replicated versions of these drugs came to a near halt. There are two types of compounding pharmacies: 503A and 503B. The Outsourcing Facilities Association (OFA) represents 503B compounding pharmacies, which can create prescription-specific compounded drugs as well as bulk orders. The OFA and the compounding pharmacy North American Custom Laboratories filed their lawsuit against the FDA on Monday, alleging the agency was “abruptly depriving patients of much needed treatment and artificially raising drug prices.” “Ignoring evidence that the shortage persists, FDA removed Tirzepatide from the shortage list without notice, without soliciting input from affected parties and the public, and without meaningful rationale,” said their complaint. The evidence that the plaintiffs cited for the shortage persisting was that the FDA noted in its announcement that “patients and prescribers may still see intermittent localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies.” Eli Lilly made a similar statement after the shortage was declared over, saying, “Patients' experiences looking for a particular dose of medicine in their local pharmacies may vary. The supply chain is complex, especially for refrigerated medicines, and there may be many reasons why a particular pharmacy does not have a particular dose of the medicine in stock. ” https://thehill.com/policy/healthcare/4922234-trade-group-sues-fda-over-ending-mounjaro-zepbound-shortage/ XX New project in Europe to provide data to enable more people with diabetes who use insulin to work as commercial pilots and air traffic controllers. The European Union Aviation Safety Agency project focuses mainly on pilots and air traffic controllers, but the data being collected will apply to cabin crew and passengers with diabetes as well currently only three countries in Europe — the United Kingdom, Ireland, and Austria — allow them to obtain a license that enables them to fly commercially, under a strict protocol that was first launched by the UK Civil Aviation Authority in 2012. The Irish Aviation Authority joined in 2015, and Austro Control followed in 2016. https://www.medscape.com/viewarticle/eu-program-aims-ensure-safety-pilots-who-use-insulin-2024a1000ia6 XX Edgepark commercial XX The two-time Xfinity Series winner was competing at Talladega in McAnally-Hilgeman Racing's No. 91 truck for his first start of the season. The last time Reed drove in a NASCAR event came last fall at Las Vegas Motor Speedway in the Xfinity Series, and his most recent Truck start came in the spring of 2021 at Darlington Raceway. “I couldn't stop making mistakes early on,” Reed said. “The truck was so fast. I think more than anything I'm really proud of myself for being able to get out there and make aggressive pushes and be able to kind of rise to the occasion.” See also Grant Enfinger Wins Talladega, Advances to Championship 4 Despite the speed, Reed's truck burst into flames shortly after crossing the finish line. Reed said he stared at the door of teammate Christian Eckes while he crossed the line in the middle of a multi-truck pileup. “Gosh, we could go anywhere we wanted today,” Reed told Frontstretch. “I made a lot of mistakes, but we put ourselves in position at the end. I hate that Bill [McAnally] has torn up race trucks.” Friday marked Reed's sixth start in the past six years in Truck and Xfinity equipment, something Reed said might have added some doubt. “When you're sitting on the couch every weekend, you think you can do it,” he reflected. “I remember I used to race every single weekend, I know how to get around these plate tracks, but you don't know, right? “It's really gratifying to come off the couch and remind myself, like ‘hey I can still do this,' at least at superspeedways. I think I can do it at other tracks too.” The day ended in a combination of a career-best Truck Series finish and a ball of fire for Ryan Reed in his return to NASCAR Craftsman Truck Series competition on Friday (Oct. 4). https://frontstretch.com/2024/10/04/ryan-reed-scores-career-best-finish-in-truck-series-return/ XX Join us again soon!
Last time Cora Opsahl was on the show, Michelle Bernabe, RN, KAT, wrote a comment on LinkedIn I thought encapsulated the gist of it all so well. She wrote, “[Cora] first became a mentor/ally through Relentless Health Value episode 372. … It opened a doorway to a whole group of very relentless people.” For a full transcript of this episode, click here. If you enjoy this podcast, be sure to subscribe to the free weekly newsletter to be a member of the Relentless Tribe. I want to start there because it's a nice comment, but it's also a call to action. Think about this and think about it not in the context of being a “stakeholder” and not in the context of being an organization but in the context of humans who work at these various organizations who, combined, comprise the bucket of companies that we lumped together using the old stakeholder word. All of these individuals are making choices every day, and all of these choices, they could be made with integrity and with the patient or member in mind … or not. In real life, right now, the overwhelming majority of members/patients in this country get their clinical care and the pleasure of paying for that care or drugs within the current ecosystem we have here in the USA. For any of us, or all of us who work within that traditional ecosystem, it is up to us to choose our own legacy here. It's probably why you listen to this show in the first place, actually. There are so many RHV (Relentless Health Value) listeners who are pushing for patients against the riptide that is the profit motives of the organization that they work for. It's hard. But yeah, it's all about finding our people and supporting each other. Okay, so let's get to the “between a rock and a hard place” portion of this discussion. Hospitals and ASOs (administrative services organizations)/carriers/TPAs (third-party administrators) often enter into or sometimes enter into what amounts to anticompetitive contracts with each other. Listen to episode 395 with Brennan Bilberry for the rundown on that one. But meanwhile, the CAA, the Consolidated Appropriations Act from 2021, holds employer plan sponsors accountable and responsible to ensure that plan assets are spent prudently, that costs paid are reasonable, and that there's no conflict of interest (COI). This is the definition of what a fiduciary is supposed to do, by the way—prudent, reasonable, and no COI. Anticompetitive contracts between a carrier and a hospital are the very definition of COI. And when that COI results in higher, maybe unreasonable, prices and non-prudent spend, well, plan sponsors are put between a rock and a hard place if they stick with their existing vendors. Rosa Novo from Miami-Dade County Public Schools put this really succinctly on a panel at a 32BJ event recently. She said what amounts to, I have no choice but to actually do the right thing here, for many reasons, but one of them is I do not look good in orange. She said, my personal butt is on the line here. And furthermore, who do class action lawsuits make look bad when their company or CEO or CFO are personally sued over conflicted benefits? See the Wells Fargo lawsuit, J&J lawsuit, etc. It sucks that employers or plan sponsors get put into this pickle by their own vendors. And that's what we're talking about today. This is a conversation that starts out talking about rates (ie, prices), edges into rights (ie, plan sponsor rights), and ends up all about power. And by the way, if you're a plan sponsor, especially in New York City, maybe doing the right thing here means hatching a plan to steer and tier in your benefit design, figuring out how to, for reals, help support the efforts of 32BJ to advantage pretty much every patient near and far. The pushback I often hear to doing something like this often involves the perception that plan members are too rich to care about reasonable prices, prudent plan spending, and COI. And yeah, to state the obvious, these same people are also sophisticated enough to smell a fine opportunity for a class action lawsuit; and also, they probably do care, as more and more studies suggest. Sorry if I just stumbled onto a sacred cow. Cora Opsahl, my guest today, is the director of the 32BJ Health Fund, serving over 200,000 folks. Their ability to kick NewYork-Presbyterian, a big, consolidated, very expensive hospital, out of their network in 2018 enabled them to offer maternity benefits for $40 in total out-of-pocket for members. And also, employees got their biggest raise ever; employers got a premium holiday and a 3% rate increase for a bunch of years after that; and yeah … this is where we start the conversation today. And yeah, it's a freakin' tangled web we weave; and this tale is a perfect case study of it. It makes me even more invested in remembering my own manifesto (that was episode 400) to ensure that I can feel good about what I personally have accomplished and what I have been a part of and the net impact of my own personal actions, since I, too, very often work in the belly of the beast. Furthermore, you will find links to a template health savings calculator for plan sponsors and also a template contract (again for plan sponsors) that 32BJ has made available. More on that in the show that follows. Also mentioned in this episode are 32BJ Benefit Funds; Michelle Bernabe, RN, KAT; Brennan Bilberry; Rosa Novo; Marilyn Bartlett; Cynthia Fisher; Zack Cooper, PhD; Claire Brockbank; Andreas Mang; Chris Deacon; Elizabeth Mitchell; and Purchaser Business Group on Health. You can learn more at health.32bjfunds.org and by following Cora on LinkedIn. Cora Opsahl is the director of the 32BJ Health Fund, a self-insured Taft-Hartley benefit fund that sets comprehensive design parameters to ensure the 200,000 members and families of Service Employees International Union 32BJ have easy and sustained access to affordable, high-quality healthcare. Since becoming director of the Health Fund in 2021, Cora has prioritized a data-driven approach to healthcare, focusing on reducing trend; solving the affordability challenge on behalf of union members; and most important, keeping members at the center of every decision. Under her leadership, the 32BJ Health Fund has saved more than $35 million annually—which it has reinvested in new and better benefits, including the first fertility benefit for members—by removing NewYork-Presbyterian hospitals and physicians from its network, transitioning to a new pharmacy vendor and pharmacy group purchasing coalition, and establishing an expanded Centers of Excellence program. Most recently, Cora conducted an innovative medical request for proposal (RFP), stipulating that all finalists must have a signature-ready contract drafted by the Health Fund prior to award. By including the Health Fund–drafted contract in the RFP process, the Fund was able to negotiate an agreement that brought unprecedented visibility and increased accountability to the 32BJ Health Fund benefit. Cora is regarded as an expert in pharmacy benefit management and previously worked at Express Scripts, where she held a variety of roles, ranging from Medicare Part D to operations to strategy and acquisitions. She earned an MBA from Saint Louis University. 06:16 Why is it imperative for employers to do something differently when it comes to being plan sponsors? 09:22 How analyzing claims data allowed 32BJ Health Fund to reshape their benefit design. 12:09 What anticompetitive rights did 32BJ run into that limited 32BJ Health Fund from managing their benefit design? 14:12 How do these anticompetitive rights have quality implications as well as cost implications? 18:43 How did 32BJ Health Fund remove NewYork-Presbyterian from their network, and how much did it save 32BJ Health Fund per year? 19:46 What did the healthcare savings allow the unions and employers to do? 20:46 Study by Zack Cooper, PhD. 21:26 Why rising healthcare costs has pushed 32BJ Health Fund to move beyond benefit design to manage healthcare spend. 24:15 Why 32BJ Health Fund wants to control the contracting process. 26:00 EP419 with Andreas Mang. 27:18 What are 32BJ Health Fund's four non-negotiables? 33:17 Wall Street Journal article on health insurance contract. 35:30 Upcoming episode with Claire Brockbank. 36:14 What is the challenge that exists in our current healthcare environment? 37:43 Cora's advice on how to get high-quality healthcare at an affordable price. You can learn more at health.32bjfunds.org and by following Cora on LinkedIn. @CoraOpsahl discusses #fiduciaryresponsibility in #healthcare on our #healthcarepodcast. #podcast #financialhealth #primarycare #patientoutcomes #healthcareinnovation Recent past interviews: Click a guest's name for their latest RHV episode! Dan Nardi, Dr Spencer Dorn (EP451), Marilyn Bartlett, Dr Marty Makary, Shawn Gremminger (Part 2), Shawn Gremminger (Part 1), Elizabeth Mitchell (Summer Shorts 9), Dr Will Shrank (Encore! EP413), Dr Amy Scanlan (Encore! EP402), Ashleigh Gunter, Dr Spencer Dorn (EP446)
This time on Code WACK! We're taking another look at Pharmacy Benefit Managers or PBMs. Why were PBMs started and how did they morph to become one of the most powerful entities in health care? Why have they caught the attention of the Federal Trade Commission? How are they a threat to consumers? To find out, we spoke to Dr. Ed Weisbart, the national board secretary of Physicians for a National Health Program and former chief medical officer of one of the biggest PBMs in the country. This is the first episode in a two-part series. Check out the Transcript and Show Notes for more!
A powerful hurricane makes landfall in Florida and causes damage across Kentucky, the superintendent of the state's largest school district announces his resignation, lawmakers on both sides of the aisle praise a new multi-million dollar center in Louisivlle, Kentucky sues Express Scripts, liquor distributors ask Kentucky lawmakers to regulate Delta-infused drinks similar to the way alcohol is regulated, and a first of its kind in college basketball.
It's In the News! A look at the top diabetes stories and headlines happening now. Top stories this week: The FTC sues PBMs over insulin pricing, a new CGM is approved in Europe, more news about GLP-1s but some research says it may not work as well for one population, diabetes camps are invited to apply for grants, and more! Find out more about Moms' Night Out Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom Edgepark Medical Supplies Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com Reach out with questions or comments: info@diabetes-connections.com Episode transcription with links: Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX The U.S. Federal Trade Commission sued the country's three largest pharmacy benefit managers on Friday, accusing them of steering diabetes patients towards higher priced insulin in order to reap millions of dollars in rebates from pharmaceutical companies. The case accuses UnitedHealth Group Inc's (UNH.N), opens new tab Optum unit, CVS Health Corp's (CVS.N), opens new tab CVS Caremark and Cigna Corp's (CI.N), opens new tab Express Scripts of unfairly excluding lower cost insulin products from lists of drugs covered by insurers. The three companies said in statements that the suit was baseless and defended their business practices, saying that they had lowered insulin prices for businesses, unions and patients. https://www.reuters.com/business/healthcare-pharmaceuticals/us-ftc-sues-drug-gatekeepers-over-high-insulin-prices-2024-09-20/ XX A new study finds metformin, may slow aging. Previous studies on "lower order" species have found that it can delay the onset of age-related diseases. Gotta say, this is only in animal studies right now, not people, human trials are next. https://www.cbsnews.com/boston/news/diabetes-drug-metformin-aging/ XX New research from the Case Western Reserve University School of Medicine identifies a potential new approach to address the opioid overdose epidemic—which has devastated families and communities nationally. The study, published in the journal JAMA Network Open, suggests semaglutide is linked to lower opioid overdoses in people with opioid-use disorder (OUD) and type 2 diabetes (T2D). Semaglutide, a glucagon-like peptide receptor (GLP-1R) molecule that decreases hunger and helps regulate blood sugar in T2D, is also the active component in the diabetes and weight-loss drugs Wegovy and Ozempic. The research team—led by biomedical informatics professor Rong Xu—analyzed six years of electronic records of nearly 33,000 patients with OUD who also had T2D. The researchers used a statistical approach that mimics a randomized clinical trial. They found patients prescribed semaglutide had a significantly lower risk for opioid overdose, compared to those who had taken any of eight other anti-diabetic medications, including other types of GLP-1R-targeting medications. About 107,500 people died from drug overdoses nationally in 2023, mostly from opioids, according to the CDC. Despite effective medications to prevent overdoses from OUD, the CDC estimates only a quarter of those with OUD receive them and about half discontinue treatment within six months. https://medicalxpress.com/news/2024-09-popular-diabetes-weight-loss-drug.html XX New research analyzing the effects of two drugs used to treat type 2 diabetes indicates a consistent lack of cardiovascular and renal benefits in Black populations. The drugs, called sodium-glucose co-transporter 2 inhibitors (SGLT2-Is) and glucogen-like peptide 1 receptor agonists (GLP1-RAs), are some of the newer treatments prescribed to lower blood sugar levels in people with type 2 diabetes. The research findings, published in the Journal of the Royal Society of Medicine, show that for White and Asian populations, SGLT2-Is and GLP1-RAs have beneficial effects on blood pressure, weight control and renal function, and significantly reduce the risk of severe heart problems and kidney disease. However, the research shows no evidence of these beneficial effects in Black populations. ""Whether the differences are due to issues with under-representation of Black populations and low statistical power, or to racial/ethnic variations in the way the body and these drugs interact with each other needs further investigation," said Professor Seidu. "It is therefore important that prescribers don't hasten to deny these newer treatments to Black populations on the back of this research." https://www.news-medical.net/news/20240923/Research-reveals-disparities-in-diabetes-drug-efficacy-for-Black-populations.aspx XX If a woman is already in a "prediabetic" state in her teen or college years, her odds for a serious complication of pregnancy later in life rises, new research shows. Ignoring prediabetes in teenagers "may represent a missed opportunity to avert pregnancy-related complications" later, said study lead author Katharine McCarthy. She's an assistant professor of population health science and policy, and obstetrics, gynecology and reproductive science at the Icahn School of Medicine at Mount Sinai in New York City. Her team published its findings Sept. 24 in the journal JAMA Network Open. Prior research has found that rates of prediabetes have tripled among Americans ages 12 to 19 over the past decade. In the new study, the Mount Sinai team tracked rates of prediabetes (using blood sugar tests) among a group of 14,000 New York City residents ages 10 to 24. None of these individuals had full-blown diabetes at the time they were tested. Having prediabetes in youth was linked to a doubling of risk of gestational diabetes -- new-onset diabetes while pregnant. Tracking blood levels of hemoglobin A1c, a measure of a person's average blood sugar level over the prior three months, was very predictive of whether or a not a woman would get gestational diabetes, the team found. Prediabetes in youth was also linked to an 18% rise in the risk for hypertensive disorders during pregnancy, such as gestational hypertension and preeclampsia, or preterm delivery. Measuring a teen girl's blood for signs of prediabetes might help protect her against trouble in a later pregnancy, McCarthy's group said. https://www.usnews.com/news/health-news/articles/2024-09-24/prediabetes-in-teens-could-raise-odds-for-complicated-pregnancies-later XX Is there a link between IBD and type 1? In a recent and very large study, researchers looked at more than 630-thousdan people and found that irritable bowel disease seemed to significantly increase the risk of type 1 diabetes and vice versa. Interestingly, patients with IBD were found to have a significantly higher probability of formerly having contracted T1D, validating the bidirectional associations between these comorbidities. The highest risk was observed in patients with ulcerative colitis (aHR = 2.02), highlighting a stronger association with this IBD subtype. Additionally, over 70% of the study cohort was followed for more than ten years, reinforcing the robustness of these findings. https://www.news-medical.net/news/20240919/IBD-increases-type-1-diabetes-risk-revealing-a-bidirectional-link-between-the-two-conditions.aspx XX Roche plans to launch its first continuous glucose monitor (CGM) in Europe “in the coming weeks,” The Accu-Chek Smartguide has European approval for adults with Type 1 or Type 2 diabetes. Roche will roll out the CGM in the Netherlands, Switzerland and Germany. Accu-Chek Smartguide can be worn for 14 days, and features predictive algorithms that Roche hopes will differentiate it from competitors Abbott and Dexcom. However, it also must be calibrated at first using a finger stick, which the other brands don't require. Roche developed the CGM with three different prediction tools: A feature to predict the risk of low blood glucose within 30 minutes, a feature to forecast glucose levels over the next two hours, and a feature to predict hypoglycemia risk at night. Pau Herrero, an algorithm and decision support tech lead at Roche, said the device provides a different picture than the trend arrows other CGMs use, which typically forecast glucose levels over the next 20 minutes. The predictions are based on multiple days of patient data using machine learning models. The company is in “active discussions” with the Food and Drug Administration on bringing Accu-Chek Smartguide to the U.S., Moreiras said, adding that he “cannot commit to any timelines.” https://www.medtechdive.com/news/roche-cgm-launch-europe/726863/ XX Exciting news! iLet users can now invite friends and family to join their Bionic Circle to see their diabetes data and receive alerts. By accepting the invite and downloading our new Bionic Circle App, loved ones can monitor an iLet user's CGM values, meal announcements, insulin doses, and alerts from anywhere. To learn how to invite followers and accept an invite, visit: https://lnkd.in/ghigJKMt XX Diabetes Canada has unveiled the key findings of a first-of-its-kind national survey on how widespread stigma, judgement and discrimination is for those who live with diabetes and the impact of those social experiences on the quality of life for people with diabetes. The survey shows that diabetes can not only negatively impact a person's physical health but can also negatively affect their personal relationships, work or studies, leisure activities, financial situation, and emotional well-being. In fact, nearly 90% of people living with type 1 diabetes and 70% of people living with type 2 diabetes experience shame and blame for having diabetes. “As someone who lives with type 2 diabetes, I know first-hand how stigma can negatively impact the quality of life for people living with this condition in Canada,” says Laura Syron, President & CEO of Diabetes Canada. “We need to change the conversation around diabetes—the values, beliefs and language—so that people living with this condition can feel more accepted and understood. These feelings can dramatically improve the likelihood that people living with diabetes can receive the support and care they need to better their health outcomes and their quality of life.” In the survey, key findings show how people living with diabetes must deal with unfair assumptions about what they can and cannot do, judgements if they consume specific foods, and being blamed for having diabetes. 40% of people with T1D never or rarely ask for support to help manage their diabetes when they need it. 56% of people with T2D never or rarely ask for support to help manage their diabetes when they need it. https://finance.yahoo.com/news/diabetes-canada-releases-first-kind-101300695.html?guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAAJIrWwjdye-ehrLNDt-LIGb5qTXaKDTIa8NWwiT7fKwFFgjDMN2nnINis6YfFePWP2ZA2DVYWXEIZQqRlQ4aKLFrYWgvw1jdI-t1n9kO6NIzdBCMXQNNCVl_S-75lDNip2SysHDJQmyqSc4wLjfDya3v9wwTWU-KgE_OqrPCTnlu XX Edgepark commercial XX This is National Glucose Awareness Week. Dexcom and Beyond Type 2 are teaming up for the new designation to encourage people to learn about the importance of glucose and its significant impact on overall health, especially for people with diabetes. The news release says: National Glucose Awareness Week will feature a variety of educational resources about the importance of glucose health and information about new, cutting-edge glucose biosensing technology. That technology is CGM.. now available over the counter as Dexcom's Stelo. Get moving: Participate in a nationwide step challenge (invitation code: glucose) from Sept. 30 to Oct. 13 to help improve your glucose health.† Step challenge participants can register to participate from Sept. 23-29, 2024 and will have the chance to compete for prizes. Get resources: Close the glucose knowledge gap with key educational resources from Beyond Type 2. https://www.businesswire.com/news/home/20240923896101/en/Dexcom-Beyond-Type-2-and-Retta-Establish-National-Glucose-Awareness-Week-to-Close-the-Glucose-Knowledge-Gap?utm_campaign=shareaholic&utm_medium=copy_link&utm_source=bookmark XX Attention diabetes camp organizers! You're invited to apply for financial support for your need based scholarships. This is the Type 1 Diabetes Camps Project: 2025-2027 Campership Initiative The initiative will also provide limited funds for selected camps to expand their revenue development efforts, funds for professional development and funds for low-income camper recruitment efforts and indirect costs. The initiative is supported by $6 million in grant funding from The Leona M. and Harry B. Helmsley Charitable Trust and $900 thousand in funding from Eli Lilly and Company over the next three years. For more information about the RFP, please login and navigate to the publicly available RFPs: https://newventurefund.force.com/login XX Join us again soon!
Lisa Dent is joined by Shannon McNulty, Partner at Clifford Law Offices, to discuss the U.S. Federal Trade Commission’s decision to go after CVS Health’s Caremark, Cigna’s Express Scripts, and UnitedHealth Group’s Optum regarding their alleged pattern of steering people towards overpriced insulin.
This Day in Legal History: McKinley Assassin Stands TrialOn September 23, 1901, the trial of Leon Czolgosz began for the assassination of President William McKinley. Czolgosz, an anarchist, had shot McKinley on September 6 at the Pan-American Exposition in Buffalo, New York. Despite efforts to save him, McKinley died eight days later from gangrene caused by the bullet wounds. The trial was swift, lasting only eight hours over two days, as Czolgosz had already confessed to the crime. His defense team, appointed by the court, argued that Czolgosz was insane, but he refused to cooperate with his lawyers or plead insanity.The prosecution presented overwhelming evidence, including eyewitness testimonies and the fact that Czolgosz shot McKinley at point-blank range in a public setting. The jury deliberated for less than 30 minutes before finding him guilty of first-degree murder. Czolgosz was sentenced to death and was executed by electric chair on October 29, 1901. His trial and execution sparked discussions about the influence of anarchism in the U.S. and led to increased efforts to suppress political radicalism in the early 20th century.From a presidential assassin from history to a would-be modern day presidential assassin, Ryan W. Routh, a 58-year-old suspect accused of attempting to assassinate former U.S. President Donald Trump, is set to appear in court on Monday. Routh allegedly hid near Trump's Florida golf course on September 15, pointing a rifle through the tree line while Trump played golf. Although he did not fire a shot and lacked a direct line of sight to Trump, who was several hundred yards away, Routh was charged with two gun-related crimes: possession of a firearm as a convicted felon and possession of a firearm with an obliterated serial number. Additional charges may follow.A Secret Service agent spotted the weapon and fired in Routh's direction, causing him to flee. He was later arrested on a nearby highway. Prosecutors are expected to argue for his detention, citing public safety concerns. The FBI is investigating the incident as an apparent assassination attempt ahead of the upcoming November presidential election. Authorities have not yet disclosed a motive, though Routh, a convicted felon with a history of supporting Ukraine, previously made statements in a self-published book suggesting that Trump could be a target for assassination. Cellphone data shows Routh may have been in the area for 12 hours before being apprehended.Trump attempted assassination suspect Ryan Routh to appear in court | ReutersAn appeals court panel recently reviewed procedural issues in Stephen Thaler's attempt to copyright an AI-generated image, raising concerns that the court may avoid larger questions about AI and copyright law. Thaler argued that his AI, the "Creativity Machine," autonomously created the work in question, but the U.S. Copyright Office rejected his application, and a lower court dismissed his case. The court found that Thaler had waived the argument that he was the author by continuing to claim the machine was the creator.During the appeal, the judges suggested that Thaler's argument may be barred since his appellate brief did not challenge the lower court's finding that he had waived his authorship claim. Legal experts fear this focus on procedural flaws could prevent the court from addressing significant issues about the role of human creativity in AI-generated works.If the court rules that AI-created works cannot be copyrighted, it could have far-reaching effects, leaving AI-generated content like images and text unprotected and placing them in the public domain. The court's decision may not close the door on AI-assisted works, but it raises questions about where the line is drawn between human and machine-generated creativity. The case highlights ongoing uncertainties about how copyright law will adapt to AI's growing role in creative industries. The key legal issue here is the court's focus on procedural waiver, which may limit the scope of the ruling and leave broader questions about AI and copyright unresolved.AI Art Appeal's Procedural Flaws Put Broader Ruling in DoubtThe U.S. Federal Trade Commission (FTC) has sued the three largest pharmacy benefit managers (PBMs)—UnitedHealth's Optum, CVS Health's Caremark, and Cigna's Express Scripts—accusing them of inflating insulin prices to gain larger rebates from pharmaceutical companies. The FTC claims that these PBMs steered patients towards higher-priced insulin by excluding cheaper alternatives from coverage, harming those with coinsurance or deductibles who couldn't benefit from the rebate. Together, these three companies control 80% of U.S. prescriptions.The PBMs denied the allegations, arguing that their practices have lowered insulin costs for businesses and patients. The case represents a significant step in the Biden administration's push to lower drug prices, particularly insulin, which has seen soaring costs over the past decade. FTC Deputy Director Rahul Rao labeled the PBMs as "medication gatekeepers," accusing them of profiting at the expense of diabetic patients.The lawsuit did not target insulin manufacturers like Eli Lilly, Sanofi, and Novo Nordisk but criticized their role in the system. The drugmakers supported reforms to lower patient costs and highlighted their programs to cap insulin prices at $35. The FTC's suit aims to address broader concerns about the U.S. healthcare system's structure and the rising cost of life-saving medications like insulin.US FTC sues drug 'gatekeepers' over high insulin pricesFTC Sues CVS, Cigna, UnitedHealth Over Rising Insulin Costs (1)Jackson Walker LLP is facing disciplinary action after a federal judge found the Texas law firm breached its ethical duties by failing to disclose a secret relationship between one of its attorneys, Elizabeth Freeman, and former Houston bankruptcy judge David R. Jones. Judge Marvin Isgur issued a scathing letter on Friday, criticizing the firm for concealing the affair, which he said violated professional responsibilities and "defiled the very temple of justice." Isgur recused himself from cases involving the firm following this recommendation.The relationship came to light after Freeman, a former partner at Jackson Walker, continued to see Jones despite telling the firm in 2021 that the relationship had ended. Isgur accused the firm of knowingly withholding this information from clients and the court, calling it an "inconceivable" ethical breach. The U.S. Trustee is now attempting to recover up to $18 million in fees earned by Jackson Walker in cases overseen by Jones while he was dating Freeman.The disciplinary case has been referred to Judge Lee H. Rosenthal, and Jackson Walker faces potential penalties, including disbarment or suspension. The firm denies violating ethical rules and claims Freeman misled them. However, Isgur emphasized that the firm's decision to protect itself at the expense of its clients and professional obligations was "intolerable." A public hearing is expected to follow, giving Jackson Walker a chance to respond to the charges.Jackson Walker ‘Defiled the Very Temple of Justice,' Judge Says This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit www.minimumcomp.com/subscribe
oin us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Novo Nordisk shares phase 2a trial data for obesity treatment The bad — Achilles Therapeutics to discontinue TIL-based therapy The ugly — Express Scripts files lawsuit against FTC
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Senseonics has received FDA clearance for a one-year continuous glucose monitoring system. The company's commercial partner, Ascensia, is in talks with insulin pump manufacturers to create an automated insulin delivery system. Zimmer is pulling its hip implant off the market due to fracture risk, Bausch + Lomb is considering a sale, and Masimo investor claims a proxy war win as CEO Joe Kiani fails to retain a board seat. The wearables market is expected to see significant growth, with adhesives playing a vital role in development. Other noteworthy stories include DermaSensor's skin cancer detection device, a Senate committee holding Steward CEO in contempt, and Medtronic detailing a study of adaptive neurostimulation in Parkinson's disease.Brisk Iced Tea brought back its classic claymation ad campaign featuring Doja Cat to target Gen Z. E.l.f. launched a skincare campaign with "Sinfluencer" Megan Stalter. Pizza Hut put resumes on boxes to help job seekers stand out. Frito-Lay used burner phones in a campaign targeting Gen Z for Flamin' Hot Cheetos. Chipotle planned a digital scavenger hunt to give out $1 million in free quesadillas. Customers' trust in AI is low, impacting purchasing decisions.Cigna is scaling back its Medicare Advantage footprint in 8 states next year, affecting roughly 5,400 members, mostly in Florida. Johnson & Johnson is facing sanctions over a plan to rebate 340B drugs, while Express Scripts is suing the FTC over a report criticizing pharmacy benefit managers. The US is behind other wealthy nations in healthcare despite spending the most, with a Commonwealth Fund analysis ranking the US last in access to care and health outcomes.Cigna is reducing its Medicare Advantage footprint in 8 states, affecting around 5,400 members, mainly in Florida. CarePoint Health may lay off 2,600 employees due to financial struggles. The House committee passed a bill to extend telehealth flexibilities in Medicare for another two years. Steward Health Care auctioned assets, with Christus Health set to purchase a Texas-based medical center for $4.5 million.MilliporeSigma is partnering with an experienced viral vector CDMO to offer solutions for the production of cell and gene therapies. They invite attendees of the Mesa conference in Phoenix to visit their booth or schedule a meeting to learn about their viral vector development and manufacturing capabilities.The Senate has voted to hold Steward CEO in contempt for defying a congressional subpoena. The US healthcare system lags behind other wealthy nations in performance despite spending the most. Oak Street Health pays $60 million to settle allegations of a kickback scheme, and J&J faces sanctions over a plan to rebate 340B drugs.Medtech news from September 19, 2024, includes updates on various companies and developments in the industry. Masimo's proxy fight is coming to an end, with a shareholder vote looming. Axonics wins a patent dispute against Medtronic, while Boston Scientific's proposal to buy Axonics is still under review.A startup from George Church's lab has raised $75 million to develop 'supercell' medicines, claiming it can create off-the-shelf therapies from induced pluripotent stem cells faster and simpler than current methods. Roche's Xofluza has shown promising results in reducing flu transmission in a phase 3 study, marking the first time an antiviral drug has achieved this in a global trial.The text discusses the latest advances in oncology research presented at the ESMO conference, focusing on the challenges faced by the pharmaceutical industry in expanding patient access and improving cancer research outcomes.The text promotes a webinar by QT Group on September 26th focusing on continuous compliance for medical software, specifically addressing how to maintain software quality and compliance with medical standa
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Amazon has partnered with Talkspace to expand its digital health benefits program, which also includes Omada Health. Community Health Systems (CHS) subsidiary is acquiring 10 urgent care centers, following in the footsteps of other for-profit health systems. Steward Health Care auctioned off Glenwood Regional Medical Center for $500,000, but there are concerns about the continued involvement of hospital landlord Medical Properties Trust in operations. The text also includes sponsored content on safeguarding healthcare against ransomware and cybercrime, as well as information on trends in telehealth and strategies for improving provider data accuracy for payers. Healthcare Dive provides news and insights for healthcare leaders and is a publication operated by Industry Dive.Roivant's subsidiary, Dermavant, is being acquired by Organon, giving Organon access to a psoriasis and eczema cream called Vtama. This acquisition will provide Roivant with additional cash to fund its research and development plans. Meanwhile, biotech M&A activity has plateaued, with private company acquisitions continuing while public company acquisitions have slowed down. One biotech, Ratio Therapeutics, backed by Bristol Myers Squibb, is optimistic about the boom in radiopharma and the pharmaceutical industry's shift towards targeted radiation drugs. In other news, Novartis' Kisqali has received expanded FDA approval which could double its market for breast cancer treatment. Additionally, Express Scripts is suing the FTC over a report critical of pharmacy benefit manager business practices. The industry is also exploring new ways to deliver genetic therapies and improve clinical trial execution through systems thinking. Overall, the biopharma industry is experiencing exciting times with various developments and advancements in drug development and healthcare technology.Zimmer has decided to pull its hip implant off the market due to fracture risk, with plans to phase out its use by December. Merit Medical has acquired Cook's lead management business for $210 million, adding devices used in heart rhythm device procedures to its portfolio. Synchron has connected brain-computer interface technology to Amazon Alexa, allowing patients to control various functions without using their hands or voice. Senseonics has received FDA clearance for a one-year continuous glucose monitoring system, and Boston Scientific has closed its acquisition of Silk Road Medical. The wearables market is expected to grow by 13% annually between 2024 and 2030, highlighting the importance of adhesives in wearable device development. AI is increasingly influencing the value chain of medical device companies, and manufacturers are exploring ways to utilize AI throughout the product lifecycle. These developments reflect the ongoing innovation and evolution within the medtech industry.Roivant has sold Dermavant to Organon in a deal worth up to $1.2 billion, allowing Roivant to focus on their autoimmune-focused Immunovant and upcoming trials. Summit Therapeutics' bispecific for non-small cell lung cancer has shown promise against Keytruda but still needs more data. Other news includes the FDA approving Keytruda for pleural mesothelioma, Bernie Sanders claiming generics companies can offer a cheaper alternative to Ozempic, Novartis expanding Kisqali's use in breast cancer, and HRSA threatening sanctions against J&J. In the world of enzyme development, SignalChem Biotech offers tailored services. Additionally, new gene therapies for sickle cell disease are reaching patients, and the race for an obesity pill is heating up among companies like Novo, Roche, and Terns.The FDA is facing challenges with conducting overseas drug manufacturing inspections, with 42% of registered plants overdue for inspections. Indian drugmaker Zydus Lifesciences received a warnin
It's Hump Day! Sam speaks with Sarah Lazare, editor of Workday Magazine and contributing editor at In These Times, to discuss her recent reporting on the UAW fighting to restore a shuttered Stellantis plant in Belvidere, Illinois. Then, they speak with Mark Joseph Stern, senior writer at Slate, to discuss the recent reporting in the New York Times regarding Chief Justice Roberts' influence on the Jan. 6th cases that were in front of the Supreme Court. First, Sam runs through updates on Israel's widespread and indiscriminate attacks across Lebanon, the UN's vote on ending Israeli occupation in Gaza and the West Bank, Fed cuts, polling, the GOP blocking another IVF protection attempt, Mike Johnson's desperate attempt to stop a Trump-backed push for a government shutdown, Express Scripts vs. the FTC, and growing labor action in the US, before watching Sen. Kennedy set quite the example at a hate crimes hearing. Sarah Lazare then joins, diving right into a history of Stellantis' plant in Belvidere, Illinois, from its opening in 1965 and through its peak in the late 2010s – when it employed nearly a third of the town's population – before the Corporation-formerly-known-as-Chrysler decided to idle the plant in 2023, essentially taking away thousands of jobs from the city. Continuing, Lazare then unpacks the plant's role in UAW negotiations with Stellantis in the wake of their overwhelmingly successful stand-up strike against the Big Three automakers (Stellantis, Ford, GM), with the reopening of the Belvedere plant one of many unprecedented wins for the union and emblematic of their emphasis on bringing workers into the manufacturing decisions that shape their lives. After briefly expanding on the details of the UAW's major wins from the stand-up strike, as well as some concessions, Sarah walks Sam through the devastating impact the idling of this plant has had on Belvidere, the incredible effort by other locals and the broader UAW to use their labor to demand the return of this plant, and the likelihood of the fight expanding into a broader strike, before wrapping up with a conversation on the ripple effect of labor rights and the importance of solidarity in building a better life for us all. Mark Joseph Stern and Sam then jump right into two major stories coming out of the recent SCOTUS leak, with Stern first outlining the revelations of Chief Justice John Roberts' complete MAGA-pilling over the last few years, including taking a commanding role on three major Supreme Court cases regarding Donald Trump, spearheading the entirety of the immunity decision and icing out the liberal judges, taking Alito off of the January 6th decision, and pushing for a landmark ruling on Trump's ballot access case. After expanding on the… “jurisprudence” behind Roberts' shift, Sam and Mark parse through the mystery of the leak, and what it tells us about the state of the Court. And in the Fun Half: Sam watches Mitch McConnell preemptively shirk blame for the GOP's upcoming government shutdown attempt, and Bret Weinstein and Heather Heying's brains expand beyond safe levels in real-time. He also dives deep into swing state and legislative poll numbers with John from San Antonio, unpacks the (im)moralities of social security with Dan Norton, and admires Henry Winkler's unabashed dissection of the absurdities of Bill Maher's Zionism. Dan Norton's biggest fan also calls in to explore the recent proliferation of anti-Haitian conspiracy and the United States' relationship to catholicism, plus, your calls and IMs! Follow Sarah on Twitter here: https://x.com/sarahlazare Check out Sarah's piece on the UAW here: https://inthesetimes.com/article/uaw-strike-stellantis-plant-fight Check out Workday Magazine here: https://workdaymagazine.org Follow Mark on Twitter here: https://x.com/mjs_DC Check out Mark's work at Slate here: https://slate.com/author/mark-joseph-stern TICKETS FOR MAJORITY REPORT ELECTION NIGHT LIVE SHOW HERE!: https://www.eventbrite.com/e/the-majority-report-with-sam-seder-election-night-coverage-live-show-tickets-1010883639177 Call your Senators at 202-224-3121 and urge them to tell Sen. Schumer NOT to bring Sen. bill 4127 to the floor! Go to https://www.whitehouse.gov/contact/ and, in the space to contact the Vice President, voice support for FTC Chair Lina Khan and for Palestine! 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For a limited time, Nutrafol is offering our listeners ten dollars off your first month's subscription and free shipping when you go to https://Nutrafol.com/men and enter the promo code TMR. Find out why over 4,500 healthcare professionals and stylists recommend Nutrafol for healthier hair. https://Nutrafol.com/men promo code TMR. Follow the Majority Report crew on Twitter: @SamSeder @EmmaVigeland @MattLech @BradKAlsop Check out Matt's show, Left Reckoning, on Youtube, and subscribe on Patreon! https://www.patreon.com/leftreckoning Check out Matt Binder's YouTube channel: https://www.youtube.com/mattbinder Subscribe to Brandon's show The Discourse on Patreon! https://www.patreon.com/ExpandTheDiscourse Check out Ava Raiza's music here! https://avaraiza.bandcamp.com/ The Majority Report with Sam Seder - https://majorityreportradio.com/
This Day in Legal History: Treaty of Fort PittOn September 17, 1778, the newly independent United States and the Lenape (Delaware) Nation signed the Treaty of Fort Pitt, marking the first formal treaty between the U.S. and a Native American tribe. The treaty established a military alliance during the American Revolutionary War, with the Lenape agreeing to assist the U.S. in its fight against the British. In return, the U.S. promised protection and the possibility of creating a 14th state for Native Americans in the future.Despite its significance as a symbol of diplomacy, the treaty was quickly undermined. U.S. forces often ignored the agreement, and American expansion continued to threaten Lenape lands. The promise of a Native American state was never realized, and tensions between the two sides worsened. This violation of the treaty set a precedent for many future treaties between the U.S. government and Native American tribes, where promises were made but rarely honored. The Treaty of Fort Pitt highlights the complex and often troubled relationship between Native nations and the U.S. government during the early years of American independence.The Biden administration is launching a new initiative to combat the smuggling of hydrofluorocarbons (HFCs), potent greenhouse gases used in refrigeration, across U.S. borders. The Environmental Protection Agency (EPA), Customs and Border Protection (CBP), and other agencies are collaborating, using new tools like artificial intelligence to identify suspicious shipments. HFC smuggling has surged as the U.S. phases out these chemicals under the 2019 American Innovation and Manufacturing (AIM) Act, which mandates an 85% reduction by 2036. Since fiscal year 2024 began, about 25 illegal shipments have been stopped, but the scale of smuggling remains large.Smugglers use various methods, such as relabeling containers and falsifying import documents, to sneak HFCs into the country. The black market for these refrigerants mirrors the illicit trade of chlorofluorocarbons (CFCs) in the 1990s after their global ban. Enforcement efforts include developing human intelligence sources, new AI technologies, and enhanced collaboration between government agencies. However, enforcement challenges persist, as it's difficult to catch every shipment and distinguish legal from illegal HFCs once they enter the market.Biden Fights Smugglers Trafficking Climate-Warming RefrigerantsCigna Group's Express Scripts is suing the Federal Trade Commission (FTC) over a July report that it claims unfairly portrays pharmacy benefit managers (PBMs). In its lawsuit, filed in Missouri, Express Scripts calls the report “unfair, biased, erroneous, and defamatory” and demands the agency retract it. This legal action intensifies the ongoing conflict between PBMs and the FTC, which has been investigating the industry for over two years.The FTC's report accuses PBMs of steering patients to their own pharmacies and charging higher rates. Express Scripts, along with other PBM giants like CVS Health and UnitedHealth Group, disputes these claims, arguing that PBMs help control drug prices and counteract pharmaceutical companies' power. Cigna's lawsuit also accuses the FTC of ignoring data it submitted, favoring instead what it calls “unsupported innuendo.” The FTC has rejected these accusations and stands by its report, stating that it aims to clarify the complexities of the PBM market. The case is now before the U.S. District Court in Missouri.Cigna Sues Federal Trade Commission Over ‘Defamatory' ReportThe U.S. antitrust trial over Kroger's $25 billion bid to acquire rival grocer Albertsons is wrapping up, but the legal battles are far from over. Following the Portland trial, where the Federal Trade Commission (FTC) and several states argued that the merger would harm shoppers and unionized grocery workers, two more trials are set to challenge the deal. Washington state's attorney general began a separate trial on Monday, arguing that the merger would raise prices, reduce competition, and allow Kroger to close unionized stores. Later this month, Colorado will bring its own case, focusing on the impact on local farmers and consumers.Kroger and Albertsons, which have already spent $864 million on merger-related costs this year, argue that the deal would lower prices and allow them to compete better with retail giants like Walmart and Amazon. Despite their assurances that no stores will close due to the merger, critics warn that closures could occur in the future. The ongoing legal challenges could prolong the merger process and add significant costs for the companies.Kroger-Albertson's US anti-trust trial to end but other legal blocks loom | ReutersIn my column for Bloomberg this week, I explore how land value taxes (LVTs) can address the inequities in the current property tax systems across the U.S.Property taxes, especially in economically disadvantaged areas, have been scrutinized for burdening low-income homeowners. A land value tax, which taxes only the land's value and not any structures or improvements, could provide a fairer alternative. LVTs can stabilize tax burdens, promote development, and reduce land speculation. This tax system would also allow for income-adjusted progressivity, helping municipalities create more consistent revenue streams while avoiding the boom-and-bust cycles tied to real estate.In contrast, traditional property taxes—which tax both land and buildings—can disincentivize property improvements, make it cheaper to hold vacant land, and unfairly burden residents in areas with declining commercial property values. This is especially evident in places like Chicago's south suburbs, where declining commercial revenue is pushing low- and middle-income homeowners to the brink. Similar stories are unfolding in towns like Harvey, Illinois, and Wake County, North Carolina, where property taxes have surged beyond many residents' ability to pay.Shifting to an LVT would alleviate these problems by taxing land rather than improvements, encouraging landowners to develop or sell underused land, and ensuring more financial stability for homeowners. The switch could be an important step in revitalizing economically depressed areas, promoting development, and creating a more equitable tax system.Land Value Taxes Can Resolve Property Tax Systems' Inequities This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit www.minimumcomp.com/subscribe
Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.CDRH Director Jeff Shuren is set to step down after 15 years, with Michelle Tarver serving as acting director of the FDA's medical devices unit. Boston Scientific predicts strong growth for Farapulse following a successful launch. The top 5 medtech deals in the first half of 2024 include Johnson & Johnson's $13.1 billion takeover of Shockwave Medical. ICU Medical is closing a Minnesota facility and cutting 83 jobs, while Cook Medical plans to sell its reproductive health business to a private equity firm. Medline is exploring an IPO in 2025, Magenta securing $105 million for trials of the world's smallest heart pump, and robotic aid improving balance and gait in children with cerebral palsy.Transitioning to healthcare news, HCA reported $17.5 billion in revenue in the second quarter and raised its full-year guidance. Humana's Centerwell plans to open 23 primary care clinics at Walmart stores. Maternal health quality varies by state, with states with more restrictive abortion bans having fewer maternal health providers and higher maternal death rates. Pharmacy benefit managers, including CVS Caremark, Optum Rx, and Express Scripts, faced scrutiny from Congress over drug pricing policies. AI is being used to transform unstructured patient data into structured reports in healthcare systems.Moving on to updates in pharmaceuticals, Pfizer's hemophilia gene therapy met its late-stage study goal, but questions remain about the long-term potential of hemophilia treatments. Biogen's tremor drug, Sage-324, failed a key trial, and the FDA's medical device chief, Shuren, is stepping down after 15 years. Novartis is investing in bispecifics for cancer, while Autobahn raised $100 million for neuropsych drugs. Bob Langer steps down from Moderna's board, and PBMs are facing bipartisan scrutiny over drug pricing policies.In the biopharma sector, Biogen and Sage Therapeutics have discontinued a phase II trial for an investigational neuroactive steroid for essential tremor after it failed to significantly improve upper limb tremors. Pfizer's gene therapy for hemophilia A has shown positive results in a phase III trial. The FDA has raised concerns about potential overtreatment with AstraZeneca's Imfinzi for resectable non-small cell lung cancer. There is speculation about whether Merck should buy out Moderna to strengthen their partnership on Keytruda-cancer vaccine.Lastly, in marketing news, Google's ad revenue remains strong despite transitions in technology, with AI implementations and cookie changes. Albertsons' retail media business is incorporating AI and in-store technology to improve operations. Coca-Cola and Delta are 'olympicizing' their campaigns with NBCUniversal, as advertisers spend over $1.2 billion for the Olympics. Google has become the official search AI partner of Team USA, leveraging its products for NBCUniversal's Olympics coverage.The marketing landscape is evolving with a focus on technology, data-driven strategies, and partnerships between brands and media companies like NBCUniversal and Google.
Oral Arguments for the Court of Appeals for the First Circuit
Government of Puerto Rico v. Express Scripts, Inc.
This Day in Legal History: Eight States Ratify Articles of ConfederationOn July 9, 1778, eight American states—New Hampshire, Massachusetts Bay, Rhode Island, Connecticut, New York, Pennsylvania, Virginia, and South Carolina—ratified the Articles of Confederation, marking a significant milestone in the establishment of the United States' first constitution. The Articles of Confederation served as the foundational legal framework for the fledgling nation during the Revolutionary War. This initial ratification by eight states paved the way for the Articles to take full effect once Maryland, the last holdout, signed on March 1, 1781.The Articles of Confederation aimed to unify the thirteen original states under a national government with limited powers, primarily to manage war efforts, conduct foreign diplomacy, and handle territorial disputes. However, the Articles granted most powers to the individual states, reflecting the colonists' fear of a strong central authority reminiscent of British rule.Despite its significance, the Articles of Confederation had several weaknesses, such as the lack of a strong central government, no executive branch, and the inability to levy taxes or regulate commerce effectively. These limitations eventually led to the drafting of the current U.S. Constitution in 1787, which created a more robust federal structure and addressed the shortcomings of the Articles.The ratification of the Articles of Confederation on July 9, 1778, remains a critical event in American legal history, symbolizing the early efforts to create a unified nation and laying the groundwork for the Constitution that governs the United States today.Federal judge Joshua Kindred, who recently resigned, engaged in a sexual relationship with a former law clerk and misled an investigating judicial panel about it, according to a Ninth Circuit judicial council report. Kindred, a Trump appointee, was found to have sexually harassed clerks and created a hostile work environment. The council's report describes his behavior as abusive, pervasive, and unprofessional, noting that his interactions with clerks were inappropriate and oppressive.Kindred submitted his resignation without explanation on July 5. The Judicial Council of the Ninth Circuit publicly reprimanded him and urged his resignation. The council also referred the matter to the Judicial Conference of the United States for potential impeachment.The report highlighted an "unusually close relationship" between Kindred and a former clerk, involving inappropriate physical contact and over 278 pages of personal text messages. Kindred's actions included discussing vulgar topics in the workplace and belittling clerks who raised concerns. The council expressed doubts about his ability to conduct himself appropriately in the future.Kindred initially denied the allegations but later admitted to crossing professional boundaries, attributing his behavior to personal turmoil, including a divorce. The investigation also found he was drinking excessively, sometimes in his chambers.This case comes amid broader scrutiny of judicial misconduct, particularly concerning judges' treatment of clerks. The judiciary has implemented new measures, such as the Office of Judicial Integrity, to address these issues. Jaime Santos, an advocate for judicial reforms, emphasized the importance of transparency and accountability in such cases to encourage clerks to report misconduct. Jeremy Fogel, a retired federal judge, noted the thoroughness and unanimity of the council's order against Kindred, highlighting the serious concern over his lack of honesty during the investigation.US Judge Resigned After ‘Sexualized Relationship' With Clerk (2)The Federal Trade Commission (FTC) released a report highlighting that concentration and vertical integration among the top pharmacy benefit managers (PBMs) are driving up drug costs and financially straining independent pharmacies. The report stems from a study launched in June 2022, investigating the practices of the six largest PBMs. FTC Chair Lina Khan emphasized that these PBMs, which manage 94% of prescription drug claims, significantly influence drug access and pricing.The report noted that the top three PBMs—CVS Caremark, Cigna's Express Scripts, and UnitedHealth Group's OptumRx—control nearly 80% of the market. Their integration with health insurers and pharmacies allows them to exercise considerable power over drug prices and availability. The FTC found that pharmacies affiliated with these PBMs received reimbursement rates for certain cancer drugs that were 20 to 40 times higher than the national average drug acquisition cost, leading to an additional $1.6 billion in revenue over three years.These high reimbursement rates contribute to increased out-of-pocket costs for patients, including those on Medicare Part D. The FTC also pointed out that PBMs may engage in anticompetitive practices by negotiating rebates with drug manufacturers to exclude cheaper competitor drugs from their formularies.The FTC's study faced challenges due to some companies' failure to provide required data and documents. The agency is prepared to take legal action against non-compliant companies. Despite the findings, PBMs argue that they help reduce prescription drug costs and blame high manufacturer list prices and patents for the rising costs.The FTC voted 4-1 to issue the interim report, with one Republican commissioner opposing it. The Pharmaceutical Care Management Association, the leading PBM trade group, remains confident that the FTC's examination will ultimately show that PBMs reduce drug costs for patients and employers.FTC Blames Pharmacy Benefit Managers for Inflating Drug CostsLegal experts believe Donald Trump faces slim chances of overturning his conviction on charges related to hush money paid to a porn star, despite a recent U.S. Supreme Court ruling that broadly recognizes presidential immunity from prosecution. Trump's lawyers have argued for setting aside the May 30 guilty verdict, citing the Supreme Court's decision that former presidents cannot be criminally prosecuted for official acts under their "core constitutional powers."However, experts point out that much of Trump's conduct in question occurred before his presidency and involved personal matters, not official acts. Cheryl Bader, a law professor at Fordham University, noted that falsifying business records to pay off a porn star does not fall within presidential duties. Trump was convicted of 34 counts of falsifying business records to conceal reimbursement to his former lawyer, Michael Cohen, for paying $130,000 to Stormy Daniels before the 2016 election. Trump has denied the encounter and claims the case is politically motivated.Prosecutors argue the payment was part of a scheme to influence the election by avoiding a sex scandal. Trump's legal team contends that evidence related to his presidency, such as social media posts and an ethics form, should not be considered official acts. Legal experts like Steven Cohen from New York Law School believe these activities are unofficial and unlikely to lead to a reversal.While Trump's lawyers declined to comment, a spokesperson for the Manhattan District Attorney's office did not respond. There are precedents for overturning convictions following new Supreme Court decisions, but Cardozo Law School professor Gary Galperin notes that even if some evidence should not have been presented, the judge may still uphold the conviction if it did not deprive Trump of a fair trial, known as a "harmless error."Trump's defense is expected to fully present their arguments in a court filing by Wednesday, with prosecutors responding by July 24. Judge Juan Merchan will decide by September 6, and if the conviction stands, Trump will be sentenced on September 18. Trump hush money conviction reversal is unlikely, experts say | ReutersTaxing carbon emissions from livestock in the US could significantly reduce greenhouse gas emissions, as cattle contribute 10% of the nation's agricultural emissions. Implementing a livestock tax would not only promote sustainable agricultural practices but also generate revenue for reforestation and responsible land use. This measure could provide a more comprehensive approach to addressing greenhouse gases compared to the gradual phase-out required for the fossil fuel industry.Currently, the US government spends about $30 billion annually on agricultural subsidies, a practice that effectively supports both carbonization and decarbonization of the economy. Agriculture's contribution to greenhouse gases, especially from methane emitted by cattle, is substantial yet often overlooked. Methane has a higher global warming potential than carbon dioxide, accounting for around 30% of the observed global temperature rise since the 18th century.Denmark's successful implementation of a livestock carbon tax demonstrates the feasibility of such policies. Starting in 2030, Denmark will tax livestock emissions, with rates increasing by 2035. This policy includes subsidies for carbon capture and reforestation, balancing environmental goals with farming realities. However, Denmark's policy focuses mainly on carbon dioxide, missing the full impact of methane emissions.The US could enhance this model by including both carbon dioxide and methane emissions in a per-head livestock tax. This would more accurately reflect the environmental cost of raising livestock, though it would likely increase meat and dairy prices. To make this tax more politically acceptable, the US could adopt a system similar to Austria's Klimabonus, which compensates residents for the costs imposed by a general carbon tax.In summary, a well-calibrated livestock tax in the US, incorporating the cost of both carbon dioxide and methane emissions, could drive sustainable agricultural practices, balance environmental and economic interests, and potentially gain public support through consumer compensation mechanisms. Taxing Cows a Pragmatic Step Toward Mitigating Climate Change This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit www.minimumcomp.com/subscribe
From humble beginnings to the heights of the pharmaceutical industry, Amy Bricker, former president of Express Scripts, sits down with Bonnie to recount her extraordinary career path. Amy takes us on a tour of her formative years, where the dream of becoming a community pharmacist in her small town set the stage for an incredible journey. It's a story that unfolds across the pillars of persistence, vision, and a heartfelt drive to transform healthcare, proving that one's origin is no boundary to professional triumph. Navigating the complexities of the healthcare system requires more than just knowledge; it requires passion and a desire to bring about real change. Amy delves into the intricate world of pharmacy benefit managers and how her role at Express Scripts played a pivotal part in managing medication costs for an array of clients from various sectors. Amy also delves into how creating and sustaining a high-performance culture in business isn't for the faint-hearted, especially in the face of mergers and acquisitions. Amy reflects on the challenges she faced while steering Express Scripts through such transformative times and shares valuable insights on the power of a positive environment and the intricacies of balancing professional success with personal growth and self-discovery. Key points throughout points include: Unlocking potential: Embracing the call to make a greater impact Express Scripts: The role of pharmacy benefit managers in healthcare and communities Leading Express Scripts through mergers, acquisitions and a global pandemic The importance of deliberate leadership and consistent actions How to overcome the challenges of blending cultures Embracing Change: Recognizing the seasons of opportunity Navigating a legal battle and new paths to fulfilment The importance of staying true to yourself and recognizing the call for change "It's less to me about putting slogans on walls or coming up with a mission statement that we'll all recite, but how do you do business inside that organization?" – Amy Bricker. Real Life Real Leaders is dedicated to exploring the real stories behind some of the world's most outstanding inspirational leaders. Each new episode teaches the highs and lows of building a successful business and uncovers the attributes that make a great leader. Get connected socially with Amy Bricker: https://www.linkedin.com/in/amy-bricker/ Get connected socially with host Bonnie Hagemann: https://www.linkedin.com/in/bhagemann/ https://edainc.io/ https://mobile.twitter.com/bonnie_hagemann https://www.linkedin.com/showcase/real-life-real-leaders-podcast/ This podcast is proudly produced in partnership with podlad.com
Loretta Boesing's son, a transplant survivor reliant on medication every 12 hours, faced a scary situation with a mail-order pharmacy, an experience that could have been fatal. Determined not to be defeated, Loretta mobilized dozens of protestors outside Express Scripts and planned to confront other PBMs that mandate mail-order systems. This week, Anthony discussed with Loretta the critical role of independent pharmacies in her son's health, her organization, Unite for Safe Medication, aims to support these pharmacies and learn how you can contribute to her cause.
Join the PBMOTR cocktail crew as they pick apart CPESN's Express Scripts partnership announcement, shed light on how states like New York, Florida, and Louisiana are getting real work done, and why PUTT's voice is so important in the fight - because when it comes to combatting PBM mafia tactics, enforcing reimbursement reform is the only way ALL pharmacies will be able to stay in business.Special Guests: Danny Dang, incoming President, Pharmacists Society of the State of New York (PSSNY), & Andrew Russell, MN Independent PharmacistOpening music by JuliusHEpisode Cocktail Menu:the JubileeGentleman Jack on iceSingtop beerthe Algorithmic Price FixerSpicy Palomathe Cross-Eyed ChillerTom CollinsFind all the PBM on the Rocks cocktails at TruthRx.org/pbm-on-the-rocksProduction & Editing by Shannon Wightman-Girard
Hosts Gregg Masters and Fred Goldstein welcome Express Scripts President Adam Kautzner to discuss “Embracing Innovation to Improve Healthcare Predictability.” Innovation in healthcare means addressing challenges that others can't or simply won't. No one knows this better than Adam who is reshaping the role PBMs play to keep costs low for patients and payers and improve patient outcomes. 2024 is expected to be another transformative but challenging year in healthcare— the continued expansion of GLP-1s is fueling affordability concerns and a lack of predictability for employers and health plans; meanwhile patients are demanding transparency, and physician shortages are reshaping the critical role pharmacists play in their communities. To stream our Station live 24/7 visit www.HealthcareNOWRadio.com or ask your Smart Device to “….Play Healthcare NOW Radio”. Find all of our network podcasts on your favorite podcast platforms and be sure to subscribe and like us. Learn more at www.healthcarenowradio.com/listen
On today's episode of The Executive Appeal Podcast join Alex D. Tremble (CEO of GPS Leadership Solutions & #KeynoteSpeaker) and Trish Vassar (VP of Global Learning and Development at Coca-Cola), as they explore the secrets to building exceptional organizational cultures. Discover actionable strategies for executive leaders to cultivate environments that foster innovation, engagement, and success. Guest Bio:Trish Vassar currently serves as the VP of Global Learning and Development at Coca-Cola where she leads an amazing global team to support the Coca Cola workforce and mission. Prior to this role she served as the Chief Learning Officer at Cigna, Vice President, Organizational and Leadership Development at Express Scripts, and the Global Lead / Senior Director, Leadership and Talent Development at Monsanto Company.
Adam Kautzner, President of Express Scripts, highlights the role pharmacy benefit management companies play in negotiating prices with drug companies and pharmacies. They also perform health safety checks to ensure patients get the correct medications and updates, and those with multi-morbidities are checked for possible drug interactions. Overcoming the supply chain challenges during the pandemic, Express Scripts continues to develop more effective solutions to lower the cost of drugs and improve access. Adam explains, "Unfortunately, prescription drugs are becoming even more expensive. So our role in that space is to work for employers, or potentially for health plans, that hire us to help improve, for patients, medication affordability, to improve patient outcomes, and ensure that for patients there is predictability at the pharmacy counter to navigate their pharmacy benefit." "We're able to do that because, as the most utilized benefit, we have a bird's eye view of all the different patients' needs that they may have. We're able to look over, if you're going to multiple doctors, getting prescribed multiple drugs from multiple doctors. We can actually perform safety checks across all of that to ensure that when you're refilling a prescription or getting a new prescription everything is safe, and there aren't going to be drug interactions. We're able to ensure that you have predictability and affordability for your pharmacy benefits." "So yes, comorbidities continue to become a broader and broader issue. I would say there are also more drugs now to treat many of those comorbidities, and some products can even treat multiple types of conditions where they've been approved for things like cardiovascular and diabetes. Those drugs that treat multiple conditions can also be helpful as well because you can actually eliminate some drugs and minimize the number of different products that you have to take." #ExpressScripts #Evernorth #PharmacyBenefitManagement #PBM #DrugCosts evernorth.com ExpressScripts.com The facts about home delivery Download the transcript here
Adam Kautzner, President of Express Scripts, highlights the role pharmacy benefit management companies play in negotiating prices with drug companies and pharmacies. They also perform health safety checks to ensure patients get the correct medications and updates, and those with multi-morbidities are checked for possible drug interactions. Overcoming the supply chain challenges during the pandemic, Express Scripts continues to develop more effective solutions to lower the cost of drugs and improve access. Adam explains, "Unfortunately, prescription drugs are becoming even more expensive. So our role in that space is to work for employers, or potentially for health plans, that hire us to help improve, for patients, medication affordability, to improve patient outcomes, and ensure that for patients there is predictability at the pharmacy counter to navigate their pharmacy benefit." "We're able to do that because, as the most utilized benefit, we have a bird's eye view of all the different patients' needs that they may have. We're able to look over, if you're going to multiple doctors, getting prescribed multiple drugs from multiple doctors. We can actually perform safety checks across all of that to ensure that when you're refilling a prescription or getting a new prescription everything is safe, and there aren't going to be drug interactions. We're able to ensure that you have predictability and affordability for your pharmacy benefits." "So yes, comorbidities continue to become a broader and broader issue. I would say there are also more drugs now to treat many of those comorbidities, and some products can even treat multiple types of conditions where they've been approved for things like cardiovascular and diabetes. Those drugs that treat multiple conditions can also be helpful as well because you can actually eliminate some drugs and minimize the number of different products that you have to take." #ExpressScripts #Evernorth #PharmacyBenefitManagement #PBM #DrugCosts evernorth.com ExpressScripts.com The facts about home delivery Listen to the podcast here
In this episode of the ShiftShapers podcast, we explore the complex world of Pharmacy Benefit Managers (PBMs) and their impact on healthcare costs, sparked by the Johnson & Johnson lawsuit. Our guest, USRxCare President Renzo Luzzatti, with a 30-year healthcare background, discusses the Consolidated Appropriations Act of 2021, which is aimed at shifting power back to payers from vendors by enhancing transparency and fiduciary responsibilities. The episode sheds light on the lawsuit against J&J for excessive pharmaceutical payments through their PBM, Express Scripts, highlighting the issue of overpayment in the industry. Luzzatti emphasizes the necessity of fiduciary PBMs, devoid of conflicts of interest, and the importance of transparency and beneficiary interests. We also discuss how employers can strategically manage their pharmacy benefits to avoid overpayment and ensure compliance with fiduciary duties, emphasizing the role of advisers in navigating this complex territory. The conversation also touches on current trends and future outlooks for managing pharmacy benefits more effectively and ethically. Each of these insights are critical to business owners and other organizational leaders who must manage healthcare benefits to be cost-effective while providing for employee health needs. USRxCare: https://usrxcare.com/
This Day in Legal History: UK's House of Lords Becomes Elected BodyOn March 7, 2007, a pivotal moment in British legal and political history unfolded as the House of Commons, Britain's lower house of Parliament, voted in favor of transforming the House of Lords into an elected body. This significant decision marked the beginning of the end for the centuries-old tradition of appointments based on noble birth, a system that had shaped the composition of the United Kingdom's upper chamber of Parliament. For hundreds of years, the House of Lords had been composed largely of hereditary peers, bishops, and appointed life peers, a reflection of a hierarchical society rooted in aristocracy and privilege.The vote by the House of Commons was not just a legislative act; it was a profound statement about the evolution of democratic principles and the push for greater accountability and representation in the UK's legislative process. The move towards an elected House of Lords aimed to enhance the democratic legitimacy of the Parliament by ensuring that members of the upper house were chosen by the public or their representatives, rather than by accident of birth or political appointment.This historic vote was the culmination of years of debate and reform efforts aimed at modernizing the United Kingdom's parliamentary system. Previous attempts to reform the House of Lords, including the significant House of Lords Act of 1999, which removed the automatic right of hereditary peers to sit in the House, laid the groundwork for this dramatic shift. The 2007 vote was a clear indication of the changing attitudes towards governance and representation, emphasizing the importance of aligning the UK's legislative bodies with contemporary democratic standards.The decision to make the House of Lords an elected body faced both applause and criticism. Proponents argued that it would lead to a more democratic and transparent legislative process, while detractors raised concerns about the potential implications for the balance of power and the traditional roles of the Houses of Parliament. Regardless of the varied opinions, the vote on March 7, 2007, remains a landmark in the journey towards reforming one of the oldest parliamentary institutions in the world, reflecting the ongoing evolution of democracy and governance in the United Kingdom.The Dartmouth College men's basketball team's decision to unionize, with a 13-2 vote in favor of being represented by the Service Employees International Union on March 5, could potentially initiate a wave of unionization across Ivy League schools. This move comes after a protracted legal battle culminating in a National Labor Relations Board official's February 5 decision, recognizing the athletes as employees under the National Labor Relations Act, despite Dartmouth College's ongoing appeal. This decision represents a significant challenge to the NCAA, which has been entrenched in legal disputes regarding athletes' labor and employment rights. Dartmouth's case, while seemingly atypical due to the school's lower-profile athletic program and lack of scholarships or deals for name, image, and likeness (NIL) for its players, reflects a broader discontent with current NCAA policies. Economic and legal experts suggest that the lack of NIL deals makes unionization more appealing for athletes at Ivy League schools, where players often balance academics, sports, and part-time jobs without athletic scholarships.The resurgence of union activity at Dartmouth, highlighted by undergraduate dining hall workers' successful organization with SEIU Local 560, demonstrates a wider trend of labor organizing in higher education. The legal struggle for the Dartmouth basketball team is far from over, indicating that future unionization efforts at other institutions may encounter similar challenges. Dartmouth College's steadfast position that its athletes are not employees, juxtaposed with the NLRB's contrasting view, underscores the ongoing debate over the classification and compensation of college athletes. This case, and the broader movement it may inspire, challenges longstanding norms regarding athlete compensation and labor rights in college sports, signaling a potentially transformative period in the relationship between student-athletes and collegiate athletic programs.Dartmouth Players' Vote Poised to Spark Ivy League Union WaveCigna Group has entered into agreements with Eli Lilly & Co. and Novo Nordisk A/S to enhance coverage for obesity medications, specifically aiming to mitigate the financial burden on employer-sponsored health plans for drugs like Wegovy and Zepbound. These deals, orchestrated through Cigna's Express Scripts pharmacy benefits manager, introduce a novel financial guarantee, capping annual spending increases for these medications at 15%. This initiative is designed to broaden access to these in-demand treatments by offering companies a safeguard against the soaring costs associated with GLP-1 treatments. Adam Kautzner, president of Cigna's Express Scripts, highlighted the unprecedented demand for weight-loss medications and the financial strain they impose on employers, with some witnessing annual spending surges of 40% to 50%.Express Scripts, serving 120 million individuals under various health plans, is now offering EncircleRx, a program that besides the drug coverage, includes patient support aimed at fostering lifestyle changes essential for the drugs' effectiveness. This program represents a strategic response to the challenges of covering high-cost obesity treatments, providing a structured framework for managing these expenses. Despite the reluctance of Lilly and Novo to discuss the specifics of their agreements with Cigna, these partnerships signal a significant shift towards addressing the affordability and accessibility of obesity treatments. The deals reflect a broader industry challenge in balancing drug costs with patient access, amidst calls from insurers for drug manufacturers to lower prices. Cigna's move to revise its long-term earnings growth forecast upwards underscores the financial implications and potential benefits of these strategic agreements in managing the costs of high-demand medications.Cigna Strikes Deals With Lilly, Novo for More Obesity CoverageThe Republican-led House Oversight Committee has formally requested Hunter Biden, son of U.S. President Joe Biden, to testify in an open hearing on March 20 as part of their ongoing impeachment investigation into the president. This inquiry has scrutinized Hunter Biden's business dealings in Ukraine and China during the time his father was vice president from 2009 to 2017, although no evidence implicating Joe Biden in any wrongdoing has been found. Alongside Hunter Biden, the committee also extended invitations to three of his former business associates to appear for testimony. Despite previous indications from Hunter Biden that he would only testify publicly, he participated in a closed-door deposition with the committee last month after facing potential contempt charges. During this contentious deposition, Hunter Biden emphasized that his father had no involvement in or benefit from his business activities. Hunter Biden's legal team has acknowledged receipt of the committee's latest request and plans to respond in writing.US House Republicans ask Hunter Biden to testify in open March 20 hearing | ReutersFTX and BlockFi, both of which declared bankruptcy in 2022, have reached a settlement agreement where FTX will pay BlockFi up to $874 million. This settlement follows lawsuits between the two companies over financial dealings and loans made to each other before their respective financial collapses. A significant part of the settlement, $250 million, is to be prioritized for BlockFi, with the balance contingent on FTX's ability to repay its own customers and creditors. The relationship between the two firms became complicated after a market crash in 2022 exposed FTX's misuse of customer funds, leading to BlockFi turning to FTX for rescue financing. Furthermore, FTX has committed to an additional payment of $185.3 million to BlockFi to cover funds held in FTX trading accounts at the time of the collapse. Despite the agreement, full repayment to FTX customers remains uncertain, and BlockFi has indicated that it is unlikely to fully repay its interest-bearing account holders, projecting that they might only recover between 39.4% and 100% of their account values. The deal also includes BlockFi's decision to withdraw its lawsuit concerning 56 million Robinhood shares previously pledged as collateral, which were seized by the U.S. Department of Justice following FTX founder Sam Bankman-Fried's arrest and subsequent conviction for embezzling $8 billion from FTX customers.FTX reaches settlement with BlockFi, may pay up to $874 million | Reuters Get full access to Minimum Competence - Daily Legal News Podcast at www.minimumcomp.com/subscribe
Our focus for the month of February is on fertility. We'll have more content later this month about the enhanced infertility coverage under the Foreign Service Benefit Plan for 2024. Today, though, we are talking about coverage for contraception. All of the information in the podcast comes from Sections 5a, 5b, and 5f and Section 7 of the 2024 FSBP Brochure available at https://www.afspa.org/wp-content/uploads/2024/01/2024_FSBP_Brochure_-RI-72-001_Final_1.8.2024.pdf. To initiate the contraceptive exception process, members can call Express Scripts at 800-841-2734.
Recorded on 02/06/24 In this episode, we take a look at the changing landscape for pharmacy reimbursement and the push towards a cost-plus model of reimbursement. Over the last few decades, growth in pharmaceutical utilization and an increasing mix of specialty drugs has helped drive strong performance for many participants in the pharmaceutical supply chain. As the largest channel for prescriptions, retail pharmacies have been an important part of helping drive growth in the industry. However, pharmacies, having faced years of margin pressure, have not seen the same degree of benefit as others in the supply chain. For many years, pharmacies have dealt with lack of transparency in how drugs are priced, as well as uncertainty about whether reimbursement will adequately cover the cost of drugs and time associated with patient care. For more than a decade, with increasing levels of generic substitution, retail pharmacies have been able to manage their margins by cross subsidizing potential losses they would see on brand drugs with the profits they would gain on generics. But, with generics now making up more than 90% of prescriptions, the benefit from generic conversions and the ability to cross-subsidize has been maxed out and the pharmacy reimbursement model is clearly in need of change. To help us discuss this topic, we're joined by Michael Rothrock, who brings more than 20 years of experience within Managed Care as well as the PBM industry. Before starting Allegheny Strategic Partners, Mr. Rothrock was the VP of Pharma Strategy and Contracting at Express Scripts, where he was responsible for leading Commercial and Medicare formulary contracting and strategy. For Disclosures, click here bit.ly/3cPHkNW
Here's what to expect on the podcast:In the face of business trials, what strategies do women employ to continue pushing forward and making progress?What are effective strategies for addressing and combating female bullying in professional environments?What self-care practices can women adopt to maintain well-being in the face of workplace challenges?How do women build resilience and confidence in the aftermath of a mistake, and what role does self-reflection play in this process?And much more! About Susan:Susan Lang is the CEO and founder of Visory Health, a women-led, patient-first health tech prescription platform that is transforming the way families access affordable healthcare through its online prescription discount card. She is also the CEO and founder of XIL Health, a strategic technology and analytics company in the drug economics space.Lang has spent more than 30 years in healthcare, where she has worked as a C-Suite executive at companies such as Express Scripts and Blink Health, working to bring innovation, transparency, accessibility, and affordability to the healthcare industry with the goal of providing the best healthcare options to Americans. She is a fierce leader and continues to break the elusive glass ceiling in a male-dominated industry. Connect with Susan Lang!Website: https://www.visoryhealth.com/Instagram: https://www.instagram.com/visoryhealthrx/LinkedIn: https://www.linkedin.com/in/susanllang/Visory Health Prescription Discount Card: https://www.visoryhealth.com/rx-savings-card Connect with Kamie Lehmann!Website: https://www.kamielehmann.com/Facebook: https://www.facebook.com/kamie.lehmann.1Instagram: https://www.instagram.com/shesinvinciblepodcast/LinkedIn: https://www.linkedin.com/in/kamie-lehmann-04683473National Domestic Violence Hotline: https://www.thehotline.org/Get your Podcast on IMDB: https://imdb.failureguy.com/submitpodcastkamieLearn more about how to minimize the emotional side effects of cancer: https://adventurefound.org/
For a full transcript of this episode, click here. Listen to this show as either a follow-on or a prequel to the shows with Mark Cuban and Ferrin Williams, PharmD, MBA (EP418) and Ge Bai, PhD, CPA (EP420). And if you're interested in this “what's going on in the world of PBMs, pharmacies, and employers” topic, also listen to the show with Joey Dizenhouse coming out on January 11, 2024. If you need the 101 on what's going on out there for indie pharmacies in your community, I'd recommend the show with Vinay Patel (EP241). What would you do if you owned an independent pharmacy and you discovered that most of your profit was coming from dispensing 10% of prescriptions? That if you just stopped filling 90% of the drugs; fired all your staff except, like, one person; and just filled the drugs that you made money on? If you did this, you would actually make more money in the pharmacy than you're currently making filling every single prescription. What would you do? This is the math that Benjamin Jolley, PharmD, my guest in this healthcare podcast and a multigenerational pharmacy leader and consultant to other pharmacies, discovered and wrestles with on the show today. And oh, by the way, a pharmacy is not gonna make it up in extra toilet paper sales or chewing gum sales when patients come into the pharmacy to pick up their meds. I asked Benjamin this, and he basically laughed at me. [What are the 10% of drugs that an indie pharmacy can make money on? You're going to find this to be a shocking coincidence. It's the same drugs that many of the consolidated PBM/pharmacies mandate are filled at their own pharmacies or mail order. And many self-insured employers maybe unwittingly sign contracts enabling this to go down, which, in effect, enables these consolidated PBM/pharmacies to essentially corner the market on profits from commercial purchasers.] So, turning our attention now to how to lose money in the pharmacy business, there's two ways to lose money: either outright losing money because the acquisition costs of the meds are actually more than the PBM (pharmacy benefit manager) mandates the indie pharmacy can charge its insured members. So, that's one way to lose money. A second way to lose money as an indie pharmacy is because generics are so cheap. The cost of providing the pill bottle might exceed the profits on a 47-cent generic, even if the profit margin is 100%—again, because the PBM sets the price. Now, you might be thinking the same thing I was thinking when Benjamin Jolley talked about this: Okay, well maybe … ugh! We want the patient to save money here, so … ? Here's the really big point that Benjamin Jolley knows because he sees this every day: What the patient pays and what the pharmacy gets paid has no relationship to each other or to what an employer plan may or may not pay. So, if the patient/member pays more and the independent community pharmacy gets paid less, that doesn't mean it will be a better deal for the employer. It doesn't mean it will be a better deal for the patient. Why? Because there's a PBM in the middle. Ge Bai talks about this in episode 420. For every $100 that is spent on generic drugs, $41 goes to the PBM. Seventy-nine percent of the time, if a plan member is in their deductible phase, it's cheaper to pay cash than to use the insurance that member is paying for. As someone said on LinkedIn the other day talking about patients paying premiums and paying more for generics than if they'd just gone in and paid cash, here's the quote: “You can pay more to pay more.” With so many deductibles as high as they are and with so many people who never reach their deductibles, as Benjmain Jolley says during the show today, we're giving this third party a lot of control over a transaction that they literally have nothing to do with something like three out of four times that any given patient picks up their generic med. How'd we get here as a society? It's weird. If you've listened to most of the shows that I've been doing lately largely spiraling around the whole “what's going on with the prices that patients/members are paying for generic drugs,” you might be thinking the same thing I am: It's such an egregious situation that it becomes an opportunity because the bar is so darn low and so many in the supply chain or the demand chain are getting royally screwed by the PBMs, not just patients. I mean, there's a lot of possible win-win collaborations, at least situationally. Local pharmacies and local businesses, for example, would seem to have a natural alliance. I'm reminded of the collaboration from a couple of years ago that Drew Leatherberry and Dan Strause talked about in episode 313. I'm super sure that you in the Relentless Health Value Tribe has or could come up with all kinds of innovative collaborations to help patients get affordable generic drugs, and I'd be super psyched to hear about them. Benjamin Jolley is a pharmacist by training. His pharmacy consulting company is Apex Pharmacy Consulting. Also mentioned in this episode are Ge Bai, PhD, CPA; Mark Cuban; Ferrin Williams, PharmD, MBA; Joey Dizenhouse; Vinay Patel; Drew Leatherberry; Dan Strause; Kyle “Transparently Kicking PBM Ass” McCormick and his pharmacy, Blueberry Pharmacy, in Pittsburgh. Also, AJ Loiacono from Capital Rx (EP379) and CPESN Networks. You can learn more at benjaminjolley.substack.com and through Apex Pharmacy Consulting. You can also connect with Benjamin on LinkedIn. Benjamin Jolley, PharmD, is a third-generation independent pharmacy operator. Since 2019, he has been dedicated to supporting pharmacy operators across the nation in unraveling the complexities of the financial systems that drive their businesses. Through his occasional blog at benjaminjolley.substack.com, he shares insights derived from his experience. In 2023, he partnered with Joe Williams to launch Apex Pharmacy Consulting. Their goal is to provide comprehensive and personalized consulting services tailored to enhance pharmacy operations. 04:47 Benjamin Jolley's recent revelation. 06:14 What are the 10% of drugs that provide all the profit for pharmacies? 09:21 What's happening with the other 90% of drugs that pharmacies are filling? 11:05 What is the breakdown of costs when fulfilling prescriptions and running a pharmacy? 18:50 EP379 with AJ Loiacono. 21:42 What is the “cost savings” within the “insane system” of PBMs not sharing profit with independent pharmacies? 23:00 What is one of the things that PBMs and pharmacies don't often talk about? 26:39 What can employers do so that patients aren't getting overcharged by PBMs? 27:51 “How do I make the PBMs irrelevant?” 33:30 What's the difference between an independent pharmacy delivery service and a service like Express Scripts? 34:36 What's the other potential solution in solving the problems independent pharmacies face, and why does Benjamin Jolley feel that it's not the best solution to pursue? You can learn more at benjaminjolley.substack.com and through Apex Pharmacy Consulting. You can also connect with Benjamin on LinkedIn. Benjamin Jolley of Apex Pharmacy Consulting discusses #indiepharmacy on our #healthcarepodcast. #healthcare #podcast #pharma #healthcareleadership #healthcaretransformation #healthcareinnovation Recent past interviews: Click a guest's name for their latest RHV episode! Emily Kagan Trenchard (Encore! EP392), Cora Opsahl (Encore! EP372), Jodilyn Owen, Ge Bai, Andreas Mang, Karen Root (Encore! EP381), Mark Cuban and Ferrin Williams, Dan Mendelson (Encore! EP385), Josh Berlin, Dr Adam Brown
For a full transcript of this episode, click here. Why did I decide to encore this episode where Cora Opsahl from 32BJ spends 29 minutes talking about the importance of getting your data if you are an employer or a union health fund? Let me quote Jeff Hogan with some light edits here. Jeff wrote about the “outsized role” that employer data and intentional analytics can and will play. This is emerging and a must-have. The show with Andreas Mang (EP419) from three weeks ago, the show with Dan Mendelson (EP385), the one with Mark Cuban and Ferrin Williams (EP418) … everything that has been talked about in all of these shows and more is gonna be hard to do without having the data so you know what's going on. But I will let Cora Opsahl explain far more succinctly than I can here. One more note before we dive in here: After you listen to this show, you might want to go back and listen to episode 373 with Cora—and that one is entitled “How to Kick a Big Hospital Out of Your Network”—because this is one of the things that 32BJ did when it got its data. 32BJ realized that if it kicked out the really expensive hospital from their network, it would (and did!) save $35 million. Kicking this one hospital out of its network enabled the union to get its biggest wage hike in however many years, and also the employers employing union members got a premium holiday and did not have to pay into the health fund for a few months. Imagine if they didn't have this data and realized the millions and millions of dollars being siphoned out of the plan by this one hospital charging way too much. It's just crazy how many employers or unions wind up becoming imprudent fiduciaries because they just don't have the data to know better. But I'll tell you who is realizing it: class action attorneys. In this healthcare podcast, I am speaking with Cora Opsahl, who directs the 32BJ Health Fund. Important to know about Cora's background is this: In previous roles, she's worked deep in the inner workings of the healthcare industry. So, she came to 32BJ armed with a BS meter that is finely tuned, which is, unfortunately, an essential skill for anyone trying to help the patients and members relying on them to successfully navigate the healthcare industry. This conversation gets into everything that the 32BJ Health Fund does with their data. They have lots of data. They demand it. So, besides kicking out overly expensive health systems from their network, here's other things that 32BJ is currently doing with their data and which other employers and unions may get a few ideas from. If you have the data, you (like 32BJ) can use it to: Make smart benefit decisions that are validated, not just guesses. Before you decide to do something (add a wellness program etc), be able to model it accurately for how much it will actually cost you—which, spoiler alert, is most of the time not what the vendor will estimate. You have way more data than the vendor does, so you can certainly use it to great effect in this way. Make sure that the right members are being communicated with so that benefit designs are successful. As Ashleigh Gunter said in episode 368, success when changing benefit designs has a lot more to do with communication than many realize. Create dashboards for leadership that may show trend lines, for example, which could be very helpful to ensure that the fund doesn't run out of money etc … little things like that. Figure out how much the fund is spending on various procedures and where. There's all this talk right now about the crazy variability of prices for the same exact service in the same local market. At one hospital, a colonoscopy could literally cost $10,000; and in another hospital—same quality, same basically everything—that same colonoscopy will be $2000 or $3000. I mean, there's a 500% delta or something in some of these cases. Ensure that if a vendor said they were going to do something, that they are actually doing it. This is especially meaningful for point solutions because of the whole squeezing the balloon thing. I can save money in a silo, and you won't realize that those dollars are getting transferred elsewhere unless you are doing your own math. This is a big deal if you start thinking about how pharmacy benefits are typically siloed from medical benefits. So, if I'm a pharmacy benefit manager, I can talk about how much I'm saving by denying patients drugs without consideration of the medical downstream implications of that. Ensure you're not paying a bill and writing a check for more than the bill was for, which is weirdly common. There's a whole show with Dawn Cornelis (EP285) about this. 32BJ has an engineering team that is creating an app to help members navigate to great doctors with fair prices. All of these things roll into basically three categories: 1. Cutting wasteful spending and finding fraud 2. Making smart benefit decisions 3. Being able to see trends and forecast the future, which is really helpful for financial solvency etc As Cora Opsahl says, “I think we [all can] recognize [that] you [cannot] make smart … decisions and be a fiduciary of [a] fund without having [data].” This whole conversation has been really a big bright spot for me and will provide hope, I think, for any employer/union who is seeking ways to protect their members and patients, the ones on their plans and therefore under their aegis and whom they have a fiduciary responsibility to look out for. 32BJ represents about 200,000 members. They are mostly in residential and commercial real estate—so, for example, your doormen, your maintenance workers, your security, your cleaners, amongst others. Members are in about 11 states, but a lot of them are in the New York City metro area. These union members who are in the fund work for over 5000 different employers. The 32BJ Health Fund has zero-dollar premiums. Wowza on that point—that's a huge benefit. Also mentioned in this episode are Jeff Hogan; Andreas Mang; Dan Mendelson; Mark Cuban; Ferrin Williams, PharmD, MBA; Ashleigh Gunter; Dawn Cornelis; and Wayne Jenkins, MD. You can learn more at 32bjhealthfundinsights.org. Cora Opsahl is the director of the 32BJ Health Fund, a self-funded plan that provides affordable, comprehensive, and innovative health coverage to 200,000 union members and their families. As director of the Health Fund, Cora has implemented multiple benefit changes that saved more than $35 million: removing NewYork-Presbyterian Hospital System and physicians from the network, transitioning to a new pharmacy vendor and pharmacy group purchasing coalition, and establishing an expanded Centers of Excellence program administered by Mount Sinai Solutions. Currently, she is leading a comprehensive medical RFP. Prior to joining the 32BJ Health Fund, Cora spent 12 years at Express Scripts, a pharmacy benefit manager, where she held a variety of roles, including with Medicare Part D, strategy and acquisitions, operations, and account management. She holds an MBA from Saint Louis University. 06:53 How much data does 32BJ Health Fund have, where do they get it, and how do they use it? 08:52 How did 32BJ Health Fund successfully demand their data from 100% of their vendors? 09:42 “We feel it's really important that we own this information ourselves.” 10:05 “It always concerns me—if a vendor doesn't want to give you the information, what are they hiding?” 10:32 “It's not just getting the data; it's then using the data.” 13:41 “Without data, you're really just taking a guess; and guesses are never gonna get you where you need to go.” 15:19 EP285 with Dawn Cornelis. 15:40 Is the cost of creating a data analytics team worth the cost savings of those data discoveries? 19:03 “The use of data has really built our knowledge.” 20:52 “It's really important to us that as we make benefit decisions, we're doing it smartly.” 25:27 EP358 with Wayne Jenkins, MD. 25:38 How is 32BJ Health Fund making their data knowledge actionable? 28:11 “If we can figure out how to make telehealth accessible … there may be an opportunity for telehealth … to upset some of these … monopoly systems or low-choice options.” 30:22 “It's really easy to think that we can solve this problem through benefit design … but in the end … it's the price.” You can learn more at 32bjhealthfundinsights.org. Cora Opsahl discusses #healthdata on our #healthcarepodcast. #healthcare #podcast #healthcareleadership #healthcaretransformation #healthcareinnovation Recent past interviews: Click a guest's name for their latest RHV episode! Jodilyn Owen, Ge Bai, Andreas Mang, Karen Root (Encore! EP381), Mark Cuban and Ferrin Williams, Dan Mendelson (Encore! EP385), Josh Berlin, Dr Adam Brown, Rob Andrews, Justina Lehman
“Find joy in the imperfection of it all. People talk about the enigma of work-life balance; it does not exist. It's more like work-life integration.” - Susan Thomas In this episode, we are talking about the often controversial concept, “Leaning In”…and discussing how, today, we just as often hear women use the phrase, “Lean Out”. When Sheryl Sandberg wrote the book Lean In: Women, Work, and the Will to Lead in 2013, it was received as the working woman's Bible. It challenged women to do more. But by 2018, the concept and author faced a major fallout as women said: that just doesn't work. What does all this mean? How are we seeing women demonstrate leaning in and leaning out today? We also have an interview with the indelible Susan Thomas, Managing Director of Health Plan Growth at Express Scripts, who shares about perspective, boundaries, and how she balances a thriving career with a full personal life - friends, children, and aging parents. In this conversation, you will hear: What is leaning in and leaning out, and do these phrases hold water in 2023? The value of perspective on your growing career. How to set boundaries for yourself and give agency to your team to set their own boundaries. Don't miss our ONE THING TO TRY and WHAT YOU GOT IN THAT BAG prompts at the end! (News flash: It's time to use that PTO and set your OOO.) To be sure you catch every episode of Women Who Work, like and follow us on Apple Podcasts and Instagram @soarlead. LINKS: - Forbes Article: Three Mom Executives Share How They Surpassed The ‘Broken Rung' - Lean In: Women, Work, and the Will to Lead --- Send in a voice message: https://podcasters.spotify.com/pod/show/womenwhowork/message
The PBM Express Scripts recently asked to convene an independent pharmacy advisory group to determine how PBMs could be better “partners” with independent pharmacies - PUTT responded with a comprehensive letter outlining many of the issues pharmacies confront in their daily dealings with PBM “partnerships”... this month, the PUTTcast is taking that conversation a step further. Join Monique Whitney, PUTT President Deborah Keaveny, and special guest pharmacy owners EpicRx CEO Brian Hose, and MPA past President Jerry Callahan as they take a deep dive into pharmacy/PBM business relationships, including how they affect: drug pricing; patient care; all forms of pharmacy including the chains, and; why FTC and legislative intervention is critical to addressing many of the issues. Because, to quote PUTT President Deborah Keaveny, “no pharmacy can provide quality patient care if it cannot generate sufficient revenue to conduct its daily operations.” To read PUTT's official letter to Express Scripts click here
The PBM Express Scripts recently asked to convene an independent pharmacy advisory group to determine how PBMs could be better “partners” with independent pharmacies - PUTT responded with a comprehensive letter outlining many of the issues pharmacies confront in their daily dealings with PBM “partnerships”... this month, the PUTTcast is taking that conversation a step further. Join Monique Whitney, PUTT President Deborah Keaveny, and special guest pharmacy owners EpicRx CEO Brian Hose, and MPA past President Jerry Callahan as they take a deep dive into pharmacy/PBM business relationships, including how they affect: drug pricing; patient care; all forms of pharmacy including the chains, and; why FTC and legislative intervention is critical to addressing many of the issues. Because, to quote PUTT President Deborah Keaveny, “no pharmacy can provide quality patient care if it cannot generate sufficient revenue to conduct its daily operations.” To read PUTT's official letter to Express Scripts click here
It's In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: Novo Nordisk will discontinue Levemir by the end of 2024, Tandem begins limited launch of software updates that will include Dexcom's G7, Beta Bionics iLet pump will be covered until some pharmacy plans, and lots more! Links and transcript below Find out more about Moms' Night Out Please visit our Sponsors & Partners - they help make the show possible! Take Control with Afrezza Omnipod - Simplify Life Learn about Dexcom Edgepark Medical Supplies Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com Reach out with questions or comments: info@diabetes-connections.com Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX In the news is brought to you by Edgepark simplify your diabetes journey with Edgepark XX This week was World Diabetes Day so there is a LOT going on.. Our top story is XX Novo Nordisk said on Wednesday it would discontinue its long-acting insulin Levemir in the United States, citing manufacturing constraints, reduced patient access and available alternatives. The Danish drugmaker said supply disruptions would start in mid-January, followed by discontinuation of the Levemir injection pen in April and of Levemir vials by the end of 2024. Novo has another long-acting insulin, Tresiba, on the market and says quote - "global manufacturing constraints, significant formulary losses impacting patient access effective in January 2024, and the availability of alternative options in the U.S. market" are key factors in the decision. The announcement comes eight months after Novo said it would cut U.S. list prices for several of its insulin products next year, including a 65% reduction in the list price of Levemir. Novo, which overtook LVMH (LVMH.PA) as Europe's most valuable listed company this year, posted record operating profit for the third quarter, with sales of its obesity drug Wegovy reaching $1.36 billion, up 28% from the previous quarter. https://www.reuters.com/business/healthcare-pharmaceuticals/novo-nordisk-discontinue-levemir-insulin-us-market-2023-11-08/ XX Big news from Tandem Diabetes this week – first, their Control IQ algorithm gets FDA approval for children as young as two years old. the technology's original 2019 clearance limited its use to those aged 6 and older. And.. they are officially rolling out the software update that will allow users to connect to either the Dexcom G6 or G7 CGM. If you're in the limited launch you got an email this week telling you the next steps – wider release is expected gradually in the first part of 2024. Integration with Abbot's FreeStyle Libre is expected very soon as well – which would mean Tandem's tslim x2 and Mobi pumps would be compatible with three CGMs. Full disclosure: there wasn't a media release that I received on this, but my son is in the limited launch group so we got the email. https://www.fiercebiotech.com/medtech/tandem-diabetes-care-cruises-fda-ok-toddler-use-automated-insulin-delivery-algorithm XX Beta Bionics iLet pump and its supplies are now covered as part of some pharmacy benefits - Express Scripts added it to its national formulary list. Historically, insulin pumps fall under the durable medical equipment (DME) insurance benefit. Usually pharmacy benefits are more flexible with fewer up front costs. The system uses an adaptive, closed-loop algorithm that initializes with the user's body weight and requires no additional insulin dosing parameters. The algorithm removes the need to manually adjust insulin pump therapy settings and variables. iLet simplifies mealtime use by replacing conventional carb counting with its meal announcement feature. This enables users to estimate the amount of carbs in their meal, categorized as “small,” “medium” or “large.” Over time, the algorithm learns to respond to users' individual insulin needs. https://www.drugdeliverybusiness.com/beta-bionics-pharmacy-benefit-bionic-pancreas/ XX The UK has launched a pioneering study to explore the development of type 1 diabetes in adults which aims to screen 20,000 individuals. Research will enable earlier and safer diagnosis of type 1 diabetes through blood tests. This makes the UK the first country to implement general population screening for type 1 diabetes in both children and adults. The Type 1 Diabetes Risk in Adults (T1DRA) study, launched on World Diabetes Day, seeks to enroll 20,000 adults aged 18 to 70. Supported by The Leona M. and Harry B. Helmsley Charitable Trust and building on the Diabetes UK-funded Bart's Oxford Family study (BOX), T1DRA aims to unravel the mysteries of adult-onset type 1 diabetes. https://www.diabetes.co.uk/news/2023/nov/groundbreaking-study-to-screen-20000-adults-for-type-1-diabetes.html XX The National Institute for Health and Care Excellence (NICE), England's cost-effectiveness watchdog, has finalized a draft guidance regarding hybrid closed-loop systems, concluding that the technology should be made broadly affordable and accessible to help people with Type 1 diabetes better manage the condition. In this month's final draft guidance (PDF), NICE recommended that hybrid closed-loop technology be offered to all people with Type 1 diabetes who are having trouble controlling the condition using their existing devices. NICE said that it has already devised a five-year rollout plan with the NHS to bring the technology to people with Type 1 diabetes. Hybrid closed-loop systems will be offered first to children, young people, existing insulin pump users and women who are pregnant or planning to become pregnant, after which they'll be issued to adults who have an average HbA1c reading of at least 7.5%. https://www.fiercebiotech.com/medtech/nice-recommends-hybrid-closed-loop-systems-type-1-diabetes-prompting-praise-medtronic XX Commercial XX Kyle Banks was diagnosed with type 1 diabetes on November 1, 2015 while performing with the traveling production of Disney's The Lion King. Performing nightly for sold out audiences across the country was a dream come true, but after experiencing symptoms of the onset of type 1 diabetes, the dream temporarily turned into a nightmare. The symptoms he experienced were typical for the onset of this chronic illness. but with limited knowledge of type 1 diabetes, he had no idea what was occurring or the drastic life change that would soon follow. In 2020, he founded Kyler Cares in partnership with Children's Hospital New Orleans and has since connected with families from across the country that are living with this disease. Kyler Cares seeks to improve health outcomes for people of color living with diabetes and ensuring families can access the resources and technology available for better management is the route the organization is taking to achieve that goal. At Kyler Cares we're working to improve health outcomes for people of color living with diabetes by improving access to diabetes technology, creating connections to education and resources, and fostering community as an added system of support on our journeys. Kyler Bear & Friends' T1 Diaries is an eight-part animated series for kids, dedicated to storytelling about life with Type 1 Diabetes. Our series is more than just an educational tool; it's a reflection of real-life stories and an avenue to strengthen community ties. It's a vehicle for us to inspire young people to begin laying a foundation of knowledge and self-confidence with management of T1D that will resonate throughout their lives until a cure for the disease is discovered. By supporting this series with a donation, you will be contributing to a project that not only educates and informs but also offers comfort and a sense of belonging to kids navigating life with T1D. ‘Kyler Bear's T1 Diaries' isn't just a series; it's a beacon of hope, a source of information, and a testament to the strength found in our amazing T1D community. Join us in bringing these stories to life XX Married At First Sight UK ends this week, but one bride says viewers haven't seen her whole story. Fans will find out if Tasha Jay, 25, decides to stay with partner Paul Liba on the Channel 4 show. But Tasha, who has type 1 diabetes, has spoken out about how footage about her condition didn't make the final cut. While she's "really sad" that it was left out, Tasha's pleased that people are now realising why she behaved in a certain way on the show at times. Married at First Sight - or MAFS - is a social experiment where experts match complete strangers who try to live as a couple. Tasha says her wedding day with Paul on the show was a "really beautiful moment" that included her telling Paul about her diabetes and his reaction. "I got filmed taking my insulin and checking my blood sugar," she tells BBC Newsbeat.. Tasha was diagnosed at aged two and half and says people have asked why that part of her was hidden in the show. "And I'm like I didn't hide it," she says. "For whatever reason they haven't shown it, which really upsets me because diabetes is a part of my story." Tasha believes that, if people had known about her diabetes, it would have changed their perception of certain moments in the show. https://www.bbc.com/news/newsbeat-67368445
Good morning from Pharma and Biotech Daily, the podcast that gives you only what's important to hear in the Pharma and Biotech world. Today, we have several key developments to discuss in the medical technology industry. Let's dive in.First, Danaher's Q3 revenue has declined due to ongoing demand challenges, but respiratory testing revenue has been a bright spot. The FDA has also updated its list of cleared AI/ML medical devices, adding 171 new devices primarily in radiology. Activist investor Carl Icahn is suing Illumina, seeking to remove board members and claiming damages over their handling of the acquisition of Grail. In addition, Olympus has issued a recall of its abdominal insufflation devices after reports of patient injuries and one death. Ashley McEvoy is stepping down as the chairman of J&J's medtech business, with Tim Schmid taking over. Small- and medium-sized medtech companies are facing challenges under the EU Medical Device Regulation. Moving on to payer news, Centene Corporation has beaten Q3 forecasts despite pressure from Medicare Advantage star ratings and redeterminations. HCA Healthcare, on the other hand, missed Q3 expectations due to costs associated with its physician staffing firm, Valesco. A report by the Robert Wood Johnson Foundation and the Urban Institute found that if the 10 remaining states expanded Medicaid, 2.3 million people would gain coverage. Prospect Medical Holdings has been given clearance to seek a buyer for its struggling four-hospital health system, Crozer Health. Kaiser Permanente imaging services workers will join an ongoing strike among pharmacy workers in Oregon and Washington. Independent pharmacies are suing Express Scripts over alleged price fixing.In the biotech world, Orbimed has raised $4.3 billion in new funds for startup investing. Novartis has delayed its FDA filing for its radiopharma drug Pluvicto due to mixed survival data. Aiolos Bio has raised $245 million for a better asthma drug targeting an inflammation-linked protein. Rampart Biosciences, an Orbimed-backed biotech, has launched with $85 million to develop a new kind of DNA medicine. Seagen's trial data at ESMO impressed, boosting stock prices for Merck and Pfizer. Roche's planned buyout of Telavant has pushed 2023's deal value total above $100 billion. PRC Clinical is partnering with TrialHub to transform the clinical research landscape, and Novo Nordisk is facing weight problems with its drug Ozempic.Moving on to Swiss pharmaceutical company Novartis, they reported a 12% increase in sales and 21% growth in core operating income for Q3. Verve Therapeutics received FDA approval for its first in-human base editing study in the US. Belgium is considering a short-term ban on Novo Nordisk's Ozempic for weight loss due to supply constraints. AstraZeneca and Daiichi Sankyo addressed safety concerns for their investigational antibody-drug conjugate candidate at the ESMO conference.Next, we have Pfizer's vaccine business, which has experienced significant growth driven by the success of its COVID-19 vaccine, Comirnaty. Pfizer is expanding its vaccine portfolio with new approvals. The recipients of the 2023 Red Jackets will be announced during a virtual event called "The Next Frontier of the Life Sciences." Other news includes the CDC updating recommendations for the RSV shot, AstraZeneca's cancer drug allaying safety concerns but still facing questions, Roche settling a US patent lawsuit against Biogen, and Wall Street increasing forecasts for anti-obesity drug sales.In funding news, Rampart Biosciences has raised $85 million to develop more potent DNA-based medicines. Invea Therapeutics and Cargo Therapeutics have joined the IPO queue, and Laronde is merging with Senda Biosciences. Ultragenyx plans to spin out a new company focused on Alzheimer's gene therapy. Roche has agreed to acquire Televant for $7.1 billion.That's all for today's episode of Pharma and Biotech Daily. Stay tuned for more important new
Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in the Pharma and Biotech world. Express Scripts, a pharmacy benefit manager owned by Cigna, is currently facing a lawsuit from independent pharmacies for alleged price fixing. It is claimed that Express Scripts collaborated with rival Prime Therapeutics to overcharge these pharmacies. This case highlights the ongoing challenges and controversies within the pharmaceutical industry.In other news, Blue Cross North Carolina has announced plans to acquire 55 FastMed urgent care clinics. The nonprofit insurer aims to restore these clinics to pre-pandemic standards after experiencing staffing shortages. This acquisition demonstrates the importance of accessible and high-quality healthcare services in the current climate.Supply chain challenges in the healthcare industry have been a major concern during the COVID-19 pandemic. Four health system executives recently shared their strategies for managing disruptions in the supply chain. These innovative approaches are crucial for ensuring the continuous availability of essential medical supplies.Meanwhile, healthcare workers at Providence St. Joseph Medical Center in California and PeaceHealth in Washington have gone on strike to demand better working conditions. This highlights the need for improved labor practices and support for frontline healthcare workers.Transitioning to industry news, Roche has made a significant move by agreeing to acquire Televant, a subsidiary of Roivant and Pfizer, in a $7.1 billion deal. This acquisition will provide Roche with access to a promising inflammatory bowel disease treatment currently in late-stage clinical trials. It demonstrates Roche's commitment to expanding its portfolio and addressing unmet medical needs.Seagen's trial data presented at the European Society for Medical Oncology (ESMO) conference has impressed investors, leading to a boost in shares for both Merck and Pfizer. The combination of Seagen and Astellas' antibody-drug conjugate Padcev, along with Merck's Keytruda, has shown significant improvements in survival rates for first-line bladder cancer. This breakthrough offers new hope for patients and showcases the potential of innovative treatment approaches.Verve Therapeutics has received FDA approval to conduct a base editing study for heart disease treatment in the US. This approval comes after the FDA requested more information about Verve's in vivo treatment. It is a significant step forward in the development of effective therapies for cardiovascular diseases.Pfizer has also received FDA approval for its new meningococcal vaccine, Penbraya. This addition to Pfizer's infectious disease portfolio will contribute to the prevention and control of meningococcal infections.Despite a recent slowdown in biotech companies going public, two new players, Invea Therapeutics and Cargo Therapeutics, have joined the IPO queue. Invea Therapeutics focuses on immune diseases, while Cargo Therapeutics develops cancer drugs. This demonstrates the continued interest and investment in innovative biotech solutions.In conclusion, the biosimilars market has experienced slow growth since its inception in 2015. However, recent developments, including the entry of new companies, are contributing to its evolution. These insights and news updates are provided by Biopharma Dive, a trusted source for in-depth journalism and analysis of the biotech and pharma industry.Thank you for joining us on this episode of Pharma and Biotech Daily. Stay tuned for more important updates from the world of pharmaceuticals and biotechnology.
Beginning in January 2024, many Federal Employee Health Benefits Program (FEHBP) plans will be offering a Medicare Prescription Drug Plan (PDP) to their members. The Foreign Service Benefit Plan will be among them. This program will result in savings for our members aged 65 and older. Join us for a detailed discussion of PDPs generally and the specifics of the FSBP PDP. Mark your calendars for two upcoming discussions of the FSBP PDP: October 31, at 12 noon ET - We will offer a live webinar with an overview of the PDP and a chance for you to ask your questions. November 30 at 11 am ET - Our monthly AFSPA Talks program will focus on the PDP and offer another opportunity for you to get answers about this program. You can learn more at www.afspa.org/fsbp/pdp. If you have questions about the benefits under the PDP, please contact the dedicated Express Scripts line at 855-690-8353, 24 hours a day, 7 days a week. For more information on Medicare Part D premiums, please visit https://www.medicare.gov/drug-coverage-part-d/costs-for-medicare-drug-coverage/monthly-premium-for-drug-plans. Please see the 2024 chart at the bottom of the page (based on 2022 income).
Steve Grzanich has the business news of the day with the Wintrust Business Minute. Deerfield-based Walgreens has named veteran healthcare executive Tim Wentworth as its new CEO. Wentworth is coming out of retirement to lead Walgreens as it transitions from healthcare retailer to health services provider. Wentworth was the CEO of Express Scripts, the nation’s […]
Host Fred Goldstein invites Chronis Manolis, Sr. Vice President, Pharmacy Services Chief Pharmacy Officer UPMC Health Plan and Michael Rothrock, MHA, MBA, Former Vice President of Pharma Strategy and Contracting for Express Scripts to discuss innovator biologics, biosimilars and unbranded biologics. Find all of our network podcasts on your favorite podcast platforms and be sure to subscribe and like us. Learn more at www.healthcarenowradio.com/listen
The US healthcare system is plagued by corruption, and Pharmacy Benefit Managers (PBMs) are taking advantage of it. Express Scripts, the largest PBM, is sending out letters to dozens of clinicians and provider practices warning them of fraud, waste, and abuse for off-label prescribing of FDA-approved drugs. PBMs are making more money than the insurers that own them, and they engage in spread pricing and clawbacks. To become a good consumer of healthcare, David Contorno and Emma Fox suggest price shopping pharmacies, exploring manufacturer assistance programs, using coupons, and international sourcing. Consumers should also be their own advocates and ask their doctor what other options are available.Episode Outline:(00:00:00) Express Scripts Fraud(00:18:21) Prescription Drug Costs(00:04:45) PBM Profits(00:13:56) Pharmaceutical Pricing(00:09:29) Negotiating Drug PricesQuotes:(00:07:57) It's a long game, right? It's expensive right now. I get that. But if we're able to cure obesity along with who knows how many other comorbidities, what does that look like ten years from now, right?(00:21:31) Be your own advocate, because at the end of the day, you're the only one who pays clinically and financially for not being an advocate for yourself.(00:03:17) But I wish we could find something where literally they were defrauding people. I think that's ultimately what they're doing.(00:13:17) Every single other country negotiates drug pricing. They say you cannot bring that drug into this country unless you agree to this price. And not only does the US. Not do that, but there's a federal law that says we can't do that.(00:15:59) The hard part is not having coverage for it, because if you have coverage, but a deductible you can't afford, you don't qualify for this program.Social Post:Are you tired of the healthcare system's corruption? Tune in to the Healthcare Hangover podcast with David Contorno and Emma Fox to learn about the shady practices of PBMs (Pharmacy Benefit Managers). Did you know that PBMs are making more money than the insurers that own them? Or that Express Scripts alone manages the pharmacy benefits for nearly a third of the US population? Don't miss this eye-opening episode and learn how to fight back against the healthcare system's corruption. #HealthcareHangover #PBMs #HealthcareSystemAre you tired of the healthcare system telling you what you can and can't do? Then you need to listen to the latest episode of The Healthcare Hangover podcast! In this episode, David Contorno and Emma Fox discuss the frustrations of dealing with insurance companies and how to get around them. Did you know that you can get the same medication for up to 70% less by importing it from a different country? Tune in to find out more about how to get the most out of your healthcare experience! #TheHealthcareHangover #HealthcareSystem #InsuranceCompaniesAre you struggling to afford your medications? Did you know that there are ways to get name brand drugs for free or at a discounted rate? On the latest episode of The Healthcare Hangover, David Contorno and Emma Fox discuss how the Part D law and Prescription Assistance Programs can help you get the medications you need at a price you can afford. Tune in to learn more about how to get the best deal on your medications! #TheHealthcareHangover #PrescriptionAssistancePrograms #AffordableMedicationsBlog Post:The US healthcare system is in a state of disarray. Pharmacy Benefit Managers (PBMs) are taking advantage of this by sending out letters to dozens of clinicians and provider practices warning them of fraud, waste, and abuse for off-label prescribing of FDA-approved drugs. Express Scripts, the largest PBM, alone manages the pharmacy benefits for roughly 100 million people. It's no surprise that PBMs are making more money than the insurers that own them. They get an admin fee every time a transaction is processed, mark up the drugs, and do clawbacks. Optum, which is owned by UnitedHealthcare, accounts for the majority of their profit.Doctors are outraged that a PBM would have any right to tell them how to make clinical decisions for their patients. Alex Lickerman supports GLP-1 for weight loss, and it is effective. However, GLP-1 is a lifelong medication, and there are some concerns about it, such as muscle mass loss. Education is missing from these medications. Express Scripts is accusing some providers of falsifying diagnosis of type two diabetes in order to get through the prior authorization process.It's up to us to become good consumers of healthcare. David Contorno and Emma Fox suggest price shopping pharmacies, exploring manufacturer assistance programs, using coupons, and international sourcing. Consumers should also be their own advocates and ask their doctor what other options are available.Membership with a PBM such as Drexi can be a great way to save money. Drexi does not do spread pricing or clawbacks, but requires a small monthly fee. When using the Drexi card, the system looks like the consumer has insurance, but the insurance is not paying for anything. Manufacturer assistance programs and coupons are also a great way to save money. It's important to price out pharmacies as prices can vary widely. Employers are making choices for their health plans that can affect the cost of prescription drugs. The US healthcare system makes money when people are sick, unlike other countries. This is why the pharma industry charges high prices for drugs because they can and still make a profit. However, there are Prescription Assistance Programs (PAP) for name brand drugs for those who don't have coverage. Income limits for PAP vary by drug and number of people in the household. Good RX and Script Co offer discounts on drugs even if you have insurance.Express Scripts is threatening doctors for trying to get cheaper drugs for patients. Pharmacists have had their clinical roles stripped away due to PBMs deciding what is covered and what is not. Pharmacists can help those without insurance get name brand drugs for free or at a discounted rate. Doctor tweeted a pediatric oncologist in Texas saying he was "sick and tired of these insurance companies telling me what I can prescribe and what I can't prescribe." Insurance companies don't tell doctors what they can and can't prescribe, they just tell them what they're willing to pay for.Pre-certification and prior authorization are two processes that doctors and patients have to go through. Doctors are burned out because they're "sick and tired of insurance companies telling me what I can do and what I can't do." People can import medications from other countries, such as Canada, UK, New Zealand, or Australia, which are 40-70% less expensive than in the US.At the end of the day, it's important to be an informed consumer. Ask your doctor what other options are available, look into manufacturer assistance programs and coupons, price out pharmacies, and explore international sourcing. It's also important to be your own advocate and fight against the corruption in the US healthcare system.Episode LinksConnect with Emma FoxWebsiteEmma's WebsiteConnect with David ContornoLinkedInWebsiteOther MaterialsThese materials help you promote your podcast. Quotes can be used for audio & video grams or quote cards. Blog and social posts will help your website and social media presence.
If you've been told your insurance won't cover your meds — or that you're gonna have to pay an arm and a leg for them — you've met a PBM: a pharmacy benefits manager. And: Experts say they play a big role in jacking up drug prices overall. But how, exactly? We took a deep dive.This episode first went out in 2019. We're bringing it back because PBMs are in the news these days: Congress is targeting them, in an effort to to be seen doing something about prescription drug prices. And PBMs' sometimes-rival, the powerful pharmaceutical industry lobby, is flooding the airwaves with ads attacking them. There's been a little news since 2019: Although Congress is still catching up, all 50 states have passed some laws pertaining to how PBMs work. We've got an update on that. Here's a transcript of this episode. Send your stories and questions. Or call 724 ARM-N-LEG.And of course we'd love for you to support this show.Correction: A previous version of this episode misidentified the parent company of Express Scripts. Hosted on Acast. See acast.com/privacy for more information.
It's In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: learning more about Lilly's plan to lower the price of some insulins, Abbott's Libre 2 and Libre 3 get FDA approval to work with automated insulin delivery systems like Control IQ and Omnipod 5, Medicare expands coverage of CGMs for people with type 2, an old blood pressure medication shows promising results in a T1D study, and more! Please visit our Sponsors & Partners - they help make the show possible! Take Control with Afrezza Omnipod - Simplify Life Learn about Dexcom Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com Reach out with questions or comments: info@diabetes-connections.com Episode transcription: Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and these are the top diabetes stories and headlines happening now XX In the news is brought to you by Athletic Greens XX Insulin prices https://www.statnews.com/2023/03/06/eli-lilly-insulin-medicaid-rebates/ Drugmaker Eli Lilly & Co. on Wednesday said it will cut prices of its most commonly prescribed insulins by 70% and cap monthly out-of-pocket costs at $35 at certain retail pharmacies for people who have private insurance. Lilly will list its Lispro injection at $25 a vial effective May 1 and slash the price of its Humalog and Humlin injections by 70% starting in the fourth quarter. The announcement comes amid growing federal pressure to lower the cost of insulin. The Inflation Reduction Act capped insulin prices for Medicare beneficiaries at $35 per month but did not protect people with private insurance or who don't have coverage from higher prices. Eli Lilly would've had to pay Medicaid about $150 for each vial of insulin used in the program if it hadn't dramatically cut the list prices for some of its older products this week. The company was about to run into a Medicaid penalty for raising the price of it's drugs faster than the rate of inflation. https://www.cnbc.com/2023/03/01/lilly-cuts-insulin-prices-70percent-cap-prices-at-35-per-month-for-private-insurance.html XX The FDA has cleared Abbott's Freestyle Libre 2 and Libre 3 continuous glucose monitors (CGM) for integration with automated insulin delivery (AID) systems. These devices have also been cleared for younger children, extended wear time, and for use during pregnancy. The FDA on March 6 cleared Abbott's Freestyle Libre 2 and Freestyle Libre 3 CGM for use with automated insulin delivery (AID) systems. AID systems connect a CGM, insulin pump, and smartphone to automatically adjust insulin dosing in real-time in response to changing glucose levels. These systems have been demonstrated to help many people with diabetes improve their time in range and reduce the time spent thinking about managing glucose each day. With this new clearance from the FDA, Libre 2 and 3 CGMs and the connected smartphone app will soon integrate with insulin pumps to adjust insulin dosing. Freestyle Libre 2 and Libre 3 CGMs were previously cleared for use by people with diabetes ages 4 and older. Freestyle Libre 3, cleared in the United States in May 2022, is compatible with both iOS and Android smartphones. Among several upgrades made from Libre 2, Libre 3 no longer requires users to manually scan their device with their smartphone to see glucose levels – data is sent to the mobile app automatically. In the announcement, Abbott said the device has also been cleared for an extended wear time of 15 days, for use by children as young as age 2, and for use during pregnancy by women with type 1, type 2, or gestational diabetes. Current users of Libre CGMs should note that the devices available now cover people with diabetes ages 4 and older, can be worn for 14 days, and are not cleared for use during pregnancy. According to Abbott, the modified Libre 2 and 3 sensors will be available in the U.S. later this year. https://diatribe.org/fda-clears-freestyle-libre-2-and-3-use-automated-insulin-delivery XX Medicare will cover continuous glucose monitors for a broader group of patients, starting in April, according to an updated policy published by the Centers for Medicare and Medicaid Services. The policy change included broader language and also came earlier than expected, making it a “welcome surprise,” and could double the market for the devices, J.P. Morgan analyst Robbie Marcus wrote in a research note. Dexcom and Abbott Laboratories had expected coverage to start in mid-year. In an earlier draft of coverage guidelines, CMS had suggested covering the devices for people with diabetes who take daily insulin, or who have a history of problematic hypoglycemia. Now, the policy includes people with non-insulin treated diabetes and a history of recurrent level 2 or at least one level 3 hypoglycemic event. “At first glance, it seems that the finalized CMS language is broader and no longer includes daily insulin language,” Marcus wrote. The policy change could open up a bigger opportunity for broader coverage by commercial insurers over the next year or two, he added. Currently, just 25% of people with Type 2 diabetes who are intensive insulin users (taking multiple shots per day) use a CGM. Covering people who take basal (daily) insulin could double the U.S. market opportunity of about 2 million people with Type 1 diabetes and 2 million people with Type 2 diabetes who are intensive insulin users, a group currently covered by CMS, Marcus wrote. https://www.medtechdive.com/news/Medicare-CGM-coverage-Dexcom-abbott-ABT-DXCM/644019/ XX Bigfoot Biomedical receives FDA clearance for the Android mobile app for Bigfoot Unity. The mobile app allows users to input and review therapy recommendations from healthcare professionals. Users can also access a glanceable display of their current glucose range and receive real-time alerts. Last month Bigfoot sold its closed-loop automated insulin delivery (AID) system technology to Insulet. CEO Jeffrey Brewer said he has confidence in the makers of the omnipod to utilize Bigfoot's “great asset” in its focus on simplicity and ease of use for pump users. He said the limited rollout generated “great data” to support Bigfoot Unity in the type 2 population. That includes ease of use, especially for people who might not be tech-savvy. The big focus for Bigfoot Biomedical, Brewer explained, remains the pharmacy channel. He said the company is currently in discussions with Express Scripts, Optum and CVS to utilize their wide reach. Brewer said that getting an agreement with one or more of those companies will enable a more broad launch this year. By wrapping the insulin delivery around CGM, Bigfoot Biomedical believes it can address the type 2 market in a new way. https://www.massdevice.com/bigfoot-biomedical-next-steps-diabetes-management/ XX Although the use of diabetes technology has increased across all racial and ethnic groups, inequities persist, according to research published in the Journal of Endocrinology & Metabolism. In the United States, race and ethnicity have been associated with inequities in diabetes treatment and outcomes. Non-Hispanic Black and Hispanic indi- viduals with type 1 diabetes (T1D) have higher hemoglobin A1c (HbA1c), higher rates of severe hypoglycemia and dia- betic ketoacidosis, and are more likely to visit emergency departments and hospitals than individuals with T1D who identify as non-Hispanic White. Researchers used a version of Optum's deidentified Clinformatics Data Mart to select Medicare Advantage beneficiaries with T1D between January 1, 2017, and December 31, 2020. Investigators found that overall, use of an insulin pump, a CGM, both insulin pump and CGM, and either insulin pump or CGM increased during the 4-year study period When evaluating the data by racial and ethnic group, investigators found that the prevalence of each outcome did increase; however, “within each annual cohort and outcome, there were significant differences between racial/ethnic groups,” with gaps in prevalence between White individuals and individuals of other races and ethnicities remaining “generally increase[ing] or remaining stable” between 2017 and 2020. When evaluating data from the 2020 cohort, there were significant differ- ences noted in the use of insulin pump and/or CGM technology based on demographic and socioeconomic factors. According to the researchers, the “persistent inequities” in diabetes technology access found in the current study have implications “not only for patients and providers, but also for health care systems and policymakers” and require multiple policy changes to improve equitable access. https://www.drugtopics.com/view/racial-ethnic-inequities-persist-in-diabetes-care XX The CLVer study tested whether improved blood glucose control using a hybrid closed loop insulin pump (also known as an automated insulin delivery or AID system) and/or verapamil preserves beta cell function one year after diagnosis.. The trial showed that verapamil, but not better blood glucose control, improved beta cell function over the year-long study. In October, the FDA approved the drug Tzeild (teplizumab) for people with diabetes antibodies but who did not yet have type 1 diabetes. This therapy was the first approved medicine to delay the onset of type 1 diabetes by an average of 2 years. The CLVer study offers further hope for researchers by showing that another medication can have additional impact in type 1 diabetes, and lays the groundwork for further study. By seeing preserved c-peptide levels in the study participants, the trial demonstrated that taking verapamil improved beta cell function. Additionally, although AID users had greater time in range of 78% compared to non-users' 64%, which is a 3.4 hour/day difference, the trial found that AID did not provide a significant improvement in insulin secretion. This study was partially funded by JDRF “Safe, effective therapies are urgently needed to delay disease progression in people recently diagnosed with type 1 diabetes,” said Dr. Sanjoy Dutta, chief scientific officer at JDRF. “This is the second trial showing that verapamil, a cheap and widely used blood pressure medication, can preserve beta cells in the new onset period. The CLVer trial moves us one step closer to our goal of having disease modifying therapies widely available for people with type 1 diabetes.” https://diatribe.org/impressive-results-show-verapamil-preserves-insulin-producing-cells-newly-diagnosed-type-1-diabetes XX Some advances in cell transplantation to treat type 1: Vertex gets FDA clearence for their application to study VX-264, a stem cell-derived, pancreatic islet cell therapy encapsulated into an immunoprotective device with the potential to treat type 1 diabetes (T1D). The VX-264 program does not require the use of immunosuppression, which may broaden the population of people with T1D that this investigational therapy could reach. This clearance means they can begin clinical trials. AND Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, announced today that the first two patients in the second cohort of its active U.S. Phase 1/2 clinical trial for the treatment of type 1 diabetes (“T1D”) and hypoglycemia unawareness (the “T1D Study”) received their first islet transplant into the higher capacity 10-channel Cell Pouch™. These patients will be monitored for safety and efficacy for three months after which a second dose of islets is anticipated to be transplanted in accordance with the protocol. Additionally, a third enrolled patient has now been implanted with the higher capacity Cell Pouch and awaits islet transplant in the coming weeks. While they are working towards not using immunosuppression, the patients in the current trial do still require immunosuppression to start after implantation of the Cell Pouch SystemTM https://www.businesswire.com/news/home/20230308005894/en/Vertex-Announces-FDA-Clearance-of-Investigational-New-Drug-Application-for-VX-264-a-Novel-Encapsulated-Cell-Therapy-for-the-Treatment-of-Type-1-Diabetes https://finance.yahoo.com/news/sernova-announces-initial-islet-transplantation-120000700.html?guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAAH6NwHdjldrxbueuanlpUGXou6yHP2dKNpYXN31GEMLWCyhkJkgwlhn9ScIDMTX5GGtf5V242uN3EvZzFtTd56z0YZaQgOss37DT2dksdasEONxWa7OOdgnWvDlwUd0-s2RPyMTPi1sw8z08CK6DUMLIrrA6dmCDZeozlwos_CDB XX Two classes of drugs prescribed off-label for some patients with Type 1 diabetes can provide significant benefits but also come with health concerns, according to a study by UT Southwestern Medical Center researchers. The findings, published in The Journal of Clinical Endocrinology & Metabolism, provide a rare view of real-world use of these medications, which are growing in popularity among patients with Type 1 diabetes as adjuvants to insulin. Type 1 diabetes is universally treated with insulin injections. However, explained Dr. Lingvay, because only a fifth of patients with Type 1 diabetes in the U.S. achieve the blood sugar control that the American Diabetes Association recommends, doctors are increasingly prescribing medications known as glucagon-like peptide-1 receptor agonists (GLP-1RAs) and/or sodium-glucose cotransporter-2 inhibitors (SGLT2is) to help patients reach this goal. Furthermore, both classes of medications have been shown in patients with Type 2 diabetes to decrease the risk of cardiac and renal events and help promote weight loss, effects that also would greatly benefit patients with Type 1 diabetes. However, the risk-benefit ratio of these medications has not been fully vetted in this patient population. In fact, both classes of drugs have been associated with increased risk of severe hypoglycemia and DKA when used in patients with Type 1 diabetes. Because both positive and negative effects of GLP-1RAs and SGLT2is were shown in strictly regulated clinical trials, their real-world effects have been unclear. To examine their efficacy, Dr. Lingvay, along with colleagues Khary Edwards, M.D., a former Endocrinology fellow at UTSW, and Xilong Li, M.B.A., Senior Database Analyst at UTSW, searched medical records for Type 1 diabetes patients treated at UT Southwestern who used any GLP-1RAs and/or SGLT2is for at least 90 days before Oct. 31, 2021. Their search turned up 104 patients: 65 who had used GLP-1RAs exclusively, 28 who had used SGLT2is exclusively, and 11 who had used both either concurrently or sequentially. After a year of use, patients on GLP-1RAs had significant reductions in weight, glycated hemoglobin A1C (a three-month average measure of blood sugar), and total daily dose of insulin. SGLT2i users had significant reductions in hemoglobin A1C and basal insulin, a baseline dose delivered outside of meals. However, SGLT2i users were about three times more likely than GLP-1RA users to experience DKA. Just over a quarter of patients taking either class of drugs stopped due to side effects such as gastrointestinal problems. The study authors say these results suggest both types of drugs can be beneficial to patients with Type 1 diabetes, but close monitoring is required. Specifically when using SGLT2is, extreme caution is advised in selecting patients with the lowest risk of DKA, performing detailed education about the risk of DKA, and ensuring careful monitoring to prevent its occurrence. https://www.utsouthwestern.edu/newsroom/articles/year-2023/february-type-1-diabetes.html XX XX XX Athletic Greens XX COVID-19 patients who took the diabetes drug metformin for two weeks after a diagnosis were less likely to develop long COVID-19 symptoms, according to results from a clinical trial. The trial enrolled about a thousand participants who were symptomatic with a COVID-19 infection for less than a week. Participants were randomly selected to receive a placebo or one of three drugs: metformin, ivermectin or fluvoxamine. About 6 percent of people who took metformin later developed long COVID-19, as determined by a medical diagnosis. In the placebo group, 10.6 percent of participants developed long COVID-19. This meant that overall people who took metformin were 42 percent less likely to develop long COVID-19 compared to people who got the placebo. The authors also note that the beneficial effect is potentially stronger for people who started taking metformin less than four days from symptom onset compared to people who started the medication four or more days after their first symptoms. The participants who received the two other drugs, ivermectin and fluvoxamine, did not see any benefits in terms of preventing long COVID-19. https://thehill.com/policy/healthcare/3889797-diabetes-drug-proves-beneficial-in-preventing-long-covid-in-clinical-trials/ XX Great article.. https://www.nytimes.com/2023/03/03/sports/baseball/garrett-mitchell-brewers.html XX On the podcast next week.. Ginger Vieira, author and diabetes advocate. Our last episode was with a family whose son was treated with Tzield to delay his T1D diagnosis. That's In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.