Podcasts about optumrx

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

Prior Authorization is a not a popular topic. In fact, we have not found many organizations willing to talk about it. Simply put, it is a complex challenge. We were pleasantly surprised when Frank Harvey, the CEO of Surescripts was willing to come on-camera to share the work they are doing in this area. Surecripts is collaborating with Cleveland Clinic and OptumRx to streamline the prior authorization process. What used to take days or hours can now be completed in seconds – without changing physician workflows. This is possible through careful coordination of data between the provider, payer, and Surescripts. This advancement not only ensures patients can access critical therapies sooner, but also reduces provider burnout. For now, this process is only for a limited number of therapeutic areas, but Surescripts plans to expand to more in the coming year. Learn more about Surescripts at https://surescripts.com/ Find more great health IT content at https://www.healthcareittoday.com/

Special guest Lori A. Wilken, PharmD, FCCP, BCACP, NCTTP, AE-C, Clinical Assistant Professor in the Department of Pharmacy Practice at the University of Illinois, Chicago, joins us to talkabout Asthma and COPD treatment.Listen in as we discuss answers to your big questions about treatment of asthma and COPD. You'll also hear practical advice from panelists on TRC's Editorial Advisory Board:Stephen Carek, MD, CAQSM, DipABLM, Clinical Assistant Professor of Family Medicine, Prisma Health/USC-SOMG Family Medicine Residency Program at the USC School of Medicine GreenvilleAndrea Darby Stewart, MD, Associate Director, Honor Health Family Medicine Residency Program and Clinical Professor of Family, Community & Occupational Medicine at the University of Arizona College of Medicine - PhoenixCraig D. Williams, PharmD, FNLA, BCPS, Clinical Professor of Pharmacy Practice at the Oregon Health and Science UniversityFor the purposes of disclosure, Dr. Wilken reports relevant financial relationships [pulmonary] with AstraZeneca/Simpson Healthcare, OptumRx. (consultant). The other speakers have nothing to disclose. All relevant financial relationships have been mitigated.TRC Healthcare offers CE credit for this podcast. Log in to your Pharmacist's Letter or Prescriber Insights account and look for the title of this podcast in the list of available CE courses.Claim CreditThe clinical resources mentioned during the podcast are part of a subscription to Pharmacist's Letter and Prescriber Insights: Chart: Biologics and Inhalation Medications for AsthmaChart: Inhaled Medications for COPDIf you're not yet a Pharmacist's Letter or Prescriber Insights subscriber, find out more about our product offerings at trchealthcare.com. Follow or subscribe, rate, and review this show in your favorite podcast app. Find the show on YouTube by searching for ‘TRC Healthcare' or clicking here. You can also reach out to provide feedback or make suggestions by emailing us at ContactUs@trchealthcare.com.

Join Lord Dr Jeremy and the PUTT crew as they band together with patients, pharmacists, physicians, and other advocacy organizations to protest PBM abusive practices at Optum HQ in Eden Prairie, MN.Special Guests: Mike Kolzer host of The Business of Pharmacy podcast, Bil Schmidtknect (@angrydadwi), Claudia Holley & Julie Baak from Arthritis Center STL, John Farina of AIDS Healthcare Foundation, Douglas Hoey CEO of the National Community Pharmacists Organization, and Matt Stoller of the American Economic Liberties ProjectOpening music by JuliusH, Production & Editing by Shannon Wightman-GirardProtest Cocktail Menu:airplane bottles of JamesonSpotted Cow beerSprinkler water (listen to find out how!)

Grab and drink & join this month's very special cocktail crew as they discuss the many reasons why this September's Friday the 13th protest at OptumRx is so important, and how raising your voice about the issues is crucial for advocating across the healthcare spectrum.Special Guests: Angry Dad Bil Schmidtknecht (@angrydadwi), AIDS Healthcare Foundation's (@AIDShealthcare) John Farina, Independent Pharmacy Alliance's (@IPAPharmacies) Anthony Reznik, & Arthritis Center STL's (@ArthritisSTL) Claudia HolleyOpening music by JuliusHEpisode Cocktail Menu:Classic Old FashionedHigh NoonIrish Whiskey in a glass (it's our host Lord Dr Jeremy - of course there's Irish whiskey)

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

Laura Panicali Linkedin Education: Beloit College- Mathematics and Computer Science

Federal antitrust regulators finalize new merger guidelines that will have a significant impact on healthcare dealmaking. An independent Iowa pharmacy files a lawsuit against UnitedHealth and OptumRx alleging high back-end fees. And, we're seeing a rise in respiratory illnesses–and a new COVID variant–ahead of the holidays. That's coming up on today's episode of Gist Healthcare Daily. Hosted on Acast. See acast.com/privacy for more information.

Good morning from Pharma and Biotech Daily, the podcast that gives you only what's important to hear in the Pharma and Biotech world. In today's episode, we have several news stories to cover. Let's dive right in.## Lawsuits and Mergers:UnitedHealth and its subsidiary OptumRx are facing a lawsuit by Osterhaus Pharmacy in Iowa over the use of "unconscionable" fees imposed by pharmacy benefit managers. The pharmacy alleges that these fees are contributing to the closure of independent pharmacies. Osterhaus Pharmacy is also suing CVS Caremark over similar issues.On the merger front, Jefferson Health and Lehigh Valley Health Network have announced their intent to merge, creating a 30-hospital health system serving Pennsylvania and New Jersey. Wisconsin's Froedtert Health and ThedaCare have also finalized their merger plans, with the combined system set to launch on January 1, 2024.Steward Health Care is facing a lawsuit under the False Claims Act for allegedly improperly billing Medicare for over 1,000 false claims. And approximately 1,800 healthcare workers at Prime Healthcare facilities in Southern California are planning a seven-day strike to protest staffing conditions.The Federal Trade Commission (FTC) and Department of Justice (DOJ) have finalized merger guidelines that could make it more difficult for healthcare mergers and acquisitions to be approved. These new guidelines are expected to give regulators more power to challenge vertical and cross-market deals.## Healthcare Tech and Research:In the healthcare tech space, hospitals are adopting advanced technologies like virtual reality and AI to improve staff burnout and enhance clinical decision-making. Additionally, researchers are exploring how to effectively leverage real-world data to optimize clinical trials and bring new therapies to market. There are also articles on increasing diversity in clinical trials, the development of cell and gene therapies, and the future of oncology research.## Biotech Deals and Intellectual Property:GlaxoSmithKline (GSK) has signed a potential $1.7 billion antibody-drug conjugate (ADC) deal with China's Hansoh Pharma, allowing GSK exclusive rights to develop and commercialize certain ADC products in China. This deal is part of GSK's strategy to expand its presence in China and tap into the growing biopharmaceutical market in the country.Biogen has secured exclusivity for its multiple sclerosis therapy Tecfidera in the European Union until early 2025. This decision upholds exclusive marketing protection for Tecfidera, preventing generic competition until February 3, 2025.These developments highlight the ongoing efforts of pharmaceutical companies to secure partnerships and protect their intellectual property rights. Both GSK and Biogen are strategically positioning themselves in key markets to drive growth and maintain their competitive edge.## Marketing News and Insights:In the marketing world, brands are evolving their influencer strategies and shaping their approaches to popular culture. Pringles and The Caviar Co.'s partnership went viral on TikTok and Instagram, creating a new snacking occasion. Oreo's return to the Super Bowl after a decade is also highlighted, referencing their memorable response to a power outage in 2013.Zacapa Rum is featured in its first global campaign titled "Lips to Soul," focusing on female empowerment. The text mentions sponsored content about building community with Gen Z on social media and rising web traffic on the platform formerly known as Twitter. Oreo will be airing its second-ever in-game spot during Super Bowl LVIII.## Blockbuster Drugs and Predictions:The article discusses the current state of blockbuster drugs in the pharmaceutical industry, noting that COVID-19 vaccines like Pfizer and BioNTech's Comirnaty experienced a rapid rise in sales due to the pandemic. However, it is predicted that sales for COVID-related blockbusters will decline in the coming years.Merck &

Recorded on 12/08/23 In this episode, we take a look at the pharmacy benefit management, or PBM, industry which has been instrumental in managing down the cost of prescription drugs and plays a vital role in holding back the rising cost of healthcare. Yet the industry is not without controversy, often criticized for lack of transparency and misaligned incentives, particularly around rebates. But it's also an industry that has continued to evolve as the healthcare landscape has changed. More recently, we've seen new entrants enter the market using technology to disrupt the status quo, and in this episode we explore how we've gotten to where we are, who's to blame, and how we solve the biggest issue: making drugs more affordable for the consumer. To discuss this topic, we're joined by Mark Thierer, Co-Founder and CEO of Waltz Health, and Jeff Park, President of Waltz Health. Mark and Jeff, both longtime PBM industry veterans, have helped transform the industry over the past 20+ years starting with SXC Health Solutions growing it into Catamaran, which became one of the major players in the PBM industry before being sold to UNH's OptumRx in 2015 for $13B. They are now back with Waltz Health, a digital health company developing technology-enabled ways to bring down prescription drug costs. For Disclosures, click here bit.ly/3cPHkNW

Henrico County has filed a federal lawsuit against three manufacturers of insulin, three pharmacy benefit managers, and 12 subsidiaries of the companies, alleging that they conspired to artificially inflate the price of the medicine, which is used to treat diabetes. In the suit, filed Nov. 20 in the U.S. District Court for the Eastern District of Virginia, Henrico alleges that insulin manufacturers Eli Lilly and Company, Novo Nordisk Inc. and Sanofi-Aventis, U.S., LLC and pharmacy benefit managers CVS Caremark, Express Scripts and OptumRx, and their subsidiaries, “have in tandem increased the prices of their insulins up to 1000%,” during the...Article LinkSupport the show

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. In today's news, Walgreens is making some changes to cut costs after poor financial performance. They are laying off 5% of their corporate workforce and their Chief Marketing Officer, Kevin Ban, is leaving the company. Meanwhile, HCA, a hospital operator, has big plans to expand their market share by 2030. They are investing billions in expanding emergency services and high acuity business lines. OptumRx, a pharmacy benefit manager, has made a positive change for patients. They have moved eight insulin drugs to preferred formulary status, which means they will be available for under $35 per month in out-of-pocket costs. These drugs used to be more expensive and harder to access. Cano Health, a primary care chain, is going through some changes as well. They have reduced their workforce by 21% in the third quarter as they look for a buyer and exit certain state markets. In the Senate, lawmakers are discussing the use of AI in healthcare. While AI has the potential to reduce administrative work and speed up drug discovery, there is a need for human oversight to prevent any potential harm. For-profit hospital operators have been facing challenges in Q3 due to physician fees and payer relations. However, HCA has been an exception and has reported higher profits compared to other health systems. Looking ahead, disputes between hospitals and workers are expected to continue even as the impacts of the pandemic subside. This could lead to strikes and bottlenecks in care. That's all for today's news. Stay tuned for more updates from Pharma and Biotech daily.

The cost of prescription drugs can make up a significant part of your healthcare budget. Today, members of Congress examining the middlemen that negotiate drug costs between drug companies and the pharmacies that sell them. They're called Pharmacy Benefit Managers or PBMs. Some of the largest PBMs are CVS Caremark, Express Scripts, and OptumRx. Lawmakers argue these companies are using various tactics that may be increasing costs for consumers. They will also hear directly from a Jacksonville (WJAX) pharmacist about the impact PBMs can have on patient care and smaller pharmacies. We breakdown what we can expect today and how this may impact your healthcare costs.

In this month's episode of the "What's On Your Mind podcast," Peter Wehrwein, managing editor of MHE connects with the now Chief Clinical Officer of OptumRx Integrated Pharmacies, David Calabrese. In this conversation, David touches on his transition in January as OptumRx's former chief pharmacy officer and market president of health plans and PBMs to his new role as Chief Clinical Officer where he now focuses more on things such as specialty pharmacy to home delivery — with an overall goal of creating whole-patient care. Throughout the conversation Calabrese also touched on the market's hot topic of insulin prices and behavioral health services within the OptumRx community, among other topics. 

Rob and Greg kick off the episode with some discussion around news and noteworthy items across the 340B landscape, including more dialogue around CMS guidance on “JG”/”TB” modifiers (1:01), 340B in the news media (4:31), grantee recertification tips (14:13) and ongoing challenges working 340B ESP (18:39). Later in the episode, they are joined by Victoria Ferris of OptumRx and Thatcher Sloan of RxBenefits to discuss pharmacy benefit strategy as an underappreciated opportunity in the 340B space (26:23).

This show was one of the most popular episodes in the past 12 months. So, here it is again for your listening pleasure. Mostly this whole episode is about the so-called “Big Three” PBMs that provide between the three of them pharmacy benefit services for 95% of insured Americans. PBM stands for pharmacy benefit manager, and the Big Three PBMs being ESI, otherwise known as Express Scripts; OptumRx, which is a part (a big profitable part) of UnitedHealth Group; and then also CVS. Yes, CVS is not just for your retail pharmacy needs; they are also a huge pharmacy benefit manager. Now, we get to the GoodRx part of our story. If you don't know how GoodRx works, I would strongly encourage you to go back and listen to “An Expert Explains” with Dr. Ge Bai from last year (AEE13). That said, here's the super short semi-reductive version to keep us all level set here. If you already know how GoodRx works, you can skip forward about four minutes. So, first of all, let's all understand that GoodRx's business model only exists because the pharmacy supply chain dominated by these three big PBMs that we just talked about is such a cluster. GoodRx profits from that dysfunction. So, as I said, here's the short version of how they do that. It all hinges on so-called spread pricing, and this is what I mean by that. Patient goes into pharmacy with a prescription for generic drug X. The patient has insurance—good news! Pharmacist checks the computer and sees that this patient should be charged, I don't know, $50 for drug X. The patient's insurance carrier picks up, say, $30 of the $50 cost; and the patient is left with, say, a co-pay of $20. Who did that little math there in the computer? The PBM (the pharmacy benefit manager) did that math. That's their thing, these PBMs. They adjudicate claims. That's what this math is called. Anybody who goes into a pharmacy with a prescription, it's the PBM on the back end who figures out how much the patient owes and how much their insurance will pay and what the patient responsibility is, etc. Goodness, you might say. How much are the PBMs being paid to perform this useful service? Turns out, it's free. That's right … the Big Three PBMs do all this adjudication for free. No charge to plan sponsors. Isn't that nice? Except it's actually not free if you dig into it. The PBM is certainly getting paid by means of arbitrage. They're taking a little something something out of the middle of every single transaction. Here's what that looks like in the example aforementioned. Recall the patient's insurance paid $30, and the patient themselves paid $20. The question is, how much did that drug cost the PBM? Remember, that's commerce: Buy low, sell high, and all that. You buy something, and then you sell it for more than you bought it for. OK, so we're talking about a generic drug here. They're cheap (usually). So, let's just say drug X costs, I don't know, $5. The PBM pays the pharmacy $5 for that generic script—and you can see how much money the PBM just made right there. The patient and their plan sponsor got charged $50, and the PBM's cost of goods was $5. Multiply that profit margin by the billions of generic prescriptions in this country that run through insurance, and you have a tidy little business model there. UHG, the parent company of OptumRx, made $24 billion in profit in 2021. Not all of that was from generic drug arbitrage (ie, taking advantage of spread pricing), but some of it was. And $24 billion is an awfully big amount when you consider whose paychecks all those pennies were lifted from. PBM services are anything but free. PBMs are collecting massive windfalls in the so-called spread between what the patient and the plan pay and what the PBM is actually buying those drugs for. Here's another wrinkle: When a PBM contracts with a pharmacy, part of their contractual terms is that the pharmacy's list price for drugs cannot be lower than a certain amount usually having something to do with the PBM's rates. So, pharmacy list prices become artificially high as a result, meaning that cash-pay patients who just wander into a pharmacy and try to pay cash pay an artificially high price. Into this mess swoops GoodRx with a killer idea. They see all that money on the table that PBMs are cleaning up in that spread. They want a piece of that action. And in the beginning, PBMs were fully on board with this. They were fully on board because the market GoodRx was going after was the uninsured market, meaning untapped turf for PBMs. And because PBMs make so much money off of each transaction, PBMs are always hungry for more transactions (the Big Three PBMs, anyway). They love more transactions. The more more more with the transactions, the more more more with the money. So, GoodRx goes to the PBMs and says, “Hey … if a cash-pay patient shows up in a pharmacy, what price would you charge them for you to adjudicate that claim? You know how much money you have to pay the pharmacy, so what can the patient price be? What spread are you willing to accept? GoodRx will take a little off the top, but you can keep your spread on this new frontier of patients that you haven't historically had access to because … uninsured. Oh, by the way, we, GoodRx … we're gonna go around to all your competitors, too (just saying)—the other two PBMs—and we're gonna show their prices, too, in our GoodRx app at different pharmacies. So, you're gonna have to compete with other PBMs in this model.” This is why GoodRx cash prices for generics are so very very often less than what the patient will pay if they use their insurance. In the GoodRx app, PBMs have competition. So, by not using their insurance, patients often pay less for generic drugs—which, by the way, are 90% of the scripts written in this country—and also, as an added bonus, patients don't have to jump through all the weird and arduous prior auths or step therapies or other hurdles that a PBM might toss in the mix. So, from a patient perspective, using GoodRx could save money, save time, and you could get your drugs faster because you don't have to wait around for some prior auth to go through. But this was not what PBMs had originally thought they were signing up for. They were working with GoodRx to gain new market share from the uninsured market, not lose market share to more and more patients forgoing their insurance, meaning forgoing shelling out to the PBM their spread on the transaction. Cue my conversation today with Dr. Ge Bai. Ge Bai, PhD, CPA, is a professor of accounting at Johns Hopkins Carey Business School and a professor of health policy and management at Johns Hopkins Bloomberg School of Public Health. In this healthcare podcast, Ge Bai and I discuss the reactions of the Big Three PBMs to consumers getting all consumer-y when it comes to buying their generic drugs—despite the fact that, in my interview with Dr. Sunita Desai (EP334), she said that studies have shown that 67% of patients are unaware that they might be able to get a better price by not using their insurance and shopping around on GoodRx or Amazon or at a cost-plus pharmacy like Blueberry in Pittsburgh or Mark Cuban's new thing. Despite that, it means 33% (one-third) of patients are aware that they can price shop and potentially get a better price not using their insurance on generic drugs; and apparently, it's making some people at some PBMs nervous. Check the ESI (Express Scripts) blog post about their new prescription benefit that automatically applies discounts. Hmmm … sounds like a defensive play to me? What do we make of this? That's my first question to Dr. Ge Bai in this episode. Also, if you're really intrigued by generic drug goings-on, go back and listen to the show with Dr. Steven Quimby (EP344) when you have a chance. It's about the high cost of generic drugs, and we go deep into supply chain machinations.   You can learn more on Ge's Web site at Johns Hopkins University. You can also connect with her on LinkedIn. Ge Bai, PhD, CPA, is professor of accounting at the Johns Hopkins Carey Business School and professor of health policy and management at the Johns Hopkins Bloomberg School of Public Health. She is an expert on healthcare pricing, policy, and management. Dr. Bai has testified before the House Ways and Means Committee, written for the Wall Street Journal, and published her studies in leading academic journals such as the New England Journal of Medicine, JAMA, JAMA Internal Medicine, Annals of Internal Medicine, and Health Affairs. Her work has been widely featured on ABC, CBS, NBC, Fox News, CNN, and NPR and in the Los Angeles Times, New York Times, Wall Street Journal, Washington Post, and other media outlets and used in government regulations and congressional testimonies.   08:39 What is ESI doing by automatically applying discounts to generic drugs? 09:53 Why are PBMs losing money when consumers don't use their benefit? 10:40 “GoodRx disrupted the ongoing game.” 10:58 How are PBMs using the Amazon discount card to discourage their patients from moving away from using their benefits? 12:07 Amazon pricing versus GoodRx pricing. 12:44 How much money is a PBM really making? 13:54 EP344 with Steven Quimby, MD. 14:24 EP334 with Sunita Desai, PhD. 14:37 How is future fear playing into the PBM business model? 16:49 Is there a negative consequence to subtracting from the bottom line in a PBM model? 17:44 “I think to have strong PBMs does not mean necessarily bad things for patients.” 19:33 What happens if everyone uses Amazon for drugs? 22:33 If every PBM gets their own discount cards, what will happen? 25:32 “We are actually witnessing a potential sea change.” 26:19 How do cost-plus pharmacies factor into the current market? 29:09 Is a profit shortfall inevitable? 29:28 “PBMs have to give a slice of their profit back to consumers. That's just reality.” 30:05 Can anything be done on the PBM side to generate a higher margin in the generic space? 31:34 “Naive plan sponsors are a big problem.” You can learn more on Ge's Web site at Johns Hopkins University. You can also connect with her on LinkedIn.   @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing What is ESI doing by automatically applying discounts to generic drugs? @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing Why are PBMs losing money when consumers don't use their benefit? @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing “GoodRx disrupted the ongoing game.” @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing How are PBMs using the Amazon discount card to discourage their patients from moving away from using their benefits? @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing Amazon pricing versus GoodRx pricing. @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing How much money is a PBM really making? @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing How is future fear playing into the PBM business model? @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing Is there a negative consequence to subtracting from the bottom line in a PBM model? @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing “I think to have strong PBMs does not mean necessarily bad things for patients.” @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing What happens if everyone uses Amazon for drugs? @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing If every PBM gets their own discount cards, what will happen? @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing “We are actually witnessing a potential sea change.” @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing How do cost-plus pharmacies factor into the current market? @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing Is a profit shortfall inevitable? @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing “PBMs have to give a slice of their profit back to consumers. That's just reality.” @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing Can anything be done on the PBM side to generate a higher margin in the generic space? @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing “Naive plan sponsors are a big problem.” @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing Recent past interviews: Click a guest's name for their latest RHV episode! Dave Dierk and Stacey Richter (INBW37), Merrill Goozner, Betsy Seals (EP387), Stacey Richter (INBW36), Dr Eric Bricker (Encore! EP351), Al Lewis, Dan Mendelson, Wendell Potter, Nick Stefanizzi, Brian Klepper (Encore! EP335), Dr Aaron Mitchell (EP382), Karen Root, Mark Miller, AJ Loiacono, Josh LaRosa, Stacey Richter (INBW35), Rebecca Etz (Encore! EP295), Olivia Webb (Encore! EP337), Mike Baldzicki, Lisa Bari, Betsy Seals (EP375), Dave Chase, Cora Opsahl (EP373), Cora Opsahl (EP372), Dr Mark Fendrick (Encore! EP308), Erik Davis and Autumn Yongchu (EP371), Erik Davis and Autumn Yongchu (EP370), Keith Hartman

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If you are looking for the most egregious profiteering and fleecing of American consumers of healthcare, there is no better example than that of the giant industry of middlemen called pharmacy benefit managers – PBMs for short – that are systematically gouging American businesses.  Most people are familiar with the few bad actors in the pharmaceutical industry.  For example, we think of the infamous “pharma bro” Martin Shkrelli that jacked up the price of his company's drugs – and then smirked his way through subsequent court proceedings.  However, the inner workings of the drug pricing game fostered by the non-transparent PBM industry is actually a far worse scenario that it is million times bigger – and more expensive – than the games of the pharma bad actors.  PBMs who collectively manage pharmacy benefits for 266 million Americans, routinely fleece American businesses using clever shell games that are the absolute antithesis of Value-Based Care. But there is good news…there is an upstart PBM – Capital Rx – that provides a more transparent, sustainable, consumer-centric, and ethical model in the administration of pharmacy benefits. Joining us this week is A.J. Loiacono, the CEO and co-founder of Capital Rx.  A.J.'s company is the fastest-growing healthcare company in the country, serving more than one million lives across its customer base of payor entities, employers, unions, health systems, and municipalities. It grew by 400% in 2020 and doubled in size in 2021.  Capital Rx are the “good guys” in the PBM industry – they offer a pharmacy benefits spending platform that links providers, patients, pharmacies and plans to bring cost-effective care to employers and their workforce. On average, Capital Rx saves its clients 27% on drug costs, mainly by refusing to use the industry standard model for drug costs: average wholesale price. As a result, Capital Rx has achieved a 96 NPS score, compared to the industry average of 14 in healthcare. A.J. is a visionary leader in the health value movement and was recently named an Entrepreneur Of The Year® 2022 New York Award finalist by Ernst & Young. Under A.J.'s leadership, Capital Rx is modernizing our healthcare infrastructure to reduce costs and deliver superior care, and they have the highest satisfaction scores in the industry. In this episode, A.J. provides you with an unfiltered perspective on our need to reimaging pharmacy benefits in our country. Episode Bookmarks: 01:30 Pharmacy Benefit Managers (PBMs) – the traditional PBM model is an egregious example of healthcare profiteering and consumer fleecing 02:00 The drug pricing game and non-transparent PBM industry has a far worse negative impact on society than “bad acting” in Big Pharma 02:30 Introduction to A.J. Loiacono and Capital Rx (the “good guys” in the PBM industry) 04:30 Prescription drugs are the fastest growing healthcare expenditure and consistently outpace other health spending. 05:30 Some employers devoting >30% of their health plans' total cost of care on pharma! 06:00 Half of patients with chronic conditions take their medications as prescribed due to high drug costs. 07:45 The slow compounding effect of incremental drug price increases year over year 08:00 The higher base of drug prices in the US (compared to other nations) and how R&D is recouped by fleecing American consumers 08:30 The opaque and inefficient PBM industry as another reason for escalating prescription drug costs 09:00 Consultant and broker compensation models are misaligned with goals of cost containment. 09:30 The three largest PBMs (CVS Caremark, Express Scripts, and OptumRx) manage 80% of all prescriptions and provide no transparency. 10:00 PBMs are making sick profits from rebates and “the billing spread” 11:00 A.J. provides a comprehensive explanation of what a PBM really does and why they are more than just middlemen 13:30 “PBMs are a problem because of the non-transparent pricing model they use – not because of the inv...

What's the bigger news coming out of Capital Rx: that the next-gen PBM just closed a $106 million dollar Series C? Or, that the health tech startup's business model has expanded significantly over the past 18 months, from PBM-only to PBM-plus-PBA, meaning that instead of just servicing the pharmacy benefits management needs of employer groups directly, that now they're also adding to their business by selling THEIR TECH to other carriers and health systems so they can use it to administrate their benefits plans?? Capital Rx's CEO AJ Loiacono takes those questions in stride, lets us in on which “side” of the business fueled their 200% year-over-year growth in 2021, and gives us the details on that tech that his business developed and why its standout compared to the inefficient infrastructure that currently exists to administrate and process pharmacy claims. The big deal here is that AJ and team are tackling one of the biggest friction points in the cost of pharmacy benefits: the cost to administer a plan. They reduce that cost, and the “net cost” of every drug is reduced. AJ says its in this way that Capital Rx operates at one-seventh the cost of his competitors, the “Big Three PBMs” (CVS's Caremark, Express Scripts, and UnitedHealth's OptumRx) and saves its customers an average 27% on their prescription drug spend. Now that Capital Rx has their slick enterprise software, will the business continue to operate a dual PBM-plus-PBA model, or will they double-down on the PBA side? AJ lets us know what's next and (spoiler alert) it sounds like things might go in a surprising direction. If Capital Rx's software is so effective at doing all the things it takes to manage pharmacy claims -- underwriting sequences, implementation management and onboarding, communication, patient portals, network management, reimbursement networks, eligibility checks, etc. – what stops Capital Rx from processing other kinds of healthcare claims? Is a step into the medical claims processing side of the healthcare world on the roadmap? Tune in and find out! * Jessica DaMassa, the emerging ‘It girl' of health tech interviewing, chats it up with the ‘who's who' of the health tech and healthcare innovation set on 'WTF Health - What's the Future, Health?' Catch 100's of interviews with leading health tech startups and the VC investors, health insurance companies, big pharma co's, and hospital systems helping bring their new ideas into the healthcare establishment. From AI and Big Data to digital health, virtual care, telehealth, digital therapeutics, payment model innovation, and investing, Jessica helps you spot the trends and figure out what's next.

The recently signed gun law, S. 2938: Bipartisan Safer Communities Act, contained a surprise dingleberry postponing a regulation designed to save seniors money on their pharmaceutical drugs by prohibiting kickbacks to an industry few have heard of: Pharmacy Benefit Managers (PBMs). This little-known but extremely powerful industry deserves much of the blame for ever rising prescription drugs costs in the United States. In this episode, Jen gives you the scoop on PBMs and how they make their money at the expense of Americans who are most dependent on medications. Please Support Congressional Dish – Quick Links Contribute monthly or a lump sum via PayPal Support Congressional Dish via Patreon (donations per episode) Send Zelle payments to: Donation@congressionaldish.com Send Venmo payments to: @Jennifer-Briney Send Cash App payments to: $CongressionalDish or Donation@congressionaldish.com Use your bank's online bill pay function to mail contributions to: 5753 Hwy 85 North, Number 4576, Crestview, FL 32536. Please make checks payable to Congressional Dish Thank you for supporting truly independent media! View the shownotes on our website at https://congressionaldish.com/cd255-pharmacy-benefit-managers-pbms We're Not Wrong Berlin Meetup Contact Justin at WereNotWrongPod@gmail.com Background Sources Recommended Congressional Dish Episodes CD134: The EpiPen Hearing US Healthcare Landscape Jessi Jezewska Stevens. Apr 23, 2020. “A Brief History of the Great American Healthcare Scam.” Bookforum. Tanza Loudenback. Mar 7, 2019. “The average cost of healthcare in 21 different countries.” Insider. Chuck Grassley and Ron Wyden. 2019. “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug [Staff Report].” U.S. Senate Finance Committee. “Health Insurance Coverage of the Total Population.” Kaiser Family Foundation. Sara R. Collins and David C. Radley. Dec 7, 2018. “The Cost of Employer Insurance Is a Growing Burden for Middle-Income Families.” The Commonwealth Fund. PBMs What are PBMs? JC Scott. Jun 30, 2022. “Drug manufacturers are root cause of high drug costs; PBMs drive costs down.” The Hill. Zach Freed. Jun 22, 2022. “The Pharmacy Benefit Mafia: The Secret Health Care Monopolies Jacking Up Drug Prices and Abusing Patients and Pharmacists.” American Economic Liberties Project. Adam J. Fein. Jun 22, 2021. “The Top Pharmacy Benefit Managers of 2020: Vertical Integration Drives Consolidation (rerun).” Drug Channels. “Flash finding: How drug money from sick people really works.” Nov 11, 2021. 46brooklyn. Adam J. Fein. Feb 3, 2019. “Don't Blame Drug Prices on ‘Big Pharma.'” The Wall Street Journal. How PBMs Make Money “DIR Fees.” National Association of Chain Drug Stores. “How PBMs Make Money: PBM Practices & Profits.” RxSafe. True North Political Solutions. Oct 25, 2017. “White Paper: DIR Fees Simply Explained.” Pharmacy Times. ACA “Vertical Integration” Loophole Peter High. Jul 8, 2019. “A View From Inside Cigna's $67 Billion Acquisition Of Express Scripts.” Forbes. Angelica LaVito. Nov 28, 2018. “CVS creates new health-care giant as $69 billion merger with Aetna officially closes.” CNBC. David Dayen. Oct 12, 2018. “Why the Aetna and CVS Merger Is So Dangerous.” The American Prospect. Jeff Byers. April 12, 2018. “Optum a step ahead in vertical integration frenzy.” Healthcare Dive. Graph: Optum opens up wider market for UnitedHealth Group Graph: Optum's pharmacy business contributes the majority of its revenue Susan Morse. May 10, 2017. “Secret weapon: UnitedHealth's Optum business is laying waste to old notions about how payers make money.” Healthcare Finance. Lobbying “Client Profile: Pharmaceutical Care Management Assn.” Open Secrets. The Demise of Independent Pharmacies Christine Blank. Oct 17, 2019. “Independents Prepare to Close Up Shop.” Drug Topics. Paulina Firozi. Aug 23, 2018. “The Health 202: Here's why rural independent pharmacies are closing their doors.” The Washington Post. What Is a Formulary? Ana Gascon Ivey. May 19, 2020. “A Guide to Medication Formularies.” GoodRx. Previous Delays in Rebate Regulation Paige Minemyer. Jan 29, 2021. “In a win for PBMs, Biden administration delays rebate rule.” Fierce Healthcare. Paige Minemyer. Jan 12, 2021. “PCMA sues Trump administration over rebate rule.” Fierce Healthcare. “Incorporating the Effects of the Proposed Rule on Safe Harbors for Pharmaceutical Rebates in CBO's Budget Projections—Supplemental Material for Updated Budget Projections: 2019 to 2029.” May 2019. Congressional Budget Office. The Gun Law Passage Process Office of the Clerk. May 18, 2022. “Roll Call 212 | Bill Number: S. 2938.” U.S. House of Representatives. Tampa Bay Times Editorial Board. May 12, 2022. “Republican lawmakers should be ashamed for failing to honor Justice Joseph Hatchett.” Miami Herald. Annie Karni. Apr 12, 2022. “House G.O.P., Banding Together, Kills Bid to Honor Pioneering Black Judge.” The New York Times. Background on Most Important Provisions Mary Katherine Wildeman. May 26, 2022. “Data show most school shootings carried out by young adults, teens.” CT Insider. Jeffrey Pierre. May 26, 2022. “Experts say we can prevent school shootings. Here's what the research says.” NPR. The Dingleberry Erik Sherman. Jun 30, 2022. “Gun Safety Bill Extends Drug Middlemen Protection From Anti-Kickback Measure.” Forbes. Molly Rutherford. Jun 28, 2022. “Gun legislation provision puts drug supply chain profits over patients.” The Hill. Marty Schladen. Jun 22, 2022. “Deep inside the gun bill: a break for prescription drug middlemen.” Iowa Capital Dispatch. Poland Train Station Taylor Popielarz, Maureen McManus and Justin Tasolides. Mar 25, 2022. “‘The help given is remarkable': Inside the Poland train station that's become a hub for Ukrainian refugees.” Spectrum News NY1. The Law and the Regulation S. 2938: Bipartisan Safer Communities Act Senate Vote: 65-33 (All Nos GOP) House Vote: 234-193 (All Nos GOP) Jen's Highlighted PDF of S. 2938: Bipartisan Safer Communities Act Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees U.S. Health and Human Services Department November 30, 2020 Audio Sources The State of Competition in the Pharmacy Benefits Manager and Pharmacy Marketplaces November 17, 2015 House Committee on the Judiciary Witnesses: Bradley J. Arthur, R.Ph., Owner, Black Rock Pharmacy David Balto, Law Offices of David A. Balto PLLC Amy Bricker, R.Ph. Vice President of Retail Contracting & Strategy, Express Scripts Natalie A. Pons, Senior Vice President and Assistant General Counsel, CVS Health Clips 53:48 Bradley Arthur: The Big Three PBMs control almost 80% of the entire market and these PBMs have the upper hand both in negotiating the contract with the payer, as well as strongly influencing the actual plan design itself. The PBM industry typically states that they can use their economic power to harness enhanced market efficiencies, but for whom? However, the staggering annual revenues that continue to grow each year of the big three suggests that these efficiencies are going directly to their corporations' bottom lines. Small community pharmacies like mine are faced on a daily basis with the impact of the PBMs' disproportionate market power. Community pharmacies routinely must agree to take-it-or-leave-it contracts from the PBMs just to continue to serve our long-standing patients. As if that weren't enough, the PBMs also directly set the reimbursement rates for pharmacies, the very same pharmacies that stand in direct competition of some of these PBM-owned mail-order and specialty pharmacies. Therefore, it comes as no surprise that the PBMs present employer and government payers with carefully tailored suggested plans designs that steer beneficiaries to these PBM-owned entities. Drug Pricing in America: A Prescription for Change, Part I January 29, 2019 Senate Committee on Finance Witnesses: Kathy Sego, Mother of a Child with Insulin-Dependent Diabetes Douglas Holtz-Eakin, Ph.D., President, American Action Forum Mark E. Miller, Ph.D., Vice President of Health Care, Laura and John Arnold Foundation Peter B. Bach, MD, MAPP, Director, Memorial Sloan Kettering Center for Health Policy and Outcomes Clips 1:57:30 Sen. John Cornyn (R - TX): Can anybody on the panel explain to me why we have a general prohibition against kickbacks — they call them rebates — under the Social Security Act, but we nevertheless allow it for prescription drug pricing? What's the sound public policy reason for excluding prescription drug pricing from the anti-kickback rule under federal law? Douglas Holtz-Eakin: I can't explain that and won't pretend to. [laughter] Sen. Cornyn: I thought I was the only one who didn't understand the wisdom of that. Well, it's not a transparent arrangement and it does produce upward pressure on drug prices. And obviously, the negotiations between the PBM and the pharma in terms of what the net cost is, is not transparent, nor is it delivered to the consumer. Is it Dr. Miller? Dr. Bach? Peter Bach: It's delivered to the consumer indirectly through the reduction of the total cost of the benefit, but it is not delivered to the actual consumer using the drug, and that is a disassociation, that is a problem. Because it essentially reverses the structure of insurance. Lowering the total costs are people who use it the least, and raising the costs are people who use it the most, relative to if you allowed the rebate to be used at the point of sale, including all discounts. 1:59:49 Douglas Holtz-Eakin: If we had the negotiation be about the upfront price, so instead of a high list price and a rebate, you just negotiate a lower price, that would be the price that Ms. Sego would pay and insurance companies would look at that and say, okay, she's not paying as much as she used to, we're going to have to make up that money somewhere else and they might raise premiums. That means that people who don't have extreme insulin drug costs would pay a little bit more in a premium every month, and people who have extremely devastating medical conditions and high health care costs would get less costs. That's exactly what insurance is supposed to do. And so the rebate system is more than giving strange incentives on pricing. It's undercutting the purpose of insurance in general. Drug Pricing in America: A Prescription for Change, Part II February 26, 2019 Senate Committee on Finance Witnesses: Richard A. Gonzalez, Chairman and Chief Executive Officer, AbbVie Inc. Pascal Soriot, Executive Director and Chief Executive Officer, AstraZeneca Giovanni Caforio, M.D., Chairman of the Board and Chief Executive Officer, Bristol-Myers Squibb Co. Jennifer Taubert, Executive Vice President, Worldwide Chairman, Janssen Pharmaceuticals, Johnson & Johnson Kenneth C. Frazier, Chairman and Chief Executive Officer, Merck & Co., Inc. Albert Bourla, DVM, Ph.D., Chief Executive Office, Pfizer Olivier Brandicourt, M.D., Former Chief Executive Officer, Sanofi Clips 1:22:03 Albert Bourla: Adverse incentives that favor higher cost biologics are keeping biosimilars from reaching patients. In many cases, insurance companies declined to include lower cost biosimilars in their formularies because they would risk losing the rebates from covering higher cost medicines. I can't think of a more concerning example of a broken system and we need to do something about it. 1:33:35 Sen. Chuck Grassley (R - IA): So many of you have voiced support for the recent rebate rule proposed by the administration. Should the administration finalized this rule, will you commit to lowering your drug prices? Richard Gonzalez [CEO, AbbVie]: Mr. Chairman, we are supportive of the rule. We'd like to see it in its final form, obviously, to make a final decision, but we are supportive of taking the discount to the patient at the point of sale. Sen Grassley: Okay. AstraZeneca? **Pascal Soriot [CEO, AstraZeneca]**The same for us Senator, I would go one step further: if the rebates were removed from the commercial sector as well, we will definitely reduce our list prices. Sen Grassley: Okay. And Bristol? Giovanni Caforio [CEO, Bristol-Myers Squibb]: We have the same positions. Sen Grassley: Okay. Johnson and Johnson? Jennifer Taubert [EVP, J&J]: Yes, we're supportive, and that definitely would be my goal. We would just need to see the final legislation, provided that there aren't additional fees that are added into the system to compensate for the rebates. Sen Grassley: Merck? **Kenneth C. Frazier: I would expect that our prices would go down if we change the system. Again, on the commercial side as well as the Medicare side. Sen Grassley: Okay, Pfizer? Albert Bourla [CEO, Pfizer]: It is a very clear intention that we will not keep a single dollar from these rebates. We will try to move every single penny to the patients and we think if this goes also to the commercial plants that will be even better for more patients. Sen Grassley: Okay. Sanofi? Olivier Brandicourt [Former CEO, Sanofi]: Lowering list price has to be linked to better access and affordability at the counter for the patients. 1:35:20 Sen. Ron Wyden (D - OR): Is it correct that your company, and nobody else, sets the starting price for all drugs sold by Pfizer? Yes or no? Albert Bourla: It is a negotiation with PBMs and they are very powerful. Sen. Wyden: But you still get to set the list price? Albert Bourla: Yes, but we set this price and the rebate limit(?). 1:35:40 Sen. Ron Wyden (D - OR): Is it correct, when a hypothetical patient, let's call her Mrs. Jones, goes to pay for her drug at the pharmacy counter, her coinsurance is based on the price of the drug you set? Albert Bourla: It is correct in many cases. Sen. Wyden: Okay. I just want you all to know that the number one reason consumers are getting hammered, is because these list prices, which you have the last word with respect to where they are, are unaffordable. And the high prices are tied to what the consumer pays at the pharmacy counter. And all this other stuff you talk about, the rebates and the discounts and the coupons, all this other stuff is window dressing, all of that. And the fact is on Part D, 40% of the drugs don't even have a rebate. So I want it understood, particularly because I've asked you, Mr. Borla, I think you and others in the industry are stonewalling on the key issue, which is actually lowering list prices. And reducing those list prices are the easiest way for American consumers to pay less at the pharmacy counter. 2:12:45 Sen. Thomas Carper (D-DE): First is eliminating rebates to PBMs. That's the first one, eliminating rebates to PBMs. The second is value based arrangements. And the third is increasing transparency industry-wide on how you set your prices. 2:13:20 Richard Gonzalez: We clearly support providing the discount at the patient level, eliminating rebates essentially. 2:14:10 Pascal Soriot: If the rebates, as I said earlier, were to be removed from Part D and the commercial sector, we would actually reduce our list prices. 2:15:10 Giovanni Caforio: I would say that not only do we support all three elements that you mentioned, but I do believe those three elements together with the continued effort to develop a generic and biosimilar market would mean significant change, and would clearly alleviate the concerns that patients have today. 2:14:44 Jennifer Taubert: We are very supportive of all three elements that you outlined 2:15:52 Kenneth Frazier: We too support all three. 2:15:55 Albert Bourla: All three elements are transformational for our industry, will disrupt it. However, we do agree that these are the three things that need to be done and also I believe that will have significant meaningful results if we do. 2:16:10 Olivier Brandicourt: We support the three Senator, but we want to keep in mind at the end of the chain the patient has to benefit, so if rebates are removed it has to be to the benefit of patients. Sen. Thomas Carper (D-DE): Good, thanks. 2:18:10 Albert Bourla: 50% of the American people are in commercial plans and these rebate rules apply to Medicare. If the rules apply to all, definitely the list price will go down. 2:18:30 Albert Bourla: The list price is not irrelevant, it's very relevant for a lot of people because they have to pay list price during the deductible period. However if the rebate rule is applied, then they become irrelevant because the patients will not be paying the list price at the purchase point. 2:19:10 Sen. John Thune (R-SD): How would manufacturers respond if the rebate rule were finalized for government programs? I mean, what does that what does that mean for the commercial market? Albert Bourla: Senator, as I said before, all these proposals that they're discussing, [undistinguishable], eliminating the rebate rule, are transformational and will disrupt the way we do business. I don't know exactly how the system will evolve, and I really don't favor a bifurcated system. I would like to have a transparent single system across both parts. So we need to see how the whole thing will evolve. 2:25:26 Johnny Isakson (R-GA): Who sets the discount and who sets the rebate? 2:26:20 Richard Gonzalez: We negotiate with payers, so managed care and PBMs— Sen. Johnny Isakson (R-GA): You're a supplier though, so you have to go negotiate with the PBMs and those people, is that right? Richard Gonzalez: Correct, and they negotiate aggressively. Sen. Isakson: Is that pretty much true with everybody, that they're the major component between the end retail consumer price and the origin of the product? Richard Gonzalez: Yes, Senator. Sen. Isakson: Well, that seems like that's someplace we ought to focus, because that's where the distorted numbers come in. Johnson & Johnson, Janssen, in your testimony, you talked about your average list price of 8.1%, up, but an average net price change of only 4.6%. So while your gross went up 8.6, your net went down 4.6 In the same pricing period. How does that happen? If you're setting the price, how does it not go up on the bottom? Jennifer Taubert: Yeah, and in fact, in 2018, our net price actually declined 8.6%, so even more than that. The intermediaries in the system are very, very effective negotiators— Sen. Isakson: Tell me who the intermediaries are. Jennifer Taubert: Those would be the PBMs and the insurers. Sen. Isakson: …and the insurance companies? Jennifer Taubert: Right, and they set the formularies for patients. Sen. Isakson: And they're not the same. They're two different people? Jennifer Taubert: Yes, correct. 2:40:45 James Lankford (R-OK): All of you have mentioned the rebate issue has been a problem and that insurance companies and PBMs are very effective negotiators. Part of the challenge of this is, health insurance companies pay their PBM based on the quality of their negotiation skills, cutting a price off the list price. And so if a list price is higher and a rebate is higher, that also gives preference to them. So the difficulty is, as you raise list price, and the rebate gets larger, the insurance company gives that preference, making it harder for biosimilars. Am I tracking this correctly? 2:43:00 Albert Bourla: Here in the US, the penetration of biosimilars is much lower than in other places, but it is disproportional to different parts of the US healthcare system. For example, in open systems, systems where the decision maker it is a PBM, the one biosimilar we have has a market share of 5% in the US. In closed systems, in systems like Kaiser, for example, integrated healthcare systems where the one who decides has the whole cost of the healthcare system in its interest, we have 73%. 5% and 73% for the same product. I agree with what Mr. Fraser said that we need to create incentives, but I would add also that we need to break this rebate trap that creates significant disincentives for providers, and the healthcare system, and insurance companies. 3:19:25 Kenneth Frazier: If you went back a few years ago, when we negotiated to get our drugs on formulary, our goal was to have the lowest copay by patients. Today the goal is to pay into the supply chain the biggest rebate, and so that actually puts the patient at a disadvantage since they're the only ones that are paying a portion of the list price. The list price is actually working against the patient. 3:19:50 Sen. Steve Daines (R-MT): Why do we have a system today? Where you all are setting, I'll just say very, very high list prices, which is the starting point for negotiation. Why? Olivier Brandicourt: Senator, we're trying to get formulary position. With those list prices. High list price, high rebates. It's a preferred position. Unfortunately the preferred position doesn't automatically ensure affordability at the end. Kenneth C. Frazier: Senator, If you bring a product to the market with a low list price in this system, you get punished financially and you get no uptake because everyone in the supply chain makes money as a result of a higher list price. Drug Pricing in America: A Prescription for Change, Part III April 9, 2019 Senate Committee on Finance Witnesses: Steve Miller, MD, Former Executive Vice President and Chief Clinical Officer, Cigna Corporation Derica Rice, Former Executive Vice President and President, CVS Health and CVS Caremark William Fleming, Pharm.D., Segment President, Healthcare Services, Humana Inc. John Prince, Chief Executive Officer, OptumRx Mike Kolar, JD, Interim President & CEO, Senior Vice President and General Counsel, Prime Therapeutics LLC Clips Sen. Ron Wyden (D - OR): Pharmaceutical Benefit Managers first showed up decades ago, back when prescription drugs were being utilized more extensively. The PBMs told the insurance companies, “we're the ones who know drug pricing, we will handle the negotiations for you.” But there is little evidence that the pharmaceutical benefit managers have actually held down the prices in a meaningful way. In fact, most of the evidence shows just the opposite. Pharmaceutical Benefit Managers actually make more money when they pick a higher price drug over a lower price drug. Colleagues, let's remember that all the way through this discussion, benefit managers make more money when they pick a higher price drug over a lower price drug. The logic on this isn't exactly complicated, graduate-level economics. PBM profits are based on taking their slice of the prescription-drug pie. More expensive drugs means there's a bigger pie. When there's a bigger pie, [there are] bigger slices for the pharmaceutical benefit managers. 50:24 Mike Kolar: Rebates and the role they play have been key areas of focus in the drug cost debate. In our view, rebates are a powerful tool to offset high prices, which are set by pharmaceutical companies, and pharmaceutical companies alone. The fact that rebates are not offered on many of the highest cost drugs, and that studies show no correlation between prices and rebates underscore that rebates are a key to mitigating rather than causing high drug prices. We pass rebates through fully to our plans, and we believe our plans should be able to choose how to apply these rebates in ways that best serve their members and market needs by balancing premiums and cost sharing. 56:05 Sen. Chuck Grassley (R-IA): I'd like to talk about consolidation, including the recent integration of PBMs with insurance companies. Last year I wrote to the Justice Department on the issues, it reported that the three largest PBMs who are before us today now covers 71% of Medicaid, Medicare Part D enrollees and 86% of standalone Drug Plan enrollees. 57:45 Derica Rice: This is a highly competitive space. In addition to the three that you've pointed out here, CMS has noted there are over 60 PBMs across the US. Therefore, the competition, there's many options for the employers that are out there, government entities, as well as unions to choose from given their specific needs. 1:10:35 Sen. Debbie Stabenow (D-MI): So when we look at Express Scripts has 100 million Americans covered, CVS 90 million, OptumRx 65 million, Prime Therapeutics 27 million, Humana 21 million, and yet Americans still pay the highest prices in the world. Even though you are negotiating for millions of people. The VA has its own pharmacy benefit manager service, they negotiate for 9 million veterans, and they pay, on average, 40% less for the same drugs that the rest of the healthcare system pays for. Despite greater volume, you are unable to secure these kinds of low prices. With all due respect, you guys are pretty bad negotiators. Given the fact that the VA can get 40% less. And so I'd like to know from each of you why that's the case. Dr. Miller? Steve Miller [Former EVP and Chief Clinical Officer, Cigna Corporation]: Yes. Part of the equation is giving patients choice. At the VA, they actually limit their formulary more than any of us at this table do. So oftentimes, they'll have one beta blocker, one ace inhibitor. And so if it's going to get to that level of choice, then we could get better prices also. Sen. Stabenow: Let me jump in, in the interest of time. I know you create nationwide drug formularies, you have pre-authorization, you give preferred status to certain medications. So you don't use any of those tools that the VA is using? Because you do. Steve Miller: We definitely use those tools, but we also give people choice. It's crucial for both physicians and patients to have the choice of the products they want to be able to access. Many of our plans want us to have broad formularies and when you have more products, it means you move less market share. Sen. Stabenow: So basically you're saying a 40% premium gives them more choice. 1:24:30 Sherrod Brown (D-OH): If the administration's rebate rule were finalized as proposed, would you in some way be required to change the way you do business? Mike Kolar: Yes, Senator we would. John Prince: Yes. William Fleming: Yes. Derica Rice: Yes. Steve Miller: Yes. Sen. Brown: Thank you. 1:25:05 Sherrod Brown (D-OH): What percentage of prescriptions that you fill across Part D actually receive a rebate? Roughly what percentage? Mike Kolar: So Senator, approximately 8% of the prescriptions that we cover in Part D are associated with a rebate. Sen. Brown: Okay, Mr. Prince? John Prince: Senator, I don't know the exact number, I know our overall business is about 7%. Sen. Brown: Okay, thank you. William Fleming: About 7-8%. Derica Rice: Senator, I do not know the exact number but we pass through 100% of all rebates and discounts. Sen. Brown: [Grunt] Steve Miller: 90% of the prescriptions will be generic. Of the 10% that are branded, about two-thirds have rebates. So it's about seven-- Sen. Brown: 7-8% like the others. Okay. To recap, PBMs do not set drug prices. Forcing you to change the way you do business -- as the administration's rule would — will not change that fact. And while the rule might impact a small percentage of drugs and Part D that receive a rebate, it does nothing to lower costs, as your answer suggests, for the other 90% of prescriptions you fill. Most importantly, absolutely nothing in the proposed rule would require Secretary Azar's former employer or any other pharma company to lower the price of insulin or any other drug. It's important to establish that, so thank you for that. 1:41:40 Catherine Cortez Masto (D-NV): Let me ask you, Dr. Fleming, in your testimony, you say Humana's analysis of the rebate rule -- and we're talking about the administration's rebate rule now — found that approximately 17% of beneficiaries will see savings at the pharmacy counter as a result of this rule. Can you tell me a little bit more about who these people are? And what kind of conditions do they have? William Fleming: Senator, there will be a number of members who are taking brand drugs for which we get rebates and so it could vary all the way from the common chronic conditions, things like diabetes or hypertension or high cholesterol, all the way over to occasionally, not usually, but occasionally on the specialty drug side. When you think of some medications like treatments for rheumatoid arthritis, multiple sclerosis, places where there's competition. Cover Art Design by Only Child Imaginations Music Presented in This Episode Intro & Exit: Tired of Being Lied To by David Ippolito (found on Music Alley by mevio)

It's "In the News.." got a few minutes? Get caught up! Top stories this week: The Federal Trade Commission probes the prescription drug middleman industry, once a week basal insulin moves forward, DIY insuln dosing systems get a thumbs up at ADA Scientific Sessions, Sernova's stem cell system releases great findings and more! Learn more about the T1D Exchange Check out Stacey's book: The World's Worst Diabetes Mom! Join the Diabetes Connections Facebook Group! Sign up for our newsletter here ----- Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners! ----- Episode Transcription Below (or coming soon!) Please visit our Sponsors & Partners - they help make the show possible! *Click here to learn more about OMNIPOD* *Click here to learn more about AFREZZA* *Click here to learn more about DEXCOM* Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and these are the top diabetes stories and headlines of the past seven days. we go live on social media first and then All sources linked up at diabetes dash connections dot com when this airs as a podcast. XX In the news is brought to you by T1D Exchange! T1D Exchange is a nonprofit organization dedicated to improving outcomes for the entire T1D population. https://t1dexchange.org/stacey/ XX The Federal Trade Commission will launch an inquiry into the prescription drug middleman industry.. requiring the six largest pharmacy benefit managers to provide information and records. They're looking at PBMs such as CVS Caremark; Express Scripts, Inc.; OptumRx, Inc.; Humana Inc and more. The largest PBMs are now vertically integrated with the largest health insurance companies and wholly owned mail order and specialty pharmacies. In these roles, pharmacy benefit managers often have enormous influence on which drugs are prescribed to patients, which pharmacies patients can use, and how much patients ultimately pay at the pharmacy counter. https://www.ftc.gov/news-events/news/press-releases/2022/06/ftc-launches-inquiry-prescription-drug-middlemen-industry?utm_campaign=https://www.ftc.gov/news-&utm_content=1654622484&utm_medium=social&utm_source=twitter XX Confirming what many of you have known for years.. an open-source automated insulin delivery system -- also known as a do-it-yourself system -- was both safe and effective for patients with type 1 diabetes. This is from the CREATE trial, designed to test DIY system, presented for the first time at the ADA Scientific Sessions. This system was made up of the OpenAPS algorithm from a version of AndroidAPS implemented in a smartphone, paired with the DANA-i insulin pump and Dexcom G6 continuous glucose monitor. The researchers previously published additional information in the Journal of Diabetes & Metabolic Disorders. https://www.medpagetoday.com/meetingcoverage/ada/99109 XX Stem cell study showing great results. Sernova says the first three patients of six total continue to be insulin independent following treatment. One of the patients has been insulin-free for more than two years, while the other two have been free of the need for medication injections for six months and three months, respectively. At this point, the other three patients in the study have not had the device long enough to determine measurable results. The first three all have A1Cs in a normal, nondiabetic range. Sernova's Cell Pouch is an implantable device that releases the primary donor islets. The device is implanted under the skin in a minimally-invasive procedure. We're talking to Sernova for next week's show; long way to go here but another good result for stem cells. https://www.biospace.com/article/sernova-cell-pouch-device-keeps-type-1-diabetes-patient-insulin-free-for-two-years/ XX Getting closer to once-a-week basal insulin. New study says Novo Nordisk insulin icodec achieved better results than Lantus in some aspects of the study and that overall it was – this is interesting wording – non-inferior. Another previous study showed it also matched well to Tresiba, but that Tresiba caused fewer lows than the once-weekly basal. This study was about type 2 diabetes but insuln icodec is in other trials for people with type 1. https://www.biospace.com/article/novo-nordisk-scores-phase-iii-insulin-win-strengthening-market-position/ XX New partnership between Diabeloop – which makes an automated insulin algorithm - and SOOIL which makes pumps. These are two French companies that have been working together since 2020 but this new announcement was delayed by COVID. They want to bring the product – Diabeloop's DBLG-1 I controller and SOOIL's Dana ACE Pump to the US, Europe and Korea. https://www.drugdeliverybusiness.com/diabeloop-sooil-automated-insulin-diabetes/ XX Civica continues to move ahead with the development of its affordable insulins. They've announced they'll partner with the German company Profil for the clinical trials. Civica plans to set a maximum recommended price to the consumer of no more than $30 per vial and no more than $55 for a box of five pen cartridges. Contingent on FDA approval, Civica anticipates that its insulins will be available for purchase beginning in 2024. https://www.healthcarepackaging.com/supplier-news/news/22262909/civicarx-civica-selects-profil-as-clinical-trial-partner-for-affordable-insulin-initiative XX New study out of Israel shows that obesity in teenagers may lead to type 1 diabetes a few years later. The study, of nearly 1.5 million Israeli teenagers, found that those who were obese were twice as likely to develop type 1 diabetes by young adulthood, versus those in the normal weight range. The senior researcher on the study says it's not clear why obesity would raise the risk of type 1. They think it may the a trigger in people with genetically susceptible. Obesity also has other effects — including vitamin D deficiency and alterations in the gut's bacterial makeup — that could impair immune function. https://www.usnews.com/news/health-news/articles/2022-06-06/obesity-in-teen-years-might-trigger-type-1-diabetes XX Right back to the news in a moment but first we've got a new sponsor. As I mentioned, The T1D Exchange Registry is an online research study, designed to harness the power of individuals with type 1 diabetes. It's a research study conducted online over time, designed to foster innovation and improve the lives of people with T1D. Personal information remains confidential and participation is fully voluntary. Once enrolled, participants will complete annual surveys and have the opportunity to sign up for other studies on specific topics related to T1D. By sharing opinions, experiences and data, patients can help advance meaningful T1D treatment, care and policy Sign up at T1DExchange.org slash Stacey (that's S-T-A-C-E-Y). XX XX XX On this week's long format episode, you'll hear my conversation with Dexcom's CEO Kevin Sayer. We get more information about the G7 launch, after FDA approval of course and I asked him your questions about everything from IOS issues to airport scanners. Next week, Sernova joins me to explain their stem cell pouch technology Listen wherever you get your podcasts That's In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

Ian Ha from Cedar is in the house to share what it takes to build a better financial experience. Does healthcare really have to be so hard? Ian will get into how improving the financial experience can lead more consumers to seek care and stay on top of their health. All that, plus the Flava of the Week about the ex-CEO of OptumRx and his plans to rewire prescription drug delivery. How can we use industry knowledge as a competitive advantage during transformation, rather than an excuse not to do it?  Thanks to Persado for spreading the awesome, yo! Persado provides healthcare organizations with pre-developed, pre-optimized marketing messaging focused on improving health goals and business objectives. (#213)  See omnystudio.com/listener for privacy information.

So … let's start here. Mostly this whole episode is about the so-called “Big Three” PBMs that provide between the three of them pharmacy benefit services for 95% of insured Americans. PBM stands for pharmacy benefit manager, and the Big Three PBMs being ESI, otherwise known as Express Scripts; OptumRx, which is a part (a big profitable part) of United Health Group; and then also CVS. Yes, CVS is not just for your retail pharmacy needs; they are also a huge pharmacy benefit manager. Now, we get to the GoodRx part of our story. If you don't know how GoodRx works, I would strongly encourage you to go back and listen to “An Expert Explains” with Dr. Ge Bai from last year (AEE13). That said, here's the super short semi-reductive version to keep us all level set here. If you already know how GoodRx works, you can skip forward about four minutes.  So, first of all, let's all understand that GoodRx's business model only exists because the pharmacy supply chain dominated by these three big PBMs that we just talked about is such a cluster. GoodRx profits from that dysfunction. So, as I said, here's the short version of how they do that. It all hinges on so-called spread pricing, and this is what I mean by that. Patient goes into pharmacy with a prescription for generic drug X. The patient has insurance—good news! Pharmacist checks the computer and sees that this patient should be charged, I don't know, $50 for drug X. The patient's insurance carrier picks up, say, $30 of the $50 cost; and the patient is left with, say, a co-pay of $20. Who did that little math there in the computer? The PBM (the pharmacy benefit manager) did that math. That's their thing, these PBMs. They adjudicate claims. That's what this math is called. Anybody who goes into a pharmacy with a prescription, it's the PBM on the back end who figures out how much the patient owes and how much their insurance will pay and what the patient responsibility is, etc. Goodness, you might say. How much are the PBMs being paid to perform this useful service? Turns out, it's free. That's right … the Big Three PBMs do all this adjudication for free. No charge to plan sponsors. Isn't that nice? Except it's actually not free if you dig into it. The PBM is certainly getting paid by means of arbitrage. They're taking a little something something out of the middle of every single transaction. Here's what that looks like in the example aforementioned. Recall the patient's insurance paid $30, and the patient themselves paid $20. The question is, how much did that drug cost the PBM? Remember, that's commerce: Buy low, sell high, and all that. You buy something, and then you sell it for more than you bought it for. OK, so we're talking about a generic drug here. They're cheap (usually). So, let's just say drug X costs, I don't know, $5. The PBM pays the pharmacy $5 for that generic script—and you can see how much money the PBM just made right there. The patient and their plan sponsor got charged $50, and the PBM's cost of goods was $5. Multiply that profit margin by the billions of generic prescriptions in this country that run through insurance, and you have a tidy little business model there. UHG, the parent company of OptumRx, made $24 billion in profit in 2021. Not all of that was from generic drug arbitrage (ie, taking advantage of spread pricing), but some of it was. And $24 billion is an awfully big amount when you consider whose paychecks all those pennies were lifted from. PBM services are anything but free. PBMs are collecting massive windfalls in the so-called spread between what the patient and the plan pay and what the PBM is actually buying those drugs for. Here's another wrinkle: When a PBM contracts with a pharmacy, part of their contractual terms is that the pharmacy's list price for drugs cannot be lower than a certain amount usually having something to do with the PBM's rates. So, pharmacy list prices become artificially high as a result, meaning that cash-pay patients who just wander into a pharmacy and try to pay cash pay an artificially high price. Into this mess swoops GoodRx with a killer idea. They see all that money on the table that PBMs are cleaning up in that spread. They want a piece of that action. And in the beginning, PBMs were fully on board with this. They were fully on board because the market GoodRx was going after was the uninsured market, meaning untapped turf for PBMs. And because PBMs make so much money off of each transaction, PBMs are always hungry for more transactions (the Big Three PBMs, anyway). They love more transactions. The more more more with the transactions, the more more more with the money. So, GoodRx goes to the PBMs and says, “Hey … if a cash-pay patient shows up in a pharmacy, what price would you charge them for you to adjudicate that claim? You know how much money you have to pay the pharmacy, so what can the patient price be? What spread are you willing to accept? GoodRx will take a little off the top, but you can keep your spread on this new frontier of patients that you haven't historically had access to because … uninsured. Oh, by the way, we, GoodRx … we're gonna go around to all your competitors, too (just saying)—the other two PBMs—and we're gonna show their prices, too, in our GoodRx app at different pharmacies. So, you're gonna have to compete with other PBMs in this model.” This is why GoodRx cash prices for generics are so very very often less than what the patient will pay if they use their insurance. In the GoodRx app, PBMs have competition. So, by not using their insurance, patients often pay less for generic drugs—which, by the way, are 90% of the scripts written in this country—and also, as an added bonus, patients don't have to jump through all the weird and arduous prior auths or step therapies or other hurdles that a PBM might toss in the mix. So, from a patient perspective, using GoodRx could save money, save time, and you could get your drugs faster because you don't have to wait around for some prior auth to go through. But this was not what PBMs had originally thought they were signing up for. They were working with GoodRx to gain new market share from the uninsured market, not lose market share to more and more patients forgoing their insurance, meaning forgoing shelling out to the PBM their spread on the transaction. Cue my conversation today with Dr. Ge Bai. Ge Bai, PhD, CPA, is a professor of accounting at Johns Hopkins Carey Business School and a professor of health policy and management at Johns Hopkins Bloomberg School of Public Health. In this healthcare podcast, Ge Bai and I discuss the reactions of the Big Three PBMs to consumers getting all consumer-y when it comes to buying their generic drugs—despite the fact that, in my interview with Dr. Sunita Desai (EP334), she said that studies have shown that 67% of patients are unaware that they might be able to get a better price by not using their insurance and shopping around on GoodRx or Amazon or at a cost-plus pharmacy like Blueberry in Pittsburgh or Mark Cuban's new thing. Despite that, it means 33% (one-third) of patients are aware that they can price shop and potentially get a better price not using their insurance on generic drugs; and apparently, it's making some people at some PBMs nervous.   Check the ESI (Express Scripts) blog post about their new prescription benefit that automatically applies discounts. Hmmm … sounds like a defensive play to me? What do we make of this? That's my first question to Dr. Ge Bai in this episode.   Also, if you're really intrigued by generic drug goings-on, go back and listen to the show with Dr. Steven Quimby (EP344) when you have a chance. It's about the high cost of generic drugs, and we go deep into supply chain machinations.    You can learn more on Ge's Web site at Johns Hopkins University. You can also connect with her on LinkedIn. Ge Bai, PhD, CPA, is professor of accounting at the Johns Hopkins Carey Business School and professor of health policy and management at the Johns Hopkins Bloomberg School of Public Health. She is an expert on healthcare pricing, policy, and management. Dr. Bai has testified before the House Ways and Means Committee, written for the Wall Street Journal, and published her studies in leading academic journals such as the New England Journal of Medicine, JAMA, JAMA Internal Medicine, Annals of Internal Medicine, and Health Affairs. Her work has been widely featured on ABC, CBS, NBC, Fox News, CNN, and NPR and in the Los Angeles Times, New York Times, Wall Street Journal, Washington Post, and other media outlets and used in government regulations and congressional testimonies. 08:45 What is ESI doing by automatically applying discounts to generic drugs? 10:00 Why are PBMs losing money when consumers don't use their benefit? 10:46 “GoodRx disrupted the ongoing game.” 11:04 How are PBMs using the Amazon discount card to discourage their patients from moving away from using their benefits? 12:13 Amazon pricing versus GoodRx pricing. 12:50 How much money is a PBM really making? 14:00 EP344 with Steven Quimby, MD.14:29 EP334 with Sunita Desai, PhD.14:43 How is future fear playing into the PBM business model? 16:55 Is there a negative consequence to subtracting from the bottom line in a PBM model? 17:50 “I think to have strong PBMs does not mean necessarily bad things for patients.” 19:39 What happens if everyone uses Amazon for drugs? 22:40 If every PBM gets their own discount cards, what will happen? 25:38 “We are actually witnessing a potential sea change.” 26:25 How do cost-plus pharmacies factor into the current market? 29:16 Is a profit shortfall inevitable? 29:35 “PBMs have to give a slice of their profit back to consumers. That's just reality.” 30:11 Can anything be done on the PBM side to generate a higher margin in the generic space? 31:41 “Naive plan sponsors are a big problem.” You can learn more on Ge's Web site at Johns Hopkins University. You can also connect with her on LinkedIn. @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing What is ESI doing by automatically applying discounts to generic drugs? @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing Why are PBMs losing money when consumers don't use their benefit? @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing “GoodRx disrupted the ongoing game.” @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing How are PBMs using the Amazon discount card to discourage their patients from moving away from using their benefits? @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing Amazon pricing versus GoodRx pricing. @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing How much money is a PBM really making? @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing How is future fear playing into the PBM business model? @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing Is there a negative consequence to subtracting from the bottom line in a PBM model? @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing “I think to have strong PBMs does not mean necessarily bad things for patients.” @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing What happens if everyone uses Amazon for drugs? @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing If every PBM gets their own discount cards, what will happen? @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing “We are actually witnessing a potential sea change.” @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing How do cost-plus pharmacies factor into the current market? @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing Is a profit shortfall inevitable? @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing “PBMs have to give a slice of their profit back to consumers. That's just reality.” @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing Can anything be done on the PBM side to generate a higher margin in the generic space? @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing “Naive plan sponsors are a big problem.” @GeBaiDC of @JohnsHopkins discusses #PBMs on our #healthcarepodcast. #healthcare #podcast #healthcarepricing Recent past interviews: Click a guest's name for their latest RHV episode! Nikhil Krishnan, Shawn Rhodes, Pramod John (EP353), Pramod John (EP352), Dr Eric Bricker, Katy Talento, Stacey Richter (INBW33), Stacey Richter (INBW32), Dr Steve Schutzer (Encore! EP294), Lisa Trumble, Jeb Dunkelberger, Dr Ian Tong, Mike Schneider, Peter Hayes, Paul Simms, Dr Steven Quimby, Dr David Carmouche (EP343), Christin Deacon, Gary Campbell, Kristin Begley, David Contorno (AEE17), David Contorno (EP339), Nikki King, Olivia Webb, Brandon Weber, Stacey Richter (INBW30), Brian Klepper (AEE16), Brian Klepper (EP335)  

The entities charged with negotiating better drug prices for consumers are pocketing the savings for themselves.  Antonio Ciaccia, president of 3 Axis Advisors, explains how these little-known Pharmacy Benefit Managers (PBMs) became Fortune 15 companies. You can follow this show on Instagram and on Facebook. And to see what Heather does when she's not talking money, go to her personal Twitter page. Be sure to email Heather your questions and request topics you'd like her to cover here. See omnystudio.com/listener for privacy information.

Rachel Phillips, PharmD, is the Senior Director of Specialty Fulfillment Operations at OptumRx that oversees their nationwide specialty pharmacy operation and a former Regional Health and Wellness Director at Walmart where she oversaw more than a 100 Walmart stores in 5 states for pharmacy, OTC, and optic areas. Rachel and I have been friends for a long time and her career trajectory is impressive. We talk about continually evaluating your career and going after new opportunities as they arise, her decision to pursue a MBA, and how the retail landscape has evolved overtime. You'll see why she has been promoted into the roles she has in this great discussion!

In this week's episode, editors of Managed Healthcare Executive, Peter Wehrwein and Briana Contreras caught up with MHE Editorial Advisory Board member David Calabrese, market president of Health Plans/PBMs at OptumRx, for another segment of the Meet the Board series. The three discussed Calabrese's career history, his personal wellbeing lifestyle, and his thoughts on the approval of the Alzheimer's drug Aduhelm, as well as the Biden Administrations interest in putting more generics and biosimilars in the market. 

On this episode we talk to our first female guest (long overdue) Lindsay Dittberner who is a friend of Sean's. She is the VP of Pharmacy Operations for OptumRx. Lindsay shares with us her life in a demanding career while raising 2 young children and balancing it all. She offers insights on parenting, mentorship and gives valuable insights to aspiring women in the workplace.

Nathan White, Chief Client Officer of RxBenefits discusses how data analytics combined with clinical oversights can reduce costs for employers and improve health outcomes for members leveraging the Pharmacy Benefits Optimizer (PBO) model. He talks about the products and technology developments the company has planned for the coming months, the significant milestones that led to the company's growth, and how its recent recapitalization by Advent International positions them to better address an underserved market in 2021. Nathan White, Chief Client Officer, joined RxBenefits in 2017 with more than 18 years of experience in pharmacy client consulting, account management, and medication compliance and safety with both CVS Health and OptumRx. Nathan's successful career has been fueled by his passion for helping benefit consultants and clients cut through the complexity inherent in the pharmacy ecosystem so that they can make intelligent decisions around pharmacy benefits and developing tailored solutions that meet each client's unique needs. #RxBenefits #PBO

David DePoyster is currently VP of Health Systems for OptumRx a Subsidiary of UnitedHealthcare. He founded and was CEO of MedSource, Inc. a medical venture development company that created over 40 healthcare companies in the areas of pharmaceuticals, surgical implants, imaging, pharmacy, surgical instruments, OEM products, and software solutions. David is a businessman and healthcare pioneer, with over 25 years of experience in healthcare company funding and development. He began his career in orthopedic implant sales and gradually began to invest in and develop ventures. He is a business development professional with a record of success optimizing cross-functional decision-making, execution, and results – driving sustainable growth for start-up and high-growth organizations. He's a big picture thinker with eye for details – pinpointing product / service synergies, gaining consensus on strategic development opportunities, and negotiating win / win agreements. He's also an engaging speaker, trainer, and mentor skilled in building relationships from the mail room to the board room – forming lasting connections.   Find out more about David and his team – https://www.optum.com/ Reach out to David –  https://www.linkedin.com/in/daviddepoyster   #iProvMade #iProv #Podcast #MarketingPodcast #HealthcarePodcast #OptumRx

In this week's episode, MHE's Senior Editor Peter Wehrwein spoke with Sumit Dutta, Optum Rx chief medical officer. The two spoke about COVID-19 vaccines and how the pharmacy benefit market responded to the pandemic.

Aidan Hanway is a lecturer and quantitative analyst by trade, and is currently helping analytics for hundreds of millions of dollars in insurance claims at OptumRX, a division of UnitedHealth Group.

We recently interviewed Tracy Spencer, senior vice president of employer groups and strategic clients at Pharmaceutical Strategies Group, a leading pharmacy intelligence and technology company. In this episode Tracy shares opportunities for employers in the PBM marketplace, the latest plan design trends and developments including copay programs, needs-based programs and more.     

In this episode, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for. 

US equity  markets settled with modest declines and snapped a three session winning streak, with some citing the soft China trade data published over the weekend  - Dow down -105-points or -0.38%, with Apple Inc (down -1.4%) leading the index lower.  The broader S&P500 -0.32%, with Health Care (down -0.68%) and Utilities (-0.49%) and Information Technology (-0.48%) the weakest of the primary sectors. The NASDAQ -0.42%. In merger and acquisition (M&A) news, Merck & Co. Inc dipped -0.20% after the pharmaceutical company said it would buy ArQule Inc (up +104%) in a deal worth US$2.7B. Separately, UnitedHealth Group Inc subsidiary OptumRx's is acquiring Diplomat Pharmacy Inc (down -32.7%) for $4 a share, well below last Friday's closing price of US$5.81.

US equity  markets settled with modest declines and snapped a three session winning streak, with some citing the soft China trade data published over the weekend  - Dow down -105-points or -0.38%, with Apple Inc (down -1.4%) leading the index lower.  The broader S&P500 -0.32%, with Health Care (down -0.68%) and Utilities (-0.49%) and Information Technology (-0.48%) the weakest of the primary sectors. The NASDAQ -0.42%. In merger and acquisition (M&A) news, Merck & Co. Inc dipped -0.20% after the pharmaceutical company said it would buy ArQule Inc (up +104%) in a deal worth US$2.7B. Separately, UnitedHealth Group Inc subsidiary OptumRx’s is acquiring Diplomat Pharmacy Inc (down -32.7%) for $4 a share, well below last Friday’s closing price of US$5.81.

There are 65,000 community pharmacies in the United States today, and the total cost to locate, staff, and operate these pharmacies is about 9% of our total national drug spending. That’s less than 1% of our national health expenditure—and falling. This is despite the fact that about 85% of our nation’s something like 6 billion prescription fills are unbranded generics, and unbranded generics are a staple of community pharmacy business. These stats are courtesy of Troy Trygstad, by the way. Bottom line, and pharmacy benefit managers pushing mail order may beg to differ, but many patients rely on walk-in pharmacies to get their meds filled timely (same day). They rely on the pharmacist for advice. They rely on the pharmacist to be an extension of the care team. This is even more stark in rural settings where there may be a pharmacist nearby but potentially not a doctor. It would kind of stink for a lot of patients if these pharmacies were pushed out of business by the elephants of the supply chain or, more accurately, on the demand chain. I’m referring to traditional PBMs (pharmacy benefit managers) and the pressures that they are increasingly putting on pharmacies, resulting in what’s beginning to amount to an existential threat for these community pharmacies. In this health care podcast I speak with Vinay Patel, who is the founder of Self Insured Pharmacy Networks. He’s also a pharmacist, and he’s also an expert in these matters. To clarify a couple things before we dive in, PBM stands for pharmacy benefit manager. There are three main pharmacy benefit managers that process the vast majority of prescriptions in this country today. These three traditional PBMs are ESI (Express Scripts), CVS Caremark, and OptumRx. Who hires and pays these PBMs? Employers, for one. And also some insurance carriers and sometimes the government, as in Medicare Part D. These PBMs, by the way … these three are vast, and they’re powerful. You can learn more at sipharmacynetwork.com. Vinay Patel, PharmD, is a pharmacist executive with a 12-year career focused on population health and community pharmacy operations. His background includes integrating pharmacy programs within multifaceted health care teams, engineering effective clinical operations to meet HEDIS program measures, and initiating a pharmacist-led hospital discharge medication reconciliation program. In his current role as founder of Self Insured Pharmacy Networks (SIPN), Vinay is revolutionizing how plan sponsors pay for pharmacy benefit administration. SIPN’s simple, clear cost-plus model allows plan sponsors to generate significant savings over traditional PBM spread pricing through true invoice cost of drugs and a per member per month fee that is never tied to prescription claims volume or billed charges.   02:49 Do clients get discounts based on PBM buying power? 03:08 “PBMs don’t actually buy drugs.” 03:42 What are PBMs really doing? 04:13 “PBMs are supposed to control the cost of drugs.” 05:49 What processing a claim really means. 08:32 Why pharmacy and health care in general don’t abide by any free market rules. 09:47 The frequency of cost fluctuations and how this puts pressure on pharmacies. 12:32 Spread pricing. 15:40 How much money the state of Ohio was paying to PBMs that never made it to the pharmacy. 16:19 “It’s not how much PBMs are making … what we have a problem with is that it’s impossible for the purchaser of PBM services to know exactly how much they’re paying in spread when they’re signing that contract.” 17:07 What’s the value of a PBM’s service? 18:41 Branded drugs and PBMs. 19:46 Misaligned incentives in PBMs and Pharma. 20:29 How drug lists and formularies are driving patients to branded drugs when there might be a generic drug available. 21:12 Direct and indirect remuneration—DIR fees. 24:14 Pharmacy performance metrics. 26:51 What’s the repercussion of PBMs owning all pharmacies? 28:28 A new “breed” of PBMs improving the value of care delivered. 28:59 “What does transparent mean in this industry?” 33:02 What Self Insured Pharmacy Networks does. You can learn more at sipharmacynetwork.com. Do clients get discounts based on PBM buying power? @RphVinay of @SIPNpbm explains in our #healthcarepodcast. #healthcare #podcast #digitalhealth #pharma #pharmamkg #PBM #pharmacy “PBMs don’t actually buy drugs.” @RphVinay of @SIPNpbm explains in our #healthcarepodcast. #healthcare #podcast #digitalhealth #pharma #pharmamkg #PBM #pharmacy What are PBMs really doing? @RphVinay of @SIPNpbm explains in our #healthcarepodcast. #healthcare #podcast #digitalhealth #pharma #pharmamkg #PBM #pharmacy “PBMs are supposed to control the cost of drugs.” @RphVinay of @SIPNpbm explains in our #healthcarepodcast. #healthcare #podcast #digitalhealth #pharma #pharmamkg #PBM #pharmacy What does processing a claim really mean? @RphVinay of @SIPNpbm explains in our #healthcarepodcast. #healthcare #podcast #digitalhealth #pharma #pharmamkg #PBM #pharmacy Why don’t pharmacy and health care in general abide by any free market rules? @RphVinay of @SIPNpbm explains in our #healthcarepodcast. #healthcare #podcast #digitalhealth #pharma #pharmamkg #PBM #pharmacy How do cost fluctuations put pressure on #pharmacies? @RphVinay of @SIPNpbm explains in our #healthcarepodcast. #healthcare #podcast #digitalhealth #pharma #pharmamkg #PBM #pharmacy What is #spreadpricing? @RphVinay of @SIPNpbm explains in our #healthcarepodcast. #healthcare #podcast #digitalhealth #pharma #pharmamkg #PBM #pharmacy Why it’s not about how much the #PBMs are making. @RphVinay of @SIPNpbm explains in our #healthcarepodcast. #healthcare #podcast #digitalhealth #pharma #pharmamkg #PBM #pharmacy What’s the value of a PBM service? @RphVinay of @SIPNpbm explains in our #healthcarepodcast. #healthcare #podcast #digitalhealth #pharma #pharmamkg #PBM #pharmacy What’s the connection between #brandeddrugs and #PBMs? @RphVinay of @SIPNpbm explains in our #healthcarepodcast. #healthcare #podcast #digitalhealth #pharma #pharmamkg #PBM #pharmacy What are the misaligned incentives in #PBMs? @RphVinay of @SIPNpbm explains in our #healthcarepodcast. #healthcare #podcast #digitalhealth #pharma #pharmamkg #PBM #pharmacy What are #DIRfees? @RphVinay of @SIPNpbm explains in our #healthcarepodcast. #healthcare #podcast #digitalhealth #pharma #pharmamkg #PBM #pharmacy A new “breed” of #PBMs improving the value of care delivered. @RphVinay of @SIPNpbm explains in our #healthcarepodcast. #healthcare #podcast #digitalhealth #pharma #pharmamkg #PBM #pharmacy

Dispatch public affairs editor Darrel Rowland talks with reporter Marty Schladen on the latest special Side Effects investigative Buckeye Forum podcast series. During this we discuss the news of how Attorney General Dave Yost announced that he is seeking repayment of nearly $16 million paid to pharmacy-benefit manager OptumRx by the Bureau of Workers' Compensation. We further address the question of if any corruption is involved regarding this ongoing investigation of Ohio’s pharmacy-benefit managers.

Welcome to this ASCO in Action Podcast. This is ASCO's monthly podcast series where we explore policy and practice issues that impact oncologists, the entire cancer care delivery, and, most importantly, the individuals we care for-- people with cancer. My name is Cliff Hudis and I'm the CEO of ASCO, as well as the host of the ASCO in Action Podcast series. For today's podcast, I am delighted to welcome Dr. Ray Page who's chair of ASCO's clinical practice committee as our guest today. Ray was recently awarded the prestigious ASCO Advocate of the Year Award for his exceptional efforts to shape health care policies to have a direct impact on our ability to provide high-quality cancer care for our patients. Our conversation today is going to focus on one of those policy-related issues that Ray has spent so much time on, and it's an area of growing concern to all oncology practices, that is, the emergence of pharmacy benefit managers in the cancer care delivery system. Now some of you will know that ASCO recently released a position statement on pharmacy benefit managers, or PBMs, as they're known, specifically focusing on their impact on cancer care. And as a little bit of background on this, in terms of policy work, ASCO has a formal process for vetting and adopting the society's policy priorities. Typically, we will develop and release a position or policy statement when we learn about an issue or a development that is impacting, or may, in the future, have an impact, on the delivery of and access to cancer care. We determined that a position statement was necessary on PBMs because serious concerns were being raised by our members through our state affiliate council, our clinical practice committee, and in direct conversation with other ASCO leaders. So as we often do, we analyze the issue carefully. We gather evidence, such as is available. We describe the issue. And, then, most importantly, we identified steps that could be taken to at least begin to address the challenges. The result was the ASCO position statement on "Pharmacy Benefit Managers and Their Impact on Cancer Care." So with that as background, I want to turn and welcome Dr. Page. And thank you for joining me today to discuss this important topic. Welcome. Thank you, Cliff, for having me here today. Great. So I want to start off with a level set, Ray. Some who may be listening today may not be familiar with PBMs, what and who they are, or what purpose they serve. Can you give a general overview of pharmacy benefit managers? How do they work? Sure, Cliff. In its simplest form, a pharmacy benefit manager, or PBM, is a middleman company that was originally utilized by payers as a third-party manager of prescription drug claims. Why did these companies ever come into being in the first place? Well, this largely developed out of the Medicare Modernization Act of 2003 and when the Medicare Part D program for oral drugs was implemented in 2006. Cliff, I believe that they had good original intent, as their primary objective was the simplification of the transactions between pharmacies and health plan sponsors. However, over time, they have evolved to where they now include a variety of new business functions in an effort to better manage drug benefits and reduce the overall drug spending cost for plan sponsors. They claim that they're controllers of cost but, in reality, they have created huge and extremely complex business relationships to where they now have put personal profits before patients. So how extensive is the PBM system? And has it increased in the last few years? And if so, why? Yeah. Today, PBMs are ubiquitous. They were involved in the transaction of several hundred billion dollars of drugs across the United States. PBMs control the pharmacy benefits of over 253 million Americans. What is concerning is after numerous acquisitions and consolidations, and this is often called horizontal integration, there are now only three behemoth companies that control 85% of the prescription drug benefit transactions in this country. These three companies are familiar to all of us. They are CVS Health, Express Scripts, and OptumRx. So one may ask, what's wrong with those guys? They're all reputable pharmacies that are managing and distributing drugs. Well, they've grown to be far more. CVS, for example, started out as a drugstore. But now they are a PBM, specialty pharmacy, a mail-order pharmacy, an insurer, a benefit plan sponsor, and now they have medical clinics and own doctors. So part of the perversity that arises is when PBMs vertically integrate with the sponsors, the insurers, the pharmacies, and clinics all into one big package to now they have complete control of the patients and the flow of all their prescriptions. Then may make transactional relationships between these entities and the drug manufacturers, distributors, and providers to where they generate enormous profits off the management of these drugs, yet none of these profits are ever passed on to the patients. Practicing oncologists and ASCO have concerns that some of these utilization management policies can have an adverse impact on our nation's most vulnerable patients, which are our cancer patients. Well, last year, ASCO released a policy statement on utilization management strategies. And these are payer-imposed practices that may, in some cases, restrict access to, or deny coverage for, selected treatments. The major concern, at that time, was that certain payer practices, such as prior authorization, step therapy, specialty tiers, and restricted formularies, all of these could hinder access to high-quality cancer care. The question we have, I think, with regard to PBMs is whether we share these same concerns when we turn to PBMs. And if that's so, can you explain some of the practices that PBMs might use and what that might mean to the cancer patient, specifically with regard to access to most appropriate therapies? Yeah, Cliff. There's several concerns that I have with the PBMs managing drugs that could adversely impact our cancer patients. And let me just describe a few. As cancer doctors, we always want to give what we think is the best personalized drug for that individual patient for the right diagnosis at the right time. I may prescribe a cancer drug that is not on a preferred formulary of the PBM because, perhaps, they have negotiated a better price with another manufacturer that gives them more profit. So they recommend replacement with another drug. This is called a step edit. And, oftentimes, your preferred drug cannot be prescribed until there is a fail-first policy with an alternative drug. So for such things as nausea and vomiting control with highly emetogenic chemotherapy, I would prefer to have no vomiting with a preferred drug rather than dealing with nausea with a fail-first inferior drug. Second, we have PBMs that want to deliver storage sensitive toxins, chemotherapy drugs, and injections to the patient's doorstep and then have them brown bag these drugs to our office for administration, although we have no record of the pedigree and the accountability of those dangerous drugs. Third, we now have PBMs refusing to give such things as IVIg infusions in our office. And for some of our patients, they have to go to the street corner CVS box and get their IVIg at the CVS infusion center. Yet I am accountable for the outcomes of that patient. Lastly, and worst, we're seeing cost shifting onto the patients. Based on their packaging and dispensing methods, the patients often have to pay multiple huge co-pays because of partial fills of oral chemotherapy drugs. So if I understand you correctly, while PBMs did not end step therapy, specialty tiers, and restrictions and formularies, they're using these previously recognized tactics as a way of notionally controlling costs, but at least having a downstream effect of potentially restricting access to what is oncologist-driven best care. Is that a fair summary? That is correct. So it is those utilization management techniques that create significant administrative burdens and impairments on getting patients appropriate, and timely, and affordable access to care. Well, you must see this firsthand, right? You're in private oncology practice at the Center for Cancer and Blood Disorders in Aledo, Texas. And I know that you have an active practice and you see a large number of patients. I'm wondering if you've had, yourself, firsthand experience of PBMs and what you've seen it has meant for your patients to have their care influence that way. And what it's meant for you and your colleagues as you work to provide highest quality care. Are there vignettes or aspects of this that come to mind? Yes. In my private practice in Fort Worth, Texas, I have firsthand experience with PBMs every day. What it means for our patients is an interference in the physician-patient relationship, pushing of care outside our Cancer Center, creating an impact on our ability to provide value-based care in an oncology medical home, causing delays in care, alterations in treatment plans, potential increases in toxicities, and more out-of-pocket costs for the patients. So let me give you a quick case of a patient that I have. Tom was diagnosed with a stage 3 rectal cancer and I recommended capecitabine and radiation therapy. I prescribed, for him, capecitabine 500 milligrams, three tablets BID, on the days of radiation therapy, which would be 180 pills, which he went down to my pharmacy to get. At my pharmacy, he was told that he was out-of-network and he would have to get this through CVS Caremark. So I saw the patient in his third week of treatment. And I found out that they had filled 120 of the 180 pills. And they told the patient that they only packaged the capecitabine in 120-pill bottles. So his first co-pay, for that first three weeks, was $400. So then he got a second bottle of 120 pills and paid a second co-pay of $400. And that was a prescription of excess pills. And so CVS, they told him just to throw away the extra 60 pills that he did not use. Now this was financially impactful for both the patient and my practice. The drug cost, if a single script was given through my practice, would have been $3,900. The drug cost for the two scripts with the extra unused pills was $7,200 through the PBM. Now under the new MACRA, MIPS payment model that we're all subject to, or under the Oncology Care Model, which is an alternative payment model, this kind of thing negatively impacts our resource use. So this process is completely out of my control, yet I get peened for not being a good steward of drug utilization. Well, that's a pretty compelling example. And I assume there are others, right? Yes, there is. There's many. Well, I think if we turn a little bit to one of the points you raised already, it was about the in-office pharmacy in your practice. Can you, for people who might not be familiar with this, can you briefly describe how it works to have an in-office pharmacy? Is this something that all oncology practices have? And how have the PBMs impacted its operation in your experience? Yes, Cliff. Most all cancer centers across the country have their own retail pharmacy, regardless of whether they're an academic center, a hospital-based practice, or an independent community practice. The impact of the PBMs affects the delivery of cancer care no matter how small or great your cancer center is. More and more cancer centers, as well as large hospital systems, are trying to get specialty pharmacy status to be able to combat some of the PBM tactics of being out-of-network, or having direct and indirect remuneration DIR fees, rebate clawbacks, and gag clauses. So let me just say that PBMs may be a place for managing common drugs for diabetes, and heart, and thyroid, and infectious diseases. But there are reasons that cancer centers prefer to have complete control of the cancer therapies that we prescribe. In general, cancer drugs not only have the risk of substantial physical toxicities that need close pharmacy management, but they also have tremendous financial toxicities for the patient that we help manage with our pharmacy staff and in which those resources do not exist within the PBMs. So it's highly preferable that cancer patients get their prescriptions through a highly-trained oncologic pharmacist at the Cancer Center who has access to their full electronic health records and drug lists and who knows them, personally, by name. Our pharmacy staff has resources to educate the patients, to work on foundation and financial assistance, and to be immediately available, by name, to triage further questions or symptoms. It is what is best for the patient. Unfortunately, PBMs are redirecting our treatments from our pharmacies to theirs, and they are trolling for other drugs that we have historically prescribed to our patients. So this loss of prescription authority and drugs to the PBMs is at a rate that's increasing at about 10% a year to where, currently, 60% of our prescriptions go outside our pharmacy to the PBM. I see. And, presumably, that has not only concerns raised for you in terms of business, but quality of care. Is that right? That's exactly right. So there's always a business aspect to the management and control of the drugs. But, most importantly, is that value-based quality care that we feel provides the safest, highest quality, most affordable care to our patients when they have access through our own individual pharmacies at the cancer centers. Well, at ASCO, as you know, we, last year, spent some time and, ultimately, we declared core values-- evidence, care, and impact. And what derives from that, for us, is we do not write papers or issue statements simply to check a box and say we did that. Instead, what we want to do is go beyond identifying, and analyzing, and reporting on a problem to, in fact, contributing to solutions. And so, to that end, what we frequently have to do is initiate conversations with stakeholders, propose ideas that might affect real change, and have a positive impact on cancer care and our patients. ASCO's recommendations on health care system changes are often sent directly to Congress. We present them to government agencies. We speak to payers, certifying bodies, and, really, everybody across the entire health policy environment and health care spectrum. So given that our desire is to make a difference, to have an impact, to effect change, can you, Dr. Page, can you outline some of the recommendations that ASCO has described as a path forward and a way to address the issues that our discussion has raised? Sure. ASCO has several suggestions. And these can get very complex and have nuances, but I'll just try to make these suggestions as simple as possible. But several things that ASCO has recommended is that PBMs and the payers, in order to address quality of care concerns related to cancer patients that they serve, they should assure that changes to prescribe therapies for the patients with cancer are made only in the context of prior consultation and approval of their physician. So, in other words, if I write a prescription for a set number, and duration, and dosing schedule for a patient, it should be given that way. And the PBM should not be making alterations in my prescription, like I gave in my example. Pharmacies should not be prevented from sharing, with the patients, their most cost effective options for purchasing needs of medications. So in other words, there's gag causes that PBMs have to where there could be a drug that the PBM is going to charge the patient $180 a month for, but the local pharmacy can prescribe that same drug for $30. But they are prohibited from disclosing that they can actually distribute that drug to them cheaper outside the PBM. CVS should leverage its regulatory authority to number one, require that PBMs provide detailed accounting of these DIR fees and instruct contractors and PBMs to use measures and standards that are more appropriate to the specialty. CMS should also enforce its any willing provider provisions in Medicare Part D preventing PBMs from excluding qualified provider-led pharmacies from its networks. So we, at ASCO, really desire that any cancer center that has a pharmacy would have the opportunity to be included in the PBM network and be able to prescribe the drugs within that network on site. And then, CMS should maximize the accountability of drug waste through the PBMs. Lastly, pharmacy and therapeutic committees of the PBMs should include full and meaningful participation by oncology specialists. So one issue that was raised in the ASCO statement, and we haven't directly touched on it yet, is simply the lack of transparency, that is, the opaque nature of PBM practices and their policies. How do you think that issue, specifically, can be addressed? Yeah, Cliff, the transparency issues are being addressed nationally at several legislative levels. There are several federal bills that are in support of the Trump blueprint to address drug costs. And they have to do with safe harbor laws that the PBMs are taking advantage of. They have to do with undoing the gag causes that I previously mentioned. And, also, to examine the fiduciary status of the PBMs. At the state level, there's dozens of bills going after the PBMs, state by state, on all fronts. And, lastly, as an ASCO delegate to the AMA, a few months ago, we submitted a resolution that we got accepted into AMA policy that requests that our AMA gather more data on the erosion of the physician-led medication therapy management in order to assess the impact of the pharmacy benefit manager tactics that they may have on the patients' timely access to medications, patient outcomes, and the physician-patient relationship, and that the AMA examine issues related to PBM-related clawbacks and those DIR fees to better inform existing advocacy efforts. And so I think it's always good to have the weight of the AMA behind our ASCO advocacy efforts to assure that our cancer patients can continue to get the best, affordable access to care. Well, that's really great to hear. You've covered a lot, both in terms of background and explanations, the history of the development of the PBMs, and what challenges have now emerged. Are there any additional steps ahead that ASCO should be taking that you know about? Is there anything else, for example, that listeners should know about pharmacy benefit managers that we've not yet touched on? Yeah. I think I just want to emphasize that this is really a David and Goliath scenario. It is very difficult to control a rapidly growing, unregulated, complexly integrated $300 billion industry that is benefiting three gargantuan companies more than our patients. And ASCO will continue to partner with fellow like-minded advocates to optimize the affordable delivery of cancer care and conquer cancer. Well, that's certainly an upbeat-sounding ending. And I'm sure with you fighting the good fight, this effort will go on and will make good progress. That seems clear. I want to thank you, Dr. Page, for joining me today for this ASCO in Action Podcast. I want to remind everybody that at ASCO, we are committed to preserving and enhancing access to high-quality cancer care for everybody with cancer. This statement on PBMs is just one of many in which ASCO's voice, and the collective voice of our members, is helping to shape the future of cancer care for everybody and refine the delivery system. I encourage our listeners to read the statement, and other policy and position statements, all of which are available on the policy and advocacy pages of our website at ASCO.org. And until next time, again, thanking Dr. Page for joining all of us, I want to thank all of you for listening to this ASCO in Action Podcast.

Columbus Dispatch reporters Cathy Candisky, Lucas Sullivan, and Marty Schladen discuss the breaking news regarding Pharmacy Benefit Managers and Medicaid. We further talk about how the Ohio Department of Medicaid is ordering the termination of contracts with pharmacy middleman that use "spread pricing," putting an end to a practice that has cost taxpayers hundreds of millions.  Finally, we talk about how Medicaid officials directed the state's five managed care plans to move to a more transparent pass-through pricing model effective Jan. 1.

Pharmacy Compliance Guide Attestations & Certifications  Every fall we hear the PBMs sending out requests for Attestations for Fraud, Waste and Abuse and HIPAA Compliance. Why do they all keep asking for the same information? When Medicare Part D came into play, the Pharmacy Benefit Managers were given the regulatory authority to manage the Medicare Part D program. Part of this program was ensuring pharmacies were properly training their staff. It initially started with annual: Fraud, Waste & Abuse Training, OIG Exclusion Verification, and HIPAA Compliance Training Then each fall, everyone had to attest they accomplished these requirement for Medicare Part D. Unfortunately, a lot of pharmacies and organizations signed off of the attestations and really didn't do it.   The attestation is a legal statement where the individual, the pharmacy owner and/or the pharmacist-in-charge was legally attesting they were accomplishing the training and had no documentation to support their claim. Legally this was a false claim under Medicare Part D and the PBM can and did recoup all Part D reimbursements from the pharmacy, which was devastating.   The PBMs then added to their requirements over the years making them sticker and more over bearing. Most especially is the OIG Exclusion verification requirement. Only pharmacy in all of health care must accomplish this task every month. It started with just one database, the Office of Inspector General, then were added the General Services Administration (GSA) and the Systems for Award Management (SAM). The GSA and SAM have publicly merged into one, but as of today, we are still receiving a database from each of them. In addition, individual states are developing their own exclusion lists that must be checked. There is no standard for the lists. Some are managed by the health departments, others by the Attorney General or the Treasury Department.   Jeff, let's break these requirements down. What is involved with the Fraud, Waste and Abuse requirement besides the OIG Exclusion? Fraud, Waste and Abuse really is not hard to comply with. It is having established policies and procedures and training. However, when someone gets in trouble with the government with stealing money through claims or misleading patients, the Fraud, Waste and Abuse processes is where all of the federal penalties come from. There are ten (10) basic policies and procedures from Fraud Waste and Abuse Prevention, Anti-Kickback, Conflict of Interest, False Claims, Whistleblower Protection and General Compliance. When you look at these policies and procedures, they are mostly common sense. Bill for what you dispense and treat patients like they are your family. There are several methods of training. CMS has training modules and like all things created by the government and their lawyers it is complicated. To use these training modules, each employee logs into the CMS system, establishes a user name and password, then embarks on a one-hour on-line training session, with on-tests along the way. When the employee has the completed the training, he or she will have a CMS training certificate for Fraud, Waste and Abuse with General Compliance. There are several problems with this training: Who has the time and the computers to have each employee to spend one hour going through the training program? In the statute Title 42 C.F.R. 422.504(B)(4)(vi) and the Medicare Prescription Drug Benefit Manual, Chapter 9, you are to train on the pharmacy's policies and procedures, which the CMS Module does not do meet There is no requirement for a test We covered the OIG/GSA/SAM verification above, however, most people have the opinion the OIG check is only for employees. This is not correct. The statutes specifically states: “Any individual or entity that has been convicted…”   Jeff, I never heard this before, so what is an entity? The best definition I have been able to define is: a HIPAA Business Associate and any vendor you purchase a product from that you then dispense to a Medicare or Medicaid patient. It also includes: 1099 employees, part-time employees and contractors. So the question is are you verifying these entities? CVS/Caremark is checking this on their on-site inspections.   So what is the HIPAA requirement? HIPAA has been around since 2003. We had a podcast earlier this year on HIPAA breaches and desk audits. If you haven't listen to it. It is quite important. HIPAA requires all health care providers and Business Associates to have a HIPAA Privacy and Security policies and procedures. Annual training on these policies occurs on how HIPAA relates to your operations. Our listeners will primary need privacy training on interactions with their patients and their requests, handling Protected Health Information and most importantly what to do when a breach occurs. Jeff, I remember the podcast on HIPAA Breaches. That was one of the most informative podcasts we have had and if you don't do anything when they occur will lead to millions in finds.  So I understand there was a new requirement added this year to attestations. Yes, Cultural Awareness Training. This was originally part of the Affordable Care Act but it was struck down by the federal courts in November 2016. But Humana and CVS/Caremark brought it back to life. This is a training to ensure the pharmacy and the staff understand the culture of your patients and the language skills if they can't speak English. My biggest concern with this added requirement for community independent pharmacies is we all live in our communities. We know our communities. If there are a second or third language in the neighborhood, we hire staff who speak these languages. We understand the local customs and cultures. Why would anyone offend your patients, who would then go to your competitor? That might make sense inside the Washington Beltway or an insurance company board room, but not in an independent pharmacy.   Now let's talk about Credentialing. What is it and why do we have to deal with it. Credentialing is simply the validation of the attestations. These normally start in late January. The PBMs want to see proof. These are mostly completed on-line or via fax. However, CVS/Caremark and OptumRx are doing follow-up on-side inspections. Each PBM has their own list of items to send in or provide the on-site auditor: Fraud, Waste and Abuse training certificate or Log I recommend only sending the Pharmacist in charge, not the entire staff HIPAA training certificate or log I recommend only sending the Pharmacist in charge, not the entire staff Specific pharmacy operational policies and procedures Pharmacy licenses Pharmacist-In-Charge License Other miscellaneous requests All in the effort to validate the attestation that was submitted in the fall were correct   Does anyone look at these documents? Good question. There are 26,000 plus independent pharmacies submitting documentation. Just the volume of documents is huge. The server size to store the data year after year will be in the terabytes. But I do know they do a random checks.   Are there any penalties? Yes, if you falsify an attestation, the pharmacy is in jeopardy of losing all Part D reimbursements for the period or year in question. Plus the pharmacy is in breach of contract and will be drop from the contract. It really can't get much worse than that.   OK, what was this NCPDP credentialing about in August? This has been on my radar. I met with NCPDP in 2016 about this project and then again at the NCPA convention in Orlando this year. NCPDP developed a platform to help pharmacies report one time, rather than multiple times each year. The concept is good. But there are challenges and concerns. First, the development was with chain pharmacies with no independent involvement. The reason was NCPDP had a massive test pool with the same organizations. It's logical, but there are more independents than chain pharmacies. This program works with the PBMs but not with the PSAOs who still are requesting the same information. So it does reduce the amount of reporting. Now my major concern is NCPDP is sharing the information they are collecting with different organizations. They are updating your NPI information. OK, that is good. But they are also sending it to the National Supplier Clearinghouse. Here is the concern. If the data submitted to NCPDP differs from the CMS 855S Medicare Enrollment Application, NSC's process is to deactivate the PTAN. If you catch it right away, the pharmacy can re-activate the PTAN with no issue. However, if the pharmacy does not catch it because they are not reconciling their reimbursements on a weekly basis and PTAN is deactivated for a period of time, the pharmacy must reactivate their PTAN from scratch. If the pharmacy had “Exempt” status, depending on the length of time, the pharmacy loses the exemption and they must start over with accreditation to continue to dispense DMEPOS products. I have seen this done already. It is as simple as changing your hours of operation, updating the NCPDP credentialing website and not updating your Medicare 855S and your PTAN is deactivated. This is a very costly error that no one thought about.   Jeff, how can you prevent that from happening? Don't let just anyone complete these attestations and credentialing documents. Complete them all the same way, every time. Keep copies so you are consistent. Always know what your CMS 855S Medicare Enrollment Application states. When a change is made on the NCPDP website, make the same change on the CMS 855S application.   Is there anything else the pharmacies need to be aware of for Credentialing? Yes, one very important item. Continuous Quality Improvement Certificates are required for Medicare Part D. Every pharmacy is required to have a Continuous Quality Improvement (CQI) program. The CQI certificate is generated by an organization certifying the pharmacy has an active CQI program. This is normally through a Patient Safety Organization. We talked about a PSO on our last podcast with the Alliance for Patient Medication Safety. We can see the PBMs looking at the CQI certificates more closely in 2018. For my clients, make sure you continue with the PQC+ entries so you can pull the CQI certificates when these requests start in January and February. If you are not sure if you have a CQI program or how to get your CQI certificate, the process is not a week or two quick fix program. There are a number of items that are required to be completed. Check out our last podcast on Patent Safety. There are not a lot of organizations talking about these subjects, especially the CQI programs and certificates. I keep my podcast factually based, but on the Continuous Quality Improvement program, certificates and enrollment with a patient safety organization, this is part of our standard pharmacy compliance program that we offer. To my knowledge, no other consulting firm offers these services.   Jeff, so wrapping up, on our conversation today, you always bring items to us that no one is talking about. See omnystudio.com/listener for privacy information.

Pharmacy Compliance Guide Attestations & Certifications  Every fall we hear the PBMs sending out requests for Attestations for Fraud, Waste and Abuse and HIPAA Compliance. Why do they all keep asking for the same information? When Medicare Part D came into play, the Pharmacy Benefit Managers were given the regulatory authority to manage the Medicare Part D program. Part of this program was ensuring pharmacies were properly training their staff. It initially started with annual: Fraud, Waste & Abuse Training, OIG Exclusion Verification, and HIPAA Compliance Training Then each fall, everyone had to attest they accomplished these requirement for Medicare Part D. Unfortunately, a lot of pharmacies and organizations signed off of the attestations and really didn’t do it.   The attestation is a legal statement where the individual, the pharmacy owner and/or the pharmacist-in-charge was legally attesting they were accomplishing the training and had no documentation to support their claim. Legally this was a false claim under Medicare Part D and the PBM can and did recoup all Part D reimbursements from the pharmacy, which was devastating.   The PBMs then added to their requirements over the years making them sticker and more over bearing. Most especially is the OIG Exclusion verification requirement. Only pharmacy in all of health care must accomplish this task every month. It started with just one database, the Office of Inspector General, then were added the General Services Administration (GSA) and the Systems for Award Management (SAM). The GSA and SAM have publicly merged into one, but as of today, we are still receiving a database from each of them. In addition, individual states are developing their own exclusion lists that must be checked. There is no standard for the lists. Some are managed by the health departments, others by the Attorney General or the Treasury Department.   Jeff, let’s break these requirements down. What is involved with the Fraud, Waste and Abuse requirement besides the OIG Exclusion? Fraud, Waste and Abuse really is not hard to comply with. It is having established policies and procedures and training. However, when someone gets in trouble with the government with stealing money through claims or misleading patients, the Fraud, Waste and Abuse processes is where all of the federal penalties come from. There are ten (10) basic policies and procedures from Fraud Waste and Abuse Prevention, Anti-Kickback, Conflict of Interest, False Claims, Whistleblower Protection and General Compliance. When you look at these policies and procedures, they are mostly common sense. Bill for what you dispense and treat patients like they are your family. There are several methods of training. CMS has training modules and like all things created by the government and their lawyers it is complicated. To use these training modules, each employee logs into the CMS system, establishes a user name and password, then embarks on a one-hour on-line training session, with on-tests along the way. When the employee has the completed the training, he or she will have a CMS training certificate for Fraud, Waste and Abuse with General Compliance. There are several problems with this training: Who has the time and the computers to have each employee to spend one hour going through the training program? In the statute Title 42 C.F.R. 422.504(B)(4)(vi) and the Medicare Prescription Drug Benefit Manual, Chapter 9, you are to train on the pharmacy’s policies and procedures, which the CMS Module does not do meet There is no requirement for a test We covered the OIG/GSA/SAM verification above, however, most people have the opinion the OIG check is only for employees. This is not correct. The statutes specifically states: “Any individual or entity that has been convicted…”   Jeff, I never heard this before, so what is an entity? The best definition I have been able to define is: a HIPAA Business Associate and any vendor you purchase a product from that you then dispense to a Medicare or Medicaid patient. It also includes: 1099 employees, part-time employees and contractors. So the question is are you verifying these entities? CVS/Caremark is checking this on their on-site inspections.   So what is the HIPAA requirement? HIPAA has been around since 2003. We had a podcast earlier this year on HIPAA breaches and desk audits. If you haven’t listen to it. It is quite important. HIPAA requires all health care providers and Business Associates to have a HIPAA Privacy and Security policies and procedures. Annual training on these policies occurs on how HIPAA relates to your operations. Our listeners will primary need privacy training on interactions with their patients and their requests, handling Protected Health Information and most importantly what to do when a breach occurs. Jeff, I remember the podcast on HIPAA Breaches. That was one of the most informative podcasts we have had and if you don’t do anything when they occur will lead to millions in finds.  So I understand there was a new requirement added this year to attestations. Yes, Cultural Awareness Training. This was originally part of the Affordable Care Act but it was struck down by the federal courts in November 2016. But Humana and CVS/Caremark brought it back to life. This is a training to ensure the pharmacy and the staff understand the culture of your patients and the language skills if they can’t speak English. My biggest concern with this added requirement for community independent pharmacies is we all live in our communities. We know our communities. If there are a second or third language in the neighborhood, we hire staff who speak these languages. We understand the local customs and cultures. Why would anyone offend your patients, who would then go to your competitor? That might make sense inside the Washington Beltway or an insurance company board room, but not in an independent pharmacy.   Now let’s talk about Credentialing. What is it and why do we have to deal with it. Credentialing is simply the validation of the attestations. These normally start in late January. The PBMs want to see proof. These are mostly completed on-line or via fax. However, CVS/Caremark and OptumRx are doing follow-up on-side inspections. Each PBM has their own list of items to send in or provide the on-site auditor: Fraud, Waste and Abuse training certificate or Log I recommend only sending the Pharmacist in charge, not the entire staff HIPAA training certificate or log I recommend only sending the Pharmacist in charge, not the entire staff Specific pharmacy operational policies and procedures Pharmacy licenses Pharmacist-In-Charge License Other miscellaneous requests All in the effort to validate the attestation that was submitted in the fall were correct   Does anyone look at these documents? Good question. There are 26,000 plus independent pharmacies submitting documentation. Just the volume of documents is huge. The server size to store the data year after year will be in the terabytes. But I do know they do a random checks.   Are there any penalties? Yes, if you falsify an attestation, the pharmacy is in jeopardy of losing all Part D reimbursements for the period or year in question. Plus the pharmacy is in breach of contract and will be drop from the contract. It really can’t get much worse than that.   OK, what was this NCPDP credentialing about in August? This has been on my radar. I met with NCPDP in 2016 about this project and then again at the NCPA convention in Orlando this year. NCPDP developed a platform to help pharmacies report one time, rather than multiple times each year. The concept is good. But there are challenges and concerns. First, the development was with chain pharmacies with no independent involvement. The reason was NCPDP had a massive test pool with the same organizations. It’s logical, but there are more independents than chain pharmacies. This program works with the PBMs but not with the PSAOs who still are requesting the same information. So it does reduce the amount of reporting. Now my major concern is NCPDP is sharing the information they are collecting with different organizations. They are updating your NPI information. OK, that is good. But they are also sending it to the National Supplier Clearinghouse. Here is the concern. If the data submitted to NCPDP differs from the CMS 855S Medicare Enrollment Application, NSC’s process is to deactivate the PTAN. If you catch it right away, the pharmacy can re-activate the PTAN with no issue. However, if the pharmacy does not catch it because they are not reconciling their reimbursements on a weekly basis and PTAN is deactivated for a period of time, the pharmacy must reactivate their PTAN from scratch. If the pharmacy had “Exempt” status, depending on the length of time, the pharmacy loses the exemption and they must start over with accreditation to continue to dispense DMEPOS products. I have seen this done already. It is as simple as changing your hours of operation, updating the NCPDP credentialing website and not updating your Medicare 855S and your PTAN is deactivated. This is a very costly error that no one thought about.   Jeff, how can you prevent that from happening? Don’t let just anyone complete these attestations and credentialing documents. Complete them all the same way, every time. Keep copies so you are consistent. Always know what your CMS 855S Medicare Enrollment Application states. When a change is made on the NCPDP website, make the same change on the CMS 855S application.   Is there anything else the pharmacies need to be aware of for Credentialing? Yes, one very important item. Continuous Quality Improvement Certificates are required for Medicare Part D. Every pharmacy is required to have a Continuous Quality Improvement (CQI) program. The CQI certificate is generated by an organization certifying the pharmacy has an active CQI program. This is normally through a Patient Safety Organization. We talked about a PSO on our last podcast with the Alliance for Patient Medication Safety. We can see the PBMs looking at the CQI certificates more closely in 2018. For my clients, make sure you continue with the PQC+ entries so you can pull the CQI certificates when these requests start in January and February. If you are not sure if you have a CQI program or how to get your CQI certificate, the process is not a week or two quick fix program. There are a number of items that are required to be completed. Check out our last podcast on Patent Safety. There are not a lot of organizations talking about these subjects, especially the CQI programs and certificates. I keep my podcast factually based, but on the Continuous Quality Improvement program, certificates and enrollment with a patient safety organization, this is part of our standard pharmacy compliance program that we offer. To my knowledge, no other consulting firm offers these services.   Jeff, so wrapping up, on our conversation today, you always bring items to us that no one is talking about. See omnystudio.com/listener for privacy information.

Listen to learn from Employers Health's Chief Marketing Officer, Mike Stull, what a Market Check and Pricing Improvement Analysis is, how it works and what it means for your business. In this episode, we'll cover PBM contracting, the various vendors including CVS Caremark, OptumRx, the various aspects of pharmacy benefits and more. We'll also highlight one of our featured vendor partners, ComPsych, and its GuidanceResources EAP.

Interview with Kelli Kovak – Consultant to Healthcare Insurance & PBM Industry [The expansion of health networks- the trend and the implications] The idea that increased collaboration among rural healthcare providers could benefit both the collaborating organizations and the communities they serve is not new. In the past, collaboration among rural pharmacies, hospitals, and insurances has been advocated as a "strategic response" to the challenges these facilities face. However, with respect to participation in multi-healthcare networks and health systems - the actual "SAVINGS" and data - offers little evidence that such arrangements yield significant benefits for rural communities, pharmacies, and hospitals. How will new health networks benefit the business of pharmacy? What's the impact to patient choice? How does private pharmacies stay connected & competitive?   References: ZoomCare Applies to be on Oregon Exchange http://www.prweb.com/releases/2015/05/prweb12695078.htm Proxsys Rx Launches Pharmacy Benefit Management Services to Save Employers 5 to 20 percent on Prescription Drug Benefits http://www.prweb.com/releases/2015/04/prweb12674822.htm UnitedHealth to Buy Catamaran for $12.8 Billion in Cash See omnystudio.com/listener for privacy information.