Alex Azar

💡New #Avalere Study 💡Do #340B contract pharmacies serve patients in rural areas? Do 340B hospitals contract with chain or independent pharmacies? Our team crosswalked a couple of data sets to get some snapshots of trends in contract pharmacy use in 340B to inform the ongoing debate in Congress. Reach out to learn how we can help you with policy design and analytics. #drugpricing #drugs #lifesciences

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CMS’ “Year 2” IRA Guidance Concedes Agency Patient Engagement Has Been a Bust A number of patient groups have quietly expressed frustration with #CMS’ “listening sessions” on the #InflationReductionAct “fair price” negotiations. If you read CMS’ “year 2” guidance carefully, it effectively admits the patient complaints are real and legitimate. The Complaints: Patient groups sat on the sidelines in the litigation challenging the constitutionality of the IRA, at least in part, because they believed that they could shape IRA implementation through agency engagement. But some groups are now expressing frustration. They expected CMS to explain how it was approaching negotiation and the underlying evaluation of the selected drugs. With that context, they expected to be able to provide meaningful feedback to CMS’ plans and preliminary assessments. According to the groups I have spoken to, that is not how things have gone. CMS is tight-lipped—in “listen only” mode. Unclear what CMS is considering and how it sees the “value” question, “patient interaction” on the IRA has devolved into CMS and patient groups staring at each other blankly. Confirmation: When you read the “year 2” guidance, it confirms the patient complaints. Deploying diplomatic “regulatory speak”, CMS says it “intends to improve upon the design of the patient-focused listening sessions”. Note the reference to “listening sessions”—confirming the agency has been in “listen only” mode. CMS admits the need for change, saying it “is soliciting comments from interested parties on event format, scope, and logistics”; it then indicates it “is considering events where there is discussion among speakers and in which CMS may ask clarifying questions”. But even this proposal isn’t getting to the core of the problem—patient groups shouldn’t have to be expert mind readers regarding CMS’ intent based on a few interspersed “clarifying questions”. CMS offers some other alternatives, too: “CMS is also weighing different event formats, such as round table sessions on broader topics with a mix of speaker types (e.g., patients, providers, and health data experts) or focus groups on targeted topics with one speaker type (e.g., patients or caregivers)”. But all that doesn’t commit CMS to doing any speaking. Just that others—patients, providers, and “experts” will be asked to speak. Patient groups can’t react in, or to, a vacuum. No Time: The guidance concedes that they can’t fix the problem for “year 1”. After all, July 31, 2024 is the deadline for manufacturers of selected drug to accept or reject CMS's final MFP offer. Indeed, CMS acknowledges that its proposed changes in patient engagement will be effective only “for…price…year 2027”. So, in another words, at least for “year 1”, we are going to get “fair prices” that don’t reflect meaningful patient input. #drugdevelopment #drugpricing #Medicare #managedcare #rarediseases #patientsfirst #lifesciences

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#DigitalHealth Execs Sentenced in $1B #Fraud Becker's Healthcare and the Chicago Tribune report that 3 former execs at #OutcomeHealth have been sentenced in what the government alleges was a $1B fraud perpetuated against #pharmaceutical manufacturers and #investors. Outcome: The rollercoaster ride of Outcome Health is quite a tale. Started in 2006, Outcome “installed screens in medical offices free of charge” and then “sold advertising to pharmaceutical companies”. By 2017, O was valued at $5.5B, with funding from Goldman Sachs and #privateequity firms. But, by 2019, things had started to go sideways. That year, Outcome paid $70 million to resolve a #DOJ fraud case. The resolution, which seemed downright modest in light of the size of the alleged fraud, was partly shaped by the company’s obligation to “cooperate” with DOJ in its “investigation of individual executives at the company”. Outcome admitted that: “from 2012 to 2017, former executives and employees perpetrated a scheme to defraud its clients by selling advertising inventory that it did not have”. Those “cooperation” provisions paved the way for the exec prosecutions that followed—and the sentences that have now been handed down. The Sentences: A co-founder and #CEO was sentenced to over 7 years, while the #COO and #CFO was sentenced to 27 months. A third exec, the president, who was also a co-founder, was sentenced to 3 years of “confinement at a halfway house”, to be followed by #deportation. Critics, who questioned the settlement of Outcome, likewise have questioned the length of the individual sentences, given the size and length of the fraud scheme; critics also question the 14 month lapse between the convictions and completion of sentencing. End Note: Crain's Chicago Business reported that that Outcone was reportedly worth $39 million in November of last year. The outcome for Outcome was pretty awful. Yikes! #lifescienses #healthcare #digital #advertizing #marketing #drugadvertizing #drugmarketing

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Cigna Group allegedly exaggerated the health conditions of its enrollees to fraudulently obtain hundred of millions in federal funds. Read more: https://direc.to/fhHz Cigna Group significantly impacts healthcare today by expanding its pharmacy and medical customer base, as evidenced by a 25% increase in pharmacy customers and a growth in medical customers. Additionally, Cigna's involvement in healthcare trends and innovations, such as the Better Care Bulletin, showcases its role in improving health outcomes and integrating technology in healthcare. The HHS Office of Inspector General (HSS-OIG) combats healthcare fraud through rigorous oversight, investigations, and audits. It collaborates with the Department of Justice (DOJ) to enforce laws and impose penalties on fraudulent activities, as seen in actions against the Center for Medicare and Medicaid Services (CMS) fraud. #unitedseniorassociation #USA #eldercare #FDA #seniorliving #ADA #AI #NIH #patientcare #compliance #hospitals #OIG #healthcare #HHSOIG #digitalhealth #HSS #CMS #assistedliving #nursinghomes #seniorcare #medicare #seniorcitizen #homehealthcare #caregiver #dementia #inhomecare #seniorhealth #kloekorby #alzheimers #mentalhealth

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When discussing the founding of Capital Rx, A. J. Loiacono typically states, “To solve the issue, we had to become the solution - a PBM.” The #PBM sector has veered off course, focusing on #rebates and maintaining a #spread on medication costs, neglecting what truly benefits plans and members. Did we take a bold approach? Definitely. By choosing not to profit from drug expenditures, implementing a flat fee, passing rebates directly, and introducing JUDI®, we didn't just disrupt the status quo. We established a new standard. Find out more here: https://okt.to/qfkl5H #PharmacyBenefits #PBMRevolution #AlignedCare

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Recommend: Excellent Moderation. I appreciated Nina’s comment about the lack of tested budget neutrality for the Medicaid waivers. What isn’t often considered is that these expansions push up Medicare DSH spending, without any improvements in services or access. Ryan mentioned their expected shopping list in a R Congress from work requirements for able bodied adults in the expansion population to a single site of services that cuts beneficiary costs. Re BB study, I find the lack of paycheck and other documentation for exchange subsidies to be incongruent with other welfare programs. In a scan, I see covered CA is specific about documenting the benefit of underestimating your income to receive a greater subsidy. It’s dishonest policy. See Paragon.

👍 In the first half of 2024, U.S. digital health startups secured $5.7 billion across 266 deals, showing a strong rebound after years of slowed investment, according to Rock Health. With early-stage deals driving the momentum, the sector is on track to surpass funding totals from 2019 and 2023. https://bit.ly/4cCRy2W Via Healthcare Dive #digitalhealth #digitalhealthfunding

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The annual ritual in which CMS proposes sharp cuts in Medicare reimbursement only to have Congress lift them at the last minute is a sort of public policy kabuki dance in which the outcome is practically preordained. Medicare reform is badly needed to end this cycle and put physicians on firmer footing so they can focus on what’s important: caring for patients. Read more at https://buff.ly/3Yo7iCs #radiology #medicalimaging #radiologists

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I’m thankful that I could share my thoughts at that very hearing. There is so much misinformation about 340B. For me, it comes down to two main points: 1- if hospitals need that money as a subsidy to fund everyday activities, they should just ask for a subsidy. Let’s open up the books of these institutions, which already get a huge subsidy with their non-profit status, and see why they are running in the red. Are they really losing money on Medicaid patients or are they just bloated and inefficient? 2- let the subsidy follow the patient. This is a drug benefit program. Why does the funding go to an institution? Imagine if we did that with SNAP, giving a bunch of money to large restaurant chains in exchange for their promise to use the revenue to provide food for poor people (with no oversight to ensure that’s done). We don’t do that; instead we give the benefit to the person who needs it. Let’s change 340B to match that model. Adam J. Bruggeman, MD, MHA, FAAOS, FAOA Daniel Choi Colin Yokanovich John Strom Peter Stein Adam Fein Deborah Williams Lisa Grabert Maya Babu, MD, MBA Katie Orrico Larry Bucshon, M.D. Ann M. Richardson, MBA

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There’s no question that AI is transforming healthcare, and understanding where industry leaders perceive opportunities is important. The latest research report from Arcadia is revealing. 63% of healthcare leaders say AI can analyze large patient data sets to identify trends and create population health intervention strategies 58% say AI can analyze individual patient data to identify opportunities to improve health outcomes 47% say AI can optimize the management and analysis of electronic health records Dive into the report to gain insights from top tech leaders and see where the industry is headed! https://lnkd.in/gf_wkWij

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Medicare reimbursement for cutting-edge digital health tools remains inconsistent at best. This is stifling innovation and hindering patient access to potentially life-changing technologies. CMS has an opportunity to address this issue head-on with two key payment rule proposals coming out next month. We need decisive action to establish clear reimbursement pathways. Prescription digital therapeutics are software-based interventions that deserve a place in the 2025 physician payment rule. What specific reimbursement models would encourage wider adoption of these tools? #MedTech #DigitalHealth #CMS https://lnkd.in/gNnuWwBU

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What does the future hold for retail medicine and virtual care? Walmart is the latest to announce their health center closure. https://lnkd.in/geZpMTkS. This following Optum news, VillageMD closing in Nevada, Teladoc Health problems, etc. What comes next? This is another in a long line of examples that technology and even consumer willingness are not enough when the reimbursement environment does not support particular care models. Are we getting ready to lose all the lessons painfully learned during the pandemic? Or will new virtual care models emerge following this round of closures?

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In her new Forefront article, Stacie Dusetzina from Vanderbilt University argues that perpetual state budget challenges suggest that the US needs to consider broad negotiation and treatment strategies to ensure equitable access to costly one-time treatments and curative therapies, particularly for Medicaid recipients. "Prices set by drug manufacturers at product launch can dramatically affect patient access to highly innovative and high-price drugs, even if those prices are reduced substantially over time due to brand or generic drug competition. One example of this phenomenon is the adoption and diffusion of direct-acting antivirals for hepatitis C, a drug class launched with high initial prices that later saw net price declines by 50 percent or more in subsequent years. The first of the direct-acting antivirals (Sovaldi) received Food and Drug Administration approval in December 2013. The company that marketed the drug, Gilead, drew substantial negative attention when announcing the intention to set a launch price of approximately $1,000 per pill before rebates or discounts (with an intended course of 84 pills to reach cure). After its initial year on the market, a report from the US Senate Committee on Finance found a shockingly low number of Medicaid beneficiaries were treated with Sovaldi or Harvoni (the second curative hepatitis C therapy, approved in October 2014), despite an estimated hepatitis C prevalence of almost 700,000 in the 44 state Medicaid programs that provided estimates to congressional staffers at that time. Although uptake of hepatitis C direct-acting antiviral medications in Medicaid has improved to some degree in recent years, we are far from the goals of eradicating hepatitis C." Read the full article here: https://bit.ly/3WZ7ac9

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Important Special Report issued by NEJM Group on the overall implications of the 2024 election on U.S. health policy. Topping the list of various health care issues in this election cycle are high health care costs, prescription drug prices and large medical bills. Concerns about opioids, fentanyl, obesity, and mental health are near the top of the list. The election outcome will substantially affect the future of health care, medicine, and public health over the next four years. There continues to be wide differences between the political parties on the Affordable Care Act, health insurance coverage access, expansion of Medicare and Medicaid, and health equity initiatives. Geopolitical planning continues to be an area of focus for our Ascent Strategy Group team, including outreach and due diligence at the RNC in Milwaukee and the DNC in Chicago this summer. #Election2024 #healthcarepolicy #healthcareregulation #healthcare #ACA #AffordableCareAct #Medicare #Medicaid #healthcosts #healthinsurance #healthequity #healthdisparities #geopoliticalplanning https://lnkd.in/ghkYSM5h

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Doing M&A in healthcare is now going to cost more, in time and money, to comply with the pre-merger filing final rule requirements. The FTC wants its info. I'm not sure if this added friction is a good thing or a bad thing... #healthcare #mergers #acquisitions #investing #venturecapital #vc #pe #privateequity #strategy Federal Trade Commission https://lnkd.in/gGw-ZF7X

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Whether private equity and REITs are the devil or a saint, nobody seems to ever explore WHY post-acute providers have had to turn to them for sources of capital. Decades of horrendous public policy choices by elected officials and bureaucrats have scared off traditional sources, be it small community banks or otherwise. It’s tough finding someone large enough and diversified enough to lend capital when a stroke of a pen by an elected official could bring forth double-digit Medicare cuts (as we saw last decade), $70 billion+ unfunded mandates (as we see this year), chronically unfunded Medicaid rates, runaway tariffs on healthcare supplies, blocked pipelines of foreign-born nurses… the list is longer than my stomach can handle. While Congress investigates the pants off private equity this year, I hope they investigate the pants off root causes as well. There aren’t enough mirrors in DC.

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