Susan B. Nichols’ Post

The outcome of the election ushers in a new era of Republican leadership following President Biden’s four-year term that saw major changes within drug policy including the historic Inflation Reduction Act. But how will Trump’s second White House reign fare for the biopharma industry? It’s a question that remains to be seen. The president-elect’s “concepts of a plan” regarding healthcare haven’t been laid out yet, but he has a few options on the table. There’s a chance he could move to revive his Most Favored Nation drug pricing policy that died out quickly after attracting lawsuits, or he could look to Project 2025, a controversial 922-page policy proposal (PDF) by The Heritage Foundation, for a few ideas. If he were to turn to Project 2025, attempts to repeal the IRA could be in motion, but after speaking with key opinion leader John Brooks, analysts at Jefferies consider that unlikely. In fact, healthcare policy in general would likely “rank lower” on Trump’s legislative agenda compared to his first term, with legislative changes possibly coming to the insurance and Medicare Advantage vein at most. https://lnkd.in/edX_9zsb JCR Pharma Mathy Bekele Jessica Smith

It has been a tumultuous past few weeks in Washington, with potentially far-reaching implications for health tech. The Supreme Court’s repeal of Chevron doctrine casts deep uncertainty over agency rulemaking procedures – particularly relevant given  the nuances of FDA regulation. The FTC’s assertive stance on pharmaceutical rebates have primed it to take legal action against PBMs. ONC has received additional wide-reaching powers, as the role of the HHS CTO has been recently folded into its portfolio. These changes come amid an election year, with neither campaign yet articulating a clear program on AI, medical device, or LDT oversight. Read more about the key sources of regulatory uncertainty facing the health tech industry at the link below. #healthtech #digitalhealth #healthpolicy #fda #ftc #scotus Elizabeth Cho-Fertikh, PhD Tomas J. Philipson, Ph.D Min Lang Tai Mai Laura Beken Vrushab Gowda, MD, JD https://lnkd.in/evaUXSbx

Thanks to Endpoints News for interviewing me and the always brilliant Leslie Isenegger, MPP about healthcare policy in last night's State of the Union. The speech was light on healthcare overall, which was surprising as the IRA drug pricing provisions is a signature accomplishment for the administration and targets a key voting block. It could be because these provisions are difficult to message to voters, as cost savings for seniors, if they see them at all, are years away. It's reminiscent of the challenge the Obama Administration faced following the passage of the Affordable Care Act. While a monumental accomplishment to get any healthcare legislation passed in this environment, the impact took years for voters to feel the effect. Policy changes to the most complex healthcare system in the world are hard, incremental and often boring. The Biden administration's singular focus on "Big Pharma" doesn't necessarily impact the convoluted system that determines drug prices, but it's good politics in an election year where quick wins are key. https://lnkd.in/gMXb7UMX

🌐 **Breaking Update: Developments in the 340B Program Landscape** 🌐 In a significant shift, Johnson & Johnson has retracted its 340B rebate proposal following a clash with the Health Resources and Services Administration (HRSA). Established in 1992, the 340B program is a lifeline for underserved communities, allowing eligible hospitals and clinics to purchase outpatient prescription medications at steep discounts, sometimes up to 50%. Earlier this year, Johnson & Johnson suggested a controversial change requiring 340B-covered entities to pay full price for certain drugs, namely Stelara and Xarelto, and then submit claims for rebates. They argued this model aimed to tackle the issue of duplicate discounts. However, HRSA opposed the proposal, labeling it as inconsistent with the 340B statute. HRSA warned that moving forward without consent could breach the statute, facing potential referral to the Department of Health and Human Services’ Office of the Inspector General. Johnson & Johnson stood firm, claiming their approach is legally justified, highlighting audit shortcomings in pinpointing program abuses. Yet, faced with HRSA’s strong opposition and the need to ensure millions have access to vital medications, they backtracked on the proposal while reserving their legal options. This decision underscored the delicate balance pharmaceutical companies must maintain when navigating the intricate dynamics of the 340B program, compliance standards, and the Inflation Reduction Act. The ongoing debate places spotlight on crucial issues of oversight and compliance within the healthcare industry. 👉 Are you navigating the ever-evolving 340B landscape? Contact the Remy team to ensure your institution is 340B future-ready! 💼 #HealthcareNews #PharmaIndustry #340BProgram #Compliance #JohnsonAndJohnson #PublicHealth #RemySolutions

Covered entities, Contract pharmacies, Disproportionate Share Hospitals, Duplicate Discounts- ·       How does 340B impact patients?  ·       What is driving the surge in 340B spend? ·       What are some ways to improve the program and attenuate any warped incentives that exist today? Knowledge is power, and William Sarraille does a fantastic job laying out the current challenges, faults, and ultimately some unattended consequences of the 340B program all while paying special attention to the impact on the patient. Below is a brilliant read that provides background, examples of impact, as well as insights on how to improve the program. Highly recommend reading for all stakeholders across pharma and patient access (lots of wisdom here). Thank you to all those involved researching, writing, and advocating for improved patient experience.

Thanks so much for everyone’s thoughts on my earlier 340B SUSTAIN Act draft comment letter. Here’s the final, reflecting your suggestions. Based on your comments, I made the following changes/additions: • Switching to Higher Cost Drugs: I added a section that discusses 340B entities switching patients to higher cost branded products from lower cost generic products, where doing so would increase patient deductible and co-insurance payments. Another example, as 46brooklyn Research says, of how 340B makes money “on the backs of sick patients”. Sadly, Adam Fein’s prior work and the “messaging” of some 340B consultants demonstrate that patients are harmed in these switches. • Are They Even Really “Disproportionate Share” Hospitals?: I revised the section stating that Congress needs to revisit the definition of a “disproportionate share” hospital. A Medicare and Medicaid payment rate of 11.75% is not a “disproportionate share”. • The Clearinghouse Concept: The bill proposes a single clearinghouse for claims data. Its “conflicts” provision eliminates most vendors that would actually have experience in performing relevant functions in the 340B space. At the same time, the bill would not consider contract pharmacies, including those dominated by the Big 3 PBMs, to be “conflicted”. Crazy. Special thanks, in addition to Adam and 46brooklyn Research to IQVIA, whose research I leaned on heavily in setting out my prescriptions for reform—pun intended. #340b #switching #generics #drugpricing

💊 We're supposed to think Medicare negotiating with Big Pharma is a big win, right? 🐭Something about the cheese seems off...🧀 Washington has been so far behind the Big Health Business Models, that this "win" seems only to be good for politicians. Is it reasonable to expect that costs will be shifted? Thinking it'll be worth reviewing earnings reports 🏧 for these companies a few quarters after the new pricing is implemented. What do you think? #MedicareSavings #DrugPriceNegotiation #HealthcareCosts #PharmaReform #SeniorSavings #HealthcarePolicy #PrescriptionDrugs #Medicare2026 #PatientAdvocacy #HealthcareEconomics https://lnkd.in/esy9fwhp

Last week, I mentioned how the government is still trailing behind Big Health's business models. 𝗪𝗲𝗹𝗹, 𝗣𝗕𝗠𝘀 𝘀𝘂𝗰𝗵 𝗮𝘀 𝗘𝘅𝗽𝗿𝗲𝘀𝘀 𝗦𝗰𝗿𝗶𝗽𝘁𝘀, 𝗖𝗩𝗦 𝗖𝗮𝗿𝗲𝗺𝗮𝗿𝗸, 𝗮𝗻𝗱 𝗢𝗽𝘁𝘂𝗺𝗥𝘅 𝗵𝗮𝘃𝗲 𝗯𝗲𝗲𝗻 𝗮𝘁 𝘁𝗵𝗶𝘀 𝗳𝗼𝗿 𝗮 𝘄𝗵𝗶𝗹𝗲, 𝗰𝗿𝗲𝗮𝘁𝗶𝗻𝗴 𝗚𝗣𝗢𝘀—𝗔𝘀𝗰𝗲𝗻𝘁, 𝗭𝗶𝗻𝗰, 𝗮𝗻𝗱 𝗘𝗺𝗶𝘀𝗮𝗿, 𝗿𝗲𝘀𝗽𝗲𝗰𝘁𝗶𝘃𝗲𝗹𝘆. They’ve claimed to be more open and transparent over the years, yet this move suggests otherwise. With 75% of U.S. pharmacy benefits under their control, why do they need these new entities? While PBMs tout increased savings and efficiencies, many of us are left questioning if these GPOs are just another layer of complexity, adding costs rather than value. The timing, especially as transparency regulations loom, makes it hard to believe this is purely about patient care. Are they truly working for the patients or just protecting their own interests? Time will tell, but skepticism is warranted. #HealthcareReform #PBMs #Pharma #DrugPricing #GPO #BigHealth #TransparencyMatters #PatientAdvocacy

💼 𝐁𝐢𝐨𝐩𝐡𝐚𝐫𝐦𝐚 𝐔𝐧𝐝𝐞𝐫 𝐓𝐫𝐮𝐦𝐩 𝟐.𝟎: 𝐖𝐡𝐚𝐭’𝐬 𝐀𝐡𝐞𝐚𝐝? With Trump back in the White House and GOP control in Congress, big shifts could be on the horizon for the biopharma landscape: ➡️ 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗙𝗹𝗲𝘅𝗶𝗯𝗶𝗹𝗶𝘁𝘆: Less aggressive FTC oversight may lead to a more open market for M&A, creating new growth paths for CDMOs and biopharma partnerships. ➡️ 𝗗𝗿𝘂𝗴 𝗣𝗿𝗶𝗰𝗶𝗻𝗴: Trump could revive past policies to reduce drug costs, though a full repeal of the Inflation Reduction Act remains unlikely. Expect ongoing pricing debates... ➡️ 𝗥𝗼𝗯𝗲𝗿𝘁 𝗞𝗲𝗻𝗻𝗲𝗱𝘆 𝗙𝗮𝗰𝘁𝗼𝗿: As a potential health leader, Kennedy's vaccine stance and regulatory vision add an unpredictable twist, especially for public health and industry standards. ➡️ 𝗜𝗺𝗽𝗼𝗿𝘁 𝗧𝗮𝗿𝗶𝗳𝗳𝘀: Import tariffs could increase costs for pharma companies shipping to the US, impacting supply chains and potentially raising prices. Big shifts in policy could mean new challenge - and opportunities - for biopharma and CDMOs ahead. What did I miss?? Comment below 👇 #CDMO #Pharma #Election Source: Fierce Pharma

Employers, a friendly reminder: The deadline to submit your RxDC report to CMS is June 1, 2024, for the 2023 data period. This crucial report details your group health plans' prescription drug and healthcare expenses. Good news! Most of our carriers are proactively handling this submission for their clients, and they may reach out to you for the necessary data. Please coordinate with your issuers, TPAs, or PBMs to ensure this process is seamless. For those with self-insured plans, remember you bear the ultimate responsibility for compliance. Start preparing now to ensure a hassle-free submission. #HealthcareReporting #RxDCReport #CMS #EmployeeBenefits