USCSchaeffer Center Scholar on PBMs under ERISA law

80% of payers anticipate significant challenges when adopting alternative funding programs, especially regarding long-term planning and regulatory compliance. Read our blog for the latest research: https://ow.ly/EZX450QI3ub. #AlternativeFundingPrograms #AFPs #Pharmacy #Payers

Today is the day to see if Johnson and Johnson will reply to HRSA’s September 17, 2024 letter that it has to cease the implementation of its rebate model. “Accordingly, as outlined in HRSA’s September 17, 2024, letter, if J&J proceeds with implementing its rebate proposal without Secretarial approval, it will violate section 340B(a)(1) of the Public Health Service Act. If J&J has not notified HRSA that it is ceasing implementation of its rebate proposal by September 30, 2024, HRSA will begin the process outlined in J&J’s Pharmaceutical Pricing Agreement related to terminating the agreement.” Never a dull moment in 340B! https://lnkd.in/e7w2quJA

Kirkland & Ellis and Hogan Lovells have filed a lawsuit alleging President Joe Biden’s secretary of Health and Human Services unlawfully rejected Eli Lilly’s alternative plan for making drugs more affordable to low-income and uninsured patients. The manufacturer of Mounjaro, Trulicity and other treatments for weight loss or diabetes accuses the U.S. Department of Health and Human Services of banning Big Pharma from implementing a cash replenishment rebate program in violation of the Administrative Procedure Act. HHS Secretary Xavier Becerra and the Health Resources and Services Administration have “unlawfully shut Lilly down” from offering cash rebates to reduce drug pricing in the “broken federal 340B program,” according to the allegations in the complaint. “HRSA’s rejection of Lilly’s cash replenishment program is unlawful, contravenes the plain language of the 340B statute, and is arbitrary and capricious,” the drugmaker alleges in the complaint submitted by Kirkland partners John C. O’Quinn, Matthew Owen and Megan McGlynn Butler and Hogan Lovells partner Cate Stetson. “Lilly’s program is consistent with the 340B statute, Lilly’s [pharmaceutical pricing agreement], and other federal laws and regulations—and is not just eminently reasonable but an improvement on the current product replenishment model.” Section 340B of the Public Health Service Act requires drug companies to sell medicine at discounted prices to eligible facilities serving low-income patients. HRSA in September rejected 340B cash replenishment programs proposed by Lilly and Johnson & Johnson, according to Lilly’s lawsuit. “HRSA has thus invoked the nuclear option of removal from not only the 340B program but also Medicaid and Medicare Part B if manufacturers implement a cash replenishment model,” counsel for Lilly alleged in the complaint. “The agency, in other words, would risk depriving seniors and poor patients of life-saving medicines rather than countenance a cash replenishment model.” Full story from Sulaiman Abdur-Rahman: https://lnkd.in/eBVDt36Q

80% of payers anticipate significant challenges when adopting alternative funding programs, especially regarding long-term planning and regulatory compliance. Read our blog for the latest research: https://ow.ly/70ki50QI3wP. #AlternativeFundingPrograms #AFPs #Pharmacy #Payers

WCRI recently released their annual Drug Trends in workers’ compensation report. As proud WCRI members, Arbicare strongly recommends membership for all stakeholders in the industry. Here are just a few interesting takeaways from this report (through Q1 2023 data). 𝐀 𝐅𝐞𝐰 𝐓𝐚𝐤𝐞𝐚𝐰𝐚𝐲𝐬 1. Drug payments per claim continue to decline led by Massachusetts with a 68% drop. 2. Louisiana and Pennsylvania saw increases with the former allowing physician dispensing and the latter experiencing more high priced mail order pharmacy claims. 3. Higher priced topical agents are also a key driver to increases in many states. 4. New York saw a 28% increase in drug payments per claim despite having a state drug formulary 5. New York NSAID payments increased by 34% with diclofenac potassium being a big driver. I’ve previously written about the trend with diclofenac potassium costing several hundred dollars per prescription more than the inexpensive diclofenac sodium. 6. I’ve written previously about fenoprofen and ketoprofen which are very high priced NSAIDs being prescribed in California. These per claim payments are thankfully down. 7. There has also been a trend of pregabalin 75mg utilization over the typical 50mg dosage. Pregabalin 75mg has a significantly higher price tag. 𝐖𝐡𝐚𝐭 𝐢𝐭 𝐦𝐞𝐚𝐧𝐬 𝐟𝐨𝐫 𝐲𝐨𝐮 1. Huge progress over the past decade, we shouldn’t lose sight of that 2. However, staying aware of unnecessary prescription costs for topicals, NSAIDS, and unique dosages will allow injured workers to get the drugs they need and reduce costs. 3. Join WCRI #workerscompensation #utilizationmanagement

#CRALifeSciences Kirsten Axelsen, Annabelle Fowler, PhD, and Amy Rowe conducted an empirical analysis to illustrate unintended consequences of the Medicaid CPI Rebate on generic markets. Both the FDA and Senate Finance Committee have highlighted how some generic drug markets are experiencing instability, with low prices contributing to shortages. Since 90% of prescriptions are for generic products, addressing root causes of instability may help to ensure continued patient access. To read the full report, click here: https://crai.news/ab2

Reposting this powerful message from Tom DePietro. It raises the critical issue that needs more attention: In what country, in what industry, is it acceptable for a business to be forced to pay more for the product they are selling than what they’re able to charge for it? In the pharmacy industry, small businesses are being crushed under the weight of this insane pricing structure. Pharmacies are being asked to pay more for the cost of a drug than they can even bill! How does that make sense in any corner of the world? Small businesses exist to build livelihoods, create jobs, and contribute to our economy as #TaxPayingCitizens. Yet one of the most valued and essential professions—#Pharmacy—is being attacked, demonized, and targeted by individuals who sat there smirking during that hearing. The arrogance and blatant disregard for truth are infuriating. How is this allowed to go on in our country? As we approach this election, we need answers. #HR9096 better be pushed through. No more empty promises, no more almost-there nonsense. It’s time for real action. @RepJerryCarl @RepNikkiBudzinski @RepJamesComer @RepSethMoulton @RepJenniferKiggans @RepLarryBucshon @RepMichaelBurgess @RepAnnaEshoo @RepKayGranger @RepJimBanks @RepLisaBluntRochester @RepBradWenstrup @RepRobertAderholt @RepHaroldRogers @RepLanceGooden @RepMattCartwright @RepBruceWesterman @RepPeteSessions @RepDaleStrong #PharmacyCrisis #StopPBMs #PharmacyJustice #HealthcareReform #SmallBusinessStruggles

This recent BioCentury Inc. article highlights one of the potential consequences of the #InflationReductionAct: tighter formularies for Part D drugs as plans look for mechanisms to manage their increased liability under the redesigned Part D benefit beginning in 2025. The question is – will tighter formularies mean plans take a "more of the same" approach, using tried and true utilization management (UM) techniques currently allowed by CMS versus more draconian measures that spark calls of drug rationing. (Remember, CMS must approve plans’ UM strategies – and if plans go too far, CMS can make them change their criteria.) While the article specifically calls out oncology as an area to watch, we'd bet big moves first in areas like immunology and inflammation, where management is already more palatable and there is less perceived differentiation between many agents. There's another key point to consider, one that is largely left unaddressed in the BioCentury article: how will rebates inform plans' calculus? Given their increased financial liability, plans seem likely to seek higher rebates where possible to mitigate their risk in the catastrophic coverage phase. And they have an incentive to do so, since they get to keep a greater percentage of rebate dollars now than in years past. (The fact that negotiated drugs are not required to pay statutory manufacturer discounts in either the initial or catastrophic coverage phases intensifies this need as well.) All of which is to say ... formularies may get tighter, but there will still be room for alternates, especially branded versions paying big rebates to approximate the lowest net cost of negotiated drugs. #PatientAccess #Medicare #Pharmaceuticals #HealthcarePolicy #UtilizationManagement #drugpricing #pharmaceuticals #IRA cc Roger Longman Jeff Berkowitz Susan Raiola Ryan Walsh Rob O'Brien Jane F. Barlow, MD, MPH, MBA Julia Murphy Morgan Robinson

80% of payers anticipate significant challenges when adopting alternative funding programs, especially regarding long-term planning and regulatory compliance. Read our blog for the latest research: https://ow.ly/rZNY50QI3sL. #AlternativeFundingPrograms #AFPs #Pharmacy #Payers

$315 billion. For too long pharmacy benefit managers have siphoned off billions of dollars from the American taxpayers. As the curtain continues to get pulled back exposing their deceptive practices, they continue to claim how they keep drug pricing down. Let's simplify this overly complex subject by asking a common sense question: IF these companies are truly keeping costs down, how do they themselves earn $315 BILLION REVENUE annually. Slay these pigs for their greedy ways. End the corruption for the American taxpayer. P.S. Pharmaceutical Care Management Association (PCMA) can't stand the limelight of the American media. Share away! https://lnkd.in/eirsstab