Hedva Barenholtz Levy’s Post

CMS released final guidance for Medicare Drug Price Negotiation for the second cycle of selected Part D drugs, and for the effectuation of the "Maximum Fair Price" (MFP) in 2026. Some key updates include: *CMS will hold up to 15 patient-centered roundtable events and one town hall meeting next spring, intended to improve upon the 10 patient listening sessions for the first cycle of negotiations. *CMS updated the timing of the first optional negotiation meeting so that it takes place after CMS provides its initial offer but before the statutory deadline for manufacturers to submit written counteroffers. *The final guidance establishes a process for dispensers to self-identify if they anticipate cash flow issues due to reliance on retrospective refunds for the provision of the MFP. CMS anticipates these entities to include sole proprietor rural or urban pharmacies with a high volume of Part D prescriptions dispensed, pharmacies that predominantly rely on prescription revenue to maintain business operations, long term care pharmacies, 340B entities with in-house pharmacies and I/T/U pharmacies. **(Primary manufacturers must include a process for mitigating material cash flow concerns for dispensing entities in their MFP effectuation plan) *CMS provdided updates to the operational requirements and parameters for MFP payment facilitation, the Medicare Transaction Facilitator (MTF), and data exchange among dispensing entities, manufacturers, and CMS. #Medicare #DrugPrices #Negotiation #PartD #CMS #Pharmacy

My latest Letter to the Editor: Why drug prices are rising The Federal Trade Commission (FTC) released its second interim report on Pharmacy Benefit Managers (PBMs) this week. After years of advocacy, it should be the final nail in the coffin containing the lie that PBMs do anything but cause high drug prices for the sickest among us and increase premiums for all of us. The report found that “‘Big 3 PBMs’—Caremark Rx, LLC (CVS), Express Scripts Inc. (ESI), and OptumRx, Inc. (OptumRx) — marked up numerous specialty generic drugs dispensed at their affiliated pharmacies by thousands of percent, and many others by hundreds of percent” among many other abuses. These are often the same medications that patients have been told they must receive via a pharmacy affiliated with their insurance’s PBM and are prohibited from receiving at a local pharmacy. The Chronicle has now published several articles about PBMs closing pharmacies, harming patients and causing drug prices to rise. Pharmacists and pharmacy owners have been sounding the alarm on this nationwide issue for years. Finding and publishing transparent information about prescription claims has often been difficult. PBMs hide their data behind confidential contracts. This FTC report, as an example, is labeled as an interim report due to PBM’s stonewalling and ignoring orders to share information. I have made trips to Tallahassee and Washington, D.C., to discuss the need for PBM reform with our locally elected officials, and hosted visits at our pharmacies to discuss these issues. While this advocacy work has had some success, there’s still more work to be done this year. PBMs must be required to divest their affiliated pharmacies. It’s a conflict of interest to be both the insurer, the PBM and the pharmacy. PBMs must reimburse local pharmacists at a rate consistent with the known cost to dispense so that local patients continue to have face-to-face access to the pharmacist of their choosing. Pharmacy networks should be open to every pharmacy and every patient. Closed networks only help PBM profits, not patients. And there must be transparency on the average wholesale cost of a prescription drug. The FTC report ultimately shows us why prescription drug prices continue to rise each year and why PBMs can’t be trusted with the nation’s prescription drugs. They must be reformed, and I call on our federal representatives in Congress to enact PBM reform this year.

Big News from CMS: 15 More Drugs Selected for Medicare Price Negotiations! The Centers for Medicare & Medicaid Services has announced the selection of 15 additional drugs for Medicare Part D price negotiations under the Inflation Reduction Act. These negotiations, set to take place in 2025, aim to lower prescription drug costs for millions of seniors, with new prices taking effect in 2027.   Why It Matters: ✔️ About 5.3 million Medicare Part D beneficiaries used these drugs between Nov 2023 and Oct 2024. ✔️ These medications accounted for $41 billion in Medicare Part D spending—14% of total covered drug costs. ✔️ Combined with the first round of negotiations, this represents over one-third of all Medicare Part D drug spending! Drugs Selected for the Second Round of Negotiations: ▪️ Ozempic, Rybelsus, Wegovy ▪️ Trelegy Ellipta ▪️ Xtandi ▪️ Pomalyst ▪️ Ibrance ▪️ Ofev ▪️ Linzess ▪️ Calquence ▪️ Austedo, Austedo XR ▪️ Breo Ellipta ▪️ Tradjenta ▪️ Xifaxan ▪️ Vraylar ▪️ Janumet, Janumet XR ▪️ Otezla 📆 Key Timeline: 🔹 March 1, 2025 – Drug companies & the public must submit data & evidence on these drugs. 🔹 June 1, 2025 – CMS will issue initial price offers to drug manufacturers. 🔹 2027 – New negotiated drug prices go into effect. Learn More: Medicare Drug Price Negotiation Program: This marks another major step toward making prescription drugs more affordable for millions of Americans. What are your thoughts on this latest round of Medicare price negotiations? #Medicare #PrescriptionDrugs #InflationReductionAct #HealthcarePolicy #CMS

On today's "Do you know", on 1/17/25 #CMS sent out the notification regarding #IRA update pertaining to Medicare Advantages & pharmacies. It was wayyyyyy down the article regarding 2027 IRA drugs list. I actually thought the Medicare Advantage and Part D Proposed Rule had very interesting information: Contract Year 2026 Medicare Advantage and Part D Proposed Rule (CMS-4208-P) New provisions for Medicare Drug Price Negotiation Program The Contract Year (CY) 2026 Medicare Advantage and Part D proposed rule includes a provision that would require that Part D sponsors’ network contracts with pharmacies require such pharmacies to be enrolled in the Medicare Drug Price Negotiation Program’s Medicare Transaction Facilitator Data Module. The rule also proposes to shorten the Prescription Drug Event (PDE) submission timeliness requirement for initial PDE records for selected drugs from 30 calendar days to 7 calendar days to help ensure prompt payments by drug manufacturers to dispensing entities to provide access to the MFP. To review or comment on the CY 2026 MA and Part D proposed rule during its 60-day public comment period, visit the Federal Register. Comments must be submitted no later than January 27, 2025. Prescription Drug Event (PDE) from 30 days to 7! I sure hope people are effected groups/ people are commenting on this proposed rule! Link to full information: https://lnkd.in/gAN4Af7Z

Hopefully today's Federal Trade Commission "interim" report will help Congress get #PBM reform over the finish line this year. Report illustrates how "PBMs wield enormous power over patients’ ability to access and afford their prescription drugs, allowing PBMs to significantly influence what drugs are available and at what price." It also quantifies how "PBMs are highly concentrated and vertically integrated with the nation’s largest health insurers and specialty and retail pharmacies." * PBMs oversee critical decisions about access to and affordability of life-saving medications, without transparency or accountability to the public. * Vertically integrated PBMs appear to have the ability and incentive to prefer their own affiliated businesses, creating conflicts of interest that can disadvantage unaffiliated pharmacies and increase prescription drug costs. * The top three PBMs processed nearly 80% of 6.6 billion prescriptions in 2023 & the top six PBMs processed more than 90%. * Pharmacies affiliated with the three largest PBMs now account for nearly 70% of all specialty drug revenue. https://lnkd.in/e9a-MHMF

"𝘛𝘩𝘦 𝘉𝘪𝘨 3 𝘗𝘉𝘔𝘴 𝘮𝘢𝘳𝘬𝘦𝘥 𝘶𝘱 𝘱𝘳𝘪𝘤𝘦𝘴 𝘰𝘯 51 𝘴𝘱𝘦𝘤𝘪𝘢𝘭𝘵𝘺 𝘨𝘦𝘯𝘦𝘳𝘪𝘤 𝘥𝘳𝘶𝘨𝘴 𝘢𝘯𝘥 𝘨𝘦𝘯𝘦𝘳𝘢𝘵𝘦𝘥 𝘮𝘰𝘳𝘦 𝘵𝘩𝘢𝘯 $7.3 𝘣𝘪𝘭𝘭𝘪𝘰𝘯 𝘪𝘯 𝘱𝘳𝘰𝘧𝘪𝘵 𝘧𝘳𝘰𝘮 2017 𝘵𝘰 2022." – FTC Report The findings don’t stop there. PBMs also profited $1.4 billion through spread pricing—billing insurers more than they reimburse pharmacies for dispensing drugs. These practices hurt patients, employers, and independent pharmacies while prioritizing profits over care. For employers, this report underscores an urgent need: 𝗮𝗰𝗰𝗲𝘀𝘀 𝘁𝗼 𝗱𝗮𝘁𝗮. Without it, managing pharmacy benefits effectively is impossible. Patients deserve a 𝘀𝘆𝘀𝘁𝗲𝗺 𝗯𝘂𝗶𝗹𝘁 𝗼𝗻 𝘁𝗿𝘂𝘀𝘁, not profit-driven manipulation. That’s why we’re committed to driving meaningful change in the PBM industry. https://lnkd.in/e67ygPzN #PBMReform #HealthcareTransparency #PatientFirst

The reality exposed in this report is one we see every day in the PBM industry. Patients, employers, and independent pharmacies are continually hurt by practices that prioritize profits over care. This is why I joined AffirmedRx—to help drive honesty, integrity, and transparency in an industry that desperately needs it. Our mission is clear: put patients before profits and build a system grounded in trust, not manipulation. The time for meaningful change is now, and I'm proud to be part of a company committed to this purpose. #PBMReform #HealthcareTransparency #PatientFirst

The 340B Drug Discount Program has faced several challenges due to its growth and confusion with the Medicaid Drug Rebate Program (MDRP). Additionally, a recent court ruling might expand the definition of a “patient” under the 340B program, increasing claims and duplicate discounts. As Dary Todd emphasizes in this piece, improving transparency, ensuring equal access to data, and resolving disputes efficiently can help restore trust and cooperation. By enhancing these aspects, we can ensure low-cost pharmaceuticals reach the patients who need them. #Pharmacy #Healthcare #340B

U.S. Department of Health and Human Services (HHS) has just announced 15 additional drugs have been selected for Medicare drug price negotiations in a continued effort to lower prescription drug costs for seniors. Most notable are the selections of Novo Nordisk's popular GLP-1 agonists, Ozempic and Wegovy. In accordance with the Inflation Reduction Act, the negotiations with participating drug companies for these 15 drugs will occur in 2025 and any negotiated prices will become effective in 2027. According to the Centers for Medicare & Medicaid Services, these drugs were selected based on their “gross covered prescription drug costs,” among other criteria. Between November 2023 and October 2024, ~ 5.3M Part D beneficiaries used the selected drugs, costing the government $41B in gross drug spending. It's unclear if the new incoming administration plans to make any changes to the program, however the current administration suggested they would be unable to do so because the law outlines detailed selection criteria. #IRA #inflationreductionact #drugpricing #pharma #glp1 #ozempic #wegovy #Medicare #PartD

Recently quoted in MedPage Today on the Biden-Harris administration’s proposed model program that would lower prices to $2 per month for certain generic drugs purchased through Medicare Part D drug plans: It is "rather meaningless [for the administration] in its final months, to announce a model that would not be operational until 2027 at the earliest. Further, I suspect that few Part D plans will choose to participate as it narrows their options in their negotiations with manufacturers, particularly for those generics that remain expensive for supply chain [reasons] or because a single manufacturer is the last to make the drug, [but] it has some merit from an affordability standpoint for those few expensive generics." https://lnkd.in/eVDJ5Byi