340B Drug Pricing Program

340B Drug Pricing Program / en Sat, 02 Aug 2025 06:17:58 -0500 Fri, 01 Aug 25 12:26:18 -0500 AHA 340B Advocacy Alliance Bulletin - AHA Regulatory Advisory on 340B Rebate Pilot Program /340b-advocacy-alliance-bulletin/2025-08-01-aha-340b-advocacy-alliance-bulletin-august-1-2025 AHA Regulatory Advisory with Summary of HRSA Notice Establishing 340B Rebate Model Pilot ProgramThe Health Resources and Services Administration (HRSA) July 31 <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGcBZxVyKOIHq1PmBQRHWLbIHrKpP22u4d6VvnEv2NWRx50cnfRzOHMt-zxSlG4GAAw2ahJGZ0%3D&amp;data=05%7C02%7Cdsamuels%40aha.org%7Cf73b05bc76d14af2adbf08ddd11f50ac%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638896655252424288%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=jXT7NdzO2h%2F2%2BUxsmkpj3bboystAIf8utA9Du9iX95U%3D&amp;reserved=0" target="_blank">announced a 340B rebate model pilot program</a> that will provide certain drugmakers the option to effectuate access to 340B discounted pricing for certain drugs under a rebate model. This voluntary rebate program will be piloted starting Jan. 1, 2026, for at least one year, which will allow HRSA to understand the “merits and shortcomings” of a rebate model in the 340B program.AHA Take The AHA July 31 said in a <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGcBZxVyJFwh5vFAeadXA0R6DGGh0-bYuPP3b60-BRomQbXRgi4vts-mV-5OOFLjlkqshbQ1RU%3D&amp;data=05%7C02%7Cdsamuels%40aha.org%7Cf73b05bc76d14af2adbf08ddd11f50ac%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638896655252436773%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=opywMXNetNfezDsyuB8x1%2BmGXpSZNQwxCo8f8xiYl3Y%3D&amp;reserved=0" target="_blank">statement</a>, “The AHA looks forward to reviewing HRSA’s 340B rebate guidance in more detail and working with the agency on this issue. However, we are concerned that this guidance authorizes a significant departure from how the 340B program has successfully operated for decades and sets a dangerous precedent for possible harmful expansions in the future. This pilot program is a response to a non-existent program integrity problem that the drug manufacturers have manufactured in the public discourse.“Nevertheless, we appreciate HRSA’s efforts to impose strict guardrails on its limited pilot program. Going forward, it will be essential that HRSA makes certain that the drug companies bear all the costs of implementing these rebate models and that those companies provide discounts expeditiously. Anything else will pose serious financial risks to patients, communities, and the hospitals that care for them.”The AHA will submit comments for the agency’s consideration and will continue to work closely with the administration and Congress to ensure the 340B program is protected for all patients and providers.AHA Regulatory Advisory AHA members can download the <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGcBZxVyDu2uXXp7lBHvaUcUx4IyHw1k7_iO-D90RLpuinOL_A2i78SElZp-IhLAp6upoQ9jgk%3D&amp;data=05%7C02%7Cdsamuels%40aha.org%7Cf73b05bc76d14af2adbf08ddd11f50ac%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638896655252449383%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=mmut37HxS5G8vQQ%2BtDiceAJxHmODxVMWq7UiXXHM9dc%3D&amp;reserved=0" target="_blank">Regulatory Advisory</a>&nbsp;containing a summary and key highlights of the guidance. If you have questions, please contact Bharath Krishnamurthy, AHA director of health analytics and policy, at <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGcBZxVyHs4eCetxOMnWb36LA65KU888TDY3aAEOSrEpU5hU4SqCCKZetKgsLDCUNSxJVIecRQ%3D&amp;data=05%7C02%7Cdsamuels%40aha.org%7Cf73b05bc76d14af2adbf08ddd11f50ac%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638896655252462003%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=5%2Fxb9x%2F%2B27ahSrilnQG4m%2BW8jyVAZumxHFNFWH3NHxA%3D&amp;reserved=0" target="_blank">bkrishnamurthy@aha.org</a>. Fri, 01 Aug 2025 12:26:18 -0500 340B Drug Pricing Program HRSA Issues Notice Establishing 340B Rebate Model Pilot Program /advisory/2025-08-01-hrsa-issues-notice-establishing-340b-rebate-model-pilot-program <div class="container"><div class="row"><div class="col-md-8">The Health Resources and Services Administration (HRSA) July 31&nbsp;<a href="https://www.federalregister.gov/public-inspection/2025-14619/application-process-for-the-340b-rebate-model-pilot-program">announced a 340B rebate model pilot program</a> that will provide certain drugmakers the option to effectuate access to 340B discounted pricing for certain drugs under a rebate model. This voluntary rebate program will be piloted starting Jan. 1, 2026, for at least one year, which will allow HRSA to understand the “merits and shortcomings” of a rebate model in the 340B program.&nbsp;This announcement comes after five drug companies last year acted unilaterally to impose various forms of a 340B rebate model, which were all rejected by HRSA. Letters sent by HRSA to these drug companies outlined the agency’s serious concerns with the scope, intent and structure of their proposed rebate schemes. Subsequently, each drug company sued the federal government, arguing that the agency lacked any authority to prevent drug companies from imposing their rebate models. In two separate rulings, federal district courts rejected the drug companies’ arguments and clarified that the Health and Human Services (HHS) Secretary must explicitly authorize the use of any rebate model in the 340B program and directed the government to promulgate guidance to this effect. The July 31 notice announcing a 340B rebate model pilot program comes as these cases remain in active litigation at the federal appellate level.&nbsp;<div><h2 id="keyhighlights">Key Highlights</h2>The 340B Rebate Model Pilot Program would:<ul><li>Begin Jan. 1, 2026, and apply only to the 10 Medicare Part D drugs subject to Medicare drug negotiation under the Inflation Reduction Act.</li><li>Require 340B hospitals to purchase these drugs at wholesale acquisition cost, submit certain data elements to drug companies, and receive a rebate within 10 calendar days of data submission for the difference between the wholesale acquisition cost and the 340B price.</li><li>Require drug companies to apply for participation in the pilot program by Sept. 15, with approvals made by HRSA by Oct. 15.</li><li>Require drug companies to submit specific plans as part of the application that detail how they will effectuate a rebate model and ensure they cover all costs associated with data submission, and no additional administrative costs are passed on to 340B hospitals.&nbsp;</li></ul></div><h2>AHA TAKE</h2>The AHA July 31 said in a <a href="/press-releases/2025-07-31-aha-statement-340b-rebate-guidance">statement</a>, “The AHA looks forward to reviewing HRSA’s 340B rebate guidance in more detail and working with the agency on this issue. However, we are concerned that this guidance authorizes a significant departure from how the 340B program has successfully operated for decades and sets a dangerous precedent for possible harmful expansions in the future. This pilot program is a response to a non-existent program integrity problem that the drug manufacturers have manufactured in the public discourse.“Nevertheless, we appreciate HRSA’s efforts to impose strict guardrails on its limited pilot program.&nbsp;Going forward, it will be essential that HRSA makes certain that the drug companies bear all the costs of implementing these rebate models and that those companies provide discounts expeditiously. Anything else will pose serious financial risks to patients, communities, and the hospitals that care for them.”The AHA will submit comments for the agency’s consideration and will continue to work closely with the administration and Congress to ensure the 340B program is protected for all patients and providers.&nbsp;<h2>340B REBATE MODEL PILOT PROGRAM DETAILS</h2>The 340B rebate model pilot program will serve as a voluntary option for drug companies to effectuate access to 340B pricing for drug purchases made by eligible 340B covered entities beginning Jan. 1, 2026, and lasting a minimum of one year. Once a drug company is accepted into the pilot program, it is not voluntary for hospitals purchasing from that drug company.This pilot program will only apply to the National Drug Codes-11 (NDC-11s) included in the Centers for Medicare &amp; Medicaid Services (CMS) Medicare Drug Price Negotiation Selected Drug List, regardless of payer. This means for calendar year (CY) 2026, the pilot program will only apply to the 10 Medicare Part D drugs whose prices were negotiated by the HHS secretary.1 HRSA notes that it could expand this program to more drugs in the future.The program will require any drug company with a Medicare Drug Price Negotiation Program (MDPNP) agreement with CMS for CY 2026 that wishes to use a rebate model to effectuate access to 340B pricing to apply for program participation by Sept. 15 with agency approvals by Oct. 15. Drug companies cannot implement a rebate model without receiving approval from HRSA, and the agency reserves the right to revoke a drug company’s approval at any time for noncompliance with the pilot program’s requirements.The rebate model will require 340B hospitals to purchase these 10 Medicare Part D drugs, subject to Medicare negotiation at the drug’s Wholesale Acquisition Cost (WAC), instead of the 340B price. 340B hospitals will then need to submit a limited set of claims data elements to drug companies within 45 calendar days of the date of dispense. These claims data elements include:&nbsp; &nbsp; &nbsp; &nbsp;a. Date of Service &nbsp; &nbsp; &nbsp; &nbsp;b. Date Prescribed &nbsp; &nbsp; &nbsp; &nbsp;c. RX number &nbsp; &nbsp; &nbsp; &nbsp;d. Fill Number &nbsp; &nbsp; &nbsp; &nbsp;e. 11 Digit National Drug Code (NDC) &nbsp; &nbsp; &nbsp; &nbsp;f. Quantity Dispensed &nbsp; &nbsp; &nbsp; &nbsp;g. Prescriber ID &nbsp; &nbsp; &nbsp; &nbsp;h. Service Provider ID &nbsp; &nbsp; &nbsp; &nbsp;i. 340B ID&nbsp; &nbsp; &nbsp; &nbsp; &nbsp;j. Rx Bank Identification Number (BIN) &nbsp; &nbsp; &nbsp; &nbsp;k. Rx Processor Control Number (PCN)Once submitted, drug companies must rebate the difference between the drug’s WAC price and 340B price within 10 calendar days of receiving the data submission. Importantly, the notice specifies that drug companies cannot deny 340B rebates for any compliance concerns, including concerns with Medicaid duplicate discount or diversion. If a drug company decides to deny a 340B rebate, it must provide the covered entity with specific documentation and a rationale for the denial. HRSA encourages both drug companies and covered entities to use the 340B Administrative Dispute Resolution (ADR) process or reach out to the agency directly with any concerns about improper denials or compliance concerns.As part of the application process, drug companies must submit plans that are no more than 1,000 words in length and address the operational requirements of the model, including plans that will ensure processing and payment within the timelines mentioned above. In addition, drug companies must include in their plan an assurance that the drug company will cover all costs for data submission and that no additional administrative costs are passed on to the covered entity. However, the notice does not specify what those additional administrative costs are and does not require all drug companies to use a single IT platform. This will mean that 340B hospitals could be required to submit data to drug companies, each with their own unique platform. A drug company’s plan also must ensure it provides technical assistance/guidance to covered entities in using the IT platform and includes sufficient guardrails to protect patient data.The agency also notes that it will require drug companies to submit periodic reports of the rebate model program and allow for stakeholder feedback. The details of these reports and opportunities for feedback will be detailed at a later date.The agency seeks comments from stakeholders in four areas:<ol><li>Are there any additional flexibilities to maximize efficiency and efficacy for participating manufacturers that should be considered in the pilot design?</li><li>Are there any additional safeguards to mitigate adverse, unintended impacts for covered entities that should be considered in the pilot design?</li><li>Are there any additional data or reporting elements that should be required to improve implementation and evaluation of the pilot?</li><li>Are there any potential implementation issues not yet sufficiently accounted for in the pilot design (e.g., logistical or administrative burdens)?</li></ol><h2>WHAT YOU CAN DO</h2>The AHA strongly encourages all 340B hospitals to submit their own comments to HRSA through the Federal Rulemaking Portal at <a href="http://www.regulations.gov">www.regulations.gov</a> within the agency’s 30-day comment period ending Aug. 31.340B hospitals should communicate their concerns with the current scope of the rebate model pilot program, as well as the potential expansion of this program to all drugs purchased under the 340B program and the potential harms it will create for their finances, operations and access to care for the patients they serve.<h2>FURTHER QUESTIONS</h2>If you have further questions, please contact Bharath Krishnamurthy, AHA’s director of health policy and analytics, at <a href="mailto:bkrishnamurthy@aha.org">bkrishnamurthy@aha.org</a>.&nbsp;<div><hr><div id="ftn1"><a href="#_ftnref1" title>1</a> <a href="https://www.cms.gov/newsroom/fact-sheets/medicare-drug-price-negotiation-program-negotiated-prices-initial-price-applicability-year-2026">https://www.cms.gov/newsroom/fact-sheets/medicare-drug-price-negotiation-program-negotiated-prices-initial-price-applicability-year-2026</a></div></div></div><div class="col-md-4"><a href="/system/files/media/file/2025/08/hrsa-issues-notice-establishing-340b-rebate-model-pilot-program-advisory-8-1-2025.pdf" target="_blank" title="Click here to download the Regulatory Advisory: HRSA Issues Notice Establishing 340B Rebate Model Pilot Program PDF."><img src="/sites/default/files/2025-08/cover-hrsa-issues-notice-establishing-340b-rebate-model-pilot-program-advisory-8-1-2025.png" data-entity-uuid data-entity-type="file" alt="HRSA Issues Notice Establishing 340B Rebate Model Pilot Program Cover." width="640" height="834"></a></div></div></div> Fri, 01 Aug 2025 10:02:31 -0500 340B Drug Pricing Program HHS announces new 340B Rebate Model Pilot Program /news/headline/2025-07-31-hhs-announces-new-340b-rebate-model-pilot-program The Department of Health and Human Services today issued a <a href="https://www.federalregister.gov/public-inspection/2025-14619/application-process-for-the-340b-rebate-model-pilot-program" title="HHS notice">notice</a> announcing a 340B Rebate Model Pilot Program as a voluntary mechanism for qualifying drug manufacturers to effectuate the 340B ceiling price on select drugs to all 340B-covered entities.&nbsp; &nbsp; The notice said HHS’ Health Resources and Services Administration’s Office of Pharmacy Affairs, which currently oversees the 340B Drug Pricing Program, is inviting certain drug manufacturers to apply for participation in the pilot program for a minimum of one year. HRSA said the pilot program will be limited to the NDC-11s included on the Centers for Medicare &amp; Medicaid Services’ <a href="https://www.cms.gov/files/zip/medicare-drug-price-negotiation-selected-drug-list.zip" title="drug list">Medicare Drug Price Negotiation Selected Drug List</a> regardless of payer.&nbsp; &nbsp; HRSA said manufacturers must submit applications to participate in the pilot program by Sept. 15, and approvals will be made by Oct. 15 for a Jan. 1, 2026, effective date.&nbsp; &nbsp; In a statement shared with the <a href="/press-releases/2025-07-31-aha-statement-340b-rebate-guidance" title="media statement">media</a> following release of the notice, AHA Vice President of Advocacy and Grassroots Aimee Kuhlman said, “The AHA looks forward to reviewing HRSA’s 340B rebate guidance in more detail and working with the agency on this issue. However, we are concerned that this guidance authorizes a significant departure from how the 340B program has successfully operated for decades and sets a dangerous precedent for possible harmful expansions in the future. This pilot program is a response to a nonexistent program integrity problem that the drug manufacturers have manufactured in the public discourse.&nbsp;&nbsp; &nbsp; “Nevertheless, we appreciate HRSA’s efforts to impose strict guardrails on its limited pilot program. Going forward, it will be essential that HRSA makes certain that the drug companies bear all the costs of implementing these rebate models and that those companies provide discounts expeditiously. Anything else will pose serious financial risks to patients, communities and the hospitals that care for them.”&nbsp; &nbsp; The agency is soliciting comments on the structure and application process of the 340B Rebate Model Pilot Program. Those comments are due Aug. 31. AHA 340B members will receive a Regulatory Advisory with more details on the notice.&nbsp; &nbsp; The rebate issue is the subject of multiple ongoing court cases in which drug companies have sued HHS for denying their requests to impose rebate models rather than following the longstanding upfront discount model that HHS has allowed since the outset of the program. The AHA has filed several amicus briefs in these cases, and it intends to file another brief in the United States Court of Appeals for the D.C. Circuit next week.&nbsp; &nbsp; In addition, the AHA May 9 sent a <a href="/lettercomment/2025-05-09-aha-urges-hhs-reject-effort-several-large-drug-companies-undermine-340b-drug-pricing-program" title="hhs letter">letter to HHS</a> urging the agency to deny drug companies’ requests to approve their “unlawful rebate models,” as they would “come at the expense of America’s most vulnerable patients and communities.”&nbsp;&nbsp; &nbsp; Thu, 31 Jul 2025 16:02:29 -0500 340B Drug Pricing Program AHA 340B Advocacy Alliance Newsletter /340b-advocacy-alliance-bulletin/2025-07-31-aha-340b-advocacy-alliance-newsletter HHS announces new 340B Rebate Model Pilot ProgramThe Department of Health and Human Services today issued a <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGcARMDjHMaBXRQp0v86AMFhrGU7ioHD1bfWpFPh2bPbpe828FAdPU7ZfdK-7MYIvgKpdr5ZOc%3D&amp;data=05%7C02%7Cdsamuels%40aha.org%7C2c25cc95794b434c647308ddd0706eb7%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638895903528566195%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=NPE1OFrofQ1b2qZCIxsBN%2BYXDTt3ZViD4yAV7U6utG0%3D&amp;reserved=0" target="_blank">notice</a> announcing a 340B Rebate Model Pilot Program as a voluntary mechanism for qualifying drug manufacturers to effectuate the 340B ceiling price on select drugs to all 340B covered entities.The notice said HHS’ Health Resources and Services Administration’s Office of Pharmacy Affairs, which currently oversees the 340B Drug Pricing Program, is inviting certain drug manufacturers to apply for participation in the pilot program for a minimum of one year. HRSA said the pilot program will be limited to the NDC-11s included on the Centers for Medicare &amp; Medicaid Services’ <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGcARMDjLse-JuOTvKr3cnodllvUn9U26PJ2LeGicYW_44gPEQYngbMHAoaj98vztg0g3nChZo%3D&amp;data=05%7C02%7Cdsamuels%40aha.org%7C2c25cc95794b434c647308ddd0706eb7%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638895903528579007%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=M4pqWqEPHAytM57cXUbEShFC28OS6f%2FYbs6I2noqSWM%3D&amp;reserved=0" target="_blank">Medicare Drug Price Negotiation Selected Drug List</a> regardless of payer.HRSA said manufacturers must submit applications to participate in the pilot program by Sept. 15 and approvals will be made by Oct. 15 for a Jan. 1, 2026, effective date.In a <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGcARMDjKtaUQYaz2Kbtb3M5z8MTSy1REn_9vpnBJ4HxlbC9MQuRGOTCs7G4y-0Z8QRqrrntVM%3D&amp;data=05%7C02%7Cdsamuels%40aha.org%7C2c25cc95794b434c647308ddd0706eb7%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638895903528591682%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=DvT3uYWBbtNbfeYDsaasVEZfiK%2BNr9erOylgxPDkKgQ%3D&amp;reserved=0" target="_blank">statement shared with the media</a> following release of the notice, AHA Vice President of Advocacy and Grassroots Aimee Kuhlman said, “The AHA looks forward to reviewing HRSA’s 340B rebate guidance in more detail and working with the agency on this issue. However, we are concerned that this guidance authorizes a significant departure from how the 340B program has successfully operated for decades and sets a dangerous precedent for possible harmful expansions in the future. This pilot program is a response to a nonexistent program integrity problem that the drug manufacturers have manufactured in the public discourse.“Nevertheless, we appreciate HRSA’s efforts to impose strict guardrails on its limited pilot program. Going forward, it will be essential that HRSA makes certain that the drug companies bear all the costs of implementing these rebate models and that those companies provide discounts expeditiously. Anything else will pose serious financial risks to patients, communities and the hospitals that care for them.”The agency is soliciting comments on the structure and application process of the 340B Rebate Model Pilot Program. Those comments are due Aug. 31. AHA 340B members will receive a Regulatory Advisory with more details on the notice. In addition, the AHA will submit comments in advance of the deadline and encourages members to submit their own comments explaining the potential harms of the rebate model and why strengthened guardrails for the pilot program are necessary.The rebate issue is the subject of multiple ongoing court cases in which drug companies have sued HHS for denying their requests to impose rebate models rather than the longstanding upfront discount model that HHS has allowed since the outset of the program. The AHA has filed several amicus briefs in these cases, and it intends to file another brief in the United States Court of Appeals for the D.C. Circuit next week.In addition, the AHA May 9 sent a <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGcARMDjCDO5cRzNvms_5ZuDXgkHq0obmeov9nEkOgpPfCDkcv3e9rRbdUYQln0Q31rNbspBXU%3D&amp;data=05%7C02%7Cdsamuels%40aha.org%7C2c25cc95794b434c647308ddd0706eb7%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638895903528604462%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=w5Lp0yTqieTZ1qHsOa%2B%2FV3IbUZ3O6YrWNW0ulinTHe4%3D&amp;reserved=0" target="_blank">letter to HHS</a> urging the agency to deny drug companies’ requests to approve their “unlawful rebate models,” as they would “come at the expense of America’s most vulnerable patients and communities.”If you have questions, please contact Bharath Krishnamurthy, AHA director of health analytics and policy, at <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGcARMDjImSA-8QOA_YnCqLuGiptnn1orY7v3ftgOwZUJ5WlcMGM8jsJBnExyTAH9z_5YfyY20%3D&amp;data=05%7C02%7Cdsamuels%40aha.org%7C2c25cc95794b434c647308ddd0706eb7%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638895903528618824%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=77GbLmxxcr9E8aJcFT%2B82GpjQz9q064GqlvqyPCTzWI%3D&amp;reserved=0" target="_blank">bkrishnamurthy@aha.org</a>.&nbsp; Thu, 31 Jul 2025 15:28:05 -0500 340B Drug Pricing Program AHA Statement on 340B Rebate Guidance /press-releases/2025-07-31-aha-statement-340b-rebate-guidance Aimee Kuhlman Vice President, Advocacy and Grassroots �� AssociationJuly 31, 2025The AHA looks forward to reviewing HRSA’s 340B rebate guidance in more detail and working with the agency on this issue. However, we are concerned that this guidance authorizes a significant departure from how the 340B program has successfully operated for decades and sets a dangerous precedent for possible harmful expansions in the future. This pilot program is a response to a non-existent program integrity problem that the drug manufacturers have manufactured in the public discourse. Nevertheless, we appreciate HRSA’s efforts to impose strict guardrails on its limited pilot program. Going forward, it will be essential that HRSA makes certain that the drug companies bear all the costs of implementing these rebate models and that those companies provide discounts expeditiously. Anything else will pose serious financial risks to patients, communities, and the hospitals that care for them.&nbsp;### Thu, 31 Jul 2025 10:42:53 -0500 340B Drug Pricing Program 340B Advocacy Alliance Bulletin - July 29, 2025 /340b-advocacy-alliance-bulletin/2025-07-29-340b-advocacy-alliance-bulletin-july-29-2025 Register for Aug. 1 AHA Site-neutral Advocacy Alliance CallThe AHA’s Site-neutral Advocacy Alliance will meet on Friday, Aug. 1, at 1 p.m. ET. This call will feature updates on the site-neutral provisions in the Centers for Medicare &amp; Medicaid Services’ calendar year 2026 outpatient prospective payment system proposed rule. See <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGb9kXtf980Li3lMtmTHxP4AWir0m_q9psts9_yniXiqFnwYuyj-ZNB3vACsLdk_2aS3ljxk6s%3D&amp;data=05%7C02%7Cdsamuels%40aha.org%7C8151afaf47534458cca008ddcec83129%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638894081397935808%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=E%2Fxlvltcg%2FSEUxyQa%2FsNIQYH7lN7PkFd%2FbuaNCiYrY4%3D&amp;reserved=0" target="_blank">AHA’s Regulatory Advisory</a> for a detailed summary of the rule.<a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGb9kXtf9HlESG8SsxlYBrhcG-W05jurPpaAezo9XQOqu9opwtUcLVW-UkKpeO91tCHrz5ulAE%3D&amp;data=05%7C02%7Cdsamuels%40aha.org%7C8151afaf47534458cca008ddcec83129%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638894081397949211%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=iJ1yrgQXJjqewrnTgvZC1y2Ed1XEha1AvgzrN9dmjJI%3D&amp;reserved=0" target="_blank">Register for the Aug. 1 call.</a>In the CY 2026 OPPS proposed rule, CMS proposes to use its statutory authority regarding a “method to control for unnecessary increases in the volume of outpatient services” to impose a site-neutral payment reduction for drug administration procedures furnished in grandfathered (excepted) off-campus provider-based departments. The site-neutral payment rate would be set at 40% of the OPPS payment rate. The agency proposes to exempt rural sole community hospitals from this proposed policy. CMS proposes to use the same statutory authority it used in 2019 to impose site-neutral payment reductions for clinic visit services in grandfathered (excepted) off-campus PBDs. As with the clinic visits, CMS proposes to implement this in a non-budget-neutral manner, estimated to save $280 million in 2026 and nearly $11 billion over 10 years. The agency also requests comments on other services to which it should consider applying site-neutral payment reductions using this “unnecessary increases in the volume of services” authority, noting specifically on-campus clinic visits and imaging without contrast services in grandfathered off-campus PBDs.Site-neutral Advocacy Resources Visit the AHA’s Site-neutral Payment Proposals <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGb9kXtgCU3O2LsniSWRWjuyOV-i2flY_G4p8VSAzFOzD1L5XIt2x9PGEujACGpTrlL_wTQwd8%3D&amp;data=05%7C02%7Cdsamuels%40aha.org%7C8151afaf47534458cca008ddcec83129%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638894081397962144%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=jWe4md9ooXa%2F5cj7J3nFjeM0NiVvscojhRI0VA3PAzA%3D&amp;reserved=0" target="_blank">Advocacy Issue page</a> for additional resources to assist in your advocacy efforts.Further Questions If you have further questions, please contact Roslyne Schulman, AHA’s director of policy, at <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGb9kXtgKzlWuRJQUUN1b2w-VadNMHIa6E0VVZ0SGOn5yOxqpwLjkC1T31KOFmM1hfzbm22SD4%3D&amp;data=05%7C02%7Cdsamuels%40aha.org%7C8151afaf47534458cca008ddcec83129%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638894081397974835%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=MoFitHq6c3PtEK7Wyc8y94q382aHO4W%2B0UeLhvyrwbM%3D&amp;reserved=0" target="_blank">rschulman@aha.org</a>, or Jason Kleinman, AHA’s director of federal relations, at <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGb9kXtfzBr0qSkDPJukXGnt8InSoJ06qNpRSkm-NqpxWhD23jpgy2o6zbRKpPmFDp5WEr1h5A%3D&amp;data=05%7C02%7Cdsamuels%40aha.org%7C8151afaf47534458cca008ddcec83129%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638894081397987481%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=mkwIg65vEhFLJCW%2FWnvplWrt6cM%2Fn%2Fa%2BP8IPnZUADuY%3D&amp;reserved=0" target="_blank">jkleinman@aha.org</a>. Tue, 29 Jul 2025 14:58:10 -0500 340B Drug Pricing Program TAKE ACTION: Engage Lawmakers in August to Build Support for Key Priorities /action-alert/2025-07-28-take-action-engage-lawmakers-august-build-support-key-priorities <div class="container"><div class="row"><div class="col-md-8">The House of Representatives has left Washington, D.C., for its August district work period, and senators could return to their states as early as next week. It is important to engage with your lawmakers while they are home and discuss the impact that the recently passed One Big Beautiful Bill Act and additional policy proposals that are under consideration will have on hospitals’ ability to provide care.Funding for the federal government, including certain important health care programs, is set to expire Oct. 1. Congress must pass all 12 appropriations bills by Sept. 30 to fund the federal government for the next fiscal year. If lawmakers fail to meet that deadline, they will need to enact a continuing resolution temporarily extending current funding levels to avoid a government shutdown. However, these health care programs including Low-volume Adjustment and Medicare-Dependent Hospital, telehealth and hospital-at-home waivers — as well as prolonging Medicaid DSH cuts from going into effect — are not guaranteed to be extended. Additionally, Congress needs to act before the end of the year to extend the Enhanced Premium Tax Credits. Meanwhile, some legislators are discussing another reconciliation package on deficit reduction efforts. Those efforts could include additional Medicaid and Medicare cuts. It is important that your legislators understand hospitals and health systems cannot sustain any additional cuts, especially as we are facing the implementation of Medicaid cuts in the <a href="/advisory/2025-07-18-detailed-summary-one-big-beautiful-bill-act-obbba-public-law-no-119-21">OBBBA</a>.While your lawmakers are home next month, please make plans to visit them in their offices, speak with them at a community event or invite them to your hospital to show them the importance of supporting policies that allow hospitals to provide care to their communities. And share with them the impact that funding reductions would have on your ability to provide services and care for the people they represent.The following are some of the top priority issues and resources that can assist you and your team in conversations with your lawmakers.<h2>Advocacy Priorities</h2><ul><li>Extend the <a href="/fact-sheets/2025-02-07-fact-sheet-enhanced-premium-tax-credits">Enhanced Premium Tax Credits</a>. The Enhanced Premium Tax Credits help individuals and families purchase insurance on the Health Insurance Marketplaces. Policies enabling these credits will expire at the end of 2025. Urge your members of Congress to extend the enhanced premium tax credits that enable millions of people to have health care coverage.</li><li>Reject <a href="/advocacy/advocacy-issues/2023-09-11-advocacy-issue-site-neutral-payment-proposals">Site-neutral Payments</a>. Site-neutral payments would compensate hospital outpatient departments the same as independent physician offices and other ambulatory sites of care, ignoring the very different level of care provided by hospitals and the needs of the patients and communities cared for in that setting. Ask your members of Congress to reject efforts to enact additional site-neutral payments proposals.</li><li>Protect the <a href="/fact-sheets/fact-sheet-340b-drug-pricing-program">340B Drug Pricing Program</a>. Hospitals depend on the 340B program to manage rising prescription drug costs and expand access to care for patients. Ask your members of Congress to oppose any harmful changes to the 340B program.</li><li>Extend <a href="/fact-sheets/2025-02-07-fact-sheet-telehealth">Telehealth</a> and <a href="/fact-sheets/2024-08-06-fact-sheet-extending-hospital-home-program">Hospital-at-home</a> Programs. These programs enable providers to care for patients at home, without having to make long drives to a facility. These programs are set to expire Sept. 30. Urge your lawmakers to extend these programs so providers can ensure continuity of care.</li><li>Prevent <a href="/advocacy/advocacy-issues/medicaid-dsh-payment-cuts">Medicaid Disproportionate Share Hospital</a> Cuts. The Medicaid DSH program provides essential financial assistance to hospitals that care for our nation’s most vulnerable populations, including children and those who are disabled and elderly. The Medicaid DSH cut for fiscal year 2026 is $8 billion and will go into effect on Oct. 1 unless Congress acts. Urge your lawmakers to provide relief from the Medicaid DSH cuts given the vital need for the program.</li><li>Extend the <a href="/advocacy/advocacy-issues/2024-10-31-advocacy-issue-rural-mdh-and-lva-programs">Low-volume Adjustment and Medicare-dependent Hospital</a> Programs. The enhanced low-volume adjustment and Medicare-dependent hospital programs provide rural, geographically isolated and low-volume hospitals additional financial support to ensure rural residents have access to care. Without action from Congress, the enhanced LVA and MDH programs will expire Sept. 30. Urge your lawmakers to extend these vital programs.</li><li>Protect <a href="/fact-sheets/2023-04-19-fact-sheet-workplace-violence-and-intimidation-and-need-federal-legislative-response">Health Care Workers</a> from Violence. The Save Healthcare Workers Act (H.R. 3178/S. 1600) is bipartisan legislation (that would make it a federal crime to assault a hospital staff member on the job. Urge your lawmakers to support this legislation.</li></ul><h2>AHA Resources</h2>Your voice is extremely important and your legislators listen to you. Be ready to tell your hospital’s story. Prepare for a successful encounter with these <a href="/advocacy/2023-03-07-advocacy-tips-and-best-practices">tips and best practices</a> for meeting with lawmakers and hosting them at your hospital. Visit the <a href="/advocacy/action-center">AHA Action Center</a> for information and resources to assist you in your advocacy.<h2>Further Questions</h2>If you have further questions, please contact the AHA at <a href="tel:1-800-424-4301">800-424-4301</a>.</div><div class="col-md-4"><a href="/system/files/media/file/2025/07/Action-Alert-TAKE-ACTION-Engage-Lawmakers-in-August-to-Build-Support-for-Key-Priorities.pdf" target="_blank" title="Click here to download the Action Alert: TAKE ACTION: Engage Lawmakers in August to Build Support for Key Priorities"><img src="/sites/default/files/inline-images/Page-1-Action-Alert-TAKE-ACTION-Engage-Lawmakers-in-August-to-Build-Support-for-Key-Priorities.png" data-entity-uuid="f8d7fe18-60fc-49cc-9704-cacdc239ac3a" data-entity-type="file" alt="Action Alert: TAKE ACTION: Engage Lawmakers in August to Build Support for Key Priorities page 1." width="695" height="900"></a></div></div></div> Mon, 28 Jul 2025 15:43:12 -0500 340B Drug Pricing Program AHA 340B Advocacy Alliance - July 28, 2025 /340b-advocacy-alliance-bulletin/2025-07-28-aha-340b-advocacy-allianace REMINDER: Register for July 29 AHA call on 340B provisions in the OPPS and PFS rulesThe AHA 340B Alliance July 29 at 3 p.m. ET will host a call for AHA members about 340B proposals contained in the hospital outpatient prospective payment system and physician fee schedule proposed rules for calendar year 2026. On the call, AHA staff will provide an overview of the 340B proposals contained in the Centers for Medicare &amp; Medicaid Services regulations, as well as provide other updates related to the 340B Drug Pricing Program.<a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGb8bCAoNs-OUIkno4qbWw2RTbXCClcGR7lp1QX-KDq0cAi_uWmNkRM1n_dXAX8531uBhxWrtU%3D&amp;data=05%7C02%7Cdsamuels%40aha.org%7C985aaa52980049e224e208ddce15248e%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638893312412065282%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=ZtFa5W8lTKLBy7DLIWjQCC%2FuhYZTybSnGVqWwScHNRg%3D&amp;reserved=0" target="_blank">REGISTER</a> by Tuesday, July 29 at noon ET, if you have not already done so. If you have trouble registering, please contact Candice Dailey at <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGb8bCAoPCxXcrkwMYkA2PPF4q1ypBFgeRi3Wo87t34k1Al7EeKEKt5xunstK-9_qWfXqcTj4I%3D&amp;data=05%7C02%7Cdsamuels%40aha.org%7C985aaa52980049e224e208ddce15248e%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638893312412078609%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=a0XBFcgkvla3kiUYhaErVL4TSXQ5IJ%2BzvV90HRsgaqw%3D&amp;reserved=0" target="_blank">cdailey@aha.org</a>.For more information on the rules being discussed, read the <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGb8bCAoD0KNbqcdXmszEzMEEtZFeA6D0eRP_fKCZFbpbJ9arDa5ReksKmgqHc7Claw2dNeabM%3D&amp;data=05%7C02%7Cdsamuels%40aha.org%7C985aaa52980049e224e208ddce15248e%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638893312412091418%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=3vQej%2BFr7MOseaYkPNwM2UO%2BeafqMbeHgnshY86Lvdc%3D&amp;reserved=0" target="_blank">July 16 AHA Regulatory Advisory</a> on the outpatient prospective payment proposed rule and the <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGb8bCAoDmHgdj1KOXF29irepXNNHdNGtn4rdFIaHQA-Z4UBWNO9MqCB2llY1L9pUu_b3b1ugk%3D&amp;data=05%7C02%7Cdsamuels%40aha.org%7C985aaa52980049e224e208ddce15248e%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638893312412104207%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=bMgbMwMhCkRSz33wBbdFSk1B%2BpaqEvvXaItH4XB%2FoM8%3D&amp;reserved=0" target="_blank">July 15 AHA Regulatory Advisory</a> on the physician fee schedule proposed rule. Mon, 28 Jul 2025 09:10:56 -0500 340B Drug Pricing Program Lawmakers introduce bill codifying 340B providers’ use of contract pharmacies to dispense discounted drugs /news/headline/2025-07-22-lawmakers-introduce-bill-codifying-340b-providers-use-contract-pharmacies-dispense-discounted-drugs Rep. Doris Matsui, D-Calif., and Sen. Peter Welch, D-Vt., today introduced the <a href="https://matsui.house.gov/sites/evo-subsites/matsui.house.gov/files/evo-media-document/tam25809.pdf" target="_blank">340B Patients Act</a>, AHA-supported legislation that would codify 340B providers' ability to use contract pharmacies to distribute 340B discounted drugs. The bill would clarify that manufacturers are required to offer 340B discount prices to covered entities regardless of the manner or location where the drug is dispensed. It would also ensure that manufacturers cannot place conditions on covered entities to buy and use 340B drugs. Additionally, the bill would impose monetary penalties on manufacturers that violate the requirements.“The �� Association thanks Representative Matsui and Senator Welch for their leadership in protecting the 340B drug pricing program and the patients and communities that benefit from it,” <a href="https://matsui.house.gov/media/press-releases/matsui-welch-reintroduce-legislation-protect-340b-drug-pricing-program" target="_blank">said</a> Aimee Kuhlman, AHA’s vice president of advocacy and grassroots. “Their important bill — which the AHA strongly supports — would put an end to drug companies’ harmful restrictions on the ability of 340B hospitals to provide critical medications to their patients through partnerships with community and specialty pharmacies. For far too long, these restrictions have made it more difficult for patients to access their medications while multinational drug companies have enjoyed record financial success.”&nbsp; &nbsp; Tue, 22 Jul 2025 14:20:43 -0500 340B Drug Pricing Program AHA files brief defending Colorado’s 340B contract pharmacy law /news/headline/2025-07-17-aha-files-brief-defending-colorados-340b-contract-pharmacy-law The AHA July 16 filed an <a href="/amicus-brief/2025-07-17-aha-others-file-brief-defending-colorados-340b-contract-pharmacy-law" title="Colorado brief">amicus brief</a> in the U.S. District Court for the District of Colorado in defense of the state’s 340B contract pharmacy law prohibiting drug companies from denying hospitals the same 340B discounts for drugs dispensed at community pharmacies that would be provided via in-house pharmacies. The brief supports the state’s attempt to dismiss a case by AbbVie claiming that the federal law that created the 340B program preempts the state law.&nbsp; &nbsp; The AHA has filed briefs in similar cases across multiple states. Joining the AHA in the Colorado filing were 340B Health, the Colorado Hospital Association and the American Society of Health-System Pharmacists.&nbsp; Thu, 17 Jul 2025 15:06:08 -0500 340B Drug Pricing Program