/ en Sun, 15 Jun 2025 11:30:56 -0500 Wed, 14 May 25 14:33:57 -0500 /340b-advocacy-alliance-bulletin/2025-05-14-340b-advocacy-alliance-bulletin-may-14-2025 <p><strong>Use model letter to submit comments in advance of forthcoming 340B rebate proposal guidance; register for AHA 340B Alliance call May 15</strong></p><p>The AHA May 9 <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGabyossYQq26KcRJi2DNzqO4PwZMJHdG3IuRx9dYX6MZwsBxDGHstmesybTyS6R4ZiDrxatQM%3D&data=05%7C02%7Cdsamuels%40aha.org%7C26c6a3a280fb47c9b95f08dd931a859a%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638828464316427050%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=UqzBhzhrutxtBGcUxGlGKveNmMk4PkUmdS0kDBQe7%2FE%3D&reserved=0" target="_blank">urged</a> the Department of Health and Human Services to deny drug companies’ requests to approve their unlawful 340B rebate models. “The 340B Program is a vital lifeline for hospitals, particularly those serving rural and low-income communities,” AHA said. “If HHS authorizes these proposed ‘rebate models,’ it would come at the expense of America’s most vulnerable patients and communities.” HHS recently announced that it will be “in a position to provide guidance” about the drug industry’s proposed use of “rebate models” by the end of May.</p><p><strong>Model letter.</strong> The AHA has developed a model letter that hospitals and health systems can use to submit their own comments to HHS. <strong>The AHA strongly encourages all 340B hospitals to submit their own letters before HHS issues its expected guidance. </strong><a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGabyossRWCCg7TQBIJ6xnPm93AKYiAuShPr_a1UGSqnqk_WC9vik2AxQDkAEOrv2M1DcrjZdE%3D&data=05%7C02%7Cdsamuels%40aha.org%7C26c6a3a280fb47c9b95f08dd931a859a%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638828464316439174%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=CwlQ6yRlH%2Be9663wtxgQxSM%2FGtwG9G%2Fk36zIM5YCfiw%3D&reserved=0" target="_blank"><strong>DOWNLOAD THE LETTER</strong></a><strong>.</strong> If you have any questions about the letter, please contact AHA General Counsel and Secretary Chad Golder at <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGabyossdyva7QvyyzlbvzZzZj9OANIdZU0q3Y19pjhjcRgP25HqlXsxyIHmM-6-ROA_LXF7qk%3D&data=05%7C02%7Cdsamuels%40aha.org%7C26c6a3a280fb47c9b95f08dd931a859a%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638828464316450971%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=%2BM2wUJ50MgeH19heiSr2Wx3PxWhdvprP7sNDorPUij4%3D&reserved=0" target="_blank">cgolder@aha.org</a>.</p><p><strong>Register for May 15 call.</strong> As a reminder, the AHA 340B Advocacy Alliance will host a call May 15 at 3 p.m. ET to discuss how it plans to advocate against these proposed “rebate models” and how member hospitals can assist in this advocacy effort. <strong>This call is for AHA members only, and registration is required to participate. </strong><a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGabyossdQj20eH2ZpkuBtTTKggq9DO1G1rZ6Md-sYEsKX0adsoWeYjCJZN1nfvXSbIbx2O9Wk%3D&data=05%7C02%7Cdsamuels%40aha.org%7C26c6a3a280fb47c9b95f08dd931a859a%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638828464316462803%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=E0GO%2FRSbFg1s%2FDUEQJV%2BJLXJdCGXpocZRlYMnABpY8E%3D&reserved=0" target="_blank"><strong>REGISTER NOW</strong></a><strong>.</strong> Registration will close at noon ET on May 15. If you have questions about registering, please contact Candice Dailey at <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGabyossSwfFuoLTMjx2VodO20NB68p0Ko7mfapfnVyfhE6Y9imn6Azn8cC6xWjSa3GKqTy4WE%3D&data=05%7C02%7Cdsamuels%40aha.org%7C26c6a3a280fb47c9b95f08dd931a859a%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638828464316477515%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=0cOVWsf7cSGKVcm3Phd8WBQr5C8u6AqafYKUYQREXnA%3D&reserved=0" target="_blank">cdailey@aha.org</a>.</p> Wed, 14 May 2025 14:33:57 -0500 340B Advocacy Alliance Bulletin <p><strong>Register for May 15 AHA call to discuss upcoming HHS ‘rebate model’ guidance</strong></p><p>The AHA on Thursday, May 15 at 3 p.m. ET will host a call for member hospitals and health systems to discuss the Department of Health and Human Services’ recent announcement that it will be “in a position to provide guidance” about the drug industry’s proposed use of “rebate models” by the end of May. In particular, in a notice filed with the United States District Court for the District of Columbia, HHS stated:</p><p>"Large-scale implementation of rebate models to effectuate the 340B ceiling price would be a significant change for the 340B Program and its stakeholders. Because the implications are not straightforward, the Department of Health and Human Services continues to carefully evaluate its options alongside ongoing efforts to address 340B program integrity matters and keeping in mind the approaching effective date of certain Inflation Reduction Act requirements. The Department expects to be in a position to provide guidance for stakeholders in thirty days."</p><p>On the call, the AHA will discuss how it plans to advocate against these proposed “rebate models” and how member hospitals can assist in this advocacy effort.</p><p><strong>This call is AHA members only, and registration is required to participate. </strong><a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGaSzo6fe8Fv-WiMlith8yyZvlSrIXcMTQnFxXjCgJIZuy_76QkCdj8TPUY4OuQntfCD1HDOi0%3D&data=05%7C02%7Cdsamuels%40aha.org%7Ce324cf5480a34e2e3b2f08dd8d9eb995%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638822435062046933%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=iYY%2Few0gdRNz8mxEZVDs0uAQW5y9Ka2g1a7BuVlhh94%3D&reserved=0" target="_blank"><strong>REGISTER NOW</strong></a><strong>.</strong> Registration will close at 5 p.m. ET on May 14. If you have questions about registering, please contact Candice Dailey at <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGaSzo6fUAbtdtjYQ3YLhwuO0HT-lEHeOzwS32rYsOGyiowF42wov6VC9ZlaVqtlMMYY-OUVJ8%3D&data=05%7C02%7Cdsamuels%40aha.org%7Ce324cf5480a34e2e3b2f08dd8d9eb995%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638822435062059767%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=HLJ7ju20n%2B3oUNzKSKgaDMxV2Cw6vBj8OawVFgJpoJ8%3D&reserved=0" target="_blank">cdailey@aha.org</a>.</p><p><strong>NEXT STEPS</strong></p><p>The AHA will submit a letter to HHS well in advance of its 30-day consideration period and provide 340B hospitals and health systems with a model letter. <strong>The AHA strongly encourages all member hospitals to submit their own comment letters.</strong></p><p>If you have further questions, please contact Chad Golder, general counsel, at <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGaSzo6fQCs8DTNhTYlbnrFmtzFtcgFpfRAsd71yt0qwDbKZ0TF8IU-LYVXjhIypjcLuZPqdzU%3D&data=05%7C02%7Cdsamuels%40aha.org%7Ce324cf5480a34e2e3b2f08dd8d9eb995%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638822435062072718%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=VvvITNidnQy8n4i%2Bu2sl2bN1W4m%2Bb%2BrTV3CRcNQiUCs%3D&reserved=0" target="_blank">cgolder@aha.org</a>, or Aimee Kuhlman, vice president of advocacy and grassroots, at <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGaSzo6fclGsx9v3i02Urqg4kf3QKDqCzXqiw0Ct-J1l3UKabQqDc9mWckfdZDlLN11s8c7Aq4%3D&data=05%7C02%7Cdsamuels%40aha.org%7Ce324cf5480a34e2e3b2f08dd8d9eb995%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638822435062088979%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=cue01HuzPpm%2B%2BD3iucNMqPmqt2ZWnGcDrvZkUNQwBwE%3D&reserved=0" target="_blank">akuhlman@aha.org</a>.</p> Wed, 07 May 2025 14:43:19 -0500 340B Advocacy Alliance Bulletin <p><strong>Cassidy releases report calling for reforms to 340B program</strong></p><p>Senate Health, Education, Labor, and Pensions Committee Chairman Bill Cassidy, M.D., R-La., today released a <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGaCFismbHKeDhurue9tn-CxwS0pXoPRhuPCuCnZR-6siYu9ybDt0gNrquqtH4yvPy9K06PwL8%3D&data=05%7C02%7Cdsamuels%40aha.org%7Cd4cddcf432dc4242c02008dd836a2d50%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638811214273726918%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=pBSNn5sZw20zEgWM%2BdeGxPIdSsORfNPVAKoDNCdeqWg%3D&reserved=0" target="_blank">report</a> detailing findings from an investigation into how covered entities use and generate revenue from the 340B Drug Pricing Program. As part of his investigation, Cassidy requested information from hospitals, Federally Qualified Health Centers, contract pharmacies and drug manufacturers.</p><p>Cassidy <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGaCFismbHz0UQR_iq24XlEm9cM9J1SkgnblgBx7shiVd4ENFti06haCSXPg0ry4ccE3Q6pi6Y%3D&data=05%7C02%7Cdsamuels%40aha.org%7Cd4cddcf432dc4242c02008dd836a2d50%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638811214273739178%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=abOupc5B9O9SEamJeBN9ktDp2v7LlIwklc21cqDzHmI%3D&reserved=0" target="_blank">said</a> the “investigation underscores that there are transparency and oversight concerns that prevent 340B discounts from translating to better access or lower costs for patients,” and the report outlines potential reforms needed to improve the program to better serve patients.</p><p>In a statement shared with media, AHA President and CEO Rick Pollack said, “The AHA appreciates Senator Cassidy’s leadership on 340B issues. As his report correctly observes, the 340B program was created to help hospitals reach more eligible patients and provide more comprehensive services. Even this investigation — which the report recognizes was ‘limited in scope’ given the variety of 340B hospitals across the country — demonstrates that hospitals use 340B savings to provide financial assistance to low-income patients and to maintain programs that enhance patient services and access to care. In short, 340B is vital in advancing health in communities across the country.</p><p>“We look forward to reviewing the report in greater detail, discussing it with our 340B members, and working with Senator Cassidy and others to ensure that the 340B program continues to benefit patients and communities, especially those in rural and other medically underserved areas.”</p> Thu, 24 Apr 2025 15:34:35 -0500 340B Advocacy Alliance Bulletin <p><strong>AHA files briefs in defense of Louisiana’s 340B contract pharmacy law</strong></p><p>The AHA April 18 filed friend-of-the-court briefs in three cases in support of Louisiana’s 340B contract pharmacy law that prohibits drug companies from denying hospitals the same 340B discounts for drugs dispensed at community pharmacies that would be provided via in-house pharmacies. The briefs, filed in the U.S. Court of Appeals for the Fifth Circuit, challenge claims by <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZ_gZtKxD09RoAtwAMpqNG1pCFHG3pJ2UtUezxOoZ-MVqM_9dqkH6Q87aXdeBB2zsNYlBgg5w%3D&data=05%7C02%7Cdsamuels%40aha.org%7C44c792eafdbf4a44a0c908dd81d70081%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638809482610111890%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=QwthHR0WHynLiYOM97aJt%2Bgg0CL%2BE%2F9Tfde8Ud3N3iY%3D&reserved=0" target="_blank">PhRMA</a>, <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZ_gZtK4M-KFAZyXRznS0S02M7Va3mf01s7E2o0YofRE1gzxWjx0aR9gMzF-gAHZbexRWxx6M%3D&data=05%7C02%7Cdsamuels%40aha.org%7C44c792eafdbf4a44a0c908dd81d70081%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638809482610124721%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=ViYrKgUYm%2Fh6D9YSgp%2BoKy%2F6d0X%2BvjUYPPqoTG%2BsLdI%3D&reserved=0" target="_blank">AbbVie</a> and <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZ_gZtK2cJ6VW31tqF_wDZ4wMocTDfSKdK_CdQoxVbOgzy4jgarFsuQlwndFwc4tutsPXWwew%3D&data=05%7C02%7Cdsamuels%40aha.org%7C44c792eafdbf4a44a0c908dd81d70081%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638809482610139074%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=7%2FJAN07nmPuOBPEv1oVEm6ZcjEfb22Qaj2aEfgisLNA%3D&reserved=0" target="_blank">AstraZeneca</a> that the federal law that created the 340B program preempts the state law.</p><p>The filings are the latest AHA has made in similar cases in multiple states. The AHA also filed friend-of-the-court briefs regarding the Louisiana cases in <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZ_gZtK4oAL2u-RBmaEUBo_WVlmRGkvrERtTDJ0NGtr-LXZnTK4s3Vq47h6Vw9dI_FPP-Qdkc%3D&data=05%7C02%7Cdsamuels%40aha.org%7C44c792eafdbf4a44a0c908dd81d70081%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638809482610152946%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=MTPOzu0rdmP%2B8pD9ngnqL1Be%2F4V%2F93n4zmwY3lEIQGk%3D&reserved=0" target="_blank">February 2024</a> and <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZ_gZtKzhK0ez1yhiQjYMy4APqaPe1xbN_pDBtFexkUlSIc-nJiXbo28DPsXsEYzFVRGngi7A%3D&data=05%7C02%7Cdsamuels%40aha.org%7C44c792eafdbf4a44a0c908dd81d70081%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638809482610165596%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=DRzokbMcutA4e3RFefeIcu6mm8%2FdaWJVGJo2RR%2FgLns%3D&reserved=0" target="_blank">December 2023</a>.</p><p>The Louisiana Hospital Association, Rural Hospital Coalition, 340B Health and the American Society of Health-System Pharmacists joined AHA in each of the latest filings.</p><p><strong>New AHA case study from Johnson County Hospital on benefits of the 340B program</strong></p><p>AHA recently published a new <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZ_gZtK134D-KbCkNs78se66L93ctPwr6gVW-kiaf0jr9AwQwWgzoIQEAkj2N51KMjBnOMgx4%3D&data=05%7C02%7Cdsamuels%40aha.org%7C44c792eafdbf4a44a0c908dd81d70081%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638809482610178158%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=p6fAEOCS0cbI52HcVS5Sosf4MCfUZ0ZBq4p4BVBBpwU%3D&reserved=0" target="_blank">case study</a> that demonstrates the critical support the 340B program provides to patients and communities at Johnson County Hospital in Tecumseh, Neb.</p><p>“For us, our focus is always on the patient — we must stretch the dollars to serve the community. Without the 340B benefit, a lot of these vital services would not be possible,” said Olivia Little, 340B director at Johnson County Hospital.</p><p>Review the full list of 340B hospital case studies <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZ_gZtKwkIDLwscdrPaCuv5VUo_jChiDCNtQULVi2dmdlCGb-SJownmRA5HuGLV9CCTRAoUA4%3D&data=05%7C02%7Cdsamuels%40aha.org%7C44c792eafdbf4a44a0c908dd81d70081%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638809482610191244%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=p%2FzOHzEA0qRRdYs7wx8lYnf7VVm7NrVKVTHujWIKpOI%3D&reserved=0" target="_blank">here</a>.</p> Tue, 22 Apr 2025 16:14:35 -0500 340B Advocacy Alliance Bulletin <p><strong>Administration releases executive order on drug pricing</strong></p><p>The White House on April 15 released an <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZ40AJBiPI91iap-M9BkMbZyvA1D6KRE1lMWNRWxgkQNpTmZWmJWzmSTmLy2a3uRtUxkt6qRQ%3D&data=05%7C02%7Cdsamuels%40aha.org%7Ca5195975d8e4428a710608dd7dc11b75%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638804990556794657%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=MoyG%2FlBm5yWHOWMRp%2BkVQMkmBmP70H2NNZbmCzk2uIs%3D&reserved=0" target="_blank">executive order</a>, “Lowering Drug Prices by Once Again Putting Americans First,” directing federal agencies to undertake a broad range of tasks aimed at reducing the costs of prescription drugs. Among many other provisions, the EO directs:</p><ul><li>The Department of Health and Human Services to carry out within 180 days an acquisition cost survey for covered outpatient drugs at hospital outpatient departments. HHS must then propose any appropriate adjustments consistent with budget neutrality provisions.</li><li>HHS to evaluate and propose regulations, as appropriate, within 180 days to ensure payment within Medicare is not encouraging a shift in drug administration volume away from physician office settings to hospital outpatient departments.</li></ul><p>In a statement shared with the media, AHA said: “340B is an essential program that helps hospitals advance health in communities across the country. We will work closely with the Administration to convey the critical role 340B plays for patients and communities, especially those in rural and other medically underserved areas."</p><p><strong>See the </strong><a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZ40AJBXSo54o_ID9OpFzH6JTgBaTzMr94oiX_88LDQ9os4p9s-lwZ3GVW3_727MjmZhPHRwU%3D&data=05%7C02%7Cdsamuels%40aha.org%7Ca5195975d8e4428a710608dd7dc11b75%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638804990556807834%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=5ZmjWzWfxrbHdYmiTiLq8wms0qu2Xxx7zo77nrFokH4%3D&reserved=0" target="_blank"><strong>AHA Member Advisory</strong></a><strong> for more details on the EO and AHA’s reaction.</strong></p><p><strong>Minnesota court dismisses PhRMA lawsuit challenging state 340B law </strong><br><br>A Minnesota state court April 15 <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZ40AJBqHKZ__unRFWfEhc_gP_9s_inOOFYNXtSLiegQZWxR_cVQxv59RDwI_RsAFn2qznIXY%3D&data=05%7C02%7Cdsamuels%40aha.org%7Ca5195975d8e4428a710608dd7dc11b75%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638804990556821481%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=20OBt5nWv7YPbTJqivf%2F4tHMqZ6oIl8%2Ft8Iqbz3eBts%3D&reserved=0" target="_blank">dismissed</a> a lawsuit filed by PhRMA challenging the state’s law protecting 340B pricing for contract pharmacy arrangements. The court ruled that the state law is not preempted by federal law, does not engage in unconstitutional extraterritorial regulation and does not violate Minnesota’s Single Subject and Title Clause.</p><p>The AHA filed an <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZ40AJBvTpp_qhiPr70yHzKSn7F2Opxdu-pyA3Xq1Fe_oqwB4udqj6uPIWxeqen2jx0nv2SP8%3D&data=05%7C02%7Cdsamuels%40aha.org%7Ca5195975d8e4428a710608dd7dc11b75%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638804990556835173%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=NGH2CzUjssJg3SStxYir8YifOemg0Dh%2BCIOCajOejHk%3D&reserved=0" target="_blank">amicus brief</a> in the case last year and filed others in similar cases for multiple states, in defense of those states’ 340B contract pharmacy laws.</p> Thu, 17 Apr 2025 08:44:53 -0500 340B Advocacy Alliance Bulletin <p><strong>HHS files brief in 340B rebate model case</strong><br><br>The Department of Health and Human Services said its decision to prevent drug companies from implementing a 340B rebate model “was within its statutory authority,” according to a <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZRO18B_DgWDae-ZtzO6oh5naCDm4JNN36f7hDf2yjUm9WbuR9bxf2bEW0mR4BUaacAvgdzTI%3D&data=05%7C02%7Cdsamuels%40aha.org%7C05f82b73d8204cc18f4308dd6598a238%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638778428443199551%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=JPdnZpWPAxxzJvBxHhpYMOISTckqJJMD1s8RTfV%2BASQ%3D&reserved=0" target="_blank">department brief</a> filed with the United States District Court for the District of Columbia. In addition, the brief said the drug companies’ “proposed cash rebate models would have upended the way the 340B Program has operated for more than thirty years” and the agency’s decision to prevent the models from being implemented was “not arbitrary and capricious.” <br><br>The HHS brief is in cases brought by Eli Lilly, Bristol Meyers Squibb and Novartis. <br><br>The AHA March 4 filed a <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZRO18B1SyJncoFakWVtQT7R2IX0B56-KBwMfSaDlU7RTZlsdqteAl-WSBKRgQFRk11bB-bKM%3D&data=05%7C02%7Cdsamuels%40aha.org%7C05f82b73d8204cc18f4308dd6598a238%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638778428443217656%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=nEZC1QlwXXnsG7U7kQ3HKaNf3JQ2pB3%2FZn9P6ndSSBg%3D&reserved=0" target="_blank">friend-of-the-court brief</a> in support of HHS, saying, “The 340B statute does not permit drug companies to unilaterally withhold discounts from 340B hospitals in exchange for the surrender of purchase data or what are, in essence, pre-payment audits. The Health Resources and Services Administration therefore correctly exercised its statutory authority to reject the rebate policies.” Others joining the AHA in that friend-of-the-court brief were the Children’s Hospital Association, the Association of American Medical Colleges and America’s Essential Hospitals. <br><br>The AHA and other groups have filed friend-of-the-court briefs supporting HHS in other 340B rebate model cases brought by <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZRO18B1KzjbxKGN9hiOB8XCyNVO-KZriJwkl-eevfvVMj4-6K4sgqm8xTROh1iQHH-TRBfWk%3D&data=05%7C02%7Cdsamuels%40aha.org%7C05f82b73d8204cc18f4308dd6598a238%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638778428443234941%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=7SIPqao8jY2Oew%2BtHvLdzOCdaMvHCuAJjLmBVpDc9RM%3D&reserved=0" target="_blank">Sanofi</a>, <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZRO18Bxxr9OxfgL0WsttZqYY2rzGdZjIB67tLpx7McW-shBy5NlJgx30Q-_uFfhaO8K4oci0%3D&data=05%7C02%7Cdsamuels%40aha.org%7C05f82b73d8204cc18f4308dd6598a238%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638778428443249180%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=Ur1c8CavNHbK0YOUiYtrimCoDOL56lITBogAwCmvFRE%3D&reserved=0" target="_blank">Kalderos</a> and <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZRO18B7DNTmuaQHeIhM351X25MHXMmZ2mK7pRYeJcG5jFzOmNOtExXiUK638hC0EKw6xb-yg%3D&data=05%7C02%7Cdsamuels%40aha.org%7C05f82b73d8204cc18f4308dd6598a238%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638778428443266679%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=uFJhf2dU9M%2B8TdqepoPQafJ4O59hTgW7WlwGzezZvWU%3D&reserved=0" target="_blank">Johnson & Johnson</a>. </p> Mon, 17 Mar 2025 16:52:54 -0500 340B Advocacy Alliance Bulletin <p><strong>AHA releases a 340B hospital case study roundup, two new case studies</strong></p><p>AHA recently published a <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZMARmNZhpbz0mishl4gq-gWV3OLR8596S0DNo97Vq2Immeb27SIOF3mJem1-1cnv4nfQElC8%3D&data=05%7C02%7Cdsamuels%40aha.org%7C6e2a49006e2d46fb387d08dd6267d254%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638774920254317254%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=Dl7qBUbjCDreDqzxhOQoalR1k8Zbra5sM6NtRxyJO6U%3D&reserved=0" target="_blank">case study resource sheet</a> that highlights how the 340B Drug Pricing Program has benefited communities and patients at an array of hospitals around the country, from New York to Georgia to Nevada.</p><p>Additionally, AHA released a new case study about the vital support the 340B program provides to communities through <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZMARmNSck3oC7g_vjPybWw1qc0BTZ5bsLpq4ktIjdpTtfBXVwlZFOKUs380u-k6y3KmQfpuA%3D&data=05%7C02%7Cdsamuels%40aha.org%7C6e2a49006e2d46fb387d08dd6267d254%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638774920254328934%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=kjeCOgLisTHKvFp%2FIa4Z4Jd8HXg6hr257CEPA9hg8iE%3D&reserved=0" target="_blank">UK St. Claire</a> in Kentucky and <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZMARmNS8WloVWFIwxOGnxnJMiFwZd6mMgGOteB5bp1y2HYa0QWcJXBejs2fllkDnxD_jthQo%3D&data=05%7C02%7Cdsamuels%40aha.org%7C6e2a49006e2d46fb387d08dd6267d254%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638774920254340828%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=QvqHMEnRxASwWQ%2FeWN2qNLjIcC4%2FdGvC2XGH6uwrRNw%3D&reserved=0" target="_blank">Our Lady of the Lake Health</a> in Louisiana.</p><p>Review the full list of 340B hospital case studies <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZMARmNSQNJMLDLDKqkGFcrXuA2_3RioYOkj8_is8qbTV-55BFLwJGu8lj-n1jjPq2ri3xXlo%3D&data=05%7C02%7Cdsamuels%40aha.org%7C6e2a49006e2d46fb387d08dd6267d254%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638774920254352150%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=0jfN4g5flT7%2BKAlGlHuXlIgvn%2FoX2R2i5GtlqluQfzk%3D&reserved=0" target="_blank">here</a>.</p> Thu, 13 Mar 2025 16:47:50 -0500 340B Advocacy Alliance Bulletin <p><strong>AHA, others file amicus briefs opposing major drug companies’ 340B rebate models</strong></p><p>The AHA this week filed a number of friend-of-the-court briefs in cases before the U.S. District Court for the District of Columbia, urging the court to uphold the Health Resources and Services Administration’s decision to reject drug companies’ proposed 340B rebate models in separate lawsuits brought by a number of drug companies to bar the agency from doing so.</p><p>The AHA filed the following friend-of-the-court briefs.</p><ul><li><a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZEQA5AywjL7ddDollDibQ1W_1PMj8T-RUhIlEZsZcOM0PwWT25t3LfJuSim2m4OQo8m8ZHp0%3D&data=05%7C02%7Cdsamuels%40aha.org%7C0f854c25497244191aac08dd5dac3f65%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638769716595606177%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=ev3iEEN6KibkAIP6%2FQyXw9iyTp7dZDfl7Ykm65Y6tuc%3D&reserved=0" target="_blank">March 6 brief</a> in case brought by Sanofi.</li><li><a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZEQA5Azz5FdiPbndPMSu9oFJpbHBR38f0Az-miF6PaFIqZaYD35ibSJGLaH_wGwsvb0tAzDw%3D&data=05%7C02%7Cdsamuels%40aha.org%7C0f854c25497244191aac08dd5dac3f65%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638769716595618323%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=VwfuSuWqm8Pm5amCp5ympyGOTOpLOYYgMUTaQQxbXEk%3D&reserved=0" target="_blank">March 5 brief</a> in case brought by Kalderos.</li><li><a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZEQA5Ay9P4bJqu35Jjx1UMxvwLxRSVjrdjq65ZSR3Vo7Y6kfwZgQSJOFjDSY6uoDLUGXxw3A%3D&data=05%7C02%7Cdsamuels%40aha.org%7C0f854c25497244191aac08dd5dac3f65%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638769716595629972%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=IsXivbmdmrM7yDSipD4Y661MvlxZ8uJo1FFwuVLgGXo%3D&reserved=0" target="_blank">March 4 brief</a> in case brought by Eli Lilly, Bristol Meyers Squibb and Novartis.</li><li><a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZEQA5A2QI6Hs7LO-2a206ecNPRuvK_o1IvXQ31rYFTOxJstQydp-fStPrhrp1CaKrqBCWlrc%3D&data=05%7C02%7Cdsamuels%40aha.org%7C0f854c25497244191aac08dd5dac3f65%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638769716595641836%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=FdIn6SzT8erGW%2BszYE4CbEV4imTC3cUR1BHxV4W6c9M%3D&reserved=0" target="_blank">Feb. 28 brief</a> in case brought by Johnson & Johnson.</li></ul><p>Others joining the AHA in the friend-of-the-court briefs were the Children’s Hospital Association, the Association of American Medical Colleges and America’s Essential Hospitals.</p><p><strong>BACKGROUND</strong></p><p>In August 2024, J&J announced a new policy that would fundamentally change access to 340B pricing from an upfront “discount” to a back-end “rebate” for certain 340B hospitals on two of their products: Stelara and Xarelto. This new policy would require 340B hospitals to purchase these drugs at a higher price (e.g., wholesale acquisition cost or group purchasing organization price) and submit certain claims data elements to J&J. Upon verification of that data (including patient eligibility), J&J would rebate 340B hospitals the difference between the higher price paid and the 340B price for that drug. In effect, 340B hospitals would be floating dollars to J&J while waiting for J&J to issue a rebate.</p><p>Immediately after J&J announced its proposal, AHA <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZEQA5A8jWAjEO7l8eJh91myaSH87yysmcikiNUT_qzW_C9MNBnUT9lOKQyEhBzhF5wr9FlVU%3D&data=05%7C02%7Cdsamuels%40aha.org%7C0f854c25497244191aac08dd5dac3f65%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638769716595653105%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=sG35vSzSvsrEPn1hDi6I8yaqT2YlJ7W3xNusqXpUR8Q%3D&reserved=0" target="_blank">expressed concern</a> to HRSA and underscored HRSA’s authority to enact “immediate enforcement action,” including assessing civil monetary penalties on J&J for intentionally overcharging 340B hospitals. On Sept. 17, HRSA ordered J&J to cease implementation of the proposal and later sent a final warning letter to J&J urging the drug company to inform the agency by Sept. 30 that it would halt its proposed 340B rebate model.</p><p>J&J announced on Sept. 30 it was ceasing implementation of the rebate model but then sued HRSA on Nov. 12, seeking to bar the agency from blocking J&J’s implementation of a rebate model. Since then, Eli Lilly, Sanofi, Novartis, Kalderos and Bristol Meyers Squibb have all sued HRSA to pursue a similar rebate model.</p><p><strong>AHA files amicus brief in 4th Circuit in support of West Virginia 340B contract pharmacy law</strong></p><p>The AHA March 4 filed a <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZEQA5A6bsUw2hFO0vLDGl8sCpHEyeIHmFgHhpqjik1Kp5JbDqkLY0CaNkGCZau4HGCjRXAD4%3D&data=05%7C02%7Cdsamuels%40aha.org%7C0f854c25497244191aac08dd5dac3f65%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638769716595664431%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=la2Kbp9QiRHzOnoddpKGNXnw0%2BvRnKfQkwnXeGdieuk%3D&reserved=0" target="_blank">friend-of-the-court brief</a> in the U.S. Court of Appeals for the 4th Circuit, urging the court to affirm a December 2024 decision by the U.S. District Court for the Southern District of West Virginia to deny a preliminary injunction sought by drug companies and PhRMA against enforcement of West Virginia’s state law protecting 340B pricing for contract pharmacy arrangements.</p><p>Joining the AHA in the March 4 filing was 340B Health.</p><p>The AHA Feb. 28 filed a similar <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZEQA5A-mUqiqHl2XIjrdnw4oblrvnpLArCtF-9LqIf4mDoKWCelW1g24QcGHilMOs9VTe8-A%3D&data=05%7C02%7Cdsamuels%40aha.org%7C0f854c25497244191aac08dd5dac3f65%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638769716595675518%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=sFE6URBTbnIMzAcTCIk3u%2FE36KhFqaAnHC1lO5v1Y9U%3D&reserved=0" target="_blank">amicus brief</a> in the U.S. Court of Appeals for the 4th Circuit defending Maryland law protecting 340B pricing for contract pharmacy arrangements against drug industry efforts to enjoin it.</p><p><strong>Reminder: Resources to address 340B underpayments by Medicare Advantage Organizations</strong></p><p>The AHA has shared resources with hospitals that may be helpful to address 340B underpayments by Medicare Advantage Organizations following the November 2023 Department of Health and Human Services’ rule outlining the department’s remedy for the earlier unlawful payment cuts to certain 340B hospitals. We understand that 340B arbitrations to address MAO underpayments are proceeding. We anticipate promising results. Hospitals can see more details on the issue in this <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZEQA5A-G4WWHFGjmaK23M-hrcu-RuhUWLnDUPeodP9POqewNqzgrXczP6RTagVk1y8YjW3gg%3D&data=05%7C02%7Cdsamuels%40aha.org%7C0f854c25497244191aac08dd5dac3f65%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638769716595689264%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=hHRj0pIks9pDJ7oGLjvr8aMZnNBol8vdduuFE0XsC9o%3D&reserved=0" target="_blank">AHA Special Bulletin</a>, originally released in November 2023, which includes a list of outside law firms with considerable experience in this area that can help hospitals enforce their contractual rights. If you have questions, please contact AHA General Counsel and Secretary Chad Golder at <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZEQA5A-_uEwMgQlE4_HjhSTNOuVppebPkUgyKrrj6pBgB0-nh4-2Pcp2cTw6K1AJncthy0oA%3D&data=05%7C02%7Cdsamuels%40aha.org%7C0f854c25497244191aac08dd5dac3f65%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638769716595702020%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=8wAxEEtFHIF6Vj6u9xNs3aWoyMRQpqY%2B0%2F1fP%2FHvE3c%3D&reserved=0" target="_blank">cgolder@aha.org</a>.</p><p> </p> Fri, 07 Mar 2025 13:24:33 -0600 340B Advocacy Alliance Bulletin <p><strong>AHA, others file amicus brief opposing J&J 340B rebate model</strong></p><p>The AHA Feb. 28 filed a <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGY_Qt0wXD1Zc_j41lCihoKznPWV-4NhL96pV4yOjAhMADDUayhGOKejn1zNlvLHq8jTSC4yjc%3D&data=05%7C02%7Cdsamuels%40aha.org%7C111dc88d1bfe4b598c4708dd5aa0b5e3%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638766368505954422%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=T0ST98jIOzo4mnti4N7xDU0GwMihpBr12gklaHEMxJk%3D&reserved=0" target="_blank">friend-of-the-court brief</a> in the U.S. District Court for the District of Columbia, urging the court to uphold the Health Resources and Services Administration’s decision to reject Johnson & Johnson’s proposed 340B rebate model in a lawsuit brought by J&J to bar the agency from doing so.</p><p>“As the Court evaluates this case, it should bear in mind what Justice Kavanaugh wrote for a unanimous Supreme Court just a few years ago: ‘340B hospitals perform valuable services for low-income and rural communities but have to rely on limited federal funding for support,’” the AHA wrote. “J&J’s rebate policy shrinks that already-limited funding even further, endangering the care that 340B hospitals provide for their patients and communities. If J&J is dissatisfied with 340B law or policy, it can seek change in the political branches. But it cannot take the law into its own hands and then seek judicial permission for its extra-legal actions.”</p><p>Others joining the AHA in the Feb. 28 filing were the Children’s Hospital Association, the Association of American Medical Colleges and America’s Essential Hospitals.</p><p><strong>BACKGROUND</strong></p><p>In August 2024, J&J announced a new policy that would fundamentally change access to 340B pricing from an upfront “discount” to a back-end “rebate” for certain 340B hospitals on two of their products: Stelara and Xarelto. This new policy would require 340B hospitals to purchase these drugs at a higher price (e.g., wholesale acquisition cost or group purchasing organization price) and submit certain claims data elements to J&J. Upon verification of that data (including patient eligibility), J&J would rebate 340B hospitals the difference between the higher price paid and the 340B price for that drug. In effect, 340B hospitals would be floating dollars to J&J, while waiting for J&J to issue a rebate.</p><p>Immediately after J&J announced its proposal, AHA <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGY_Qt0wcVBGefvGb-ewQbaJAQKaBb1vY0t06cnAfJw4-Uj2cciH243mTC7t0zWFkicypqcxa0%3D&data=05%7C02%7Cdsamuels%40aha.org%7C111dc88d1bfe4b598c4708dd5aa0b5e3%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638766368505966450%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=w%2BS8e%2FyLakY1T4iXx86DAOhBMAuCecItkX2wWsxzU%2Fw%3D&reserved=0" target="_blank">expressed</a> concern to HRSA and underscored HRSA’s authority to “immediate enforcement action,” including assessing civil monetary penalties on J&J for intentionally overcharging 340B hospitals. On Sept. 17, HRSA ordered J&J to cease implementation of the proposal and later sent a final warning letter to J&J urging the drug company to inform the agency by Sept. 30 that it would halt its proposed 340B rebate model.</p><p>J&J announced on Sept. 30 it was ceasing implementation of the rebate model but then sued HRSA on Nov. 12, seeking to bar the agency from blocking J&J’s implementation of a rebate model. Since then, Eli Lilly, Sanofi, Novartis and Bristol Meyers Squibb have all sued HRSA to pursue a similar rebate model.</p><p>The AHA will file additional amicus briefs in those cases in the coming days.</p> Mon, 03 Mar 2025 09:29:46 -0600 340B Advocacy Alliance Bulletin <div class="container row"><div class="row"><div class="col-md-8"><p><strong><u>Today’s Headlines:</u></strong></p><p><strong>Leading Story</strong></p><ul><li>HPE Investigates Breach As Threat Actor Claims To Steal Source Code</li></ul><p><strong>Data Breaches & Data Leaks </strong></p><ul><li>Nothing to Report </li></ul><p><strong>Cyber Crimes & Incidents</strong></p><ul><li>Microsoft Exposes WhatsApp Spear Phishing Campaign of Star Blizzard</li></ul><p><strong>Vulnerabilities & Exploits</strong>  </p><ul><li>AWS Warns of Multiple Vulnerabilities in Amazon WorkSpaces, Amazon AppStream 2.0, & Amazon DCV</li><li>Aruba Network Vulnerabilities Let Attackers Execute Arbitrary Code Remotely</li></ul><p><strong>Trends & Reports</strong></p><ul><li>Cisco Unveils New AI Application Security Solution</li><li>One in Ten GenAI Prompts Puts Sensitive Data at Risk</li></ul><p><strong>Privacy, Legal & Regulatory</strong></p><ul><li>FCC Orders Telecoms To Secure Their Networks After Salt Typhoon Hacks</li></ul><p><strong>Upcoming Health-ISAC Events</strong></p><ul><li>Global Monthly Threat Brief <ul><li>Americas – January 28, 2025, 12:00-01:00 PM ET</li><li>European – January 29, 2025, 03:00-04:00 PM CET</li></ul></li></ul></div><div class="col-md-4"><div><p><strong>For help with Cybersecurity and Risk Advisory Services exclusively for AHA members, contact:</strong></p><h3><a href="/system/files/media/file/2020/11/AHA-Riggi-Senior-Advisor-for-Cyber-and-Risk-Bio-08102020.pdf">John Riggi</a></h3><h4>National Advisor for Cybersecurity and Risk, AHA</h4><h4><a href="mailto:jriggi@aha.org?subject=Cybersecurity and Risk Advisory Services Query">jriggi@aha.org</a></h4><h4>(O) <a href="tel:1-202-626-2272">+1 202 626 2272</a></h4><div class="external-link spacer"><a class="btn btn-wide btn-primary" href="/system/files/media/file/2020/11/AHA-Riggi-Senior-Advisor-for-Cyber-and-Risk-Bio-08102020.pdf" target="_blank">More on John Riggi</a></div><div class="external-link spacer"><a class="btn btn-wide btn-primary" href="/guidesreports/2018-06-15-cybersecurity-and-risk-advisory-services" target="_blank">Learn more about AHA's Cybersecurity and Risk Advisory Services</a></div></div></div></div></div> Tue, 21 Jan 2025 08:58:28 -0600 340B Advocacy Alliance Bulletin