/ en Mon, 16 Jun 2025 20:54:20 -0500 Mon, 16 Jun 25 15:13:46 -0500 /news/headline/2025-06-16-aha-report-hospitals-are-complying-340b-rules-drug-companies-are-not <p>The AHA June 16 released a <a href="/guidesreports/2025-06-16-more-drug-company-oversight-needed-maintain-compliance-340b-program-rules">report</a> showing hospitals that participated in the 340B Drug Pricing Program are not only subject to disproportionately greater oversight by the federal government, but they also significantly outperform drug companies in terms of program compliance.  <br><br>The report analyzed publicly available federal audit data and observed trends in findings for both 340B hospitals and drug companies from fiscal years 2018-2022. Duplicate discount and diversion findings in 340B hospital audits have declined significantly, reflecting very high rates of compliance in recent years, according to the report. Meanwhile, of the audits conducted for drug companies during the same period, 60% had at least one adverse finding, and 93% of those with an adverse finding were required to issue repayments to 340B providers.  <br><br>“Policymakers should reject the baseless claims made by drug companies of widespread program abuse by 340B hospitals and urge HRSA [Health Resources and Services Administration] to increase their audits of drug companies,” the report notes. “Greater oversight of these drug companies is necessary to ensure the continued success of the 340B program for the millions of vulnerable patients and communities nationwide who rely on it.” </p> Mon, 16 Jun 2025 15:13:46 -0500 340B Drug Pricing Program <p><strong>AHA report: Hospitals are complying with 340B rules, but drug companies are not</strong></p><p>The AHA today released a <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGbGNAlcpb6Q2eUdEnaepRxIQQE9iUqXzjdGQR5iBcjmrIKsfUoVCM8wMApq8mPEYDZwTmsobo%3D&data=05%7C02%7Cdsamuels%40aha.org%7C4b7859bbf9444cf6d5f908ddacfd6c05%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638856926657797391%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=Yi%2F965jWatafqzXaztpQ3fizLc94iTYhIaGV1JnZ8pA%3D&reserved=0" target="_blank">report</a> showing hospitals that participated in the 340B Drug Pricing Program are not only subject to disproportionately greater oversight by the federal government, but they also significantly outperform drug companies in terms of program compliance.</p><p>The report analyzed publicly available federal audit data and observed trends in findings for both 340B hospitals and drug companies from fiscal years 2018-2022. Duplicate discount and diversion findings in 340B hospital audits have declined significantly, reflecting very high rates of compliance in recent years, according to the report. Meanwhile, of the audits conducted for drug companies during the same period, 60% had at least one adverse finding, and 93% of those with an adverse finding were required to issue repayments to 340B providers.</p><p>“Policymakers should reject the baseless claims made by drug companies of widespread program abuse by 340B hospitals and urge HRSA [Health Resources and Services Administration] to increase their audits of drug companies,” the report notes. “Greater oversight of these drug companies is necessary to ensure the continued success of the 340B program for the millions of vulnerable patients and communities nationwide who rely on it.”</p> Mon, 16 Jun 2025 13:16:35 -0500 340B Drug Pricing Program /news/chairpersons-file/2025-06-16-importance-legal-advocacy <p>Advocacy is such an important part of what we do as hospitals and health systems — and what the AHA does on behalf of our field — to help ensure that we get the resources we need to care for our communities. When most people think of advocacy efforts, they might think first about legislation and regulatory efforts. But legal advocacy is another important component of this work that has an effect on all of us and the work that we do.</p><p>One example is the 340B Drug Pricing Program. 340B is a vital lifeline for over 2,100 of AHA’s member hospitals, particularly those who serve rural or low-income communities. There is currently an effort led by drug companies to move to a “rebate model,” rather than the long-standing “upfront discount” model. Many 340B hospitals do not have the infrastructure to comply with rebate policies, meaning that critical resources would have to be shifted from patient care to meet the new demands.</p><p>The AHA is engaged in many court cases on this issue, and it continues to urge the Department of Health and Human Services to reject the drug companies’ unlawful requests that would result in negative consequences for patients and communities. The AHA — working with many state hospital associations — also is engaged in many cases defending state laws prohibiting drug companies from denying hospitals the same 340B discounts for drugs delivered to community pharmacies.</p><p>Sometimes legal advocacy occurs outside the courts. One example of this is the AHA’s efforts with the Department of Justice and the Federal Trade Commission related to unnecessary or burdensome anticompetitive regulation. The AHA recently sent letters to DOJ and FTC with recommendations for addressing regulations that foster anticompetitive conduct by insurers and limit the ability of hospitals and health systems to thrive in a competitive free market, among other recommendations.</p><p>Of course, there are many overlapping efforts with legislative and regulatory advocacy as well, including tariff implications and trade in critical supply chains, community benefit, and response to executive orders, just to name a few. The AHA is listening to our members and the challenges you face and is dedicated to engaging on all advocacy fronts to help protect the resources and provisions you need to focus on what you do best: making health better for the people we serve.</p><p>I will be speaking with Chad Golder, AHA’s general counsel, for our next Leadership Dialogue episode. Tune in later this month to learn more about the current legal environment, the work the AHA is doing on behalf of our members, and what you can do to help.</p><h2>Helping You Help Communities — Key AHA Resources</h2><ul><li><a href="/type/amicus-brief" title="AHA Amicus Briefs"><strong>AHA Amicus Briefs</strong></a></li><li><a href="/lettercomment/2025-05-09-aha-urges-hhs-reject-effort-several-large-drug-companies-undermine-340b-drug-pricing-program" title="AHA Comment Letter to HHS"><strong>AHA Urges HHS to Reject the Effort by Several Large Drug Companies to Undermine the 340B Drug Pricing Program</strong></a></li><li><a href="/lettercomment/2025-05-23-aha-comments-doj-anticompetitive-deregulations-rfi" title="AHA Comment letter to DOJ"><strong>AHA Comments on DOJ Anticompetitive Deregulations RFI</strong></a></li><li><a href="/lettercomment/2025-05-23-aha-comments-ftc-anticompetitive-deregulations-rfi" title="AHA Comment letter to FTC"><strong>AHA Comments on FTC Anticompetitive Deregulations RFI</strong></a></li><li><a href="/testimony/2025-05-14-aha-senate-statement-trade-critical-supply-chains" title="AHA Statement for Senate Hearing on Trade and Critical Supply Chains"><strong>AHA Statement for Senate Hearing on Trade in Critical Supply Chains</strong></a></li></ul> Mon, 16 Jun 2025 09:50:51 -0500 340B Drug Pricing Program /guidesreports/2025-06-16-more-drug-company-oversight-needed-maintain-compliance-340b-program-rules <div class="container"><div class="row"><div class="col-md-8"><p>Drug companies have repeatedly challenged the integrity of the 340B program, particularly among 340B hospitals.<a href="#fn1"><sup>1</sup></a> In fact, several drug companies have cited these concerns as a basis to pursue unilateral, unlawful self-enforcement of the program, including their recent efforts to impose a 340B “rebate model.”<a href="#fn2"><sup>2</sup></a> To investigate the veracity of these claims, the ���������� Association (AHA) reviewed the publicly available federal audit data and observed trends in findings for both 340B hospitals and drug companies over a 5-year period of fiscal years (FY) 2018-2022.<a href="#fn3"><sup>3</sup></a> The findings demonstrate that not only are hospitals subject to disproportionately greater oversight by the federal government, but that they outperform drug companies in terms of program compliance to a substantial degree. These discrepancies underscore the need for increased federal oversight of drug manufacturers, as well as rejection of their unlawful approach to convert the discount program to a rebate model.</p><h2>Background</h2><p>For over 30 years, the 340B Drug Pricing Program has been a vital resource for covered entities<a href="#fn4"><sup>4</sup></a> to stretch their limited federal resources and provide more comprehensive care to more patients. In codifying the 340B program into law, Congress recognized the importance of program integrity and entrusted this responsibility to the Health Resources and Services Administration (HRSA).<a href="#fn5"><sup>5</sup></a> The law gives HRSA both the authority to promulgate regulations and guidance that establish program rules, as well as the ability to annually conduct audits of 340B covered entities and drug companies to ensure they are in compliance with these rules.</p><p>340B covered entities are subject to numerous rules. Chief among them are statutory prohibitions against diversion (i.e., giving a 340B drug to an ineligible patient) and duplicate discounts (i.e., receiving both a 340B discount and a Medicaid rebate on the same drug).<a href="#fn6"><sup>6</sup></a> The agency monitors compliance with these rules by reviewing patient records to identify any instances of diversion or duplicate discounts. In the event a violation is found, HRSA requires the covered entity to take corrective action, which can include repayment of 340B discounts erroneously obtained back to drug companies.</p><p>Drug companies participating in the program are also subject to HRSA oversight and audits. Those companies are statutorily required to ensure they do not overcharge 340B covered entities by selling a 340B-eligible drug at above the 340B ceiling price. Similar to the requirement for covered entities, if a violation is found, drug companies must engage in corrective action, which can include payment to the covered entity for the total amount of the overcharge.</p><p>HRSA’s audit program dates back more than a decade. HRSA began auditing 340B covered entities in 2012 and performs 200 audits annually, of which approximately 160 are for 340B hospitals (or ~6% of participating hospitals). HRSA began audits for drug companies in 2015 and performs approximately five audits every year (~0.6% of participating drug companies). The results of these audits are posted publicly on HRSA’s 340B program integrity website,<a href="#fn7"><sup>7</sup></a> including the nature of any audit findings and the corrective action taken, including whether repayment was required.</p><h2>Results</h2><p><strong>The analysis of federal audit data shows high rates of compliance for audited 340B hospitals and consistently high rates of noncompliance among audited drug companies.</strong></p><p><img src="/sites/default/files/inline-images/Figure-1-Share-of-Audit-Findings-for-Diversion-and-Duplicate-Discounts-FYs-2018-2022.png" data-entity-uuid="43b9ba20-d1d1-4512-b57e-175554a5d3f7" data-entity-type="file" alt="Figure 1. Share of Audit Findings for Diversion and Duplicate Discounts, FYs 2018-2022. 2018: Diversion 39.7%; Duplicate Discounts 30.8%. 2022: Diversion: 10.7%; Duplicate Discounts 13.2%." width="668" height="398" class="align-right">Duplicate discount and diversion findings in 340B hospital audits have declined significantly, reflecting very high rates of compliance in recent years. Between FY 2018 and FY 2022, 340B hospital audit findings for duplicate discount and diversion decreased by a combined 62.1%. Specifically for duplicate discount findings, in FY 2018, 30.8% of 340B hospital audits included at least one duplicate discount finding. This percentage dropped to 13.2% by FY 2022 or a 57% decrease over this 5-year period. Similarly, in FY 2018, 39.7% of audited 340B hospitals had at least one diversion finding. That dropped to just 10.7% in FY 2022 or a 73% decrease over this 5-year period (see Figure 1).</p><p>In contrast to hospitals, drug company audits reveal a consistent pattern of noncompliance. There was a total of 30 audits conducted for drug companies between FY 2018 and FY 2022 with 60% of these audits having at least one adverse finding. Of those drug companies that had at least one adverse finding, 93% were required to issue repayments to covered entities, underscoring a pattern of noncompliance among drug companies.</p><p><img src="/sites/default/files/inline-images/Figure-2-Share-of-Adverse-Audit-Findings-Resulting-in-Repayment-Sanctions-FYs-2018-2022.png" data-entity-uuid="02dd81a5-a186-4bff-9e37-8961acdecc47" data-entity-type="file" alt="Figure 2. Share of Adverse Audit Findings Resulting in Repayment Sanctions, FY 2018-2022. 2018: Manufacturers 100%; Hospitals 71%. 2019: Manufacturers: 100%; Hospitals 55%. 2020: Manufacturers 100%; Hospitals 38%. 2021: Manufacturers 100%; Hospitals 26%. 2022: Manufacturers: 75%; Hospitals 28%." width="670" height="481" class="align-right">Repayment requirements following audit findings highlight key differences in the nature of noncompliance between hospitals and drug companies. The most egregious audit findings by 340B hospitals and drug companies require repayment to the other entity. As shown in Figure 2, the percent of audit findings where 340B hospitals were required to repay manufacturers either due to a diversion or duplicate discount finding was consistently lower and decreased from 71% in FY 2018 to 28% in FY 2022, or a 61% decrease. In contrast, 100% of drug companies with an adverse finding in FYs 2018-2021 required repayment to covered entities, with only a drop-off in FY 2022 to 75%. However, it is important to note that this drop-off represents only one fewer drug company that was required to repay covered entities in FY 2022 compared to prior years.<a href="#fn8"><sup>8</sup></a></p><h2>Discussion</h2><p>The data above demonstrate 340B hospitals’ commitment to ensuring program integrity, reflecting ongoing efforts to strengthen internal oversight, including regular self-audits of their 340B programs. Many hospitals have also established 340B committees to develop rigorous compliance frameworks, modify workflows, and hold staff accountable when errors occur, among other actions.<a href="#fn9"><sup>9</sup></a></p><p>At the same time, drug companies continue to demonstrate a high degree of noncompliance with program rules and regulations. Strikingly, nearly all audit findings require drug companies to repay 340B covered entities for overcharges. This lack of compliance is particularly concerning given that drug companies have the ability to audit covered entities when they have a legitimate concern of noncompliance, but there is no reciprocal ability of covered entities to audit drug companies when they are being overcharged for 340B drugs. Moreover, HRSA scrutinizes 340B hospitals at 10 times the rate of drug companies (6% vs. 0.6%), despite the fact that it is 340B hospitals that have shown greater rates of compliance as compared to drug companies.</p><p>Compliance with rules and regulations is absolutely critical for the success of any government program. This is why Congress gave HRSA the responsibility to audit both drug companies and 340B covered entities. These findings contradict allegations made by drug companies against 340B hospitals and instead unequivocally demonstrate that drug companies — not 340B hospitals — are in great need of increased scrutiny to improve compliance with 340B program rules and regulations.</p><p>Policymakers should reject the baseless claims made by drug companies of widespread program abuse by 340B hospitals and urge HRSA to increase their audits of drug companies. Greater oversight of these drug companies is necessary to ensure the continued success of the 340B program for the millions of vulnerable patients and communities nationwide who rely on it.</p><hr><h3>End Notes</h3><ol><li id="fn1"><a href="https://www.phrma.org/resources/phrma-statement-on-the-340b-drug-pricing-program" target="_blank" title="PhRMA: PhRMA Statement on the 340B Drug Pricing Program">phrma.org/resources/phrma-statement-on-the-340b-drug-pricing-program</a></li><li id="fn2">See September 2024 Johnson & Johnson rebate model announcement: <a href="https://transparencyreport.janssen.com/johnson-johnson-rebate-model-summary-letter" target="_blank" title="Johnson & Johnson Rebate Model Summary Letter">transparencyreport.janssen.com/johnson-johnson-rebate-model-summary-letter</a></li><li id="fn3">FY 2022 is the latest year of complete data available. Currently, HRSA has only posted 171 of its 200 audit results for FY 2023.</li><li id="fn4">Covered entities include six types of hospitals (CAH, SCH, RRC, DSH, PED, CAN), community health centers, and other select federal grantee organizations. <a href="https://www.hrsa.gov/opa/eligibility-and-registration" target="_blank" title="HRSA: 340B Eligibility">hrsa.gov/opa/eligibility-and-registration</a></li><li id="fn5"><a href="https://www.hrsa.gov/sites/default/files/hrsa/rural-health/phs-act-section-340b.pdf" target="_blank" title="HRSA: Sec. 340B Public Health Service Act">hrsa.gov/sites/default/files/hrsa/rural-health/phs-act-section-340b.pdf</a></li><li id="fn6">Ibid.</li><li id="fn7"><a href="https://www.hrsa.gov/opa/program-integrity" target="_blank" title="HRSA: 340B Drug Pricing Program: Program Integrity">hrsa.gov/opa/program-integrity</a></li><li id="fn8">Between 2018 and 2021, every drug company that had at least one adverse audit finding also required repayment to covered entities. However, in 2022, three out of the four drug companies that had an adverse audit finding required repayment to covered entities, hence the drop from 100% to 75% in FY 2022.</li><li id="fn9"><a href="https://www.utmb.edu/policies_and_procedures/IHOP/Clinical/Pharmacy/IHOP%20-%2009.14.05%20-%20Roles%20and%20Responsibilities%20in%20the%20340B%20Drug%20Pricing%20Program.pdf" target="_blank" title="UTMB Health: Roles and Responsibilities in 340B Drug Pricing Program">utmb.edu/policies_and_procedures/IHOP/Clinical/Pharmacy/IHOP%20-%2009.14.05%20-%20Roles%20and%20Responsibilities%20in%20the%20340B%20Drug%20Pricing%20Program.pdf</a></li></ol></div><div class="col-md-4"><a href="/system/files/media/file/2025/06/More-Drug-Company-Oversight-Needed-to-Maintain-Compliance-with-340B-Program-Rules.pdf" target="_blank" title="Click here to download the More Drug Company Oversight Needed to Maintain Compliance with 340B Program Rules: Trends in Audit Findings for 340B Hospitals and Drug Companies report PDF."><img src="/sites/default/files/inline-images/Pages%20from%20More-Drug-Company-Oversight-Needed-to-Maintain-Compliance-with-340B-Program-Rules-page-1.png" data-entity-uuid="865e2242-5187-4a91-964e-1dba7a1db0b3" data-entity-type="file" alt="More Drug Company Oversight Needed to Maintain Compliance with 340B Program Rules: Trends in Audit Findings for 340B Hospitals and Drug Companies page 1." width="695" height="900"></a><div class="external-link spacer"><a class="btn btn-wide btn-primary" href="/340b-drug-pricing-program" target="_blank" title="AHA's 340B Drup Pricing Program landing page">See More 340B Drug Pricing Program Resources</a></div></div></div></div> h2 { color: #003087; } h3 { color: #9d2235; } Mon, 16 Jun 2025 08:47:21 -0500 340B Drug Pricing Program <p><strong>Digital ad campaign highlights how the 340B program supports patients and communities</strong></p><p>The AHA, along with other national hospital groups, is currently running a digital ad campaign highlighting for policymakers the benefits of the 340B Drug Pricing Program to patients and communities and the danger of drug company-backed unlawful 340B rebate models. The ads, which link to websites with more information about the benefits of 340B, kicked off last month and will run through the end of July in the Washington, D.C., region on the websites of prominent news outlets, in influential health care newsletters and on social media.</p><p>The AHA is joined in this effort by 340B Health, Children’s Hospital Association and the Catholic Health Association.</p><p><strong>AHA files briefs defending South Dakota and Tennessee 340B contract pharmacy laws</strong></p><p>The AHA last week filed an <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGbCck5GsrBfd_K_8P-EoHGwSm8N_Ln8Dvq_4W1DzxSBGGpVXO5LStpztExOpGFEAUFsjO4Aq4%3D&data=05%7C02%7Cdsamuels%40aha.org%7Cdac6a5161ef44e5d970108ddaab26bd1%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638854405500398442%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=l5fIWyLGABOz%2Fzug8BchD0SPgimfPhxYKSrTK3p2ki0%3D&reserved=0" target="_blank">amicus brief</a> in the U.S. District Court for the Middle District of Tennessee 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 state law is unconstitutional.</p><p>Joining the AHA in the Tennessee filing were 340B Health, the Tennessee Hospital Association and the American Society of Health-System Pharmacists.</p><p>The AHA May 14 filed a similar <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGbCck5GrHYeQhYa-WxwBkIAT6uhU8yK_WM-4A1a82tYvZ_Jf6vhYvtZQXNjNo3f1zRACPkBnk%3D&data=05%7C02%7Cdsamuels%40aha.org%7Cdac6a5161ef44e5d970108ddaab26bd1%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638854405500410777%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=HFZJe00iW5Ns0EHhwdh5a6KWJ1hfRPlpw1hPbVF%2B7mI%3D&reserved=0" target="_blank">friend-of-the-court brief</a> in the U.S. District Court for the District of South Dakota. 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.</p><p>Joining the AHA in the South Dakota filing were 340B Health, the South Dakota Association of Healthcare Organizations and the American Society of Health-System Pharmacists. The AHA has filed briefs in similar cases for multiple states.</p> Fri, 13 Jun 2025 11:32:45 -0500 340B Drug Pricing Program /news/headline/2025-06-05-aha-files-brief-defending-tennessees-340b-contract-pharmacy-law <p>The AHA June 4 filed an <a href="/amicus-brief/2025-06-04-aha-files-brief-defending-tennessees-340b-contract-pharmacy-law" target="_blank">amicus brief</a> in the U.S. District Court for the Middle District of Tennessee 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 state law is unconstitutional.</p><p>The AHA has filed briefs in similar cases for multiple states. Joining the AHA in the Tennessee filing were 340B Health, the Tennessee Hospital Association and the American Society of Health-System Pharmacists.</p> Thu, 05 Jun 2025 15:01:03 -0500 340B Drug Pricing Program /amicus-brief/2025-06-04-aha-files-brief-defending-tennessees-340b-contract-pharmacy-law <p class="text-align-center"><strong>UNITED STATES DISTRICT COURT</strong><br><strong>FOR THE MIDDLE DISTRICT OF TENNESSEE</strong></p><p><br>ABBVIE INC., <em>et al.</em>,<br>           <em>Plaintiffs,</em><br>                 <br>                 v.                                                       Case No. 3:25-cv-00519                                                                                                    Judge Aleta A. Trauger<br><br>JONATHAN SKRMETTI, in his official capacity as <br>ATTORNEY GENERAL OF THE STATE OF TENNESSEE<br><br>       <em>Defendant.</em></p><p class="text-align-center"><br><strong>BRIEF OF </strong><em><strong>AMICI CURIAE</strong></em><strong> AMERICAN HOSPITAL ASSOCIATION, 340B HEALTH, TENNESSEE HOSPITAL ASSOCIATION, AND AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS IN OPPOSITION TO PLAINTIFFS’ MOTION FOR A PRELIMINARY INJUNCTION</strong></p><p class="text-align-center"> </p><table><tbody><tr><td>William T. Ramsey (#009245)<br>James G. Thomas (#007028)<br>Nathan C. Sanders (#033520)<br>Simon N. Levitsky (#040944)<br>NEAL & HARWELL, PLC<br>1201 Demonbreun St., STE 1000<br>Nashville, TN 37203<br>(T) (615) 238-3503<br>(F) (615) 726-0573<br>wtr@nealharwell.com<br>jthomas@nealharwell.com<br>nsanders@nealharwell.com<br>slevitsky@nealharwell.com</td><td> </td><td>William B. Schultz<br>Margaret M. Dotzel<br>Ezra B. Marcus<br>ZUCKERMAN SPAEDER LLP<br>2100 L Street NW, Suite 400<br>Washington, DC 20037<br>Tel: (202) 778-1800<br>Fax: (202) 822-8106<br>wschultz@zuckerman.com<br>mdotzel@zuckerman.com<br><a class="ck-anchor" href="mailto:emarcus@zuckerman.com" id="mailto:emarcus@zuckerman.com">emarcus@zuckerman.com</a><br><br><br> </td></tr></tbody></table> Wed, 04 Jun 2025 13:40:28 -0500 340B Drug Pricing Program /news/headline/2025-05-16-judge-hhs-has-authority-preapprove-implementation-340b-rebate-models <p>A U.S. district court judge for the District of Columbia May 15 ruled the Department of Health and Human Services must preapprove the use of 340B “rebate models” before they can be implemented, which the department has not yet done for any of the models pursued by the plaintiff drug companies. <br> <br>Judge Dabney Friedrich issued the <a href="https://sponsors.aha.org/rs/710-ZLL-651/images/2025-05-15_340B_Rebate_Models_Ruling" target="_blank">ruling</a> in a case brought by a number of drug companies, finding that when the statute says that in implementing price reductions, “any rebate or discount” taken into account shall be “as provided by the Secretary,” it means that HHS has the authority to approve or reject the proposed rebate models. “Put another way, the statute contemplates that the Secretary may ‘have as a condition’ or ‘stipulate’ how any rebate or discount is accounted for in the price ultimately paid by covered entities.” <br> <br>In a statement shared with the media, AHA General Counsel and Secretary Chad Golder said, “When Johnson & Johnson first proposed its rebate model, the AHA wrote to the Department of Health and Human Services asking it to prevent J&J’s brazen attempt to take the law into its own hands. Last night, the district court correctly upheld HHS’ authority to do just that. We urge the Department to stand firm by continuing to reject the drug industry’s efforts to undermine the 340B program and harm the hospitals that serve America’s rural and underserved communities. If HHS changes course now, America’s most vulnerable patients will suffer. Hospitals cannot afford to bear the administrative costs that the drug companies will inflict on them with their rebate models, nor can they afford to advance millions of dollars to these drug companies for any period of time, as the rebate models would force hospitals to do.” <br> <br>The AHA and other groups have filed friend-of-the-court briefs supporting HHS in 340B rebate model cases brought by <a href="/amicus-brief/2025-03-04-aha-others-file-amicus-brief-opposing-eli-lilly-bristol-meyers-squibb-and-novartis-340b-rebate-models)" target="_blank">Eli Lilly, Bristol Meyers Squibb and Novartis</a>; <a href="/amicus-brief/2025-03-06-aha-others-file-amicus-brief-opposing-sanofi-340b-rebate-model" target="_blank">Sanofi</a>; <a href="/amicus-brief/2025-03-04-aha-others-file-amicus-brief-supporting-hrsa-decision-reject-340b-rebate-model-policies" target="_blank">Kalderos</a>; and <a href="/amicus-brief/2025-02-28-aha-others-file-amicus-brief-opposing-jj-340b-rebate-model" target="_blank">Johnson & Johnson</a>. <br> <br>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. <br> <br>The AHA May 9 submitted a detailed <a href="/lettercomment/2025-05-09-aha-urges-hhs-reject-effort-several-large-drug-companies-undermine-340b-drug-pricing-programHHS" target="_blank">letter</a> urging it to deny drug companies’ requests to approve their unlawful 340B rebate models. <br><br> </p> Fri, 16 May 2025 15:00:13 -0500 340B Drug Pricing Program /news/headline/2025-05-15-aha-files-brief-defending-south-dakotas-340b-contract-pharmacy-law <p>The AHA May 14 filed an <a href="/amicus-brief/2025-05-14-aha-others-files-brief-defending-south-dakotas-340b-contract-pharmacy-law" title="amicus brief">amicus brief</a> in the U.S. District Court for the District of South Dakota 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. <br> <br>The AHA has made filings in similar cases for multiple states. Joining the AHA in the South Dakota filing were 340B Health, the South Dakota Association of Healthcare Organizations and the American Society of Health-System Pharmacists. </p> Thu, 15 May 2025 15:05:14 -0500 340B Drug Pricing Program /news/headline/2025-05-14-aha-comments-hhs-340b-drug-rebate-models <p>The AHA May 9 <a href="/lettercomment/2025-05-09-aha-urges-hhs-reject-effort-several-large-drug-companies-undermine-340b-drug-pricing-program">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> Wed, 14 May 2025 16:05:11 -0500 340B Drug Pricing Program