/ en Sat, 26 Apr 2025 23:26:36 -0500 Mon, 21 Sep 20 18:18:40 -0500 /special-bulletin/2020-09-21-aha-video-how-us-supreme-court-vacancy-could-affect-health-care-cases-0 <p>The AHA this afternoon posted a video with analysis on the impact of the U.S. Supreme Court vacancy and what it means for legal cases that matter to hospitals and health systems. The opening on the court occurred when Supreme Court Justice Ruth Bader Ginsburg passed away Friday, Sept. 18.</p><p>On this video, AHA General Counsel Melinda Reid Hatton and acclaimed appellate litigator Cate Stetson, a partner at law firm Hogan Lovells, discuss Justice Ginsburg’s contribution to the Supreme Court and justice in America, the legal challenges facing the Affordable Care Act, and lawsuits that could affect hospitals and health systems.</p><p><a href="/special-bulletin/2020-09-21-aha-video-how-us-supreme-court-vacancy-could-affect-health-care-cases">Click here to watch the video.</a></p><h2>Further Questions</h2><p>If you have questions, please contact the AHA at <a href="tel:1-800-424-4301">800-424-4301</a>.</p><hr><p> Your browser does not support the video tag.</p><p>NOTE: If the video does not automatically launch and play, please reload the page and advance the progress button to the 10-second mark if needed. <a href="/system/files/media/video/2020/09/Hatton-Stetson.mp4">Click here to watch the video in a new window.</a></p> Mon, 21 Sep 2020 18:18:40 -0500 340B Delayed Regulations on Transparency and CMPs /special-bulletin/2020-09-21-aha-video-how-us-supreme-court-vacancy-could-affect-health-care-cases <p> Your browser does not support the video tag. </p> <p>NOTE: If the video does not automatically launch and play, please reload the page and advance the progress button to the 10-second mark if needed. <a href="/system/files/media/video/2020/09/Hatton-Stetson.mp4">Click here to watch the video in a new window.</a></p> Mon, 21 Sep 2020 16:00:17 -0500 340B Delayed Regulations on Transparency and CMPs /legal-documents/2019-02-28-status-report <p>Following a December 17, 2018 status conference, the Court issued a minute order requiring defendants to "file [a] status report[] pertaining to their progress in publishing pricing data by not later than February 28, 2019 . . . ." Minute Order, Dec. 18, 2018. Consistent with their representations at the status conference, Defendants anticipate that covered entities will have access to ceiling prices via the Office of Pharmacy Affairs Information System pricing system on April 1, 2019. The attached <a href="/system/files/2019-02/2019-02-28_HHS-Declaration.pdf">declaration from Krista Pedley</a>, Director of the Office of Pharmacy Affairs, Healthcare Systems Bureau, Health Resources and Services Administration, U.S. Department of Health and Human Services, provides additional details on Defendants' progress.</p> Thu, 28 Feb 2019 14:50:38 -0600 340B Delayed Regulations on Transparency and CMPs /legal-documents/2019-02-28-declaration-krista-pedley Thu, 28 Feb 2019 14:48:17 -0600 340B Delayed Regulations on Transparency and CMPs /legal-documents/2018-12-18-court-order-status-reports-and-amendment-complaint-dec-12-2018 <p>In a status conference held on December 17, 2018, the parties agreed that, with respect to plaintiffs' principal claims relating to the final 340B Rule, the case is now MOOT. Upon consideration of plaintiffs' oral motion for leave to amend their complaint, the government's consent to that motion, and the entire record herein, it is hereby ORDERED that plaintiffs' oral motion is GRANTED; it is further ORDERED that plaintiffs shall file an amended complaint by not later than December 21, 2018; it is further ORDERED that defendants shall file status reports pertaining to their progress in publishing pricing data by not later than February 28, 2019 and March 14, 2019; it is further ORDERED that a status conference is SCHEDULED for March 18, 2019 at 9:30 a.m. in Courtroom 30; and it is further ORDERED that proceedings in this action are otherwise STAYED until further order of this Court. SO ORDERED.</p> Tue, 18 Dec 2018 14:03:57 -0600 340B Delayed Regulations on Transparency and CMPs /news/headline/2018-11-30-aha-efforts-spur-hrsa-publish-340b-ceiling-prices-april-1 <p>As urged by the AHA, the Health Resources and Services Administration today <a href="https://www.hrsa.gov/opa">announced</a> that it expects to publish online by April 1 drug ceiling prices under the 340B Drug Pricing Program. HRSA also notified stakeholders that the secure pricing component of the 340B Office of Pharmacy Affairs Information System will be open for the submission of manufacturer pricing data in the first quarter of 2019.</p> <p>The Department of Health and Human Services yesterday issued a final <a href="/news/headline/2018-11-29-hhs-make-jan-1-effective-date-final-rule-340b-ceiling-prices">rule</a> making Jan. 1 the effective date of its final regulations on drug ceiling prices and civil monetary penalties for manufacturers under the 340B program. The AHA <a href="/press-releases/2018-11-29-statement-final-340b-drug-pricing-program-ceiling-price-and-civil">said</a> it was pleased that, in response to its lawsuit, the “final rule ensures that the implementation of the long-delayed” 340B ceiling price and civil monetary penalties policies will be effective Jan. 1. </p> <p>The AHA, Association of American Medical Colleges, America's Essential Hospitals, 340B Health and three hospital systems in September filed a <a href="/news/headline/2018-09-11-hospital-groups-sue-hhs-seeking-340b-price-transparency-now">lawsuit</a> to force implementation of this rule in order to “shine needed light on drug pricing and to hold price-gouging drug companies accountable.”<br />  </p> Fri, 30 Nov 2018 14:39:49 -0600 340B Delayed Regulations on Transparency and CMPs /legal-documents/2018-11-21-340b-delay-memorandum-opposition-defendants-motion-dismiss-and-reply <h4><a href="/system/files/2018-11/181121-memorandum-opposition-def-dismiss.pdf">Memorandum in Opposition to Defendants' Motion to Dismiss and Reply in Support of Summary Judgment</a></h4> <h4><a href="/system/files/2018-11/181121-340b-delay-proposed-order.pdf">Proposed Order</a></h4> <h4><a href="/system/files/2018-11/181121-340b-delay-exhibits.pdf">Exhibits</a></h4> <hr /> <p>THE AMERICAN HOSPITAL ASSOCIATION, et al., Plaintiffs, v. THE DEPARTMENT OF HEALTH AND HUMAN SERVICES, et al., Defendants. Case No. 18-2112 (JDB)</p> <p>In the mid-2000s, the Office of the Inspector General of the Department of Health and Human Services (“HHS”) issued a series of reports identifying various shortcomings of the 340B Drug Pricing Program, including the absence of a clear methodology for calculating ceiling prices, the secretive nature of ceiling prices, and the absence of enforcement by HHS. See Mem. In Supp. of Pls.’ Mot. for Summ. J., ECF No. 2-1 (“Pls.’ S.J. Mem.”) at 3-6. That drumbeat of criticism led Congress to address each of those problems. To improve the accuracy of ceiling prices, Congress required HHS to develop a “system to . . . verify the accuracy of ceiling prices calculated by manufacturers,” including to enact “precisely defined standards and methodology for the calculation of ceiling prices.” 42 U.S.C § 256b (d)(1)(B)(i). To improve transparency, Congress required that 340B providers be given online access to “the applicable ceiling prices for covered outpatient drugs as calculated and verified by the Secretary.” Id. § 256b(d)(1)(B)(iii). And to improve compliance, Congress required HHS to impose “sanctions in the form of civil monetary penalties” against drug companies that “knowingly and intentionally” overcharge 340B<br /> providers. Id. § 256b(d)(1)(A).</p> <p>Each of those statutory mandates was designed to protect 340B providers from the problems that had plagued them – and that continue to plague them because HHS has repeatedly delayed implementing the Final 340B Rule, 82 Fed. Reg. 1,210 (January 5, 2017). Those harms also give Plaintiffs standing to challenge HHS’s impermissible delays in complying with Congress’s mandate. Meanwhile, on the merits, Defendants HHS and the Secretary of HHS have apparently concluded that their repeated, extended delays were unwarranted, and thus they have declined to defend them.</p> <p>The Court should deny Defendants’ motion to dismiss, grant judgment for Plaintiffs, and issue an order directing HHS to make the Final 340B rule effective by January 1, 2019, and to post the ceiling prices for 340B drugs by April 1, 2019, at the latest.</p> Wed, 21 Nov 2018 10:44:50 -0600 340B Delayed Regulations on Transparency and CMPs /legal-documents/2018-11-13-340b-delay-governments-memorandum-opposition-motion-summary-judgment <h2>Government’s memorandum, in opposition to our motion for summary judgment and in support of their motion to dismiss</h2> <p>Plaintiffs are i) hospitals that buy drugs through a government-created drug discount program known as the 340B Program, and ii) hospital associations whose members allegedly do the same. They content that the U.S. Department of Health and Human Services has violated the Administrative Procedure Act, 5 U.S.C. 706, by delaying the implementation of a rule that would make changes to the program. And they filed an early summary judgment motion, seeking to focus attention on the merits of their complaint.</p> <p>Download the full brief below.</p> Tue, 13 Nov 2018 15:28:46 -0600 340B Delayed Regulations on Transparency and CMPs /legal-documents/2018-11-07-340b-reg-delay-briefing-schedule-proposed-order-nov-7-2018 <p>In a November 2, 2018 Order, the Court instructed the parties to file, by no later than November 8, 2018, a joint proposed schedule for briefing, plaintiffs' motion for summary judgment and defendants' planned motion to dismiss. Order, ECF No. 19, at 6. The parties conferred and agreed on the schedule proposed below, which conforms to the four specifications set out in the Court's Order.</p> Wed, 07 Nov 2018 14:28:03 -0600 340B Delayed Regulations on Transparency and CMPs /legal-documents/2018-11-02-340b-delay-order-denying-governments-motion-stay <p>Plaintiffs, a collection of hospitals, hospital associations, and healthcare providers, have brought this action against the Department of Health and Human Services (“HHS”) and Secretary of HHS Alex M. Azar II, in his official capacity, arguing that HHS’s decision to continue to delay implementation of a final rule (the “Rule”) it issued on January 5, 2017, is arbitrary and capricious and constitutes “unreasonably delayed” agency action under the Administrative Procedure Act (“APA”), 5 U.S.C. § 500 et seq. Compl. [ECF No. 1] 21–22, 57–62. Concurrent with the filing of their complaint, plaintiffs moved for summary judgment. The government now moves to stay the case pending the outcome of an anticipated rule that would advance the effective date of the Rule, or, in the alternative, to stay briefing of summary judgment until after the Court has decided the government’s yet-to-be-filed motion to dismiss. For the reasons described below, the government’s motion will be denied.</p> <p>Download the order below.</p> Fri, 02 Nov 2018 12:24:28 -0500 340B Delayed Regulations on Transparency and CMPs