/ en Fri, 25 Apr 2025 17:28:18 -0500 Wed, 05 Feb 25 09:22:30 -0600 <div class="container"><div class="row"><div class="col-md-8"><p>The AHA late yesterday told the administration that its current and proposed tariffs on Canada, Mexico and China may jeopardize the availability of vital medications and essential health care devices.</p><p>“We ask that you consider granting exceptions to the current and proposed tariffs for medical devices and pharmaceuticals made in Mexico, Canada and China that are essential to the provision of safe, effective care in America's hospitals, clinics, and other settings,” AHA President and CEO Rick Pollack wrote in a <a href="/lettercomment/2025-02-05-aha-urges-administration-grant-exceptions-tariffs-medications-and-medical-supplies" target="_blank">letter</a> to President Trump. “It is especially critical to have these exceptions for products already in shortage and for which production in the countries subject to increased tariffs supply a significant part of the U.S. market.”</p><p>Since the announcement of the potential tariffs, conversations with the leaders of Canada and Mexico led to a delay in the imposition of tariffs on products made in those countries, but AHA said, “We believe the principle still prevails.”</p><p>Specifically, AHA expressed concern about dangers for patients associated with the disruption in the supply of cardiac drugs, oncology drugs and others made in China, as well as the supply of active pharmaceutical ingredients — the U.S. gets nearly 30% of its APIs from China — “meaning that these tariffs may also limit the availability of U.S. drug manufacturers to produce critical drugs here in the U.S.”</p><p>The AHA also expressed concern about the potential impact of tariffs on medical devices designed to protect patients from infection, such as single-use blood pressure cuffs, stethoscope covers and sterile drapes, as well as supplies that health care workers need to care for patients, including gowns, gloves, face masks, respirators and other equipment, “much of which is manufactured in China and cannot be easily replaced by domestic manufacturers.”</p><p>The AHA Feb. 3 issued a <a href="/advisory/2025-02-03-tariffs-canada-china-and-mexico" target="_blank" title="Member Advisory PDF">Member Advisory</a> with additional information about the tariffs. The AHA will continue to monitor this issue and provide additional updates as needed.</p><h2>ADDITIONAL INFORMATION ON EXECUTIVE ACTIONS</h2><p>The Trump administration continues to issue executive orders and administrative actions that reinforce the administration’s priorities. The AHA has compiled a <a href="/system/files/media/file/2025/01/2025-New-Executive-Orders-20250127.pdf" target="_blank" title="AHA tracker ">tracker</a> of the actions the administration has taken that may be of interest to hospitals and health systems. The tracker will be updated regularly as new actions are released.</p><h2>FURTHER QUESTIONS</h2><p>If you have further questions, please contact Nancy Foster, AHA vice president of quality and patient safety policy, at <a href="mailto:nfoster@aha.org">nfoster@aha.org</a>. </p></div><div class="col-md-4"><a href="/system/files/media/file/2025/02/aha-urges-administration-to-grant-exceptions-for-current-and-proposed-tariffs-for-medications-and-medical-supplies-advisory-2-5-2025.pdf"><img src="/sites/default/files/inline-images/cover-aha-urges-administration-to-grant-exceptions-for-current-and-proposed-tariffs-for-medications-and-medical-supplies-advisory-2-5-2025.png" data-entity-uuid="29876587-0bcc-48ec-8b34-dcc8529a1acd" data-entity-type="file" alt="Cover of the Member Advisory" width="640" height="834"></a></div></div></div> Wed, 05 Feb 2025 09:22:30 -0600 Medication management /news/headline/2023-10-06-agencies-extend-telehealth-prescribing-flexibilities-controlled-medications-through-2024 <p>The Drug Enforcement Administration and Substance Abuse and Mental Health Services Administration Oct. 6 released a <a href="https://public-inspection.federalregister.gov/2023-22406.pdf" target="_blank">temporary rule</a> extending telehealth prescribing flexibilities for buprenorphine and other controlled substances for new practitioner-patient relationships through Dec. 31, 2024. The agencies previously extended the flexibilities through Nov. 11, 2024, while they consider changes to proposed rules released in March that would limit telehealth prescriptions for buprenorphine and other controlled substances to a 30-day supply unless the prescriber or referring clinician have evaluated the patient in person. <br />  <br /> AHA has <a href="/news/headline/2023-03-29-aha-comments-dea-telehealth-rules" target="_blank">urged</a> the agencies to establish a special registration process (as statutorily mandated) to waive the in-person evaluations for practitioners who register with the DEA.</p> Fri, 06 Oct 2023 13:48:51 -0500 Medication management /news/headline/2023-07-20-senate-committee-advances-bill-reauthorize-preparedness-programs <p>The Senate Health, Education, Labor and Pensions Committee today 17-3 to pass as amended the Pandemic and All-Hazards Preparedness and Response Act (<a href="https://www.help.senate.gov/hearings/s-2333-pandemic-and-all-hazards-preparedness-and-response-act">S. 2333</a>), which would reauthorize the Hospital Preparedness Program at the current funding level of $385 million through fiscal year 2029. Among other <a href="https://www.help.senate.gov/imo/media/doc/pahpara_section_by_section2.pdf">provisions</a>, the bill would require drug makers to notify the Food and Drug Administration when they anticipate a meaningful shortage and report who makes the active pharmaceutical ingredients in their drugs. AHA has <a href="/system/files/media/file/2023/07/aha-responds-to-senate-help-committee-on-pahpa-reauthorization-letter-7-10-2023.pdf">urged</a> Congress to at least double current annual funding for the HPP, which it called “vastly insufficient,” as well as address drug and device shortages.</p> Thu, 20 Jul 2023 16:01:00 -0500 Medication management /news/headline/2022-06-21-fda-approves-second-generic-naloxone-spray <p>The Food and Drug Administration <a href="https://www.fda.gov/news-events/press-announcements/fda-roundup-june-21-2022">approved</a> the second generic naloxone nasal spray, an emergency treatment for known or suspected opioid overdose. The agency approved the first generic naloxone nasal spray in <a href="/news/headline/2019-04-23-fda-approves-first-generic-naloxone-nasal-spray">2019</a>.</p> Wed, 22 Jun 2022 14:24:43 -0500 Medication management /news/headline/2020-04-01-aha-others-urge-dea-increase-annual-caps-controlled-substances <p class="paragraph"><span><span><span><span>The AHA, American Medical Association, American Society of Anesthesiologists, American Society of Health-System Pharmacists, and Association for Clinical Oncology are </span><a href="/lettercomment/2020-04-01-request-immediately-increase-allocation-controlled-substances-combat-covid"><span>urging</span></a><span> the Drug Enforcement Agency to allow drug manufacturers and 503B outsourcing facilities to receive increased annual production quota controlled-substance allocations during the COVID-19 crisis. </span></span></span></span></p> <p><span><span><span><span>Doing so, the organizations say in a letter to the DEA, will allow them to meet “legitimate, and absolutely critical, patient care needs” caused by huge spikes in demand for morphine, hydromorphone, fentanyl and other opioids because of the number of patients requiring ventilation</span></span></span></span></p> Wed, 01 Apr 2020 16:00:46 -0500 Medication management /case-studies/2020-01-14-value-initiative-members-action-university-tennessee-medical-center <p><b>University of Tennessee Medical Center – Knoxville, Tenn.</b><br /> <i>Standardization Results in Enhanced Value and Improved Outcomes</i></p> <p>Multidisciplinary teams at the University of Tennessee Medical Center used lean methodology to create evidence-based care plans throughout any episode of care, including the ED, outpatient, inpatient, post-acute and home care. The medical center also implemented a comprehensive medication analysis for patients receiving nine or more medications. By standardizing clinical pathways and order sets, UTMC has reduced readmissions, lengths of stay and costs. </p> Tue, 14 Jan 2020 10:56:46 -0600 Medication management /news/headline/2019-11-06-fda-approves-new-test-detect-hiv-drug-resistance-mutations <p>The Food and Drug Administration yesterday <a href="https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-first-next-generation-sequencing-test-detecting-hiv-1-drug-resistance">approved</a> the first test to use next generation sequencing technology to detect HIV drug-resistance mutations in patients taking or about to start antiviral therapy. “The right combination of antivirals can lower viral loads, or the amount of virus in the blood stream, and help keep patients with HIV healthy for many years,” said Peter Marks, M.D., director of FDA’s Center for Biologics Evaluation and Research. “However, according to a recent report from the Centers for Disease Control and Prevention and the World Health Organization, the percentage of people living with HIV around the world that have resistance to some HIV drugs has increased from 11% to 29% since 2001.”</p> Wed, 06 Nov 2019 14:56:02 -0600 Medication management /news/headline/2019-10-29-groups-voice-support-drug-shortages-bill-fda-reports-root-causes <p>The AHA, American Society of Anesthesiologists, American Society of Clinical Oncology, American Society of Health-System Pharmacists and Institute for Safe Medication Practices today voiced strong <a href="/lettercomment/2019-10-29-groups-voice-support-drug-shortages-bill-fda-reports-root-causes">support</a> for the Mitigating Emergency Drug Shortages Act (S.2723), which includes provisions recommended by a recent drug shortages summit convened by the organizations. Introduced by Sens. Susan Collins, R-Maine, and Tina Smith, D-Minn., the legislation would require manufacturers to disclose the root causes and expected duration of shortages, and develop contingency plans to ensure an ongoing supply. It also would extend reporting requirements to include contract manufacturers and active pharmaceutical ingredients; develop recommendations to incentivize manufacturers to enter the market for drugs in shortage; and examine the national security risk of shortages.<br />  <br /> “Over the past decade, America’s hospitals and health systems have experienced far too frequent shortages of widely used drugs that are absolutely crucial to patient care and public health,” <a href="https://www.asahq.org/about-asa/newsroom/news-releases/2019/10/healthcare-groups-applaud-new-legislation-to-address-drug-shortages">said</a> AHA Executive Vice President Tom Nickels. “The AHA thanks Senators Susan Collins and Tina Smith for their bipartisan commitment to tackling the issue of drug shortages by introducing today’s legislation. We look forward to working with Congress to advance the MEDS Act, which will help prevent, mitigate and resolve drug shortages and secure the supply of these life-saving products for patients and the hospitals and health systems that proudly care for them.”<br />  <br /> A <a href="https://www.fda.gov/drugs/drug-shortages/report-drug-shortages-root-causes-and-potential-solutions">report</a> released today by the Food and Drug Administration identifies a lack of manufacturer incentives to produce less profitable drugs and focus on continuous quality improvement, and logistical and regulatory challenges that make it difficult for the market to recover from a disruption as root causes for the nation’s drug shortages. Requested by members of Congress, the report recommends actions to create a shared understanding of the impact of drug shortages and the contracting practices that may contribute to them, and developing a system to rate and reward high-quality drug manufacturing facilities. It also recommends promoting sustainable private-sector contracts to ensure a reliable supply of medically important drugs, among other actions.<br />  </p> Tue, 29 Oct 2019 14:43:44 -0500 Medication management /news/headline/2019-10-25-fda-sterilization-facility-closures-could-prompt-future-device-shortages <p>The Food and Drug Administration today <a href="https://www.fda.gov/news-events/press-announcements/statement-concerns-medical-device-availability-due-certain-sterilization-facility-closures">alerted</a> the public to growing concern about the potential for medical device shortages as facilities that sterilize devices using ethylene oxide close. “Since we first became aware of this issue earlier this year, we have continued to focus intently on addressing the immediate impacts of these closures and potential closures to help ensure patients can have access to the safe, effective, and high-quality medical devices they need today,” said Acting FDA Commissioner Ned Sharpless, M.D. “We continue to communicate directly with manufacturers and monitor the supply of devices sterilized in facilities that have closed or that may close, paying special attention to life-saving, life-sustaining, and other critical devices.” He urged health care providers and medical device makers to assess their supplies of affected devices and report anticipated shortages or distribution delays by email to <a href="mailto:deviceshortages@fda.hhs.gov">deviceshortages@fda.hhs.gov</a>.</p> Fri, 25 Oct 2019 14:54:57 -0500 Medication management /news/headline/2019-10-18-energy-and-commerce-committee-approves-drug-pricing-bill <p>The House Energy and Commerce Committee last night approved a revised version of the Lower Prescription Drug Costs Now Act (H.R. 3) — <a href="https://docs.house.gov/meetings/IF/IF00/20191017/110114/BILLS-116-3-P000034-Amdt-1.pdf">legislation</a> that would make a series of changes to the Medicare program in an effort to lower the price of prescription drugs. During the markup, which lasted nearly eight hours, the committee adopted only one amendment, which would increase the Medicare Part B reimbursement for biosimilars for five years.<br />  <br /> The legislation would increase the number of single-source drugs from 25 to 35 that the Department of Health and Human Services would be required to negotiate directly with drug manufacturers. The bill, which was introduced last month, would, among other provisions, apply new inflationary rebates to Medicare Part B and Part D drugs that have had price increases above the rate of inflation since 2016; cap the Medicare Part D annual out-of-pocket limit at $2,000 and convert the current coverage gap into a benefit-wide responsibility; and realign the Medicare Part D catastrophic phase cost-sharing responsibilities.<br />  <br /> The House Education and Labor Committee approved its version of the bill yesterday. The House Ways and Means Committee is expected to mark up the bill next week, and the full House of Representatives will likely consider the bill in the coming weeks.</p> Fri, 18 Oct 2019 14:14:40 -0500 Medication management