/ en Thu, 03 Jul 2025 00:26:25 -0500 Fri, 16 May 25 11:55:19 -0500 /lettercomment/2025-05-16-aha-responds-commerce-department-investigation-critical-minerals <p>May 16, 2025</p><p>Stephen Astle<br>Director, Defense Industrial Base Division<br>Office of Strategic Industries and Economic Security<br>U.S. Department of Commerce<br>1401 Constitution Ave, NW<br>Washington, DC 20230</p><p><em><strong>RE: Notice of Request for Public Comments on Section 232 National Security Investigation of Imports of Processed Critical Minerals and Derivative Products (XRIN 0694-XC124), April 25, 2025</strong></em></p><p>Dear Director Astle: </p><p>On behalf of our nearly 5,000 member hospitals, health systems and other health care organizations, our clinician partners — including more than 270,000 affiliated physicians, 2 million nurses and other caregivers — and the 43,000 health care leaders who belong to our professional membership groups, the ���������� Association (AHA) appreciates the opportunity to comment on the Department of Commerce’s request for public comment on its Section 232 national security investigation on processed critical minerals and derivative products. The investigation could form the basis for future tariffs or other trade restrictions on these products.</p><p>Critical minerals — including certain rare earth materials — are essential to the manufacture and operation of many medical devices that hospitals and health systems use to diagnose and treat patients every day. For example, magnetic resonance imaging (MRI), computerized tomography (CT), positron emission tomography (PET), radiopharmaceuticals and radiation therapy equipment all require the ready availability of critical minerals to function as intended. A substantial proportion of the critical minerals used in medical devices and therapies are either extracted or processed internationally, even when the device or therapy is manufactured in the U.S.</p><p>The AHA shares the administration’s long-term goal of securing reliable sources for critical minerals, including by strengthening domestic capabilities for mining and processing such minerals where possible. At the same time, achieving this goal will require a significant amount of time, given the logistical complexity and resources involved in shifting the supply chain for critical minerals. In the short term, we are concerned that tariffs on critical minerals used in health care — and any retaliatory action from the countries on which tariffs are imposed — could inadvertently disrupt the availability of critical diagnostic and treatment tools on which effective patient care relies. Tariffs and retaliatory actions from other nations also could significantly raise hospital costs.</p><p><strong>The AHA urges the administration to consider tariff exceptions for critical minerals and derivative products that are used for medical purposes. </strong>These exceptions could be coupled with continued engagement with multiple stakeholders —hospitals and health systems, device and drug manufacturers, mining and mineral processors and others — to explore approaches to making the supply chain for critical minerals used in medical devices and therapies more resilient and, when feasible, less dependent on international sources.</p><p>Multiple minerals on the critical minerals list are essential to aiding diagnosis and delivering treatments, and are heavily dependent on international sources, especially China. For diagnostic imaging, gadolinium is a rare earth material used in contrast fluid, which improve MRI precision. Contrast fluid can help identify vascular aneurysms and blockages, spinal cord injuries and brain tumors. Lutetium, another rare earth material, is used to produce very high-resolution PET/CT scans that help physicians determine how aggressive a tumor is and inform treatment plans. The U.S. is 80% reliant on international sources for rare earth materials.<sup>i</sup> Lutetium along with yttrium are also critical components of radiopharmaceuticals that are used to help shrink certain kinds of tumors. All of the yttrium used in the U.S. is imported, with 93% of it coming from China.<sup>ii</sup> Tungsten is also an essential component used to make certain linear accelerators that deliver radiation therapy treatment, with over half of the U.S. supply coming from China.<sup>iii</sup> Tariffs on these and other critical minerals used in health care could lead to disruptions in the availability of these critical patient care tools.</p><p>Lastly, the AHA is concerned about the potential for tariffs to raise the costs of delivering care to hospitals and health systems. Tariffs on critical minerals could have a particularly significant impact on complex medical devices that are higher cost and lower volume, in part due to requiring specialized parts and customization to meet the needs of health care providers. A recent survey found that 82% of health care experts expect tariff-related expenses to raise hospital costs by at least 15%, and 90% of supply chain professionals expect procurement disruptions.<sup>iv </sup>Given that hospital payments are set by government and private payer contracts, the costs would be borne by hospitals directly. As underscored by the AHA’s recent Cost of Caring report, such cost increases could further compound the broader financial headwinds challenging hospitals’ ability to provide care to patients and communities.<sup>v</sup></p><p>Thank you for the opportunity to provide feedback on this notice. We welcome the opportunity to discuss with your team how to preserve access to medical devices and technologies that depend on critical minerals and ensure that hospitals can continue delivering safe and effective care. Please contact me if you have questions at <a href="mailto:ademehin@aha.org">ademehin@aha.org</a>.</p><p>Sincerely,</p><p>/s/</p><p>Akinluwa (Akin) A. Demehin<br>Vice President<br>Quality and Safety Policy<br>______</p><div><div id="edn1"><p><small class="sm"><sup>i</sup> United States Geologic Services (USGS) Mineral Commodities Summaries. </small><a href="https://pubs.usgs.gov/periodicals/mcs2025/mcs2025-rare-earths.pdf"><small class="sm">https://pubs.usgs.gov/periodicals/mcs2025/mcs2025-rare-earths.pdf</small></a></p></div><div id="edn2"><p><small class="sm"><sup>ii</sup> USGS Mineral Commodities Summaries. </small><a href="https://pubs.usgs.gov/periodicals/mcs2025/mcs2025-yttrium.pdf"><small class="sm">https://pubs.usgs.gov/periodicals/mcs2025/mcs2025-yttrium.pdf</small></a></p></div><div id="edn3"><p><small class="sm"><sup>iii</sup> USGS Mineral Commodities Summaries. </small><a href="https://pubs.usgs.gov/periodicals/mcs2025/mcs2025-tungsten.pdf"><small class="sm">https://pubs.usgs.gov/periodicals/mcs2025/mcs2025-tungsten.pdf</small></a></p></div><div id="edn4"><p><small class="sm"><sup>iv</sup> </small><a href="https://www.beckershospitalreview.com/supply-chain/hospital-finance-supply-leaders-predict-15-increase-in-tariff-related-costs/"><small class="sm">https://www.beckershospitalreview.com/supply-chain/hospital-finance-supply-leaders-predict-15-increase-in-tariff-related-costs/</small></a></p></div><div id="edn5"><p><small class="sm"><sup>v </sup></small><a href="/costsofcaring"><small class="sm">/costsofcaring</small></a><small class="sm"> </small></p></div></div> Fri, 16 May 2025 11:55:19 -0500 Medical Device Purchasing /news/headline/2025-05-12-us-china-temporarily-agree-reduce-tariffs-90-days <p>The U.S. and China reached a joint agreement to temporarily reduce tariffs for 90 days, the White House <a href="https://www.whitehouse.gov/fact-sheets/2025/05/fact-sheet-president-donald-j-trump-secures-a-historic-trade-win-for-the-united-states/">announced</a> May 12. Both countries will lower tariffs by 115% effective May 14. This will reduce U.S. tariffs on Chinese goods to 30% — a 10% baseline tariff and a 20% tariff imposed in February due to concerns about the movement of illicit fentanyl from China. The U.S. also will retain other tariffs applied to Chinese goods. These tariffs were adopted prior to April 2 and include Section 301, Section 232 and most favored nation tariffs. </p> Mon, 12 May 2025 15:17:05 -0500 Medical Device Purchasing /advisory/2025-02-05-aha-urges-administration-grant-exceptions-current-and-proposed-tariffs-medications-and-medical-supplies <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 Medical Device Purchasing /lettercomment/2025-02-05-aha-urges-administration-grant-exceptions-tariffs-medications-and-medical-supplies <div class="container"><div class="row"><div class="col-md-8"><p>February 4, 2025</p><p>The Honorable Donald J. Trump<br>President of the United States of America<br>White House<br>1600 Pennsylvania Avenue<br>Washington, D.C. 20500</p><p>Dear President Trump:</p><p>America's hospitals stand with you in seeking ways to prevent the ravages of illicit drug use in this country. Every day, the doctors, nurses and other caregivers in our hospitals and health systems treat those suffering from addiction. They work tirelessly to prevent deaths from overdoses of fentanyl and other addictive drugs. We commend your focus on this issue in the first few days of your second term. We are, however, concerned that the approach of using tariffs may inadvertently put others' lives at risk by jeopardizing 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. 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. We are aware, 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 we believe the principle still prevails.</p><p>Despite ongoing efforts to build the domestic supply chain, the U.S. health care system relies significantly on international sources for many drugs and devices needed to both care for patients and protect our health care workers. Tariffs, as well as any reaction of the countries on whom such tariffs are imposed, could reduce the availability of these life-saving medications and supplies in the U.S. For example, U.S. providers import many cancer and cardiovascular medications, immunosuppressives, antibiotics and combination antibiotics from China. For many patients, even a temporary disruption in their access to these needed medications could put them at significant risk of harm, including death. Carefully planned chemotherapy treatments and antibiotic schedules are essential to giving patients the best chance of overcoming their disease. Similarly, the provision of necessary cardiovascular medications must be continuous to preserve their cardiovascular health.</p><p>Beyond the use of these finished products, many raw ingredients for pharmaceuticals come from China. These are commonly known as active pharmaceutical ingredients (APls). These chemicals are the most important components of any pharmaceutical manufacturer's supply chain. The U.S. gets nearly 30% of its APls 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.<a href="#fn1"><sup>1</sup></a></p><p>China is also the source of many medical devices. Some of these devices are single­ use devices designed to protect the patient from infection, such as single-use blood pressure cuffs, stethoscope covers and sterile drapes. Others are small devices used ubiquitously in hospitals, such as anesthesia instruments, cautery pencils, needles and syringes, pulse oximeters and blood pressure cuffs. Disruption in the availability of these instruments would curtail hospitals' ability to perform life-saving surgeries and keep patients safe from contagion and greatly reduce our ability to effectively diagnose and monitor patient conditions.</p><p>Finally, the protection of our health care workers from infectious diseases is vital to their health and the ability of the health care system to continue caring for patients. Health care workers need gowns, gloves, face masks, respirators and other equipment, much of which is manufactured in China and cannot be easily replaced by domestic manufacturers. In 2023, Chinese manufacturers provided the majority of the N95 and other respirators used in health care. Additionally, China was the source for one-third of the disposable face masks, two-thirds of the non-disposable face masks, and 94% of the plastic gloves used in health care.<a href="#fn2"><sup>2</sup></a> The lack of this essential equipment will not only put patients at risk but also threaten our health care delivery personnel.</p><p>Thank you for your consideration of our concerns on this important matter. We welcome the opportunity to discuss how to preserve access to essential pharmaceuticals and devices with your team. Please feel free to have your designee contact me or Nancy Foster, AHA vice president for quality and patient safety policy, at 202-626-2337 or nfoster@aha.org.</p><p>Sincerely,</p><p>/s/</p><p>Richard J. Pollack<br>President and Chief Executive Officer</p><hr><ol><li id="fn1">Neils Graham, Atlantic Council, April 19, 2023; The US is relying more on China for pharmaceuticals and vice versa.</li><li id="fn2">AdvaMed presentation 2023</li></ol></div><div class="col-md-4"><div class="external-link spacer"><a class="btn btn-wide btn-primary" href="/system/files/media/file/2025/02/AHA-Urges-Administration-to-Grant-Exceptions-for-Tariffs-for-Medications-and-Medical-Supplies.pdf" target="_blank" title="Click here to download the AHA Urges Administration to Grant Exceptions for Tariffs for Medications and Medical Supplies letter PDF.">Download the letter PDF</a></div><p><a href="/system/files/media/file/2025/02/AHA-Urges-Administration-to-Grant-Exceptions-for-Tariffs-for-Medications-and-Medical-Supplies.pdf" target="_blank" title="Click here to download the AHA Urges Administration to Grant Exceptions for Tariffs for Medications and Medical Supplies letter PDF."><img src="/sites/default/files/inline-images/Page-1-AHA-Urges-Administration-to-Grant-Exceptions-for-Tariffs-for-Medications-and-Medical-Supplies-letter.png" data-entity-uuid="7b65288a-4404-46df-a4d2-2055dbbc12b4" data-entity-type="file" alt="AHA Urges Administration to Grant Exceptions for Tariffs for Medications and Medical Supplies letter page 1." width="695" height="900"></a></p><div><h4>Latest Podcast</h4><div></div></div></div></div></div> Wed, 05 Feb 2025 07:54:44 -0600 Medical Device Purchasing /news/headline/2020-02-18-fda-india-collaborate-stop-unapproved-medical-products <p>The Food and Drug Administration, in its first enforcement operation with the government of India, recently stopped about 500 shipments of unapproved prescription drugs and combination medical devices from reaching U.S. consumers, the agency <a href="https://www.fda.gov/news-events/press-announcements/fda-takes-action-indian-government-protect-consumers-illicit-medical-products">announced</a> today. The shipments, many sent through third-party countries to conceal their origin, included about 50 FDA-regulated products, including cancer and HIV medications and opioid products, FDA said. “Consumers and physicians purchasing medicines cannot be assured the products they are receiving are legitimate, safe or effective if they are obtained from outside of the FDA-regulated pharmaceutical supply chain,” said FDA Commissioner Stephen Hahn, M.D.  </p> Tue, 18 Feb 2020 14:58:12 -0600 Medical Device Purchasing /news/headline/2019-04-15-fda-alerts-providers-temporary-shortage-breathing-tube <p>The Food and Drug Administration Friday <a href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635925.htm">alerted</a> hospitals and others to a temporary shortage of a tracheostomy tube used to help adult and pediatric patients breathe in health care facilities and at home. Made by Smiths Medical, the Bivona tracheostomy tubes are sterilized with ethylene oxide before they are marketed in the U.S. FDA last month <a href="/news/headline/2019-03-27-fda-closure-medical-device-sterilization-facility-could-prompt-shortages">announced</a> the potential for medical device shortages due to the closure of a large ethylene oxide sterilization facility in Willowbrook, Ill., and the future planned closure of a similar facility in Michigan. The temporary shortage is more likely to impact pediatric patients because the supply of alternative tubes for pediatric patients is limited, FDA said. “We recognize the challenges this shortage imposes for these pediatric patients who need access to new tubes now, and are working to limit the impact to patients as much as possible by helping the company quickly move their sterilization to another facility,” the agency said. Health care professionals who have patients urgently in need of a new Bivona tube should contact Smiths Medical directly to inquire about current inventory, FDA said.</p> Mon, 15 Apr 2019 14:37:16 -0500 Medical Device Purchasing /news/headline/2019-03-12-cms-outlines-planned-changes-competitive-bidding-program-2021 <p>The Centers for Medicare & Medicaid Services last week <a href="https://www.cms.gov/newsroom/fact-sheets/dmepos-competitive-bidding-round-2021">announced</a> planned changes to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Competitive Bidding Program for 2021. Under the program, DMEPOS suppliers compete to become Medicare contract suppliers to furnish 16 product categories in 130 competitive bidding areas. The program’s last contracts expired in December. In May, CMS will announce bidder registration and bidding dates for the 2021 program.</p> Tue, 12 Mar 2019 15:12:55 -0500 Medical Device Purchasing