Regulatory Update
ACR Supports Monica Bertagnolli, MD for NIH Director
The American College of Radiology® (ACR®) joined 115 other organizations in a letter of support of the nomination of Monica Bertagnolli, MD to lead the National Institutes of Health (NIH). The
letter was delivered to U.S. Senate leadership and the Senate Committee on Health, Education, Labor and Pensions (HELP). Dr. Bertagnolli currently serves as the NIH’s National Cancer Institute director.
President Biden
announced his intent to nominate Dr. Bertagnolli to serve as director of the NIH on May 15. Since then, HELP Committee Chair, Sen. Bernie Sanders (I-VT) has stated that he will not allow the HELP Committee to review the NIH Director nominee, or any other U.S. Department of Health and Human Services Senate-appointed nominees until he receives a plan from the Biden administration on lowering drug prices. There has not been an announcement of when the Senate will move forward with Dr. Bertagnolli's nomination.
For more information, contact
Katie Grady, ACR Government Affairs Director.
ACR Submits Congressional Testimony in Support of NIH Funding
The American College of Radiology® (ACR®)
submitted congressional testimony on March 23 to the U.S. House Labor, Health and Human Services, Education, and Related Agencies Appropriations Subcommittee in support of an increased funding recommendation for the National Institutes of Health (NIH) in the federal fiscal year (FY) 2024. ACR urged the subcommittee to provide at least $50.9 billion for FY 2024, a $3.5 billion increase compared to FY 2023 levels, in addition to the release of the 21st Century Cures funds. Additionally, with the authorization of the Advanced Research Projects Agency for Health (ARPA-H), ACR supports an increase to this new agency while maintaining a separate appropriation outside of the NIH base budget in FY 2024.
The testimony pointed to radiology and imaging advancements ACR has participated in, made possible by federal investments in the agency. The four examples, which are listed below, show how robust NIH funding has improved radiology patient care.
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The National Lung Screening Trial (NLST).
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The Randomized Evaluation of Patients with Stable Angina Comparing Utilization of Noninvasive Examinations (RESCUE) Trial.
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The Tomosynthesis Mammographic Imaging Screening Trial (TMIST)
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An NCI-designated central public repository of medical images and associated clinical data from lung cancer screening patients.
For more information, contact
Katie Grady, ACR Government Affairs Director.
NRC Leaders Prioritize Patients Over Special Interests in Extravasation Vote
The bipartisan leadership of the U.S. Nuclear Regulatory Commission (NRC)
voted unanimously in favor of
recommendations from NRC medical team staff, federal advisory committee members and radiation experts to use harm-based reporting—not dose estimate-based reporting—of certain nuclear medicine (NM) agent extravasations as Medical Events. The NRC’s Medical Event reporting mechanism facilitates case-specific analyses by NRC staff and advisors of significant errors or permanent harms during medical uses of radiological material. Phenomena that can occur inside the body without administration error, such as shunting, seed migration, and extravasation, are generally excluded.
The NRC broadly defines extravasation as the infiltration of injected fluid into the tissue surrounding a vein or artery. Extravasation is a known potential with any type of intravenous (IV) drug or media and is primarily influenced by patient-specific characteristics and conditions. Some IV drugs and media (e.g., certain chemotherapeutic compounds and large fluid volume infusions) have a much higher potential for tissue injury if extravasated. By contrast, most NM imaging agents are administered in very small volumes of solutions with inert chemical properties unlikely to cause injury. When traces of NM agents extravasate, these typically resolve spontaneously within minutes via reabsorption into the venous and lymphatic systems without injuring tissue or negating the corresponding medical procedure.
A device company that sells related devices and software-as-a-service filed a petition with the NRC in 2020 urging the agency to require novel measurements and dose estimate-based reporting of extravasations (PRM-35-22). The petition raised the collective eyebrows of government watchdogs and stakeholder groups including the American College of Radiology® (ACR®) and other national medical associations. If implemented, it would have severely impacted patient access and cost by making novel products and controversial methods of dose estimation a requisite part of approximately 20 million IV administrations annually. It would have inexplicably rendered the consequence of an insignificant extravasation occurrence the same as a healthcare provider administering treatment to the wrong patient or injecting the wrong drug. The petition also could have resulted in nationwide reliance on a single-source vendor for compliance systems and services, likely to result in canceled imaging and therapy procedures, wasted NM agent doses and adversely affected patients during supply or service disruptions.
The ACR applauds the NRC for appropriately and independently evaluating the company’s petition and choosing to implement a risk-informed approach that focuses on significance and patient safety.
For more information, please contact
Michael Peters, ACR Senior Government Affairs Director. |
