Public Policy Initiatives
Lucerno Dynamics encourages patients and their family members, patient advocates, patient safety organizations, clinicians, physicists, medical physicists, radiation safety officers, hospital administrators, accreditation organizations, payers, benefit advisers, regulators, and risk managers to become familiar with Lucerno’s public policy efforts to improve patient safety and the quality of nuclear medicine procedures. These efforts, which we pursue with our Washington, D.C. partners CRD Associates, are focused on ensuring that nuclear medicine injection extravasations, that exceed medical event reporting criteria, are shared with the patient, their physician, and the Nuclear Regulatory Commission.
Lucerno Nuclear Regulatory Commission and Congressional Engagement Timeline
To access actual communications click on the text in blue font
Lucerno requests NRC to expeditiously approve petition for rulemaking (PRM)-35-22 based on further evidence that the existing reporting criteria is inconsistent and unwarranted
June 28, 2021: Lucerno submitted a letter to the NRC encouraging an expeditious approval of Petition for Rulemaking (PRM)-35-22. The letter includes notification of a paper that published in Frontiers in Medicine today that challenges three commonly held views on diagnostic radiopharmaceutical extravasations. The letter also used three recent cases involving radiopharmaceuticals to highlight the current inconsistency in reporting criteria that PRM-35-22 is intended to address. The communication to NRC also included a presentation and an analysis of a recent radiotherapy extravasation.
ACMUI expert witness supports premise of Lucerno NRC petition
May 14, 2021: Lucerno submitted an analysis of the ACMUI – NRC meeting on March 16. The ACMUI had requested a presentation by Dr. van der Pol regarding an article he published on extravasations. The Lucerno analysis showed out Dr. van der Pol’s comments supported Lucerno’s petition requesting the NRC to remove the extravasation reporting exemption policy, since extravasations are NOT virtually impossible to avoid and can result in tissue doses that exceed current NRC reporting limits. Dr. van der Pol stated that extravasations should not happen, but when they do they can result in very high doses to patient tissue.
Lucerno provides additional pertinent information to NRC regarding the need to expeditiously grant the petition for rulemaking
February 12, 2021: Lucerno provides additional relevant information regarding the need for the NRC to expeditiously grant the petition for rulemaking and eliminate the extravasation exemption policy. The information includes independent research funded by the North Carolina Policy Collaboratory that demonstrates that significant extravasations of routinely used radiopharmaceuticals can result in absorbed doses to patient tissue that exceeds NRC medical event reporting limits. The information also includes additional cases of significant extravasations that exceed reporting limits. Lucerno also provided additional evidence how significant extravasations negatively affect image quality and quantification, patient care, and patient safety.
2021 Omnibus Includes Nuclear Medicine Patient Safety, Transparency Provisions
December 22, 2020: Fiscal Year 2021 Omnibus Appropriations Act includes critical language to protect the safety of nuclear medicine patients and directs NRC, CMS, and VA to prioritize patient safety by improving medical event reporting. Current NRC policy includes a loophole from reporting requirements allowing significant extravasations to remain hidden from NRC, patients, and treating physicians. Significant extravasations can negatively affect disease diagnosis and treatment in the short-term and can lead to adverse tissue reactions from the radiation in the long-term.
The NRC Petition Short Summary and Comments
December 9, 2020: In May 2020, Lucerno officially petitioned the Nuclear Regulatory Commission to eliminate an incorrect policy that exempted significant extravasations from being reported to the NRC and to the patients. Between September 15 and December 8, the NRC requested public comments on the petition. Comments from the nuclear medicine community expressing concern about eliminating the reporting exemption revealed misconceptions about medical event reporting, patient harm, and characteristics of commonly used radiopharmaceuticals. Some public comments against the petition included incorrect information. Lucerno has and will continue to identify these types of comments and share this information with the NRC Commissioners and medical staff.
The NRC also received many comments from patients, patient advocates, members of Congress, the Organization of Agreement States, nuclear medicine and radiology luminaries, the Association of Vascular Access, and others from the nuclear medicine community that strongly endorsed the petition.
State Senator Natalie Murdock visits Lucerno
August 24, 2020: State Senator Natalie Murdock visits with Lucerno to learn more about nuclear medicine extravasations, their effects on North Carolina patients, and the Petition for Rulemaking that Lucerno submitted to the Nuclear Regulatory Commission to eliminate the extravasation reporting exemption.
Lucerno provides information to NRC regarding the need to expeditiously grant the petition for rulemaking
July 20, 2020: Lucerno provides additional relevant information regarding the need for the NRC to expeditiously grant the petition for rulemaking and eliminate the extravasation exemption policy. The information includes a recent paper by Arveschoug et al., Extravasation of [177Lu] Lu-DOTATOC: case report and discussion. Lucerno also provides 13 new cases that show patients are receiving high doses of radiation to their tissue that exceed reporting limits. Additionally, the information included an update on a new dosimetry method for calculating the dose to tissue from an extravasation. A paper on this new method has been submitted for peer-review publication. Finally, Lucerno provides a link to a recently published white paper by Dr. Darrel Fisher, specialist in the dosimetry and biological effects of internal emitters and former member of the NRC’s Advisory Committee for the Medical Use of Isotopes (ACMUI). The white paper supports the petition and provides further reasons why the NRC needs to expeditiously correct this reporting inconsistency.
2021 Appropriations Bills Enhance Nuclear Medicine Patient Safety, Transparency
July 16, 2020: The House Appropriations Committee advanced bills that include critical language to protect the safety of nuclear medicine patients and enhance transparency within the American healthcare system. Congress directs NRC, CMS and VA to prioritize patient safety by improving medical event reporting and encouraging communication with patients of these surprisingly frequent and preventable extravasations.
The report accompanying the Energy & Water Development Appropriations bill includes the following provision focused on the NRC:
Re-Evaluation of Nuclear Medicine Event Reporting.—The Committee is pleased the Commission is independently evaluating extravasation medical event reporting and is engaging outside stakeholders and the Organization of Agreement States. Extravasations that exceed medical event reporting limits provided in 10 C.F.R. Part 35 Subpart M can harm patients through unintended radiation exposure, compromised imaging that negatively affects care, additional interventional procedures, and repeated imaging procedures. The Committee is concerned that the recommendations from the NRC Advisory Committee on Medical Use of Isotopes regarding the medical event reporting of extravasations are not focused on patient safety. The Committee encourages the Commission to keep patient safety at the forefront and to complete its evaluation of the inconsistent approach to medical event reporting expeditiously. Consistent application of medical event reporting criteria will reveal potential problems, both local or generic issues, with a facility’s medical use of radioactive material and ensure that affected patients and their physicians will know about extravasations that exceed reporting limits. The Committee encourages the Commission to clarify when extravasations should not be excluded from the medical event reporting criteria and directs the Commission to provide a briefing on this topic not later than 30 days after enactment of this Act.
The report accompanying the Labor, Health & Human Services, Education Appropriations bill includes the following provision focused on Centers for Medicare & Medicaid Services (CMS):
Extravasations.—The Committee is aware of evidence demonstrating the prevalence of extravasations in nuclear medicine procedures. Extravasations of diagnostic radiopharmaceuticals negatively affect the sensitivity and quantification of nuclear medicine scans and can affect disease staging and treatment assessment, result in unnecessary invasive procedures and additional radiation exposure, and lead to higher costs for patients and payers. The Committee is pleased CMS is engaging with outside stakeholders to consider using a variety of levers to encourage providers to engage in nuclear medicine injection quality control and assurance. The Committee requests an update on this issue in the fiscal year 2022 Congressional Budget Justification.
The report accompanying the Military Construction & Veterans Affairs Appropriations bill includes the following provision focused on the Veterans Health Administration (VHA):
Nuclear Medicine Quality Improvements.—The Committee is aware of evidence demonstrating the prevalence of extravasations in nuclear medicine procedures. Extravasations of diagnostic radiopharmaceuticals negatively affect the sensitivity and quantification of nuclear medicine scans. Extravasations can affect disease staging and treatment assessment, result in unnecessary invasive procedures and additional radiation exposure, and lead to higher costs for patients and payers. Additionally, extravasations of diagnostic and therapeutic radiopharmaceuticals can expose patient’s tissue to radiation doses that far exceed dose thresholds that are known to lead to side effects. As America’s largest integrated healthcare system, VHA should lead by example in acting to reduce medical errors and medical waste. The Committee encourages VHA to monitor injection quality, image extravasations when they occur, perform dosimetry, notify patients and their physicians when doses exceed reportable limits, and implement programs to reduce extravasations in the future. The Committee requests an update on this issue in the fiscal year 2022 Congressional Budget Justification.
Congressional members support Lucerno’s NRC petition
June 18, 2020: Congressmen Butterfield, Holding, and Price sent a letter to the Nuclear Regulatory Commission calling on the Commission to expeditiously grant the petition for rulemaking to eliminate the inconsistency in medical event reporting regarding nuclear medicine injection extravasations. The members believe the petition will establish clearer safety standards, increase transparency to patients, and protect the public from unintended radiation. They ask the NRC to consider new evidence that infiltrations are not “virtually impossible to avoid” and encourage the NRC to prioritize patient safety.
Lucerno submits petition for rulemaking to the NRC
May 18, 2020: To ensure that patient safety is at the forefront of nuclear medicine procedures, Lucerno Dynamics submitted a petition for rulemaking. The petition would close a 40-year-old regulatory loophole that exempts nuclear medicine centers from reporting extravasations. The petition would require nuclear medicine centers to tell patients, their physicians, and the NRC when significant extravasations occur. We encourage clinicians, regulators, patient advocates, healthcare quality organizations, and patients to support this effort to improve health and safety of all nuclear medicine patients.
Lucerno requests NRC to reject ACMUI Patient Intervention recommendation
April 1, 2020: Lucerno requests NRC reject the ACMUI Patient Intervention recommendation because it completely conflicts with the clinical evidence.
Lucerno provides Congress “Myth versus Fact” document
March 31, 2020: In order to dispel false and misleading statements and assumptions about infiltrations, Lucerno provided a Myth versus Fact document to Members of Congress and their legislative staffs. This document is intended to provide Congress with factual and verifiable information regarding the frequency and dangers of nuclear medicine infiltrations and how the occurrence of infiltrations can be drastically reduced.
ACMUI subcommittee on Patient Intervention suggests patients at fault for extravasations
March 30, 2020: The Advisory Committee on the Medical Use of Isotopes (ACMUI) subcommittee on Patient Intervention presented recommendations to the ACMUI at the Spring Meeting. In essence, the subcommittee suggested that NRC should consider infiltrations as patient intervention that would not have to be reported to NRC as a medical event. This recommendation suggests the patient is to blame for infiltrations and is NOT supported by any evidence. Additionally, the recommendation is in direct conflict with comments from previous ACMUI members.
NRC reports to Congress on Extravasation topic
March 17, 2020: NRC reports back to Congress on the topic – Updates to Injection Quality Monitoring, Classification, and Reporting Requirements for Extravasations.
NRC’s report provided Congress with background on extravasations, the position of the Advisory Committee on the Medical Use of Isotopes Assessment of Extravasations, and NRC’s planned next steps. Lucerno has developed follow-up questions that we intend to share with NRC.
Lucerno provides additional evidence to NRC
March 16, 2020: Lucerno provides two pieces of additional evidence to the NRC for their independent evaluation of the extravasation topic. The first piece of evidence is a recent paper that summarizes a 2018 IAEA technical meeting of global radiation experts, including NRC’s Lisa Dimmick. The topic of the meeting was the prevention of unintended exposures and accidents in nuclear medicine, and the focus was extravasations. Also, Lucerno provides three more cases of dosimetry that show patients are receiving high doses of radiation to their tissue when they are infiltrated.
NRC regulatory partner supports reporting of extravasations
March 4, 2020: Lucerno provides additional evidence to the NRC from Australia and the Organization of Agreement States.
Lucerno provides article, JNM and EANM PET/CT protocols, and three dosimetry cases as additional evidence to NRC
February 12, 2020: Lucerno provides three pieces of additional evidence to the NRC to help the NRC staff conduct an independent evaluation of the infiltration issue. The first piece of evidence was a paper that published ahead of print in the American Society of Clinical Oncology JCO Oncology Practice journal on 2/11/2020. Next, was evidence that nuclear medicine centers will not have to go beyond their current standard of practice if they have to report infiltrations, since many guidelines suggest that centers image injections sites if they suspect an infiltration. Finally, Lucerno provided three more cases of dosimetry that show patients are receiving high doses of radiation to their tissue when they are infiltrated.
NRC announces independent evaluation of extravasation issue
January 28, 2020: NRC publicly announces they are conducting an independent evaluation of the infiltration/extravasation issue. Additionally, NRC states they are working on their report on the extravasation issue that is due to Congress by March 20.
Here is an excerpt from the meeting transcript of the NRC staff discussing the topic of infiltrations or extravasations.
“The last activity that I wanted to highlight is related to extravasations involving radiopharmaceuticals. Generally, an extravasation is the inadvertent injection of a medical fluid into tissue surrounding the vein or in artery. An Advisory Committee on the Medical Use of Isotopes (ACMUI) subcommittee concluded that extravasation is a practice of medicine issue and not an item that needs to be regulated by the NRC. And that extravasation should not be considered a medical event unless there is an unattended permanent functional damage. Considering ACMUI’s recommendation and the interest from external stakeholders, the NRC Staff has begun an independent evaluation of whether extravasation of a radiopharmaceutical should be considered a medical event. Additionally, the further consolidated appropriations act will require the Staff to provide a separate report to congress on this matter, this spring.”
Here is the slide that was presented to the Commissioners.
Royal Free London Hospital presentation highlights harm to patients from radiopharmaceutical infiltrations – Lucerno provides to NRC
January 28, 2020: Lucerno sends a copy of a Royal Free London presentation, “Extravasation of radionuclides: recognizing the danger and managing the consequences” by Tamar Willson to the NRC that Lucerno discovered during our ongoing research on the dangers of infiltrations or extravasations. The presentation highlights that patients can receive high radiation doses that result in harmful patient side effects from interventional radiology procedures and then showed how the same effects can happen if a nuclear medicine dose is “tissued” or infiltrated/extravasated. The presentation highlights the fact that “tissuing” happens and the associated risk factors. The presentation also highlights a patient case and shows the harm that is caused to the patient from a therapeutic radiopharmaceutical infiltration. The images are graphic. Finally, the author suggests that tissuing of the diagnostic radiopharmaceuticals can also cause patient harm.
In this same communication with the NRC, Lucerno provided an update from the SNMMI Mid-Winter meeting. Nuclear medicine centers confirmed that infiltrations certainly occur in their centers at the published rate of 15% or higher. Nuclear medicine leaders were surprised to hear that diagnostic radiopharmaceuticals could lead to high equivalent doses to tissue, were concerned that they may have to report many infiltrations to the NRC, but also were confident that using quality improvement methods, their centers could dramatically reduce their rate of infiltrations. None of the nuclear medicine professionals we spoke with believed infiltrations were caused by patients; they all recognized that their teams contribute to causing infiltrations.
University of Tennessee Knoxville paper provides additional evidence to NRC
January 22, 2020: Lucerno provides additional evidence to the NRC on the extravasation topic. Lucerno shares a recently published paper from the University of Tennessee Knoxville describing their very low infiltration rate. This paper clearly shows that the NRC 1980 policy that exempts infiltrations because “infiltrations are nearly impossible to avoid” is incorrect. Lucerno also shares a 2017 article that shows the side effects of high radiation doses to patient tissue, and the difficulty for patients to necessarily connect these delayed side effects to their previous radiation exposure. Finally, Lucerno provided three additional cases that demonstrate that extravasations can possibly exceed the NRC reporting limit.
Lucerno responds to NRC request for additional evidence supporting dosimetric method
January 10, 2020: Lucerno responds to an NRC request for evidence that the nuclear medicine community or physics community accepts the dosimetric method that Lucerno employee, Josh Knowland, is using to calculate tissue dose. Lucerno provides NRC with the abstract, a copy of the American College of Nuclear Medicine acceptance letter, and in advance of the meeting – the actual poster that was to be presented at the Society of Nuclear Medicine and Molecular Imaging and American College of Nuclear Medicine Mid-Winter Meeting on January 24, 2020.
President Trump signs omnibus spending bill with extravasation language
December 20, 2019: President Trump signs the omnibus spending bill that includes language highlighting evidence about occurrence of extravasation and the risks they pose to patients, and directs NRC, VA, and CMS report back to Congress within 90 days on the topic of infiltrations.
The report accompanying the Energy & Water appropriations bill includes the following provision, a version of which was contained in both the House and Senate versions:
Re-Evaluation of Nuclear Medicine Event Reporting. – The Committee is aware of evidence demonstrating the prevalence of extravasations in nuclear medicine procedures within and across health care providers. Extravasations of diagnostic radiopharmaceuticals negatively affect the sensitivity and quantification of nuclear medicine scans. Extravasations can affect disease staging and treatment assessment, result in unnecessary invasive procedures and additional radiation exposure, and lead to higher costs for patients and payers. The Committee supports the work of the Commission and the Advisory Committee on medical Use of Isotopes to consider new evidence in evaluating whether all radiotracer extravasations should be reportable as medical events under 10 C.F.R. Part 35. Not later than 90 days after the enactment of this Act, the Commission shall provide to the Committees on Appropriations of both Houses of Congress a report on updates to injection quality monitoring, classification, and reporting requirements regarding extravasations.
The Centers for Medicare & Medicaid Services (CMS) maintains conditions of participation (CoPs), which providers must meet in order to begin and continue participating in the Medicare and Medicaid programs, including for nuclear medicine services. The report accompanying the Labor, Health & Human Services, Education Appropriations bill includes the following provision, a version of which was contained in both the House and Senate versions:
Extravasations.—The Committee is aware of evidence demonstrating the prevalence of extravasations in nuclear medicine procedures. Extravasations of diagnostic radiopharmaceuticals negatively affect the sensitivity and quantification of nuclear medicine scans. Extravasations can affect disease staging and treatment assessment, result in unnecessary invasive procedures and additional radiation exposure, and lead to higher costs for patients and payers. The Committee encourages CMS to consider adding required monitoring of injection quality and submission of reportable extravasations to the Nuclear Regulatory Commission to its conditions of participation for nuclear medicine services. The Committee requests an update on this issue in the fiscal year 2021 Congressional Budget Justification.
The Veterans Health Administration is the largest integrated health care system in the United States, providing care at 170 VA Medical Centers. The report accompanying the Military Construction-VA Appropriations bill includes the following provision:
Nuclear Medicine Quality Improvements.—The Committee is aware of evidence demonstrating the prevalence of extravasations in nuclear medical procedures. Extravasations of diagnostic radiopharmaceuticals negatively affect the sensitivity and quantification of nuclear medicine scans. Extravasations can affect disease staging and treatment assessment, result in unnecessary invasive procedures and additional radiation exposure, and lead to higher costs for patients and payers. As America’s largest integrated healthcare system, the VAMC should lead by example in acting to reduce medical errors and medical waste. The Committee encourages VAMCs to monitor injection quality and develop a physician/patient reporting system to disclose when extravasations occur. No later than 90 days after the enactment of this Act, VHA shall provide to the Committees on Appropriations of both Houses of Congress a report on efforts to monitor injection quality and reduce the incidence of extravasations.
Lucerno provides additional extravasation cases to NRC
December 20, 2019: Lucerno provides additional infiltration cases for NRC review and additional support for the dosimetric method used to calculate radiation dose.
Bone scanning radiopharmaceutical extravasation results in patient receiving 31 Sv to tissue – Lucerno informs NRC
November 18, 2019: Lucerno provides the NRC an additional case that demonstrates how patients are being exposed to very high arm tissue doses that exceed NRC reporting limits. Lucerno also suggests that the NRC consider the impact of these infiltrations on patient safety with regard to a publication on their own website.
Lucerno provides detailed explanation of dosimetry calculation method to NRC
November 12, 2019: Lucerno responds to an NRC request for a detailed explanation of the method used to calculate dosimetry of tissue radiation exposure.
Congressman David Price visits Lucerno
October 2019: Representative David Price visits Lucerno Dynamics for a briefing on infiltrations.
Lucerno requests NRC reject ACMUI extravasation recommendation
October 9, 2019: Lucerno submits a detailed request asking NRC to reject the ACMUI recommendation. Lucerno highlights the inaccuracies inherent in the ACMUI recommendation. Lucerno submits detailed evidence demonstrating that patients who experience moderate to significant infiltrations are unintentionally exposed to high radiation doses to their tissue. Doses range from 1,000 mSv to 31,300 mSv compared to NRC reporting limits (500 mSv).
Senator Thom Tillis visits Lucerno
September 13, 2019: Senator Thom Tillis visits Lucerno Dynamics for a briefing on infiltrations.
ACMUI recommends that NRC retain 1980 extravasation reporting exemption loophole
September 10, 2019: ACMUI and their subcommittee recommend that the NRC retain the infiltration reporting exemption and the NRC consider infiltrations to be the result of patient intervention.
Lucerno provides additional information to NRC and ACMUI supporting correcting regulatory loophole
April – August 2019: Lucerno provides additional information (peer-reviewed published evidence that infiltrations can be reduced, patient letters of support, physician and healthcare quality organization letters of support, case studies) to NRC and ACMUI to support removing the infiltration reporting exemption. Lucerno and CRD educate members of Congress, their staff, and members of the Appropriations Committee on the infiltration issue and request Appropriations report language for NRC, VA, and CMS agencies.
Lucerno presents evidence to ACMUI that the incidence of nuclear medicine extravasations can be significantly improved
April 3, 2019: Lucerno presents evidence to the ACMUI that the incidence of nuclear medicine infiltrations can be significantly improved. ACMUI Chairman establishes a subcommittee to review the NRC internal 1980 policy that exempts infiltrations from being reported as a medical event – even when the infiltration unintentionally exposes patient tissue to radiation doses that exceed medical event reporting criteria.
Lucerno submits extensive dossier supported by peer-reviewed evidence that the quality of nuclear medicine injections can be improved
April 2, 2019: Lucerno submits written evidence to the NRC and ACMUI asking that they reevaluate their 1980 internal policy that exempts infiltrations from being reported as medical events.
NRC invites Lucerno to present evidence to the Advisory Committee on the Medical Use of Isotopes
February 2019: NRC invites Lucerno to present evidence to the NRC’s Advisory Committee on the Medical Use of Isotopes (ACMUI) at the ACMUI Spring 2019 meeting.
Lucerno meets with NRC for the first time – shares information about nuclear medicine injection extravasations
December 2018: Lucerno presents information to the Nuclear Regulatory Commission (NRC) on the frequency of nuclear medicine infiltrations and provides evidence that counters the NRC belief that infiltrations cannot be avoided in nuclear medicine injections.