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 infiltrations, 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

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.

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 2018 meeting.

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.

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.

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.

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.

September 13, 2019: Senator Thom Tillis visits Lucerno Dynamics for a briefing on infiltrations.

(L-R) Steve Perrin, Dr. Dan Sullivan, Senator Thom Tillis, Ron Lattanze, Tonia Bryant, Dr. Brian Goldstein, Josh Knowland, Iryna Barvi, Dr. Charles Scarantino.

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).

October 2019: Representative David Price visits Lucerno Dynamics for a briefing on infiltrations.

(L-R) Ron Lattanze, Pam Kohl, Steve Perrin, Congressman David Price, Iryna Barvi, Josh Knowland, and Dr. Dan Sullivan.

November 12, 2019: Lucerno responds to an NRC request for a detailed explanation of the method used to calculate dosimetry of tissue radiation exposure.

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.

December 20, 2019: Lucerno provides additional infiltration cases for NRC review and additional support for the dosimetric method used to calculate radiation dose.

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.

NRC

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.

CMS

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.

VA

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.