Committee Report
SNM Board of Directors
June 11-12, 2009
SNM-ACNP JOINT GOVERNMENT RELATIONS COMMITTEE
Committee Charges for 2008-2009:
The Government Relations Committee is charged with reviewing federal regulations and congressional legislation
that could possibly affect the nuclear medicine community as such policy issues arise. To that end, we deal with
the following federal agencies:
Nuclear Regulatory Commission (NRC)
Food and Drug Administration (FDA)
Center for Medicare and Medicaid Services (CMS)
Environmental Protection Agency (EPA)
Department of Energy (DOE)
Department of Transportation (DOT)
Department of Health and Human Services (HHS)
To accomplish our goals, we lobby directly and with contractors and have established good communication and
working alliances with industry partners and other professional organizations associated with nuclear medicine.
This includes, but is not limited to CORAR, ACR, AMI, ASNC, and NEI.
Current Working Objectives/Goals (please reference Strategic Plan):
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Provide the lead on legislative and regulatory issues.
Continue to support basic and translational research at DOE Office of Science. Conduct follow-up in the
wake of the FY 2008 appropriations victory, and work on the probable need for FY 2009 appropriations
increases. Continue to advocate for the initiatives in the NAS "Advancing Nuclear Medicine Through
Innovation" study.
Support the CARE legislative efforts of the SNMTS.
Continue to work toward cooperative working partnerships with the NRC, FDA, and other regulatory
agencies. Monitor and appropriately respond to the emerging and continuing issues at NRC and FDA.
Assist the MI Center of Excellence in advocating for change in the FDA imaging agents review/approval
processes.
Work with the SNM RPSC Committee on Radiopharmaceuticals on government relations issues
surrounding isotope production, domestic supply of Mo-99, etc.
Work with Coding & Reimbursement Committee leaders to appropriately address policy/GR needs in the
area of CMS and related Medicare legislation.
Work together with the SNMTS Advocacy Committee and other relevant committees to enhance the
grassroots advocacy programs and initiatives of SNM.
Continue to build bridges with HHS and the CDC on issues including travel security and radiation alarms,
as well as radiological incident / emergency preparedness and education.
Progress of Charge/Objectives/Goals to Date:
LEGISLATIVE
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The "Medicare Improvements for Patients and Providers Act" (which was vetoed by the President in July,
but the veto was quickly overturned the same day) would require accreditation of providers of the
technical component for advanced diagnostic imaging services including MRI, CT, and nuclear medicine
(including PET). The Secretary of HHS will identify the appropriate entity to perform this accreditation by
January 1, 2012 (at this time ACR and ICANL are the most prominent organizations involved in this
accrediting activity). Additionally, it establishes a two-year voluntary demonstration program to test the
use of appropriateness criteria for advanced diagnostic imaging services by January 1, 2010.
REGULATORY
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Continued dialogue with the FDA regarding various regulatory issues including those affecting SNM's
ongoing clinical trials initiative.
The SNM along with ACR, ASTRO, AMI and the NOPR submitted a joint comment letter to CMS
regarding the NCA for PET (FDG) for solid tumors. Following the CMS draft proposal in January, the SNM
is again working with the coalition to produce substantive comments to CMS.
MISCELLANEOUS
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Continue to work with the SNM Isotope Availability Task Group to address domestic isotope supply issues
in the wake of the Mo-99 supply crisis of December 2007,the HFR shutdown in August 2008, and the
NRU reactor shutdown in May 2009.
Additional Goals/Objectives Added for 2009-2010:
LEGISLATIVE
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Continue working on the issues listed in the previous section of this report.
The President's FY 2010 Budget Request was rolled out in February 2009. SNM continues to work to
ensure an increase of $17.5 million in the appropriations for DOE for basic nuclear medicine research.
More legislative work will need to be done to secure increased funding in the legislative process.
The passage of the CARE legislation remains a priority for 2009.
The reimbursement freeze for RIT is only temporary, so work will need to be done to permanently fix the
cost calculation methodologies for therapeutics like Bexxar and Zevalin.
Legislative work should be done to fix other Medicare reimbursement problems, including the
classification of diagnostic radiopharmaceuticals by CMS as "supplies" rather than "drugs." This issue led
to the bundling problem in the 2008 HOPPS rule. A policy statement has been approved by the Board of
Directors and will be used to help further the campaign.
SNM commented on the Senate Finance Committee Report: Transforming the Health Care Delivery
System: Proposals to Improve Patient Care and Reduce Health Care Costs. Comment topics include:
MOC adoption into PQRI, adherence to appropriateness criteria, SGR, and comparative effectiveness
research.
SNM commented on the Senate Finance Committee Report: Financing Comprehensive Health Care
Reform: Proposed Health System Savings and Revenue Options. Comment topics include: adjusting
reimbursement for high growth, over-valued physician services.
Continue to develop position statements to define SNM’s official position on critical health reform topics.
Critical positions include: appropriateness criteria and physician payment reform.
REGULATORY
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Continue working on the issues listed in the previous section of this report.
Continue working cooperatively with, and building relationships with, the NRC staff and Commissioners.
MISCELLANEOUS
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Explore developing educational programs and grant proposals to work with HHS / CDC and ORISE on
emergency preparedness and response issues / education.
Working with broad imaging stakeholder group (ACR, AAPM, CORAR, ANS, ASTRO, NEI, and ASNC) to
develop a Mo-99 White Paper outlining a consensus statement on the conversion from HEU to LEU and a
reliable, domestic supply of Mo-99.