Regulatory

WMIS is a progressive organization that builds the school of thought, scientific paradigms and practices of Molecular Imaging to advance the growing field of Molecular Imaging. The primary focus of WMIS is in vivo molecular imaging, as well as in vitro studies that underlie the in vivo approaches. From basic science to clinical practice, the society interacts with government agencies, foundations and the public to increase their knowledge and awareness of molecular imaging and to gain their support. The following is a list of comments, letters and coalitions that the society actively participates in to help address issues for our members.

Current Coalitions: 

The coalition for PET Drug Approval

Joint WMIS/SNM Workshop on Beta Amyloid

The Voice of WMIS:  Comments, Letters and Support

CMS

October 15, 2015
Comment of World Molecular Imaging Society (WMIS) on Positron Emission Tomography (NaF-18) To Identify Bone Metastasis of Cancer (CAG-00065R) Proposed Decision Memorandum
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February 27, 2015
Comment Letter in support of Society of Nuclear Medicine and Molecular Imaging Proposal for Calendar Year 2016 Reconfiguration of Nuclear Medicine APCs
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August 2, 2013
Comment on Proposed Decision Memorandum on Beta-Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431N)
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July 10, 2013
Request for Comment Period Extension on Proposed Decision Memo for National Coverage Analysis for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease
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June 11, 2013
WMIS Welcomes CMS Decision: Expanding Coverage for FDG-PET and Ending NOPR Data
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April 2, 2013
National Oncologic PET Registry (NOPR) Comment on Proposed Decision Memorandum for Positron Emission Tomography (FDG) for Solid Tumors (CAG-00181R4)
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January 28, 2013
Draft Guidance on Coverage with Evidence Development—Joint Comments of the World Molecular Imaging Society (WMIS) and the National Oncologic PET Registry (NOPR) Working Group
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January 11, 2013
Comment on Proposed Decision Memorandum for Positron Emission Tomography (CAG-00065R2)
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October 25, 2012
Beta-Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-0431M)
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October 4, 2012
Joint Comment on Reconsideration of Section 220.6 of the NCD on Positron Emission Tomography (FDG) (CAG-00181R4)
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December 30, 2009
Joint Comment on Proposed Decision Memorandum for Positron Emission Tomography [18F-NaF] to Identify Bone Metastasis of Cancer (CAG-00065R1)
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December 9, 2009
Public Comment on CAG-00181R3 (Limited-Scope Reconsideration of CAG-00181R Regarding Certain Restrictions on Coverage of FDG-PET for Initial Treatment Strategy Evaluation)
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August 28, 2009
Comments of the Academy of Molecular Imaging/Institute for Molecular Technologies on CMS-1413-P (Payment Policies Under the Physician Fee Schedule, and Other Part B Payment Policies for CY 2010) — Equipment Utilization Rates & Adoption of PPIS Data
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August 28, 2009
Comments of the Academy of Molecular Imaging/Institute for Molecular Technologies on CMS–1414–P (Proposed Changes to the Hospital Outpatient Prospective Payment System (OPPS) and CY 2010 Payment Rates)
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August 27, 2009
Comments on Proposed Decision Memorandum for Positron Emission Tomography (FDG) for Cervical Cancer (CAG-00181R2)
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July 2, 2009
Joint Comments on Positron Emission Tomography (NaF-18) to Identify Bone Metastasis of Cancer (CAG-00065R1)
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May 29, 2009
Comments on Reconsideration of National Coverage Determination on Positron Emission Tomography (FDG) as to Cervical Cancer (CAG-00181R2)
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February 3, 2009
Proposed Decision Memo for Positron Emission Tomography (FDG) for Solid Tumors (CAG 00181R)
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January 17, 2008
Comments on Proposed Decision for Positron Emission Tomography (FDG) for Infection and Inflammation (CAG-00382N)
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August 27, 2007
Medicare Program: Proposed Changes to the Hospital Outpatient Prospective Payment System and CY 2008 Payment Rates; PET/CT Scans; OPPS: Packaged Services
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September 19, 2006
Medicare Program; Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2007 Payment Rates; Payment for PET/CT
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September 14, 2006
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2007; DRA Proposals
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August 24, 2006
Guidance for Coverage with Evidence Development
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September 15, 2005
Medicare Program; Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2006 Payment Rates
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September 7, 2005
Proposed rule for the Medicare Program regarding Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2006 – NUCLEAR MEDICINE SERVICES
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FDA

July 3, 2012
Letter to FDAModify the current RDRC guidelines to permit an alternative assessment of human safety for new tracers
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June 13, 2011
Medical Imaging Drugs Advisory Committee (Docket # FDA-2011-N-0002)
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March 28, 2011
USP 823 changes: Comments from the AMI
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March 10, 2009
NaF Response to FDA Clinical Statistical and Information Request Comments
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November 30, 2010
FDA rule, 21 CFR Part 212, “Current Good Manufacturing Practice for Positron Emission Tomography Drugs”
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