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Government Relations

• Update on Kinevac Availability

  Sep 17, 2014 — Bracco Diagnostics Inc. announced that production is moving forward with targeted efforts for Kinevac commercial availability by the end of September.

• Upcoming Webinar: Oncologic PET Coding & Reimbursement

  Aug 20, 2014 — On September 23, 2014, Merlino Health Care Consulting Corp. will hold the webinar "Oncologic PET Coding & Reimbursement, Where Are We Today?"

• NTP to Resume Normal Operations

  Aug 13, 2014 — NTP Radioisotopes has received approval to resume normal operations.

• Scheduled NTP Shutdown Moved Up

  Jul 24, 2014 — Recently, NTP Radioisotopes experienced a minor operational incident at their manufacturing facility, and their Nuclear Regulator instructed them to not proceed with any operation until they had the opportunity to review the situation. NTP moved up their scheduled two week maintenance period to minimize the impact of the current situation.

• Technetium Tc99m Exametazime Injection (Ceretec Kit) Shortage

  Jul 15, 2014 — On July 14, 2014, FDA announced a shortage of Technetium Tc99m Exametazime Injection (Ceretec Kit).

• CMS Releases CY 2015 Hospital Outpatient Prospective Payment System Proposed Rule

  Jul 3, 2014 — On July 3, 2014, CMS released the CY 2015 HOPPS proposed rule.

• CMS Releases CY 2015 Medicare Physician Fee Schedule Proposed Rule

  Jul 3, 2014 — On July 3, 2014, CMS issued a proposed rule that would update payment policies and payment rates for services furnished under the MPFS on or after Jan. 1, 2015.

• CMS Releases Instructions Related to the NCD to End the Coverage with Evidence Development Requirement for FDG PET for Solid Tumors

  Jul 1, 2014 — CMS has released instructions to Medicare Administrative Contractors regarding the processing of claims pursuant to the June 11, 2013 final decision to end the coverage with evidence development (CED) requirement for certain FDG PET studies for solid tumors.

• SNMMI Receives 2014 Creating New Beginnings Award for Donations to Shelter House

  Jun 27, 2014 — On June 24, SNMMI received the 2014 Creating New Beginnings Awards for its donations and efforts to Shelter House, Inc. Representative Gerry Connolly (D-VA) recognized both Shelter House and SNMMI and entered their names into the Congressional Record of the 113th Congress.

• Bracco Provides a Summary on Kinevac Shortage

  May 23, 2014 — Kinevac is anticipated to be commercially available in the third quarter of 2014. Bracco has provided a summary of the most current information about the Kinevac shortage.

• The Joint Commission Postpones Release of New Hospital Requirements

  May 16, 2014 — CMS updated its interpretive guidelines and survey procedures for Medicare Condition of Participation in December 2013. The Joint Commission determined that two standards of performance for deemed status hospitals were needed. The changes will be postponed until July 2015.

• CMS Releases Final Rule Concerning Direct Supervision

  May 8, 2014 — On May 7, 2014, CMS released the Final Rule for Part II Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction. This new rule finalized the previously proposed change of removing the term “direct" from the current requirement at § 482.53(b)(1).

• Bracco Announces that All Remaining Kinevac Inventory has been Depleted

  Apr 29, 2014 — All remaining Kinevac inventory has been depleted, resulting in an “Out of Stock” situation by April 30. Bracco anticipates any remaining customer orders, where product has been allocated and held at their warehouse, may be shipped within the next few weeks. All unfulfilled orders will remain on the back order list.

• SNMMI Releases Q&A Regarding the Price Increase for Macroaggregated Albumin (MAA)

  Apr 23, 2014 — SNMMI has released a Coding Corner Q&A in response to the drastic price increase that went into effect on April 1, 2014 for macroaggregated albumin (MAA).

• Shine Medical Technologies to Supply Moly-99 to GE Healthcare

  Apr 4, 2014 — SHINE Medical Technologies, Inc. announced that it has entered into a strategic long-term supply agreement with GE Healthcare, a division of the General Electric Company, for supply of molybdenum-99 (moly-99).

• Bracco Diagnostics Inc. Launches New CardioGen-82® Website

  Apr 1, 2014 — On April 1, 2014, Bracco Diagnostics Inc. launched a new CardioGen-82® (Rubidium Rb 82 Generator) Website with Enhanced Resources.

• Congress Passes Legislation Linking Physician Payments to Appropriate Use Criteria

  Mar 31, 2014 — On March 31, 2014, the Senate voted to pass H.R. 4302 the Protecting Access to Medicare Act of 2014. This legislation makes permanent changes to how physicians are paid by connecting it to appropriate use criteria.

• Congress Continues Work on SGR Legislation As Deadline Approaches

  Mar 28, 2014 — On March 27, the House passed H.R. 4302, a year-long SGR patch, by voice vote.

• Bracco Releases Status Update on the Commercial Availability of Kinevac

  Mar 28, 2014 — Bracco has a limited supply of Kinevac in inventory. Bracco will continue to partially fulfill back orders aligned with the inventory on hand. An ‘Out of Stock’ situation is anticipated by the end of April.

• NRC Advisory Committee on Medical Uses of Isotopes Names SNMMI Members to Fill Open Seats

  Mar 28, 2014 — The Nuclear Regulatory Commission (NRC) selected two SNMMI members to fill open seats on the Advisory Committee on Medical Uses of Isotopes (ACMUI). They are Vasken Dilsizian, M.D., as Nuclear Cardiologist and Philip Alderson, M.D., as Health Care Administrator.

• Update on Mo-99 Availability

  Mar 27, 2014 — Standing customer orders for Technetium-99m generators should be met throughout April, despite the ongoing Molybdenum-99 (Mo-99) supply challenges faced by the nuclear medicine industry.

• A Limited Supply of Kinevac will be Available - March 21 Update

  Mar 21, 2014 — Bracco has a limited supply of Kinevac in inventory. Customer shipments are underway in an effort to meet patient needs. Bracco will continue to partially fulfill back orders aligned with the inventory on hand.

• A Limited Supply of Kinevac will be Available - March 14 Update

  Mar 14, 2014 — Bracco received a limited supply of Kinevac and has begun shipping product to customers this week. Kinevac inventory will continue to be rationed until such time manufacturing meets a ‘routine’ production schedule and Bracco inventory is replenished.

• JDI Determines a Price Adjustment on MAA and DTPA is Required

  Mar 7, 2014 — Jubilant DraxImage has determined that a onetime market price adjustment on MAA and DTPA is required. This market –wide pricing adjustment will take effect on March 1st 2014 to support ongoing sustainability and continuity of these critical products in the US.

• A Limited Supply of Kinevac will be Available - March 7 Update

  Mar 7, 2014 — A limited supply of Kinevac will be commercially available and shipped to Bracco. Initially, all back orders will be partially fulfilled. Bracco inventory will continue to be rationed until inventory is replenished.

• NRU Reactor Scheduled for Maintenance in April, Disrupting Mo-99 Supply

  Feb 28, 2014 — The NRU reactor is scheduled for one month of maintenance starting April 13. Mo-99 supply will be disrupted during this time.

• Bracco Releases Status Update on the Commercial Availability of Kinevac

  Feb 28, 2014 — On February 28, Bracco released an update on their work with manufacturers and governmental agencies regarding Kinevac commercial availability.

• Update on Mo-99 Availability

  Feb 25, 2014 — Standing customer orders for Technetium-99m generators should be met throughout March, despite the ongoing Molybdenum-99 (Mo-99) supply challenges faced by the nuclear medicine industry.

• CMS Releases Instructions on the NCD for Beta Amyloid PET in Dementia and Neurodegenerative Disease

  Feb 24, 2014 — CMS has released instructions to contractors related to its National Coverage Determination for Beta Amyloid PET in Dementia and Neurodegenerative Disease.

• DOE Releases Funding Opportunity Announcement for Nuclear Medicine Research

  Feb 12, 2014 — The Department of Energy released a funding opportunity announcement (FOA) for targeted radiochemistry and associated technology development for integrated nuclear medicine research and training with human application.

• PCORI’s $90 Million Call for Pragmatic Studies Proposals Focuses on Topics of Particular Interest to Specialties

  Feb 11, 2014 — The Patient-Centered Outcomes Research Institute (PCORI) is making up to $90 million available to support a series of large pragmatic clinical studies designed to advance patient-centered outcomes research under “real world” conditions. A webinar is scheduled for February 28 from 2:30pm-3:30pm. Applicants must submit letters of intent no later than 5 p.m. Friday, March 7 for the funding.

• Congress Introduces Legislation to Replace the SGR

  Feb 6, 2014 — House and Senate leaders have introduced bipartisan legislation to replace the SGR.

• SNMMI Submits Comments to CMS on CY 2014 HOPPS & MPFS Final Rules

  Jan 29, 2014 — On January 27, SNMMI submitted comments to CMS on the CY 2014 HOPPS & MPFS Final Rules.

• Update on Mo-99 Availability

  Jan 27, 2014 — The ongoing Molybdenum-99 (Mo-99) supply challenges faced by the nuclear medicine industry remain in effect.

• BRAIN Initiative Adds Imaging Funding

  Jan 23, 2014 — The BRAIN Initiative at NIH will now include funding for advanced imaging projects. The deadline is March 13, 2014.

• President Signs Omnibus; Includes $5 Million for Nuclear Medicine Research

  Jan 21, 2014 — President Obama has signed the $1 trillion omnibus spending bill, which includes $5 million for nuclear medicine research with human applications.

• Status Update on NTP’s Radiochemical Production Facility

  Jan 16, 2014 — NTP Radiochemical production facility expects to be at full production at the beginning of February 2014.

• President Signs Budget Agreement; Includes Three Month SGR Patch

  Dec 26, 2013 — President Obama signed the bipartisan budget agreement that will partially reduce spending cuts previously mandated under sequestration and increase discretionary spending for FY 2014 and FY 2015.

• Update on Mo-99 Availability

  Dec 20, 2013 — The challenges faced by a number of the processors and reactors involved in the production of Molybdenum-99 (Mo-99) continue, ultimately affecting, at times, the supply of Mo-99 to the global nuclear medicine industry.

• The Joint Commission Announces New and Revised Diagnostic Imaging Standards

  Dec 20, 2013 — The Joint Commission Announces New and Revised Diagnostic Imaging Standards

• Applications for the 2014 Robert E. Henkin Government Relations Fellowship

  Dec 3, 2013 — The Henkin Fellowship is designed to provide young professionals with direct exposure to the government relations activities of SNMMI.

• Status Update on NTP’s Radiochemical Production Facility

  Dec 2, 2013 — Investigations into the incident which took place in the NTP Radiochemical production facility on November 2, 2013 have been completed and the root cause identified.

• FDA Issues New Warning on Regadenoson and Adenosine

  Nov 22, 2013 — Following its placement of regadenoson on its quarterly list of drugs to monitor, the FDA has issued a new warning for both regadenoson and adenosine.

• Update on Mo-99 Availability

  Nov 21, 2013 — Currently the HFR reactor in The Netherlands is shut down due to an issue with one of the control rods. This shutdown may last for up to three months.

• Mallinckrodt Releases New Letter Updating the Mo-99 Supply Outlook

  Nov 20, 2013 — On November 20, 2013, Mallinckrodt released a customer letter which provides an update to the current outlook on Mo-99 availability for the remainder of 2013.

• Mallinckrodt Releases Letter Updating the Mo-99 Supply Outlook

  Nov 15, 2013 — On November 15, 2013, Mallinckrodt released a customer letter which provides an update to the current outlook on Mo-99 availability for the remainder of 2013.

• Request a Review of 2012 PQRS Participation Results

  Nov 7, 2013 — Eligible professionals, designated support staff/vendors, and group practices who submitted data for the 2012 Physician Quality Reporting System (PQRS) program can now request to have an informal review of their 2012 PQRS reporting performance.

• Update Regarding Shortage of DRAXIMAGE® MAA Kits

  Oct 31, 2013 — SNMMI has continued to track the supply of macroaggregated albumin (MAA). We are pleased to report that the shortages that occurred as a result of manufacturing improvements to automate the production process have been resolved.

• SNMMI Applauds FDA Approval of Flutemetamol F-18 Injection (Vizamyl)

  Oct 29, 2013 — SNMMI applauds the FDA for its approval of flutemetamol F-18 injection (Vizamyl) for PET imaging of the brain to estimate beta amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease or other causes of cognitive decline.

• SNMMI Statement on Regadenoson

  Oct 21, 2013 — The FDA has placed regadenoson—a commonly used cardiac imaging agent—on its quarterly list of drugs to monitor.

• CMS Requires CED for Coverage of Beta-Amyloid PET; SNMMI Expresses Disappointment

  Sep 30, 2013 — SNMMI is disappointed that the final decision on beta-amyloid positron emission tomography (PET) from CMS requires coverage with evidence development (CED).

• SNMMI Comments on The Joint Commission's Proposed Changes to Diagnostic Imaging Services

  Sep 25, 2013 — On September 24, the Society of Nuclear Medicine and Molecular Imaging submitted comments to The Joint Commission on their proposed changes to diagnostic imaging services.

• CMS Requires CED for Coverage of Beta-Amyloid PET; SNMMI Expresses Disappointment

  Sep 25, 2013 — SNMMI is disappointed that the final decision on beta-amyloid positron emission tomography (PET) from the Centers for Medicare and Medicaid Services (CMS) requires coverage with evidence development (CED).

• SNMMI Comments on The Joint Commission's Proposed Changes to Diagnostic Imaging Services

  Sep 25, 2013 — On September 24, the Society of Nuclear Medicine and Molecular Imaging submitted comments to The Joint Commission on their proposed changes to diagnostic imaging services.

• SNMMI Submits Comments to CMS Regarding Beta Amyloid

  Aug 2, 2013 — On August 1, 2013, SNMMI submitted comments to CMS regarding the proposed decision memorandum for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease.

• Call to Action: CMS Beta Amyloid Coverage Decision

  Jul 25, 2013 — On July 3, CMS released a proposed decision on coverage for beta amyloid (Aß) imaging.

• CMS Releases CY2014 Hospital Outpatient Prospective Payment System Proposed Rule

  Jul 9, 2013 — More than 4,000 hospitals, including general acute care hospitals, inpatient rehabilitation facilities, inpatient psychiatric facilities, long-term acute care hospitals, children’s hospitals, and cancer hospitals are paid under the OPPS. There are approximately 5,000 Medicare-participating ASCs paid under the ASC payment system.

• CMS Releases CY2014 Medicare Physician Fee Schedule Proposed Rule

  Jul 8, 2013 — On July 8, 2013, CMS issued a proposed rule that would update payment policies and payment rates for services furnished under the Medicare Physician Fee Schedule (PFS) on or after Jan. 1, 2014.

• Complimentary PQRS Web Seminar

  Jun 17, 2013 — A complimentary PQRS web seminar will be held on Tuesday, June 25 at Noon ET/11:00 a.m. CT

• NRG and Mallinckrodt Comment on the Status of the HFR

  Jun 5, 2013 — NRG, the operator of the High Flux Reactor (HFR), recently provided an update concerning the necessary repairs that are currently affecting the reactor.

• NRG Comment on the Status of the HFR

  Jun 5, 2013 — NRG, the operator of the High Flux Reactor (HFR), reported they anticipate that the HFR will return to service on June 11, 2013

• Career Opening for Imaging Physician at the FDA

  May 29, 2013 — The FDA's Office of New Drugs is recruiting an exceptional medical officer radiologist, nuclear medicine physician or other physicians with expertise in medical imaging.

• Mallinckrodt Update on the Status of the HFR

  May 23, 2013 — On May 10, Mallinckrodt, the Pharmaceutical business of Covidien, released a customer letter regarding the unplanned HFR shutdown that began in November 2012.

• SNMMI Applauds FDA Approval of Radium-223 Dichloride (Xofigo)

  May 16, 2013

• NRC Issues Enforcement Guidance Memorandum Regarding Rubidium-82

  May 7, 2013 — On April 18, the Nuclear Regulatory Commission issued an enforcement guidance memorandum (EGM).

• NRC Issues Regulatory Issue Summary Regarding Molybdenum-99

  May 3, 2013 — NRC recently issued as RIS related to Molybdenum-99.

• Comment Letter Submitted to CMS Regarding Coverage for Amyloid PET Imaging

  Apr 19, 2013 — CMS is currently considering coverage for amyloid PET imaging. The following is a letter to CMS signed by experts in Alzheimer’s disease and neuroimaging, many of whom had the opportunity to testify at the January 2013 MEDCAC meeting.

• NRG customer letter on HFR status

  Apr 3, 2013 — The Nuclear Research and consultancy Group (NRG) has issued a customer letter on the status of the HFR reactor in the Netherlands.

• 2 percent Medicare physician services cut to go into effect April 1

  Mar 29, 2013 — On Monday, April 1, 2013, all Medicare physician services will be subject to a 2 percent payment cut under the budget sequestration. As of now, the sequester will be in effect for nine years, unless Congress and the White House are able to reach a significant deficit reduction agreement that replaces it.

• CARE Act Reintroduced

  Mar 28, 2013 — On March 13, Rep. Ed Whitfield (KY-1), along with Rep. John Barrow (GA-12) and Rep. Allyson Schwartz (PA-13), introduced the Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy (CARE) Act of 2013.

• Update: Mallinckrodt customer letter on the supply of Mo-99

  Mar 26, 2013 — Mallinckrodt, the Pharmaceutical business of Covidien, has provided an update on the molybdenum-99 (Mo-99) supply outlook. They have made extensive efforts, at substantial cost, in order to improve their expected Mo-99.

• SNMMI Applauds FDA Approval of Tc 99m Tilmanocept (Lymphoseek)

  Mar 14, 2013 — The Society of Nuclear Medicine and Molecular Imaging (SNMMI) commends the US Food and Drug Administration (FDA) for its approval of Tc 99m tilmanocept (Lymphoseek) injection.

• Update: Mallinckrodt customer letter on the supply of Mo-99

  Mar 11, 2013 — Mallinckrodt, the Pharmaceutical business of Covidien, has provided an update on the molybdenum-99 (mo-99) supply outlook.

• CMS Posts the Final Decision Memo of the PET NCA Reconsideration

  Mar 8, 2013 — On Thursday, March 7, the Centers for Medicare & Medicaid Services (CMS) posted a final decision memo for positron emission tomography (PET).

• Sequestration to cause billions in spending cuts

  Mar 4, 2013 — Following Congress’s failure to pass legislation, an $85 billion sequester cut went into effect at 11:59pm on Friday, March 1.

• Update: Mallinckrodt provides additional information on Dutch High-Flux Reactor

  Mar 1, 2013 — On February 28, 2013, Mallinckrodt issued a customer letter stating new information regarding the operational status of the Dutch High-Flux Reactor (HFR). Mallinckrodt was informed by the Nuclear Research and consultancy Group (NRG) that they expect a return to service for the reactor no earlier than the beginning of May.

• Bracco resumes production schedules for CardioGen-82

  Feb 27, 2013 — On February 22, 2013, Bracco released a customer letter with an update regarding the recent delays in the shipments of CardioGen-82 (Rubidium Rb 82 Generator.

• CMS increases transparency through Affordable Care Act "Sunshine" Rule

  Feb 19, 2013 — On February 1, 2013, in its efforts to create greater transparency in health care markets, the Centers for Medicare and Medicaid Services (CMS) announced the final rule called the “National Physician Payment Transparency Program: Open Payments.”

• Update: Mallinckrodt provides additional information on Dutch High-Flux Reactor

  Feb 11, 2013 — On January 30, 2013, Mallinckrodt issued a customer letter stating the status and additional news, provided by the NRG, for the Dutch High-Flux Reactor (HFR).

• PCORI accepts applications for panel experts

  Feb 8, 2013 — The Patient Centered Outcomes Research Institute (PCORI) has begun accepting applications for the first four advisory panels.

• Society of Nuclear Medicine and Molecular Imaging Statement on MEDCAC Meeting for Brain Amyloid Imaging

  Feb 7, 2013 — Reston, VA - The Society of Nuclear Medicine and Molecular Imaging (SNMMI) is disappointed that the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) does not believe that adequate evidence exists to determine whether brain amyloid imaging with positron emission tomography (PET) changes health outcomes.

• CMS Releases Proposed Rule Concerning Direct Supervision

  Feb 5, 2013 — CMS released the Proposed Rule for Part II Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction.

• CMS offers New Guidance for Stage 2 Meaningful Use

  Feb 1, 2013 — On January 8, the Centers for Medicare and Medicaid Services released new guidance regarding the Stage 2 criteria for the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs, also known as meaningful use.

• SNMMI submits letter regarding CMS's Proposed Decision Memo for PET

  Feb 1, 2013 — SNMMI recently submitted a comment letter to the Centers for Medicare & Medicaid Services (CMS) regarding their proposed decision memo for positron emission tomography.

• NRC announces its licensing decision in regards to Ra-223 Cl

  Feb 1, 2013 — The U.S. Nuclear Regulatory Commission’s (NRC) staff has reviewed the radiation safety aspects of radium-223 dichloride (223RaCl2) and determined, based on available information, that licensing under Title 10 of the Code of Federal Regulations (10CFR) Part 35, Subpart E “Unsealed Byproduct Material – Written Directive Required” is appropriate.

• Update: Mallinckrodt provides additional information on Dutch High-Flux Reactor

  Jan 10, 2013 — On January 9, 2013, Mallinckrodt, the Pharmaceutical business of Covidien, provided additional information regarding the operational status of the Dutch High-Flux Reactor.

• American Taxpayer Relief Act Passes, Includes Imaging as Pay-For

  Jan 7, 2013 — On January 1, 2013 both the Senate (89-8) and the House of Representatives (257-167) passed H.R. 8, the American Taxpayer Relief Act of 2012.

• Mallinckrodt Provides Additional Information on Dutch High-Flux Reactor

  Dec 21, 2012 — Mallinckrodt, the Pharmaceutical business of Covidien, has provided additional information regarding the delayed return to operation for the Dutch High-Flux Reactor (HFR).

• CMS Proposal Regarding Reimbursement for New Oncology PET Tracers

  Dec 17, 2012 — Last week, the Centers for Medicare and Medicaid Services (CMS) proposed a new policy that could make it easier for new oncology PET tracers to win reimbursement.

• NRC extends call for nominations on the Advisory Committee on Medical Uses of Isotopes

  Dec 11, 2012 — On Tuesday, December 11, 2012, The U.S. Nuclear Regulatory Commission (NRC) released a notice of extension of call for nominations for the advisory committee on medical uses of isotopes.

• Mallinckrodt Provides Update on Dutch High-Flux Reactor

  Nov 30, 2012 — Mallinckrodt, the Pharmaceutical business of Covidien, has provided an update regarding the delayed return to operation for the Dutch High-Flux Reactor (HFR).

• SNMMI submits comments on Beta Amyloid Imaging

  Nov 29, 2012 — On November 8, 2012, SNMMI submitted comments to the Centers for Medicare and Medicaid Services (CMS) regarding the National Coverage Analysis Tracking Sheet for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease.

• Election Summary

  Nov 29, 2012 — On November 6, 2012, the United States held elections for the Presidency as well as Senate and House offices. While the long term implications of these election results are still undetermined, there were clear winners in these long run races.

• AMA CPT Codes Released; Changes for the Endocrine System of Nuclear Medicine Services Effective on January 1, 2013

  Nov 28, 2012 — The 2013 Current Procedural Terminology (CPT) electronic file was released by the American Medical Association (AMA) on August 31, 2012.

• CMS Issues CY 2013 Physician Fee Schedule Final Rule

  Nov 2, 2012 — The Centers for Medicare & Medicaid Services (CMS) today issued a final rule for the Medicare Physician Fee Schedule.

• CMS Issues CY 2013 HOPPS Final Rule

  Nov 2, 2012 — The Centers for Medicare & Medicaid Services (CMS) finalized the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) rule on November 1, 2012, updating Medicare payment policies and rates for hospital outpatient and ASC services beginning January 1, 2013.

• Rep. Markey Releases Report on Compounding Pharmacies

  Oct 30, 2012 — On Monday, October 29, Rep. Ed Markey (MA-7) released a report titled “Compounding Pharmacies, Compounding Risk.”

• Covidien and Babcock & Wilcox Discontinue Joint Venture

  Oct 16, 2012 — On October 15, Covidien and B&W announced that they are discontinuing their joint venture towards the develop of solutions-based reactor technology for medical isotope production.

• CRCPD Approves Part Z

  Oct 15, 2012 — The Conference of Radiation Control Program Directors (CRCPD) recently approved Part Z, which concerns Medical Credentialing.

• CMS Seeking Comments on NCD for Beta Amyloid PET in Dementia and Neurodegenerative Disease

  Oct 10, 2012 — CMS is reconsidering Section 220.6 of the National Coverage Determination (NCD) Manual pursuant to a request from the Eli Lilly and Company that coverage for PET tracers be expanded to include those agents that image beta-amyloid plaques in the context of the diagnosis of dementia.

• SNMMI Submits Letter to GAO Regarding Quality

  Oct 5, 2012 — On October 5, SNMMI submitted a letter to the GAO regarding their document entitled "Questions for Selected Experts in Medical Imaging On Accreditation for Advanced Diagnostic Imaging Suppliers."

• Sequestration- What it may mean to Nuclear Medicine and Molecular Imaging

  Sep 21, 2012 — What will sequestration mean to the Nuclear Medicine and Molecular Imaging field? Sequestration is a package the automatic spending cuts included in the Budget Control Act (BCA) passed in August 2011.

• PCORI Announces Second Cycle for CER Funding Announcements

  Sep 17, 2012 — On September 17, 2012, PCORI launched the second funding cycle for CER funding announcements. These requests are to support $96 million in comparative clinical effectiveness research in order to give patients and caregivers the ability to make more informed health care decisions.

• NOPR Requests Reconsideration of NCA for PET (FDG) for Oncologic Indications

  Sep 17, 2012 — On July 20, 2012, The National Oncologic PET Registry (NOPR) Working Group submitted a formal request to the Centers for Medicare and Medicaid Services (CMS), asking that it reconsider the current National Coverage decision on FDG-PET and to end the NOPR data collection requirements for FDG-PET for the remaining cancers/indications still reimbursed only under coverage with evidence development.

• FDA Announced Approval for Production and Use of Choline C 11 Injection

  Sep 13, 2012 — The U.S. Food and Drug Administration (FDA) announced today approval for the production and use of Choline C 11 Injection, a PET imaging agent used to help in the detection of prostate cancer.

• SNMMI Submits Comments on Proposed Medicare Physician Fee Schedule Rules for CY 2013

  Sep 4, 2012 — SNMMI has submitted comments to the Centers for Medicare and Medicaid Services regarding the CY 2013 proposed rules for the Medicare Physician Fee Schedule.

• SNMMI Submits Comments on Proposed Hospital Outpatient Prospective Payment System Rules for CY 2013

  Sep 4, 2012 — SNMMI has submitted comments to the Centers for Medicare and Medicaid Services regarding the CY 2013 proposed rules for the Hospital Outpatient Prospective Payment System.

• CMS Final Rule for Stage 2 Meaningful Use Released

  Aug 31, 2012 — The U.S. Centers for Medicare and Medicaid Services (CMS) has released its final rule for stage 2 meaningful use on August 23, 2012.

• FDA Issues GDUFA Documents

  Aug 27, 2012 — The Food and Drug Administration (FDA) has issued five documents to answer questions about the programs requirements and details regarding implantation from industry.

• PQRIwizard Now Available for Nuclear Medicine Physicians

  Aug 6, 2012 — The PQRIwizard is now live! SNMMI has partnered with CE City to offer the PQRIwizard, a fast, convenient, and cost-effective online tool to help collect and report quality measure data for the Physician Quality Reporting System (PQRS) incentive payment program.

• FDA Announces Rates for Fee Schedules

  Aug 1, 2012 — On August 1, 2012 the Food and Drug Administration (FDA) announced the rates for PDUFA and GDUFA fee schedules for FY 2013.

• Cost Estimates Released by CBO

  Aug 1, 2012 — On July 31, 2012, the Congressional Budget Office released cost estimates of a one-year Medicare physician payment patch.

• FDA Guidance and Workshop on Pediatric X-Ray Imaging Devices

  Jul 25, 2012 — On Monday, July 16, the Food and Drug Administration (FDA) hosted a public workshop to gather feedback on draft guidance for Pediatric X-ray Imaging Device Premarket Notifications.

• PCORI Posts for Comments on Draft Methodology Report

  Jul 24, 2012 — On July 23, 2012, The Patient-Centered Outcomes Research Institute (PCORI) posted for comments on the draft Methodology Report.

• CMS reconsidering the National Coverage Determination (NCD) Manual

  Jul 20, 2012

• CMS Announces 15 New Advance Payment ACOs

  Jul 19, 2012 — On July 18, 2012, the Center for Medicare and Medicaid Services (CMS) announced 15 of the latest Medicare Accountable Care Organizations will be participating in the Advance Payments ACO Model.

• Obama Signs FDA User Fee Legislation into Law

  Jul 17, 2012 — On July 9, 2012, President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law

• NRC Releases Licensing Guideline for Y-90 Microsphere Brachytherapy

  Jul 9, 2012 — NRC has recently revised the licensing guidance for yttrium-90 (Y-90) microsphere brachytherapy. Y-90 microspheres are manual brachytherapy sources used for permanent implantation therapy and are regulated under 10 CFR 35.1000.

• CMS Issues CY 2013 Physician Fee Schedule Proposed Rule

  Jul 6, 2012 — The Centers for Medicare & Medicaid Services (CMS) today issued a proposed rule that would increase payments to family physicians by approximately 7 percent and other practitioners providing primary care services between 3 and 5 percent.

• Supreme Court Offers Ruling on Health Care Reform Law

  Jun 28, 2012 — Today, June 28, 2012, the Supreme Court of the United States issued the much anticipated ruling on the Patient Protection and Affordable Care Act (ACA), also known as the Health Care Reform Law

• FDA User Fee Legislation Clears the Senate

  Jun 27, 2012 — On Tuesday, June 26, 2012, the Senate passed a compromise five-year measure to reauthorize FDA drug and medical-device user fees for five years and to create two new user fee programs, one for generic drugs and the other for generic biologic drugs.

• FDA User Fee Reauthorization Bill Clears Senate

  Jun 27, 2012 — On Tuesday, June 26, 2012, the Senate passed a compromise five-year measure to reauthorize FDA drug and medical-device user fees for five years and to create two new user fee programs, one for generic drugs and the other for generic biologic drugs.

• Applications for ACO Notice of Intent due Friday

  Jun 26, 2012 — At the beginning of June, the CMS Innovation Center announced that they will be accepting applications for an additional round of Advance Payment Accountable Care Organizations (ACOs) beginning in January 2013.

• The Senate Introduces S. 3338, the CARE Act

  Jun 26, 2012 — On Monday, June 25, Senators Tom Harkin (D-IA) and Mike Enzi (R-WY), Chairman and Ranking Member on the Senate Health, Education, Labor and Pensions (HELP) Committee, along with Senator Roger Wicker (R-MS), introduced S. 3338, the Consistency, Accuracy, Responsibility and Excellence (CARE) in Medical Imaging and Radiation Therapy Act of 2012.

• House Passes FDA User Fee Reauthorization Compromise by Voice Vote

  Jun 21, 2012 — On Wednesday, June 20, 2012, the House passed by voice vote a compromise measure to reauthorize drug and medical-device-user fees for five years and to create two new user fee programs, one for generic drugs and the other for generic biologic drugs.

• Congressional Hearing on Medical Imaging and Radiation Therapy

  Jun 21, 2012 — On Friday, June 8, 2012, the House Energy and Commerce Committee held the hearing “Examining the Appropriateness of Standards for Medical Imaging and Radiation Therapy Technologists.”

• U.S. Supports Efforts to Encourage Reliable Supplies of Mo-99 Produced Without Highly Enriched Uranium

  Jun 20, 2012 — On June 7, 2012, The White House released a fact sheet, “Encouraging Reliable Supplies of Molybdenum-99 Produced without Highly Enriched Uranium,” which announced the steps that the United States will take to ensure a reliable supply of medical isotopes while minimizing the use of highly enriched uranium (HEU) for civilian purposes.

• PCORI Releases First Four Funding Announcements

  Jun 5, 2012 — On May 23, 2012, The Patient-Centered Research Institute (PCORI) released its first funding announcement to support comparative clinical effectiveness research to give patients and their caregivers the ability to make better health care decisions.

• House Passes User Fee Reauthorization Bill

  Jun 1, 2012 — On May 30, 2012 the House passed the reauthorization bill for FDA user fee programs that will help fund the review of prescription drugs and medical devices. This will also create programs for generic and biologic drugs.

• Update on Senate and House User Fee Reauthorization Bill

  May 25, 2012 — On May 24, 2012, the Senate passed the Food and Drug Administration’s user fee reauthorization bill and according to the Congressional Budget Office, it would reduce the federal deficit by $363 million over 10 years.

• SNM Submits Comments to CMS on ICD-10 Postponement of Compliance Date

  May 23, 2012 — On May 17, 2012, the Society of Nuclear Medicine (SNM) submitted comments to the Centers for Medicare & Medicaid Services (CMS) on their proposed rule on the postponement of the compliance date to October 1, 2014, for the move to the International Classification of Diseases.

• HHS Announces Health Care Innovation Awards

  May 22, 2012 — On May 8, 2012, Health and Human Services (HHS) announced the first group of organizations that will receive the Health Care Innovation awards.

• SNM Joins Other Imaging Organizations to Urge the Passage of S.99

  May 18, 2012 — On May 16, 2012, SNM joined with other imaging organizations to urge the passage of S. 99, the American Medical Isotope Production Act of 2011.

• FDA Announces the Save the Date for the REdI Spring 2012 Conference

  May 17, 2012 — On Tuesday, May 15, The Food and Drug Administration (FDA) Small Business Regulatory Education for Industry announced the save the date for the REdI Spring 2012 Conference.

• CMS Releases Final Rule for Conditions of Participation

  May 16, 2012 — The Centers for Medicare & Medicaid Services (CMS) has released a final regulation to revise the existing Conditions of Participation for hospitals and critical access hospitals.

• House Committee Advances FDA User Fee Legislation

  May 11, 2012 — On Thursday, May 10, 2012, the House Energy and Commerce Committee advanced legislation to extend for five years Food and Drug Administration user fees, which fund review and prescription drugs and medical devices.

• SNM Submits Comments to CMS Regarding EHR Stage 2 Proposed Rule

  May 8, 2012 — The Centers for Medicare and Medicaid Services (CMS) issued the Electronic Health Record Incentive Program, Stage 2, proposed rule on March 7, 2012.

• TAG Team Helps Kentucky Bill Become Law

  Apr 25, 2012 — With the help of SNM’s Technologist Advocacy Group (TAG Team), Kentucky House Bill 137 was recently signed into law by Governor Steve Beshear. HB 137 was a proposal to establish an independent licensure board for radiography, nuclear medicine technology, and radiation therapy.

• Bracco Customer Letter on Progress and Updates for CardioGen-82

  Apr 24, 2012 — On March 26, 2012, Bracco released a customer letter with an update on the progress and path going forward, since receiving the clearance from the Food and Drug Administration (FDA) to reintroduce CardioGen-82 (Rubidium Rb 82 Generator).

• Update on Possible Xenon-133 Shortage

  Apr 20, 2012 — On April 19, 2012, Lantheus issued a customer letter to provide an update on the previous communication regarding the possible supply shortage of Xenon.

• FDA Approves PET Imaging Agent Amyvid

  Apr 11, 2012 — The Food and Drug Administration (FDA) has approved the PET imaging agent Amyvid, developed by Eli Lily and Co. and Avid Radiopharmaceuticals.

• HHS Proposed Rule Delays ICD-10 Compliance by One Year

  Apr 10, 2012 — On April 9, 2012, the Department of Health and Human Services (HHS) announced a proposed rule that creates an identifier under the Health Insurance Portability and Accountability Act of 1996 that would implement administrative simplification provisions of the Affordable Care Act.

• Robert E. Henkin Sends Dr. Grady to Capitol Hill

  Apr 6, 2012 — Dr. Erin Grady, the first recipient of the SNM Robert E. Henkin Government Fellowship, spent the week of March 19, 2012 visiting Capitol Hill and government agencies to learn first-hand how the federal legislative and regulatory process impacts nuclear medicine and molecular imaging.

• Possible Shortage of Xenon-133

  Apr 4, 2012 — Due to the planned maintenance of the Canadian National Research Unit (NRU) Mo-99 reactor shutdown, the United States will be facing a temporary shortage of Xenon-133 (Xe-133) for approximately one month. As of now, a replacement supply is unavailable as the alternative supplier commercially approved for the U.S. market is also unable to produce the product at the time.

• Supreme Court Discusses Constitutionality of Health Care Reform Law

  Mar 29, 2012 — On March 26, 2012, the Supreme Court began hearing arguments in a case brought about by 26 states and a group representing small businesses. The case covers the constitutionality of the individual mandate provision and the health care reform law included in the Affordable Care Act.

• NRC Releases Proposed Fee Schedule

  Mar 26, 2012 — On March 15, 2012, the NRC released the proposed FY 2012 fee schedule, detailing licensing, inspection and annual fees charges to its applicants and licensees.

• SNM Comments on PCORI Draft National Priorities for Research and Research Agenda

  Mar 20, 2012 — On March 13, 2012, The Society of Nuclear Medicine provided commented on the Patient-Centered Outcomes Research Institute (PCORI) Draft National Priorities and Research Agenda.

• MedPAC Recommends New Fee-For-Service Benefit Design

  Mar 20, 2012 — On March 8, 2012, the Medicare Payment Advisory Commission (MedPAC) recommended the development of a new fee-for-service benefit design that could include higher patient co-payments for advanced diagnostic imaging services.

• Obama’s Proposed Budget – What it Means to Advanced Imaging

  Feb 24, 2012 — On February 13, 2012, President Obama offered his fiscal 2013 budget proposal, including a $76.4 billion Health and Human Services budget that would trim $360 billion in Medicare and Medicaid payments over the next 10 years, in part by cutting payments to certain providers.

• HIT Announces Proposed Stage 2 Rules

  Feb 23, 2012 — On Wednesday, February 22, 2012, Dr. Farzad Mostashari, national coordinator for health IT announced proposed stage 2 rules, which are said to be different from stage 1, which did not include radiology

• SNM Comments on Risk Management Concepts

  Feb 21, 2012

• Grady Chosen as First Recipient of Henkin Fellowship

  Feb 21, 2012 — SNM and the Education and Research Foundation for the SNM are pleased to announce that Erin Grady, MD, is the first recipient of the Robert E. Henkin Fellowship.

• Congress Passes 10 Month SGR Fix

  Feb 17, 2012 — Late Friday morning, the House of Representatives (293-132) and the Senate (60-36) passed the bipartisan agreement on legislation to extend the payroll tax holiday through the end of the year.

• HHS Announces Intent to Delay ICD-10 Compliance Date

  Feb 16, 2012 — Health and Human Services Secretary Kathleen G. Sebelius announced that HHS will initiate a process to postpone the date by which certain health care entities have to comply with International Classification of Diseases, 10th Edition diagnosis and procedure codes (ICD-10).

• Bracco Releases CardioGen-82 Training Slides

  Feb 14, 2012

• Bracco Meets with NRC and Agreement Staff to Discuss the Re-Introduction of CardioGen-82

  Feb 9, 2012

• NRC Releases 2011 Regulatory Issue Summary on Patient Release

  Feb 7, 2012 — The Nuclear Regulatory Commission (NRC) released its 2011 summary, discussing NRC’s policy on the release of Iodine-131 therapy patients to locations other than private residences.

• FDA Issues Draft PET FAQ Guidance

  Feb 6, 2012 — On February 2, 2012, the Food and Drug Administration (FDA) issued draft FAQ guidance for PET drugs entitled, “FDA Regulation of PET Drug Products, Questions and Answers.”

• PCORI Issues Draft National Priorities, Calls for Comment

  Jan 23, 2012 — The Patient Centered Outcomes Research Institute (PCORI) is an independent, non-profit health research organization. Its mission is to fund research that offers patients and caregivers the information they need to make important healthcare decisions.

• SNM Comments to Improve Coverage Evidence Development

  Jan 20, 2012 — On January 19, 2012, The Society of Nuclear Medicine commented on the potential to improve Coverage with Evidence Development (CED).

• SNM Comments on Conditions of Participation

  Jan 18, 2012 — Currently Hospital CoP Nuclear Medicine Services§482.53(b)(1) states: "In-house preparation of radiopharmaceuticals is by, or under, the direct supervision of an appropriately trained registered pharmacist or a doctor of medicine or osteopathy.” Over the years, some CMS contracted inspectors have cited Hospital Nuclear Medicine Departments for not meeting Hospital CoP requirements. This has happened when the Nuclear Medicine Technologist prepares a radiopharmaceutical without a physician or pharmacist immediately available on hospital premises or physically present.

• NRC and ACMUI Selects New Member

  Jan 13, 2012 — On January 10, 2012, Darice Bailey was chosen by The Nuclear Regulatory Commission (NRC) as the State Government Representative on the Advisory Committee on the Medical Uses of Isotopes (ACMUI). Established in 1958, ACMUI advises the NRC on technical and policy issues related to the regulation of the medical uses of radioactive material.

• FDA Update on Ongoing CardioGen-82 Investigations

  Jan 13, 2012 — On January 12, 2012, The Food and Drug Administration (FDA) updated the public and healthcare professionals about preliminary findings from the ongoing investigations following Bracco Diagnostics, Inc. voluntary recall of CardioGen-82 on July, 25, 2011.

• New ICD-9-CM Volume 1, 2 Diagnosis Codes

  Jan 11, 2012 — The ICD-9-CM diagnosis code; 793.1 - Non specific (abnormal) findings on radiological and other examination of body structure; lung field, is frequently reported on FDG PET scan claims when PET is performed prior to biopsy for diagnosis of lung cancer in patients with lung masses, solitary pulmonary nodules and multiple pulmonary nodules.

• SNM Submits Comments to FDA on Standards for Clinical Imaging Endpoints

  Jan 10, 2012 — On October 18, 2011, SNM submitted comments on draft guidance for Industry on Standards for Clinical Trial Imaging Endpoints.

• CMS HCPCS Level II Codes Effective January 1, 2012

  Jan 9, 2012 — The 2012 Healthcare Common Procedure Coding System (HCPCS) electronic file has been posted with updated file information on the Centers for Medicare and Medicaid Services (CMS) web site.

• Congress Agrees to Short Term SGR Fix

  Jan 5, 2012 — Congressional leaders have announced that they have accepted a two-month fix to the sustainable growth rate (SGR) formula used to calculate Medicare physician payments.

• Bracco, Inc Releases CardioGen-82 Customer Update Letter

  Jan 4, 2012 — On December 29, 2011, Bracco released a customer letter to provide updated information regarding the voluntary recall of CardioGen-82 (Rubidium Rb82 Generator).

• The Department of Health and Human Services Announces Pioneer ACOs

  Dec 21, 2011 — On December 19, 2011, the Department of Health and Human Services announces that thirty-two leading health organizations from all over the U.S. will be participating in the Pioneer Accountable Care Organization (ACOs) Model.

• House Rejects Legislation to Extend Tax Cuts, Prevent Physician Payment Cuts

  Dec 21, 2011 — On Tuesday, December 20, 2011, the House of Representatives voted 229-193 to reject legislation passed by the Senate that would have extended a payroll tax cut and long-term unemployment benefits, and prevented cuts to physician payments by two months.

• ACO Application Deadlines Announced

  Dec 8, 2011 — On November 17, 2011 The Centers for Medicare & Medicaid Services (CMS) announced new deadlines for Accountable Care Organizations that are interested in the Advanced Payment Model and the Shared Savings program.

• Supercommittee Fails to Reach Deficit-Reduction Agreement

  Dec 8, 2011 — After nearly three months of negotiations, the Joint Select Committee on Deficit Reduction, also known as the supercommittee, failed to reach an agreement on the deficit-reduction proposal leaving in place a 27 percent cut in Medicare physician payments that will take effect on January 1, 2012.

• FDA Holds Meeting on Generic Drug User Fees

  Dec 8, 2011 — On Thursday, December 8, 2011, The Food and Drug Administration (FDA) announced a public meeting to discuss recommendations proposed for enactment of a Generic User Fee Act (GDUFA).

• FDA Extends Filing Deadline for PET Radiopharmaceuticals

  Dec 7, 2011 — The Food and Drug Administration (FDA) has issued an extension to the December filing deadline for Positron Emission Tomography (PET) radiopharmaceuticals.

• Legislation Introduced to Address 2012 Medicare Accreditation Requirements

  Dec 2, 2011 — On November 2, Rep. James Renacci (R-OH) introduced HR 3328, which would provide a six-month grace period for Medicare imaging service suppliers to receive accreditation through an approved accrediting organization.

• 2012 Nuclear Medicine Coding Update Webinar

  Nov 23, 2011 — Each New Year brings changes to coding and billing for nuclear medicine. Join Denise Merlino, MBA, CNMT, FSNMTS, CPC, as she recaps significant changes during the past year and discusses the common pitfalls and how to avoid them.

• SNM and ERF announce creation of Robert E. Henkin Government Relations Fellowship

  Nov 10, 2011 — SNM and the Education and Research Foundation for SNM are pleased to announce the creation of the Robert E. Henkin Government Relations Fellowship.

• Update: CMS Releases Final ACO Rule

  Nov 9, 2011 — On Thursday, October 20, 2011, The Centers for Medicare and Medicaid Services (CMS) released the final Medicare Shared Savings Program rule, formalizing policies for voluntary Accountable Care Organizations (ACOs), which differs significantly from the earlier proposed plan.

• Study Casts Doubt on Savings from Prior Authorization

  Oct 24, 2011 — The Moran Company for the Access to Medical Imaging Coalition has released a study which concludes that the attempts to reduce payments for advanced imaging services in Medicare won’t save money.

• PCORI's Pilot Project Grant Program looks for Stakeholders to Participate in Merit Review

  Oct 19, 2011 — The Patient-Centered Outcomes Research Institute (PCORI) is looking for patients, scientists and other stakeholders to participate in merit reviews of the PCORI Pilot Project Grant Program application in February 2012. This will help to determine the quality and significance of submitted research proposals.

• NRC Sponsors ICRP Symposium on International System of Radiological Projection

  Oct 19, 2011 — On October 24-26, The International Commission on Radiological Protection (ICRP) will hold its first Symposium on the International System of Radiological Protection in Rockville, MD.

• FDA Announces Draft Guidance on Media Fills

  Oct 19, 2011 — On September 30, 2011, The Food and Drug Administration (FDA) announced the availability of a draft guidance entitled,”Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs.”

• Bracco, Inc Releases CardioGen-82 Customer Update Letter

  Oct 19, 2011 — On October 17, 2011, Bracco released a customer letter to provide updated information regarding the voluntary recall of CardioGen-82 (Rubidium Rb 82 Generator). In support of a market return, Bracco is in the process of revalidating its manufacturing process and reviewing labeling and user training to ensure proper generator use.

• MedPAC Approves Recommendations to Congress Regarding SGR Repeal

  Oct 18, 2011 — On Thursday, October 6th MedPAC voted to approve their recommendations to Congress concerning the repeal and replacement of the Sustainable Growth Rate (SGR). If approved by Congress, the plan would create a 10-year freeze across all services and cost an estimated $300 billion. Consequently, the new plan would require offsets which would result in significant cuts to specialty providers, including imaging professionals.

• PCORI Announces First Chief Operating Officer

  Oct 18, 2011 — On October 17, 2011, The Patient-Centered Outcomes Research Institute (PCORI) announced the appointment of Dr. Anne C. Beal, M.D., M.P.H., as its first Chief Operating Officer. She is a pediatrician and public health specialist committed to using research to improve health care delivery.

• FDA, CMS launch pilot program for voluntary parallel review of innovative devices

  Oct 7, 2011 — On Friday, October 7, 2011, The U.S. Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) launched a “parallel review” pilot program for concurrent review of medical devices for FDA approval and Medicare coverage.

• FDA Announces a Public Workshop on MRI Safety

  Sep 22, 2011 — On Tuesday, September 20, 2011, The Food and Drug Administration (FDA) announced a public workshop called: “Magnetic Resonance Imaging (MRI) Safety Public Workshop.”

• MedPAC Releases Proposal on SGR

  Sep 21, 2011 — On September 15th and 16th, MedPAC held its monthly public meeting to discuss its policies and recommendations. The first session was of particular interest to SNM, titled “Moving forward from the Sustainable Growth Rate system.” MedPAC will be recommending the repeal of the Sustainable Growth Rate (SGR) which will result in a 10-year freeze across all services and cost an estimated $300 billion.

• President Barack Obama's deficit plan includes a $1.3 billion cut in adanced imaging services

  Sep 20, 2011 — President Barack Obama’s proposal to cut $3 trillion from the deficit includes changes to Medicare reimbursements for advanced imaging services, which could save the government $1.3 billion over the next 10 years. This proposal also requires mandatory prior authorization for advanced imaging services by 2013.

• Proposed Funding of Nuclear Medicine Research in 2012 Senate Appropriations Bill

  Sep 19, 2011 — The Society of Nuclear Medicine applauds the Senate Appropriations Committee’s recent approval of HR 2354, the Fiscal Year 2012 Energy and Water Development appropriations bill, which proposes an allocation of $12,000,000 to continue nuclear medicine research with human application.

• Update: FDA’s Proposed Generic Drug User Fee Program

  Sep 16, 2011 — On August 25th, the FDA hosted a public meeting to provide an update to ongoing negotiations to establish a generic drug user fee program.

• Bracco Releases CardioGen-82 Customer Update letter

  Sep 14, 2011 — On September 14, 2011, Bracco released a customer letter to provide recent information regarding the voluntary recall of CardioGen-82 (Rubidium Rb 82 Generator).

• CORAR Announces its Next Executive Director

  Sep 12, 2011 — The Council of Radionculides and Radiopharmaceuticals (CORAR) announced the selection of Michael Guastella as its next Executive Director in succession to the retiring Henry H. Kramer, Ph.D., FACNP, the founding Executive Director of CORAR.

• NIH Releases Update to Medical Conflict-of-Interest Disclosure Rule

  Aug 25, 2011 — The revised rule requires researchers receiving more than $5,000 in income from drug or device manufacturers to disclose those payments.

• FDA Issues Draft Guidance for Clinical Trial Imaging Endpoints

  Aug 22, 2011 — The Food and Drug Administration (FDA) has issued a draft Guidance for Industry on “Standards for Clinical Trial Imaging Endpoints.” The purpose of the draft Guidance is to assist sponsors in the use of imaging endpoints in clinical trials of therapeutic drugs and biological products.

• PCORI's Public Feedback Period Closes Soon

  Aug 18, 2011

• New FDA cGMP Guidance for Small Businesses Available

  Aug 5, 2011 — The Food and Drug Administration (FDA) has announced the availability of a guidance for small business entities entitled ‘‘PET Drugs— Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide.’’

• IOM Releases Report Recommending Substantial Changes to FDA's 510(k) Plan

  Aug 4, 2011 — On July 29, 2011, The Institute of Medicine (IOM) released a report recommending substantial changes to the FDA’s 510 (k) approval process for devices. Devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the 510(k) process, named for Section 510(k) of the FFDCA.

• Second ACO Accelerated Learning Session Now Open for Registration

  Aug 4, 2011 — The second ACO Accelerated Development Learning Session on September 15-16 in San Francisco, CA is now open for registration.

• NRC Directs Staff to Evaluate the Feasibility and Need for a Study to Determine Radiation Doses to Members of the Public

  Aug 4, 2011

• Bracco Diagnostics, Inc. Recalls CardioGen-82

  Aug 4, 2011

• CMS Issues Final Rule for Medicare Payment Policies

  Aug 4, 2011 — On August 1, 2011, The Centers for Medicare & Medicaid Services (CMS) issued a final rule for fiscal year (FY) 2012 that will update Medicare Payment policies and rates. This rule, will affect Medicare payments to general acute care hospitals and long-term care hospitals for inpatient stays, supports efforts to promote ongoing hospital care improvements that will lead to better patient care while addressing long-term health care cost growth.

• PCORI Seeks Public Feedback on Topics for "Tier 1" Pilot Projects

  Aug 3, 2011 — The Patient-Centered Outcomes Research Institute (PCORI) is seeking public feedback on eight initial topics for a series of “Tier 1” pilot projects that will assist PCORI in establishing national priorities for research, support the development of novel methods or the collection of preliminary data that can be used to advance the field of patient-centered outcomes research (PCOR), and inform the development of a future PCORI research agenda.

• FDA Requests 12 Member Nominations to Serve on MIDAC

  Aug 2, 2011 — The Food and Drug Administration (FDA) is requesting 12 member nominations to serve on the Medical Imaging Drugs Advisory Committee in Center for Drug Evaluation and Research

• FDA Announces PDUFA and MDUFA Fee Schedule for FY 2012

  Aug 1, 2011 — The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees (PDUFA) and the fee rates and payment procedures for medical device user fees (MDUFA) for fiscal year (FY) 2012.

• NRC Invites Nominations for the Position of Agreement State Representative

  Jul 28, 2011 — The Nuclear Regulatory Commission (NRC) invites nominations for the Agreement State representative position on NRC’s Advisory Committee on Medical Use of Isotopes (ACMUI).

• FDA alerts public to stop using CardioGen-82 for cardiac positron emission tomography (PET) scans due to potential for increased radiation exposure

  Jul 26, 2011 — On July 26, 2011, The U.S. Food and Drug Administration (FDA) alerted the medical imaging community to stop using CardioGen-82.

• PCORI Asks Public Input on Working Definition of 'Patient-Centered Outcomes Research'

  Jul 20, 2011 — On July 20, 2011, The Patient-Centered Outcomes Research Institute (PCORI) will start the beginning of a process to receive public feedback on the working definition of “patient-centered outcomes research,” which is the main focus of PCORI’s work.

• Debt Ceiling Debate and Potential Medicare Imaging Cuts

  Jul 20, 2011 — As we head into the second half of 2011, Congress continues its negotiations with the White House on deficit reduction legislation and raising the debt ceiling. A current plan being proposed by Congress could include cuts to medical imaging services and Graduate Medical Education (GME).

• NRC Issues Final Safety Culture Policy Statement

  Jun 21, 2011

• PCORI Survey on its Mission, Priorities, and Outreach Strategies

  May 26, 2011 — The Patient-Centered Outcomes Research Institute (PCORI) is an independent organization created to help others make better-informed health decisions. PCORI is currently accepting responses to a set of eight questions about its mission, priorities and outreach activities.

• CMS Announces Accelerated Development Sessions for Accountable Care Organizations

  May 19, 2011

• SNM Wins Five-Year Award for Phantom Program with the U.S. Department of Veteran Affairs

  May 13, 2011

• FDA Issues Guidance for Bioequivalency Data for ANDAs

  May 6, 2011 — The U.S. Food and Drug Administration (FDA) has issued guidance intended to assist applicants who are submitting abbreviated new drug applications (ANDAs) in complying with FDA's requirements for the submission of bioequivalence (BE) data.

• NRC Releases Regulatory Guide for Ensuring Radiation Exposure is ALARA

  May 6, 2011 — The U.S. Nuclear Regulatory Commission (NRC) has released Regulatory Guide 8.18: Information Relevant to Ensuring that Radiation Exposures at Medical Institutions will be As Low As Reasonably Achievable (ALARA).

• SGR Letter to House Energy and Commerce Committee

  May 5, 2011

• Senate Passes Repeal of PPACA Provision Requiring Submission of IRS Form 1099

  Apr 6, 2011 — The Senate passed H.R. 4, the "Comprehensive 1099 Taxpager Protection and Repayment Exchagne Subsidy Overpayments Act of 2011."

• HHS Releases National Strategy for Quality Improvement in Health Care

  Mar 28, 2011 — The National Quality Strategy will promote quality health care that is focused on the needs of patients, families, and communities.

• CMS Listening Session: Development of Additional Imaging Efficiency Measures for Use in the Hospital Outpatient Quality Data Reporting Program

  Mar 22, 2011 — The purpose of the listening session was for CMS to solicit comments from stakeholders regarding the CMS approach to developing imaging efficiency measures for the Hospital Out Patient Quality Data Reporting Program (HOP QDRP).

• FDA Announces Public Meeting Related to PET Drugs

  Mar 21, 2011 — FDA announced that they will hold a public meeting on the topic of how to successfully make application for an NDA and/or ANDA.

• SNM Takes Part in Recent Mo-99 Stakeholders Meeting

  Mar 21, 2011 — The purpose of the meeting was to provide updates on supply challenges for Mo-99 and the current activities underway to ensure a domestic source of radioisotopes.

• SNM Capitol Hill Day 2011

  Mar 21, 2011 — Participants in SNM's Capitol Hill Day will visit Capitol Hill to discuss timely policy issues relevant to the practice of nuclear medicine.

• US Pharmacopeia Seeks Public Comment on General Chapter <823>

  Jan 10, 2011

• Registration for the Medicare Electronic Health Record Bonus Payments Begin January 3, 2011

  Jan 3, 2011

• FDA Issues Guidance for Industry on ANDAs: Impurities in Drug Products

  Dec 16, 2010

• Congress Passes a One-Year Fix to the Sustainable Growth Rate (SGR)

  Dec 13, 2010

• President Obama Approves One-Month Medicare Fix

  Dec 1, 2010

• Physician Payment and Therapy Relief Act of 2010

  Nov 22, 2010 — It has been announced that Medicare payments to physician are scheduled to be reduced by 23 percent as of December 1, 2010. This is a necessary move to avoid a disruption in payments while Congressional leaders continue to seek funding offsets for legislation that will stabilize Medicare physician payments through 2011.

• New Standards Helping Lower Medicare Improper Payment Rates for 2010

  Nov 19, 2010

• Request for Comments on the Use of Electronic Signatures for NRC Documents Related to the Medical Use of Byproduct Material Maintained at Licensees’ Facilities

  Oct 20, 2010

• OECD Nuclear Energy Agency Releases Report: The Supply of Medical Radioisotopes: Interim Report of the OECD/NEA High-level Group on Security of Supply of Medical Radioisotopes

  Sep 27, 2010

• NRC Issues Notice of Public Meeting and Request for Comments on Radiation Protection Regulations and Guidance

  Sep 27, 2010

• GAO Announces Appointments to PCORI Board of Governors

  Sep 23, 2010

• NRC Issues Regulatory Issue Summary: Radiation Safety Officers for Medical-Use Licenses Under 10 CFR Part 35

  Sep 23, 2010

• Trailblazer Updates Systems and Further Clarifies Radiopharmaceutical Guidance

  Sep 21, 2010

• ACMUI Issues Call for Nominations for Patients' Rights Advocate Position

  Sep 21, 2010

• NRC Issues Revised Draft Safety Culture Policy Statement

  Sep 21, 2010

• CMS and FDA Issue Request for Comments on the Parallel Review of Medical Products

  Sep 17, 2010

• FTC, CMS and OIG Announce Public Workshop Regarding Accountable Care Organizations and Implications Regarding Antitrust, Physician Self-Referral, Anti-Kickback and Civil Monetary Penalty Laws

  Sep 17, 2010

• SNM Submits Comments on Proposed Hospital Outpatient Prospective Payment Rules for CY 2011

  Sep 1, 2010

• NRC Announces New Members of the ACMUI

  Aug 30, 2010

• SNM Submits Comments on Proposed Medicare Physician Fee Schedule Rules for CY 2011

  Aug 26, 2010

• Pharmalucence, Inc. Issues Urgent Drug Recalls

  Aug 24, 2010

• NRC Announces Public Meeting to Discuss the Development of Safety Culture Policy Statement

  Aug 24, 2010

• NRC Submits Inter-Agency Task Force Report on Radiation Source Protection and Security

  Aug 20, 2010

• CMS Announces Five New Members to the Advisory Panel on Ambulatory Payment Classification Groups

  Aug 20, 2010

• SNM and SNMTS Ask Members to Contact Senators to Urge them to Cosponsor the Consistency, Accuracy, Responsibility and Excellence (CARE) in Medical Imaging and Radiation Therapy Act of 2009

  Aug 20, 2010

• AECL Reports NRU is Operational

  Aug 18, 2010

• NRC Announces Meetings Regarding Implementation Guidance for Physical Protection of Byproduct Material

  Aug 9, 2010

• CMS Issues Decision Memo for PET for Initial Treatment Strategy in Solid Tumors and Myeloma (CAG-00181R3)

  Aug 5, 2010

• FDA Issues Preliminary Report and Recommendations on the Utilization of Science in Regulatory Decision Making

  Aug 5, 2010

• CMS Issues Final Rule: Medicare and Medicaid Programs; Electronic Health Record Incentive Program

  Jul 28, 2010

• HHS Issues Final Rule: Health Information Technology: Initial Set of Standards, Implementation Specifications and Certification Criteria for HER Technology

  Jul 28, 2010

• NRC Issues Final Rule: Export and Import of Nuclear Equipment and Material; Updates and Clarifications

  Jul 28, 2010

• SNM Sends Letter to Members of the House Energy and Commerce Subcommittee on Health

  Feb 26, 2010

• Further Update on CMS Final Payment Rules

  Dec 28, 2009

• NRC Call for Nominations for ACMUI Nuclear Pharmacist Position

  Mar 30, 2007 — The U.S. Nuclear Regulatory Commission is advertising for nominations for the position of nuclear pharmacist on the Advisory Committee on the Medical Uses of Isotopes. Nominations are due on or before May 29, 2007.

• NRC Releases RIS Addressing Status of NARM Rulemaking

  Mar 29, 2007 — The U.S. Nuclear Regulatory Commission issued a Regulatory Issue Summary to inform the public of the status and plans for the implementation of the future final rule on naturally occurring and accelerator produced radioactive material.

• Mallinckrodt Tc-99m Generators Return to Market

  Mar 29, 2007 — Mallinckrodt announced the return to full production and shipping of their Ultra-Technekow DTE® (technetium Tc-99m generator) on Monday, April 2, for use on Tuesday, April 3.

• BMS Medical Imaging Update Regarding Tc-99m Generator Supply

  Mar 28, 2007 — BMS Medical Imaging released a letter to customers regarding the progress of its efforts to meet demand in North America three weeks after Mallinckrodt's voluntary recall of its Ultra-TechneKow® DTE Generator (Technetium Tc99m Generator).

• 2007 RT in DC Hill Event Held to Support CARE Legislation

  Mar 23, 2007 — ASRT held their annual "R.T. in D.C." event on March 18-20, 2007, in Washington, D.C., to support the CARE legislation. Several SNMTS leaders attended the meeting, including members of the SNMTS Advocacy Committee and Scope of Practice Task Force.

• Notice Regarding the Revised Form CMS-1500

  Mar 15, 2007 — It has recently come to CMS' attention that there are incorrectly formatted versions of the revised CMS-1500 (08-05) form being sold by print vendors, specifically the Government Printing Office (GPO).

• MDS Nordion Scales Up Molybdenum-99 Production

  Mar 13, 2007 — MDS Nordion has taken immediate action to scale up Molybdenum-99 (Mo-99) production in response to Mallinckrodt’s recently announced voluntary recall of Ultra-TechneKow® DTE Generators.

• BMS Medical Imaging Update Regarding Mallinckrodt's Voluntary Recall of Ultra-TechneKow® DTE Generator (Technetium Tc99m Generator)

  Mar 7, 2007 — Bristol-Myers Squibb (BMS) Medical Imaging released a letter to customers updating the community on actions they are taking to meet demand in North America in the wake of Mallinckrodt's recent voluntary recall of its Ultra-TechneKow® DTE Generator (Technetium Tc99m Generator) manufactured on or after February 23, 2007.

• SNM Coding Corner Now Available to the Public

  Jan 2, 2007 — Thanks to a grant provided by Bracco Diagnostics, Inc., the SNM is pleased to announce that access to the Coding Corner will now be available free of charge.

• Medicare Physician Payment Cut Halted, DRA Imaging Cuts Stick

  Dec 15, 2006 — In the early hours of December 8th, Congress passed the Tax Relief and Health Care Act of 2006. Included in the bill are several Medicare provisions, one of which prevents the 5% cut in 2007 Medicare physician payment rates due to the sustainable growth rate (SGR) by freezing the Medicare conversion factor at its 2006 level.

• SNMTS Advocacy Committee Chair Update: CARE Legislation in the 109th Congress

  Dec 13, 2006 — The House adjourned around 4:00 a.m. on Saturday, December 9, without taking action on the Consumer Assurance of Radiologic Excellence Bill. However, we are confident the legislation is well positioned for the 110th Congress...

• Senate Passes RadCARE

  Dec 7, 2006 — On December 6, 2006, the Senate unanimously passed S.2322, also known as the RadCARE bill. The bill had already passed the Senate Health, Education, Labor and Pensions Committee earlier this year to proceed to the full Senate vote.

• NRC ACMUI: Call for Nominations

  Nov 27, 2006 — The NRC is advertising for nominations for the position of radiation therapy medical physicist on the Advisory Committee on the Medical Uses of Isotopes.

• DRAXIS Radiopharmaceutical Unit Approved to Run 2 Clinical Trials to Treat Neuroblastoma

  Nov 22, 2006 — Targeted radiation therapy with DRAXIMAGE I-131 MIBG to be included in Phase I and Phase II trials coordinated with 13-member consortium of U.S. universities and hospitals...

• FDA PDMA Pedigree Requirements: Compliance Policy Guide and Q&A Documents

  Nov 15, 2006 — The recently announced CPG and Q&A guidance documents explain FDA's current thinking on issues related to the pedigree requirements of the Prescription Drug Marketing Act.

• FDA Press Release: FDA Announces Actions to Strengthen its Postmarket Program for Medical Devices

  Nov 10, 2006 — In a November 9 press release, the U.S. Food and Drug Administration announced its plan for modifying the way it monitors the safety of medical devices after they reach the marketplace.

• NRC Final Rule on National Source Tracking of Sealed Sources

  Nov 9, 2006 — The NRC is amending its regulations to implement a National Source Tracking System for certain sealed sources (specifically, Category 1 and 2 sources for the purposes of this final rule).

• NRC Requests Public Comments Regarding the AAPM Petition for Rulemaking (Docket No. PRM-35-20)

  Nov 3, 2006 — The petitioner requests that 10 CFR 35.57, "Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist" be revised to recognize medical physicists certified by either the American Board of Radiology (ABR) or the American Board of Medical Physics (ABMP) on or before October 24, 2005, as "grandfathered for the modalities that they practiced as of October 24, 2005."

• CMS Announces Changes to Policies and Payment for Hospital Outpatient Services (HOPPS)

  Nov 2, 2006 — On November 1, 2006, the Centers for Medicare & Medicaid Services (CMS) issued a final rule for Medicare payment for hospital outpatient services in calendar year (CY) 2007.

• New, Revised and Deleted Nuclear Medicine CPT® Codes Effective January 1, 2007

  Oct 25, 2006 — The 2007 CPT Code books are now available. The American Medical Association has released the new 2007 CPT Code Books that include new, revised, and deleted Nuclear Medicine Codes. Changes proposed by the Society of Nuclear Medicine have been made to clarify existing codes to accurately reflect current diagnostic practices as well as to delete codes that are obsolete and are no longer performed according to current practice standards.

• SNM Comments to CMS RE: 2007 Proposed MPFS Rule

  Oct 10, 2006 — On October 9, 2006, the SNM sent comments to the Centers for Medicare & Medicaid Services (CMS) regarding the Medicare Physician Fee Schedule (MPFS) proposed rule for calendar year (CY) 2007.

• NRC RIS-06-018: Requesting Exemption from the Public Dose Limits for Certain Caregivers of Hospital Patients

  Sep 29, 2006 — The NRC recently released Regulatory Issue Summary 2006-18, which provides guidance to licensees on the means they may use to obtain an exemption, on a situational basis, from the dose limits in 10 CFR 20.1301 for "caregivers" (family, friends, etc.) of patients.

• SNM Comments to CMS RE: 2007 Proposed HOPPS Rule

  Sep 21, 2006 — On September 19, 2006, the SNM sent comments to the Centers for Medicare & Medicaid Services (CMS) regarding the hospital outpatient prospective payment system (OPPS) proposed rule for calendar year (CY) 2007.

• Senate HELP Committee Approves RadCARE Bill

  Sep 20, 2006 — The Senate Health Education, Labor and Pensions (HELP) Committee, under the leadership of Chairman Mike Enzi (R-WY), voted unanimously to approve S. 2322, the Consumer Assurance of Radiologic Excellence (RadCARE) bill.  The bill now moves to the full Senate where it hopefully will be considered before Congress adjourns later this year.

• Empire Fixes NOPR Claims Denials Issues

  Sep 12, 2006 — Empire Medicare Service officials notified the SNM that effective September 1, 2006, the system issue for use of the QR modifier on the NOPR claims has been resolved.

• SNM, ACR, and ASNC Submit Comments to the NRC on Proposed NARM Rulemaking

  Sep 12, 2006 — The Society of Nuclear Medicine, American College of Radiology, and American Society of Nuclear Cardiology submitted public comments in response to the proposed U.S. Nuclear Regulatory Commission rulemaking on naturally occurring and accelerator produced radioactive material.

• NRC Proposed Rulemaking on Accelerator Products

  Aug 29, 2006 — The SNM Public Affairs Department asks SNM members working with accelerators and/or accelerator products (such as PET drugs) to review the proposed NRC NARM rulemaking...

• NRC Advisory Committee on the Medical Uses of Isotopes: Call for Nominations

  Aug 16, 2006 — The U.S. Nuclear Regulatory Commission is advertising for nominations for the position of patient advocate on the Advisory Committee on the Medical Uses of Isotopes.

• SNM Comments on Proposed Revisions of USP General Chapter <797>

  Aug 15, 2006 — On August 15, 2006, the Society of Nuclear Medicine (SNM) submitted comments to the U.S. Pharmacopeia (USP) regarding the proposed revisions of USP General Chapter <797> Pharmaceutical Compounding - Sterile Preparations.

• New York Establishes Licensure for Nuclear Medicine Technologists

  Aug 14, 2006 — New York state bill #A4882-B—an act to amend the public health law, in relation to the practice of radiologic technology and to repeal article 35 of such law relating to the practice of x-ray technology—was signed into law on July 26, 2006, by Governor George E. Pataki.

• CMS Issues 2007 Proposed Medicare Physician Fee Schedule (MPFS) Rule

  Aug 11, 2006 — On August 8, 2006, the Centers for Medicare and Medicaid Services (CMS) issued the proposed rule for the Medicare Physician Fee Schedule (MPFS) for calendar year (CY) 2007.

• CMS Issues 2007 Proposed Hospital Outpatient Prospective Payment System (HOPPS) Rule

  Aug 11, 2006 — On August 8, 2006, the Centers for Medicare & Medicaid Services (CMS) posted an advanced notice of the hospital outpatient prospective payment system (OPPS) proposed rule for calendar year (CY) 2007.

• NORIDIAN FIXES NOPR CLAIMS DENIALS (QR modifier) ISSUE; Empire Fix Still Pending

  Aug 11, 2006 — Attention NOPR participants billing the CMS Noridian and Empire Contractors: Today, Noridian staff notified the SNM that effective August 11, 2006, the system issue for use of the QR modifier on the NOPR claims has been resolved.

• FDA Unique Device Identification; Request for Comments

  Aug 11, 2006 — The Food and Drug Administration is requesting comments to help the agency understand how the use of a unique device identification (UDI) system may improve patient safety, e.g., by reducing medical errors, facilitating device recalls, and improving medical device adverse event reporting.

• NRC Names Directors for New Reactors, National Materials Offices

  Aug 3, 2006 — Charles Miller will become Director of the new Office of National Materials Program, combining the Office of State and Tribal Programs (STP) with elements of the current Office of Nuclear Material Safety and Safeguards (NMSS) dealing with materials licensing, rulemaking and decommissioning...

• Requirements for Expanded Definition of Byproduct Material; Meeting

  Aug 3, 2006 — NRC released additional information about the upcoming public meeting on the proposed NARM rulemaking.

• NRC Seeks Public Comment on Proposed Rule Reflecting Expanded Authority Over Other Radioactive Material

  Jul 26, 2006 — The Nuclear Regulatory Commission is seeking public comments on a proposed rule to incorporate newly added radioactive byproduct material into its regulatory framework as mandated by the Energy Policy Act of 2005. The Act expands the definition of byproduct material, thereby placing additional radioactive material under NRC's jurisdiction.

• Commissioner Peter B. Lyons Takes Oath of Office at NRC

  Jul 14, 2006 — Peter B. Lyons was sworn in on June 28 as a Commissioner of the U.S. Nuclear Regulatory Commission by Chairman Nils J. Diaz at the NRC headquarters in Rockville, Maryland...

• Dr. Dale Klein Sworn In As NRC Chairman

  Jul 7, 2006 — Dr. Dale E. Klein, designated by President Bush as chairman of the Nuclear Regulatory Commission (NRC), was sworn in Saturday in a private ceremony at the NRC headquarters in Rockville, Maryland...

• CMS Provides Clarification for Hospitals on How to Correctly Bill for Drugs and Units Charged

  Jun 30, 2006 — Hospitals and providers are reminded to ensure that units of drugs administered to patients are accurately reported in terms of the dosage specified in the full HCPCS code descriptor. That is, units should be reported in multiples of the units included in the HCPCS descriptor.

• CMS Announces Proposed Changes to Physician Fee Schedule Methodology and Results of Five Year Review

  Jun 27, 2006 — On June 21, the Centers for Medicare & Medicaid Services (CMS) issued a notice proposing changes to the Medicare Physician Fee Schedule (MPFS) that CMS states, "will improve the accuracy of payments to physicians for the services they furnish to Medicare beneficiaries."

• First Look at Potential NRC Regulations on Accelerator/Cyclotron Products

  Apr 12, 2006 — The Commission Paper (SECY-06-0069, Proposed Rule: Requirements for Expanded Definition of Byproduct Material (RIN: 3150-AH84)) and the associated enclosures, including the draft proposed rule package, are being made publicly available to provide additional time for stakeholders' review before the public comment period begins.

• NRC ACMUI to Meet in April

  Apr 12, 2006 — The U.S. Nuclear Regulatory Commission will convene a meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on April 25 and 26, 2006. A sample of agenda items to be discussed during the public sessions includes...

• AHRQ Quality Indicators Workgroup on Inpatient and Patient Safety Composite Measures

  Apr 4, 2006 — The Agency for Healthcare Research and Quality is seeking nominations for members of an AHRQ-convened Quality Indicators Workgroup on Composite Measures for the Inpatient Quality Indicators and the Patient Safety Indicators as part of a general workgroup on composite measures.

• FDA/NCI/CMS Oncology Biomarker Qualification Initiative

  Mar 20, 2006 — The March 20, 2006 Federal Register announced an agreement between the FDA, NCI, and the CMS to develop strategic plans, set priorities, and leverage resources and expertise from multiple sources, including the private sector, toward the goal of improving the clinical utility of biomarker technologies as diagnostic and assessment tools that facilitate the development of safer and more effective cancer therapies.

• FDA Unveils Critical Path Opportunities List Outlining Blueprint To Modernizing Medical Product Development by 2010

  Mar 20, 2006 — Health and Human Services (HHS) Secretary Mike Leavitt and HHS' Food and Drug Administration (FDA) today released an initial list of priority research projects that could advance innovation in medical products. The announcement of the Critical Path Opportunities List signals the next major step in FDA's Critical Path Initiative, aimed at modernizing medical product development, so new medical discoveries are brought to patients faster and at a lower cost.

• SNM President Prompts Disclosure of DOE/NIH Study of Nuclear Medicine Research

  Mar 1, 2006 — Details of a $743,000 Department of Energy/National Institutes of Health study to determine the importance of nuclear medicine research came to light during an educational briefing called to examine "The Future of Medical Imaging: Transforming Health Care."

• Senate RadCARE Bill Would Improve Quality of Patient Care, Says SNMTS

  Feb 27, 2006 — The Senate version of the Consumer Assurance of Radiologic Excellence (known as RadCARE, S2322), provides for national education and credentialing standards for nuclear medicine technologists, radiologic technologists and radiation therapists and will improve the quality of patient care.

• RadCARE Bill Introduced In The Senate

  Feb 23, 2006 — The Society of Nuclear Medicine Technologist Section is pleased to announce that the RadCARE Bill was reintroduced in the Senate on February 17, 2006 by Senator Mike Enzi, Republican from Wyoming and Senator Ted Kennedy, Democrat from Massachusetts.

• SNM Opposes New Payment Caps on Imaging Services Detailed in Federal Deficit Reduction Act

  Feb 7, 2006 — SNM opposes a provision of the federal Deficit Reduction Act that impacts its members: payment caps to physicians' offices with imaging equipment that are set to begin in 2007.

• Hospital Radiopharmaceutical Reimbursement Changes

  Feb 2, 2006 — Nuclear Medicine Departments had a lot to do to ready their charge description masters for CY 2006.

• Public Invited to Comment on Reducing Burden of Federal Regulations Governing Health Care Industry

  Jan 18, 2006 — An HHS/OMB project is underway to identify immediate steps and longer-term proposals for reducing the regulatory burden and improving the translation of biomedical research into medical practice, while maintaining the highest quality health care and other patient protections . . .

• SNM Submits Comments to FDA on PET Drugs CGMP Draft Rule and Guidance

  Dec 20, 2005 — The Society of Nuclear Medicine (SNM) commented on the draft rule and guidance for current good manufacturing practice (CGMP) for positron emission tomography (PET) drugs (21 CFR Part 212).

• BMS Medical Imaging to Continue to Meet Technetium Needs

  Dec 15, 2005 — In the wake of recent developments, BMS Medical Imaging released a letter to customers stating they do not anticipate any appreciable difficulties in meeting overall technetium Tc99m generator demand in North America for as long as required...

• DOE Off-Site Source Recovery Project

  Dec 12, 2005 — The Department of Energy sponsors a program to recover excess and unwanted radioactive sealed sources presenting disposal difficulties with reduced or no costs to the licensees...

• George Sgouros, PhD, Johns Hopkins University School of Medicine, Speaks on Behalf of SNM at DOE BERAC Meeting—DOE, NIH, and NAS to Compile Report on NM Research Future

  Dec 6, 2005 — Representing the Society of Nuclear Medicine (SNM), George Sgouros, PhD, a researcher at Johns Hopkins University School of Medicine, spoke to the Department of Energy (DOE) Office of Biological and Environmental Research Advisory Committee (BERAC) at the December 5 public meeting regarding the budget cuts to basic nuclear medicine research within the Medical Applications and Measurement Science Program.

• FDA Final Rule: Amended Export Requirements for Unapproved New Drug Products

  Nov 23, 2005 — The Food and Drug Administration (FDA) is amending its regulations on the exportation of investigational new drugs, including biological products. The final rule describes four different mechanisms for exporting an investigational new drug product...

• Senate Approves Energy & Water FY '06 Appropriations; NM Research Loses Out

  Nov 16, 2005 — The Senate completed action and adopted the Conference Report on the fiscal year (FY) 2006 Energy and Water Appropriations Bill. This completes Congressional action on the bill and it will now be sent to President George W. Bush for his expected signature.

• Medicare Participation Options for Physicians

  Nov 14, 2005 — Physicians who wish to change their current participation or non-participation status may do so between November 15 and December 31. To respond to inquiries and help ensure physicians are making informed decisions about their contractual relationships with the Medicare program, the AMA has developed the following brief overview of the participation options for physicians...

• NRC to Hold Public Meeting on Rulemaking Concerning New Authority Over NARM

  Nov 1, 2005 — The Nuclear Regulatory Commission will hold a roundtable discussion open to the public Nov. 9 at agency headquarters in Rockville, Md., to seek input on a new rulemaking to extend NRC's regulatory authority over accelerator-produced radioactive material and certain discrete sources of naturally occurring radioactive material.

• CMS Releases 2006 HCPCS Level II Annual Update

  Oct 28, 2005 — On October 27, the Centers for Medicare and Medicaid Services (CMS) released the 2006 Healthcare Common Procedure Coding System (HCPCS) Level II code set. This file contains over 60 changes for nuclear medicine radiopharmaceuticals and drugs, which will become effective January 1, 2006.

• Nuclear Medicine APC Task Force and SNM Comment on Proposed CY 2006 HOPPS Payment Rates

  Sep 21, 2005 — On September 15, the Society of Nuclear Medicine and the Nuclear Medicine APC Task Force submitted comments to Mark McCellan, MD, PhD, administrator of the Centers for Medicare & Medicaid Services, on the proposed changes to the Hospital Outpatient Prospective Payment System.

• NRC, States to Coordinate Increased Controls over Radioactive Materials

  Sep 7, 2005 — The Nuclear Regulatory Commission and the 33 Agreement States are coordinating efforts to increase the control of radioactive materials, according to an NRC press release.

• Time-Limited Waiver Issued for ARM in Radiopharmaceuticals

  Sep 1, 2005 — NRC ensures the continued safe medical use of accelerator-produced radioactive material (ARM) in radiopharmaceuticals while new regulations are being written, per the Energy Policy Act of 2005.

• FDA Federal Register Announcement Requests Nominations for Voting Members on Public Advisory Panel

  Aug 24, 2005 — The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Radiological Devices Panel of the Medical Devices Advisory Committee. There will be two openings for this panel starting on February 1, 2006.

• CARE Bill Update - August Recess

  Aug 10, 2005 — The Alliance for Quality Medical Imaging and Radiation Therapy announced the 91st cosponsor has just signed onto the Consumer Assurance of Radiologic Excellence bill. We need to continue advocating on behalf of this initiative. Now is an ideal time to meet with your Representative at her/his district office . . .

• Proposed CMS Physicians Fee Schedule Includes 4.3% Payment Reduction and Prohibition on Self-referral for Nuclear Medicine Services

  Aug 10, 2005 — The proposed physicians fee schedule for 2006 released August 1 by CMS includes a provision that would reduce payment rates for physicians fees by 4.3% and add diagnostic and therapeutic nuclear medicine services to the list of health services for which physicians are prohibited from self-referring their patients.

• Conference Report on the Energy Policy Act

  Aug 3, 2005 — The Energy & Natural Resources Conference Committee released their report dealing with the Energy Policy Act. Items of interest within the report include....

• NRC Seeking Comments Regarding Amendments to Regulations Dealing With National Source Tracking

  Jul 28, 2005 — The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations to implement a National Source Tracking System for certain sealed sources and is seeking comments...

• Medicare Proposes Payment Rates and Policy Changes for Hospital Outpatient Services

  Jul 19, 2005 — Acute care hospitals will receive a 3.2 percent inflation update in Medicare payment rates in 2006 for outpatient services under a proposed Outpatient Prospective Payment System (OPPS) rule announced by the Centers for Medicare & Medicaid Services (CMS).

• NRC Press Release Announces the Approval of Expedited Procedures for Permitting Higher Dose Limits for Patient Caregivers

  Jul 13, 2005 — The Nuclear Regulatory Commission has approved new procedures for permitting visitors to patients receiving nuclear medicine or brachytherapy to receive radiation doses above current regulatory limits if warranted by the patient’s needs.

• SNM Comments on Radiopharmaceuticals at HCPCS Open Meeting

  Jun 21, 2005 — SNM presented comments on drugs, radiopharmaceuticals, biologicals and radiologic imaging agents at the HCPCS working group open meeting, June 14, 2005. An Acrobat file of the presentation is available in the Related Items box below.

• House Accepts Subcommittee Budget Recommendation to Include $35 Million for Nuclear Medicine Research

  May 26, 2005 — The full House of Representatives voted Tuesday, May 24, to accept an Energy & Water Development Appropriations Subcommittee budget recommendation that includes $35 million for the Department of Energy’s Medical Applications and Measurement Science Program.

• SNM Reacts Positively to House Energy & Water Development Appropriations Subcommittee Recommendation that $35 Million Be Included for DOE’s Medical Applications and Measurement Science Program

  May 19, 2005 — The House Appropriations Committee met May 18 to determine funding for the various programs within the Department of Energy (DOE), including the Medical Applications and Measurement Science Program.

• CMS Releases Coding & Coverage Instructions for PET Services April 1, 2005Effective Dates Retroactive to January 28th, PET Claims Paid No Later than April 18th

  Apr 25, 2005 — The Centers for Medicare and Medicaid Services (CMS) released change request 3741 on April 1, 2005 detailing coding changes and long awaited expanded coverage clarifications for PET imaging services. During emergency meetings within various departments, CMS officials decided to uphold the decision to discontinue the use of many of the G PET codes and implement the American Medical Association (AMA), Current Procedural Terminology (CPT) PET codes for all covered PET imaging procedures.

• SNM to Comment on FDA Draft Guidance Regarding Exploratory IND Studies

  Apr 15, 2005 — SNM is developing comments regarding FDA's recent draft guidance document, "Guidance for Industry, Investigators and Reviewers: Exploratory IND Studies."

• Radioimmunotherapy Cited Before Senate Subcommittee as Example of Promising New Cancer Treatment, Reason for Continued NCI Support

  Apr 12, 2005 — In a recent appearance before a Senate appropriations subcommittee, NCI Director Andrew von Eschenbach, MD, cited development of an anti-CD20 radioimmunotherapeutic agent as one of the successes in the NCI’s war on cancer.

• CARE Bill Reintroduced in the House

  Apr 7, 2005 — The Society of Nuclear Medicine Technologist Section is pleased to announce that the Consumer Assurance of Radiologic Excellence (CARE) bill was re-introduced in the U.S. House of Representatives on Thursday, March 17, by Representative Charles "Chip" Pickering, Jr., (R-MS 3rd).

• Coding UPDATE: PET Providers Should Hold Claims Beginning April 4, 2005

  Apr 4, 2005 — The SNM was contacted by a Medicare & Medicaid Services (CMS) official requesting our assistance in communicating this important coding and payment information to both hospital and nonhospital PET providers.

• NIH Announces New Policy Increasing Public Access to Research Publications

  Feb 3, 2005 — The National Institutes of Health (NIH) announced today a new policy designed to accelerate the public's access to published articles resulting from NIH-funded research. The policy urges—but does not require—scientists to provide manuscripts resulting from such research to NIH as soon as possible after completion of the peer review process, and within 12 months of final publication.

• Molecular/Nuclear Imaging by Qualified Providers Benefits Patients, Outweighs Potential Risks

  Feb 3, 2005 — The recent addition of gamma-radiation and X-rays to the list of “known human carcinogens” by the Department of Health and Human Services’ National Toxicology Program (NTP) should have little impact on the use of molecular/nuclear medicine. SNM advises that the benefits patients receive from appropriately indicated, appropriately performed diagnostic imaging greatly outweigh potential risks stemming from the radiation exposure.
  Click here to read the full press release

• Medicare Expands Coverage of PET Scans For AD and FTD

  Jan 23, 2005 — CMS announced today it has expanded Medicare coverage of PET to include some beneficiaries who meet the diagnostic criteria for Alzheimer's disease or fronto-temporal dementia and to include other beneficiaries at risk for Alzheimer's disease who are enrolled in a large and easily accessible clinical trial.

• New NIH Grants Listed; Faster Processing for Bioengineering Research Partnership Applications Announced

  Jan 20, 2005 — The Cancer Imaging Program has listed a number of NIH awards and grants of interest to the nuclear medicine community in their latest newsletter and has announced that the Bioengineering Research Partnerships program is adding an additional application receipt date in order to provide more timely responses to applications.

• Cancer Imaging Program/NIH Funding Initiatives

  Dec 9, 2004 — The Cancer Imaging Program has compiled a list of new National Institutes of Health funding initiatives in novel cancer therapies, nanotechnology, biomedical computing, and other areas ...

• SNM and ACNP Leadership Present Information on Radioactive Drugs at FDA Meeting

  Nov 18, 2004 — SNM and ACNP leadership contributed six presentations to the “Radioactive Drugs for Certain Research Uses” meeting of the FDA’s Radioactive Drug Research Committee (RDRC) on November 16 in Rockville, MD.

• Medicare Announces Increases in Final Physician Payment Rule for 2005

  Nov 10, 2004 — CMS issued Medicare’s final rule for physician payment for 2005, with new benefits and higher payments for preventive services including a 'Welcome to Medicare Physical' and increased payment rates to physicians.

• Final 2005 HOPPS Rule Posted on CMS Web Site

  Nov 8, 2004 — CMS has posted the final changes to the hospital outpatient prospective payment system on their website. The new rules can be viewed by clicking the link above. A permanent link to these rules will be kept in the SNM Practice Managment area.

• Coding Changes Will Help Beneficiaries And Speed Use of Technology

  Nov 1, 2004 — Improvements by Medicare for revising the process it uses to update the code sets that make it possible to pay for certain health care items and services will help get new technologies to patients more quickly, the Centers for Medicare & Medicaid Services (CMS) announced.

• Information Alert: GAO Study on Acquisition Cost of Radiopharmaceuticals

  Oct 10, 2004 — Update—the GAO has notified the NM APC TF that a final data collection tool to collect drug and radiopharmaceutical cost information was sent to a wide sample of hospitals...

• NM APC TF Comments Sent to CMS Today Regarding Proposed 2005 HOPPS

  Oct 7, 2004 — The Nuclear Medicine APC Task Force (NMTF) has submitted comments and recommendations to assist the Centers for Medicare and Medicaid Services (CMS) in refining the proposed changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2005 Payment Rates.

• SNM Letter to CMS Regarding Proposed Revisions to the Payment Policy under the 2005 Physician Fee Schedule

  Sep 24, 2004 — SNM comments on the August 5, 2004, (69 Fed. Reg. 47487) proposed rule on revisions to payment policies under the 2005 physician fee schedule of the Medicare Program.

• Summary of Coverage Criteria/Guidelines for AD and FTD PET Studies Effective September 15, 2004

  Sep 16, 2004 — Following is a summary of the coverage criteria/guidelines posted by CMS in their 'Decision Memorandum for Positron Emission Tomography (FDG) and Other Neuroimaging Devices for Suspected Dementia...'

• New PET G HCPCS Codes- PENDING

  Sep 7, 2004 — You may have seen some new PET codes in recent Transmittals (278 and 255) and in publications such as Part B news, however, these codes are 'place holder codes' for the contractors, there currently are no published coverage decisions on these PET G HCPCS codes and the indications.

• CMS Proposed Payment Rates for Hospital Outpatient Services will Increase Payments for Preventive Services and Brachytherapy

  Sep 1, 2004 — Medicare beneficiaries will have greater access to preventive benefits and lower copayments for hospital outpatient services, while hospitals will see a 3.3 percent inflation update in payment rates for outpatient services under a proposed rule announced today by the Centers for Medicare and Medicaid Services.

• Proposed Physician Fee Schedule for 2005 Now Available

  Sep 1, 2004 — The CMS Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2005 (CMS-1429-P) went on display at the Office of the Federal Register on July 27, 2004, and will be published in the Federal Register on August 5, 2004.

• NCI Soliciting Contract Proposals from Small Companies Producing Radioactive Materials

  Aug 31, 2004 — The National Cancer Institute is now soliciting SBIR program contract proposals. Companies can apply for funds to design targetry to produce and separate novel radionuclides and to create radiochemicals with automated synthesis modules. Contract proposals are due November 5...

• FDA Approves Drugs to Treat Internal Contamination from Radioactive Elements

  Aug 31, 2004 — The Food and Drug Administration (FDA) today announced the approval of two drugs, pentetate calcium trisodium injection (Ca-DTPA) and pentetate zinc trisodium injection (Zn-DTPA) for treating certain kinds of radiation contamination. The...

• Federal Register Announced Dates for the APC Panel Meeting

  Aug 16, 2004 — The Federal Register announced the second biannual meeting of the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel) for 2004.

• Final Inpatient PPS Rule Increases Access to High Quality Hospital Care Through Financial Relief to Hospitals

  Aug 5, 2004 — The Centers for Medicare and Medicaid Services (CMS) issued the FY 2005 hospital inpatient prospective payment system (PPS) regulation, which provides for greater access to high-quality care in USA hospitals.

• NCI to Solicit Contract Proposals from Small Companies Producing Radioactive Materials

  Jul 26, 2004 — The National Cancer Institute (NCI) will announce solicitation for the 2004 SBIR contract proposals in August 2004. Companies can apply for funds to design targetry to produce novel radionuclides and separate them and to create radiochemicals with automated synthesis modules.

• Medicare Proposes Expanded Coverage and New Studies of FDG-PET for the Diagnosis Alzheimer's Disease

  Jul 17, 2004 — The Centers for Medicare and Medicaid Services (CMS) announced today that it intends to expand Medicare coverage of positron emission tomography (PET) to include some Medicare beneficiaries with suspected Alzheimer’s disease.

• SNM Comments to CMS on Proposed Expanded Coverage

  Jul 17, 2004 — The SNM has sent comments to the Centers for Medicare & Medicaid Services (CMS) urging CMS not to create separate G series HCPCS codes for expanded PET coverage for Alzheimer’s disease and other suspected dementia. This is administratively burdensome for providers, creating cumbersome charge description masters based on a variety of payers.

• Positron Emission Tomography (FDG) and Other Neuroimaging Devices for Suspected Dementia

  Jun 1, 2004 — CMS updated the NCA Tracking Sheet to post technology assessment and expert panel meeting summary and transcript.

• CMS Corrects Two Coding Errors

  Jun 1, 2004 — In response to communications from the SNM, CMS is correcting two errors related to new CPT code 78804, Radiopharmaceutical localization of tumor or distribution of radiopharmaceuticals agent(s) whole body, requiring two or more days imaging.

• Senators Request PET Expansion Under Medicare

  May 5, 2004 — A letter signed by 37 members of the U.S. Senate was sent last week to Health and Human Services Department Secretary Tommy Thompson urging the department to make PET available to Medicare beneficiaries for diagnosis of seven additional cancers.

• CARE ACT Support Tops 100 in House, Two More Senators Added

  Apr 29, 2004 — Support for the Consumers Assurance of Radiologic Excellence (CARE) bill continues to grow with 21 co-sponsors added to the House total and two to the Senate total since March 10.

• HIPAA Transaction Extension (Compliance Plan)

  Apr 19, 2004

• Kansas Enacts Technologist Licensure Act

  Apr 16, 2004 — In another state legislative victory for nuclear medicine technologists licensure, the Kansas legislature has passed and Governor Kathleen Sebelius has signed legislation requiring the licensing of radiographers, radiation therapists and nuclear medicine technologists.

• Privacy Rule Update - Changes Proposed

  Apr 16, 2004

• FY2005 SNM Appropriations Testimony

  Apr 14, 2004 — Written testimony submitted to the House and Senate Labor-Health and Human Services Appropriations Subcommittees and the Energy and Water Appropriations Subcommittees.

• AMA Offers Information on New Medicare Law

  Apr 9, 2004 — The AMA has developed a document, titled What the New Medicare Law Means to You to help educate physicians on the many features of the new Medicare law that will have an impact on medical practices.

• NRC Reorganization Shifts Heads of NMSS and RES

  Apr 8, 2004 — In a reorganization at the NRC, Martin Virgilio, currently director of the Office of Nuclear Materials Safety and Safeguards (NMSS) has been named Deputy Executive Director for Materials, Research and State Programs (RES), replacing Carl Paperiello. Jack Strosnider, deputy head of the Office of Nuclear Regulatory Research (RES), will replace Virgilio at NMSS.

• Nuclear Medicine Retains Exemption from Stark Rule Against Self-referral Procedures

  Apr 8, 2004 — A CMS ruling has reaffirmed that nuclear medicine procedures are exempt from the Stark rule against self-referral which prohibits physicians from referring patients to designated health services (DHS) facilities in which they or their partners may own an interest.

• Committee on Medical Uses of Isotopes Charter Renewed; Dr. Leon Malmud Named Chair

  Apr 7, 2004 — The NRC has renewed the charter for the Advisory Committee on the Medical Uses of Isotopes (ACMUI). Dr. Leon Malmud, a past president of the SNM, will become chair of the committee this fall.

• Proposed Annual Payment Rate Update and Policy Changes for Prospective Payment System (PPS) and Long Term Care Hospitals (LTCH)

  Mar 18, 2004

• RT in DC Efforts Net More Co-Sponsors for CARE Bill

  Mar 17, 2004 — Following last week's Capitol Hill blitz by more than 100 radiologic technologists, six more Representatives and one additional Senator have signed on as cosponsors of the Consumers Assurance Radiologic Excellence bill.

• CMS Requests Public Comments on Coverage of PET for Alzheimer's Disease

  Mar 16, 2004 — The Centers for Medicare and Medicaid Services is requesting input from the public regarding the use of PET scans in diagnosing mild to moderate Alzheimer's Disease.

• Medicare Nominee Balks at Drug Issue

  Mar 11, 2004 — Mark McClellan, President Bush's choice to run Medicare, said Monday that he would not answer senators' questions about his opposition to importing prescription drugs from Canada before he takes over the government health program.

• Global Billing for Reading Scans Off Site Now Permitted

  Mar 9, 2004 — A change to the CMS regulations makes billing for the services of off-site medical image interpretation easier for imaging centers.

• More Co-Sponsors Sign On to CARE Bill

  Mar 8, 2004 — Five more Representatives and one additional Senator have signed on to the Consumers Assurance Radiologic Excellence bill.

• SNM/ACNP Comments Regarding NRC Part 35 Proposed Rule on Medical Use of Byproduct Material

  Mar 4, 2004 — The SNM and ACNP offer their concerns and suggestions to the Nuclear Regulatory Commission (NRC)...

• Mark McClellan Nominated to Head CMS

  Feb 23, 2004 — President George W. Bush has nominated Mark McClellan, MD, PhD, to be administrator for the Centers for Medicare and Medicaid Services (CMS).

• Gregory B. Jaczko Nominated for NRC

  Feb 17, 2004 — President George W. Bush announced his intention to nominate physicist Gregory B. Jaczko, PhD, to the NRC. Jaczko is legislative aid to Senator Harry Reid, who is strongly opposed to the NRC's plan to store nuclear waste at Yucca Mountain in Nevada.

• Two New Cosponsors for RadCARE in Senate; Three for CARE in House

  Feb 12, 2004 — Sen. Tim Johnson, Sen. Richard Durbin, Rep. Maurice Hinchey, Rep. Mike Rogers, and Rep. Steve Rothman have signed on as cosponsors of the CARE Act.

• NRC Publishes Proposed FY 2004 License Fees in February 2 Federal Register - Broad Scope Medical License Set at $25,100

  Feb 2, 2004

• Two New Sponsors for CARE Act

  Jan 28, 2004 — Rep. Karen McCarthy (D-MO 5th district) and Rep. Jack Quinn have signed on as cosponsors of HR 1214, the CARE Act.

• NRC Revises Safety Standards for Packaging and Transportation Of Radioactive Material

  Jan 28, 2004 — The NRC has updated U.S. regulations for transportation of radioactive materials to make the rule similar to international standards established by the International Atomic Energy Agency (IAEA).

• FDA Sees Rebound in Approval of Innovative Drugs in 2003

  Jan 22, 2004 — The Food and Drug Administration today announced improved results over last year on overall drugs and biologics approvals for calendar year 2003, and decreases in the time it took the Agency to review and approve most applications.

• Updated APC Chart Now Available

  Jan 21, 2004 — The reimbursement educational tool APC Chart - Medicare Hospital Out Patient APC Nuclear Medicine Procedures, Radiopharmaceuticals, and Drugs is now updated and available online...

• FDA Meeting: Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee

  Jan 13, 2004 — This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

• Interim Final Rule for 2004 HOPPS

  Jan 8, 2004 — CMS has published the Interim Final Rule for 2004 HOPPS - payment for radiopharmaceuticals in the January 6, 2004 Federal Register.

• Interim Final 2004 Physician Fee Schedule

  Jan 8, 2004 — The Interim Final 2004 Physician Fee Schedule rule is now available online.

• Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2004 - Final Rule

  Jan 6, 2004 — The SNM Coding and Reimbursement Committee offers comments and recommendations on the final rule.

• Final Comments Sent to CMS from the Nuclear Medicine APC Task Force

  Jan 6, 2004 — APC Task Force final comments in response to the final 2004 Hospital Outpatient Prospective Payment System (HOPPS) rule published in the November 7, 2003 (68 Fed. Reg. 63398).

• Thompson Names Dennis Smith Acting Administrator of CMS

  Dec 19, 2003 — HHS Secretary Tommy G. Thompson has named Dennis G. Smith as interim head of the Centers for Medicare & Medicaid Service following the resignation of CMS Administrator Tom Scully.

• NRC Call for Nominations: Cardiology Physician to Serve on ACMUI

  Dec 12, 2003 — The U.S. Nuclear Regulatory Commission (NRC) is advertising for nominations for the position of Interventional Cardiology Physician on the Advisory Committee on the Medical Uses of Isotopes (ACMUI).

• NRC Publishes Proposed Revisons to T&E Requirements and Certifying Board Recognition

  Dec 10, 2003 — The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations governing the medical use of byproduct material to change its requirements for recognition of specialty boards...

• CMS Administrator Tom Scully Resigns

  Dec 5, 2003 — CMS Administrator Tom Scully announced on December 3 that he will resign effective December 15.

• Dean Steps Down as Deputy Director of the National Institute of Biomedical Imaging and Bioengineering

  Nov 25, 2003 — Donna J. Dean, Ph.D., deputy director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB), one of the National Institutes of Health (NIH), announced today that she will leave her position...

• Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2004

  Nov 5, 2003 — Prior to publication in the November 7 Federal Register, CMS has posted the 2004 Physician Fee Schedule...

• 2004 HOPPS Payment Rates

  Nov 5, 2003 — CMS has released the final 2004 HOPPS payment rates. We have just begun to start our analyses, but wanted to share a high priority development...

• NRC Issues New Regulations on Recentness of Training

  Oct 27, 2003 — The NRC has issued a new regulatory summary for "NRC medical use licensees" and "NRC master materials license medical-use permittees" who are seeking to have board-certified individuals recognized as authorized users, authorized medical physicists, or authorized nuclear pharmacists if these individuals' training and experience were completed more than 7 years ago.

• SNM's Coding and Reimbursement Committee Files Comments on Medicare Part B Payment Reform

  Oct 14, 2003 — The comments from the SNM Coding and Reimbursement Committee cover radiopharmaceuticals as drugs, payment system revisions, Physician Fee Schedule Payment changes, SGR, and the rulemaking process.

• Comments filed on Proposed 2004 Physician Fee Schedule

  Oct 7, 2003 — SNM Coding and Reimbursement Committee Chair, Dr. Gary Dillehay, has submitted comments to CMS on the proposed 2004 Physician Fee Schedule. CMS will publish the final rule later this year...

• NM APC Task Force Comments on Proposed 2004 HOPPS Rule

  Oct 1, 2003 — The Nuclear Medicine APC Task Force has submitted a response to the proposed 2004 Hospital Outpatient Prospective Payment System (HOPPS) rule that was published in the August 12, 2003 Federal Register 68 Fed. Reg. 47965.

• CMS Will Accept Non-Compliant Electronic Transactions After Deadline

  Sep 25, 2003 — The Centers for Medicare & Medicaid Services (CMS) is implementing a contingency plan to accept electronic transactions that do not comply with HIPAA standards after the October 16 compliance deadline.

• Updated - Payment for Radiopharmaceuticals and Drugs Under APC's

  Sep 22, 2003 — September 10, 2003 - Update to the Nuclear Medicine APC Task Force's chart, Payment for Radiopharmaceutical and Drugs Under APC's, reflecting CMS corrections and changes identified in CMS Transmittal 1, Change Request 2914, effective October 1, 2003. . .

• Medicare Physician Fee Schedule (PFS) CY 2003 National Payment Rate Table

  Sep 16, 2003 — SNM has created a nuclear medicine-specific table reflecting the most up-to-date national physician fee schedule (PFS) information for calendar year 2003...

• NRC Information Notice 2003-12: Problems Involved in Monitoring Dose to the Hands Resulting from the Handling of Radiopharmaceuticals

  Sep 16, 2003 — The U.S. Nuclear Regulatory Commission (NRC) is issuing this information notice (IN) to alert licensees of potential difficulties that may be encountered when monitoring doses to the hands of workers involved in handling radiopharmaceuticals.

• CMS Posts Correct Coding Initiative Edits on Internet

  Sep 3, 2003 — The Centers for Medicare and Medicaid Services (CMS) today made it easier for physicians and other providers to bill properly and be paid promptly for their services to people with Medicare coverage. CMS has posted on its web site the automated edits used to identify questionable claims and adjust payments to reflect what would have been paid if the claim had been filed correctly. . .

• October 2003 Update of the Hospital Outpatient Prospective Payment System (HOPPS)

  Sep 3, 2003 — CMS has published a program memorandum detailing changes to the OPPS for the October 2003 update. Two codes were newly created to support expanded coverage of PET scans for thyroid cancer and perfusion of the heart using Ammonia N-13. . .

• CMS Proposes New Rules to Pay for Medicare Covered Drugs

  Aug 20, 2003 — The Centers for Medicare and Medicaid Services proposed new rules that would improve the way that Medicare pays for covered drugs and is asking for public input on the best way to achieve that goal. . .

• Remarks of Dr. Ken McKusick to the APC Advisory Panel

  Aug 20, 2003 — Dr. Ken McKusick comments in front of the APC Advisory Panel on the proposed 2004 HOPPS rule. Specifically, Dr. McKusick discusses the reclassification of many nuclear medicine procedures, and the APC bundling of many radiopharmaceuticals with procedure payment.

• Proposed Changes to the Hospital Outpatient Prospective Payment System (OPPS) and Calendar Year 2004 Payment Rates

  Aug 13, 2003 — This proposed rule would revise the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. In addition, it would describe proposed changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes would be applicable to services furnished on or after January 1, 2004.

• NRC Commissioners Grant Wisconsin Agreement State Status

  Aug 12, 2003 — As an Agreement State, Wisconsin is allowed to regulate byproduct material, source material, and special nuclear material in quantities not sufficient to form a critical mass. In a June 30 decision, which was released yesterday, the commission said that Wisconsin program has satisfied NRC requirements for compatibility with NRC's regulatory regime. There are now 33 Agreement States.

• Vice Admiral John J. Grossenbacher to be Nominated to Head NRC

  Aug 12, 2003 — President George Bush intends to nominate Vice Admiral John J. Grossenbacher, now serving as commander of the U.S. submarine forces in the Atlantic, to be the new chairman of the Nuclear Regulatory Commission (NRC), according to a White House press release.

• SNM Announces New Government Relations Web Page

  Aug 12, 2003 — Reston, VA - As a first step in the overall effort to make the Society of Nuclear Medicine (SNM) website more user friendly, we have updated the Government Relations section. The new section focuses on items such as how to communicate with legislators, action alerts, nuclear medicine issues, and technologist licensure information...

• Final Update to the 2003 Medicare Physician Fee Schedule Database - Program Memorandum AB-03-119

  Aug 12, 2003 — The Division of Practitioner Service has identified various inconsistencies in the 2003 Medicare Physician Fee Schedule Database (MPFSDB). The Centers for Medicare and Medicaid Services (CMS) will make the updated files available to carriers and intermediaries on the CMS Mainframe Telecommunications System on August 5, 2003. . .

• Proposed Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2004 (CMS-1476-P)

  Aug 11, 2003 — On August 8, 2003, the CMS Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2004 (CMS-1476-P) went on display at the Office of the Federal Register. CMS is proposing these changes to ensure that their payment systems are updated to reflect changes in medical practice and the relative value of services. This proposed rule would refine the resource-based practice expense relative value units (RVUs) and make other changes to Medicare Part B payment policy. . .

• CMS to Re-open Public Comment Period Regarding Off-label Use(s) of Ibritumomab Tiuxetan and Tositumomab for Non-Hodgkin's Lymphoma

  Aug 8, 2003 — The comment period regarding off-label use(s) of Ibritumomab Tiuxetan and Tositumomab for Non-Hodgkin's Lymphoma will re-open for 30 days. CMS is modifying the title of the NCD to reflect its expanded scope. The due date for review of the NCD request is extended to November 4, 2003. . .

• Nuclear Medicine Procedure CPT/HCPCS Codes - Effective October 1, 2003

  Jul 24, 2003

• Expanded Coverage of Positron Emission Tomography (PET) Scans and Related Claims Processing Requirements - for Thyroid Cancer and Perfusion of the Heart Using Ammonia N-13, CMS Program Memorandum AB-0

  Jul 7, 2003

• NRC Amends Licensing, Inspection and Annual Fees Rule

  Jul 1, 2003

• Monoclonal Antibodies Used as Reagents in Drug Manufacturing

  Jul 1, 2003

• Medicare Fraud Alert

  Jun 30, 2003

• 42CFR - Standards For Accredidation

  Jun 30, 2003

• Draft Licensure Bill

  Jun 30, 2003

• Alliance for Quality Medical Imaging and Radiation Therapy

  Jun 30, 2003

• National Licensure Bill - Changes as of May 1, 2000

  Jun 30, 2003

• Representative Rick Lazio's Comments as He Introduces CARE Act

  Jun 30, 2003

• Licensure Bill Introduced in Congress

  Jun 30, 2003

• Comment Letter Submitted to Montana Board of RadiologicTechnologists in the Matter of the Proposed Amendment of ARM

  Jun 30, 2003

• Letter to FDA on IRBs

  Jun 30, 2003

• Draft PET Consensus Document

  Jun 30, 2003

• Letter to FDA on In Vivo Proposed Regulations

  Jun 30, 2003

• Comment Letter on Draft Guidance for Developing Medical Imaging Drugs

  Jun 30, 2003

• Federal Register Notice on Availability of FDA Guidance Document and Request for Comments

  Jun 30, 2003

• Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring

  Jun 30, 2003

• Federal Register Notice from FDA on Amending Regulations for Foreign Establishments, and the Listing of Human Drugs, Animal Drugs, Biological Products, and Devices

  Jun 30, 2003

• Federal Register Notice by FDA Announcing Safety of and Approval of PET

  Jun 30, 2003

• Federal Register Notice Announcing FDA Draft Guidance on PET Drug Applications for NDA's and ANDA's

  Jun 30, 2003

• Letter to HCFA in support of Alzheimer PET Scans

  Jun 30, 2003

• Current Good Manufacturing Practice for Positron Emission Tomography Drug Products - Preliminary Draft Proposed Rule - Public meeting May 21

  Jun 30, 2003

• FDA Seeks Marketing Applications for Prussian Blue Products

  Jun 30, 2003

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