the Health Care Financing Administration
(HCFA) announced that it needed more
in the “Eureka!” theory of medical
progress.Working late in a darkened
lab, a metapho...
innovation and clinical acceptance. Newsline
looks at recent advances in this technology that
some believe to be the “Eure...
good so far,” she says. “As expected, we began
with the use of combined imaging...
Weatherhead, the company’s VP for Sales and
Marketing, Nuclear Medicine and PET. The
biograph system integrates Siemens’s ...
Newsline 19N
s part of a continued
of communication and
foster the creation of a vital,
20N THE JOURNAL OF NUCLEAR MEDICINE • Vol. 42 • No. 5 • May 2001
The Societ...
22N THE JOURNAL OF NUCLEAR MEDICINE • Vol. 42 • No. 5 • May 2001
early 100 physicians, scientists, and Internet...
24N THE JOURNAL OF NUCLEAR MEDICINE • Vol. 42 • No. 5 • May 2001
C o m m e n t a r yNEWSLINE
ver the last few years, the...
26N THE JOURNAL OF NUCLEAR MEDICINE • Vol. 42 • No. 5 • May 2001
renewal applicant can simply state that it will
28N THE JOURNAL OF NUCLEAR MEDICINE • Vol. 42 • No. 5 • May 2001
failure to inform the NRC inspector violated 10
30N THE JOURNAL OF NUCLEAR MEDICINE • Vol. 42 • No. 5 • May 2001
32N THE JOURNAL OF NUCLEAR MEDICINE • Vol. 42 • No. 5 • May 2001
compliance strategy that avoids the PIs is a
NRC Part 35 to OMB. The Nuclear Reg-
ulatory Commission (NRC) has sent Part 35
to the Office of Management and Budget
FDA Guidance on
Foreign Clinical
Administration (FDA) released a
brief guideline stat...
by descriptions of practices that are unique to this region.Areas cov-
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  1. 1. I natrackingsheetreleasedonApril11,2001, the Health Care Financing Administration (HCFA) announced that it needed more time “to examine the comparative performance ofallsystemtypesapprovedformarketingbythe FDA [Food and Drug Administration] as PET scanners.” April 11 had been the date originally announcedforthisdecision.Inthetrackingsheet [see full text at right], HCFA noted that “…it is clear no single design specification (i.e., crystal thickness) can differentiate a quality cut-off but infactwillrequiresomeperformance-basedstan- dard.” HCFA noted that numerous recent sub- missions of supporting information provided by industry and academicians led to the postpone- ment of the release of a finalized version of the National Coverage Determination until May 4, 2001. When released, the final decision will be posted on the HCFA Web site at www.hcfa.gov; additional information will be available at the Society of Nuclear Medicine (SNM) Web site at www.snm.org. In a joint statement issued on April 11, SNM andtheAmericanCollegeofNuclearPhysicians (ACNP) stated that their members are: …pleased that HCFA will begin reimburse- ment July 1, 2001, for the previously announcedexpansionofPETcoveragetoaddi- tional indications using dedicated full-ring PET scanners. We are disappointed that they have not yet extended this broader coverage to the use of coincidence cameras. SNMandACNPareworkingwithHCFAstaff astheycontinuetheirevaluationofPETscanning systems.ThejointstatementalsonotedthatSNM andACNPlookforwardtotheJuneadvisorycom- mittee meeting that will revisit and possibly recommendexpansionofPETcoverageinrecur- rent breast cancer. HCFA Postpones Full PET Decision Until May NEWSLINE Newsline 9N Medicare Coverage Policy ~ Decisions Positron Emission Tomography (PET) Scanner Technology (#CAG-00090A) Tracking Sheet Our previous national coverage decisions on PET scans (§50-36 of the Medicare Coverage Issues Manual) provided coverage for limited uses of FDG- PET. Further, it requires that the scans for these more limited indications be performed with a camera that has either been approved or cleared for mar- keting by the FDA to image radionuclides in the body. In our consideration of a public request for expanded coverage of FDG-PET scans (# CAG-00065, decision memorandum dated 12/15/00), the majority of literature submitted was derived from imaging studies using full ring bis- muthgermanate(BGO)PETscanners.Therewerealsopublishedstudiesshow- ing that some other scanner types may miss clinically important malignant lesions. Thus, in the new coverage decision we announced our intention to limit the new indications (described in the 12/15/00, decision memorandum) to high performance PET scanners with specific structural features. It has come to our attention that there may be additional PET scanner sys- tems with performance “equivalent to” or “better than” the scanners to which we are limiting the new indications. We have, therefore, internally generated a formal coverage request to examine the comparative performance of all system types approved for marketing by the FDA as PET scanners. This request will allow us to develop a uniform and appropriate quality standard for imag- ing systems that will be eligible for Medicare reimbursement for all covered uses of FDG-PET. Information collected so far has illustrated a potentially greater gap in sys- tem performance than recognized as of 12/15/00, between dedicated PET and gamma camera systems. Further, it is clear that no single design specification (i.e. crystal thickness) can differentiate a quality cut-off but in fact will require some performance-based standard. We are now exploring further the poten- tial patient risks associated with the lower quality images and/or the greater acquisition time associated with camera PET systems. In an effort to help HCFA be expeditious, industry coupled with various aca- demicians has provided a substantial number of additional scientific studies to address the above concerns. Receipt of this new material on March 23, 2001, has required us to extend until May 4, 2001, the finalized version of the National Coverage Determination on the gamma camera issue.
  2. 2. M uchofthegeneralpublicstillbelieves in the “Eureka!” theory of medical progress.Working late in a darkened lab, a metaphorical light bulb appears over Pro- fessor Smith’s head and a new, lifesaving piece of medical apparatus is quickly sketched out on the tabletop. Within a matter of months, a man- ufactureristurningoutthousandsofthemachines, medical care is revolutionized, and Professor Smith accepts the Nobel Prize. In fact, the last time such a rapid concept-to- reality transition to the clinical setting was made waswiththeintroductionoftheX-raymorethan 100 years ago. Today, even the most beneficial innovationsmustmeetincreasinglystringentreg- ulatoryrequirements,provetheirworthinavari- ety of applications, find a niche in the unspo- ken but potent turf wars among medical specialists, gain approval for reimbursement, be fundedforacquisitionandinstallation,andprove consistent and reliable in the everyday clinical environment. For the past two years, hybrid imaging systems in nuclear medicine have been traversing this difficult terrain between Hybrid Imaging in Nuclear Medicine: Continuing Innovation in Form and Function NEWSLINE 10N THE JOURNAL OF NUCLEAR MEDICINE • Vol. 42 • No. 5 • May 2001 Images of a 78-year-old man with squamous cell carcinoma of the lung. The fused PET/CT image shows good alignment of modalities and revealed additional FDG uptake in a mediastinal lymph node. (Images obtained through Siemens Medical Systems—Nuclear Medicine Group, courtesy of David Townsend, PhD, University of Pittsburgh) Images of a 50-year-old man with a history of left upper lobe non–small cell lung cancer involving the T1 vertebra. The fused CT/PET image was significant in restaging after initial treatment. (Images obtained through GE Medical Systems, courtesy of the University of Zurich, Switzerland, and Rambam Medical Center, Haifa, Israel)
  3. 3. innovation and clinical acceptance. Newsline looks at recent advances in this technology that some believe to be the “Eureka!” factor that will propelnuclearmedicinetotheforefrontofimag- ing in the 21st century. Fusion: The Focus for the New Millennium InhisHighlightsLecturesumminguppresen- tations at the 2000 annual meeting of the Soci- ety of Nuclear Medicine, Henry N. Wagner, Jr., MD(JohnsHopkinsSchoolofPublicHealth,Bal- timore, MD), noted the growing importance of fused images in nuclear medicine (J Nucl Med. 2000;41[8]:9N). More than 40 papers on fused image tomography (including MRI/PET, MRI/SPECT, CT/PET, CT/SPECT, and even magnetoencephalography/PET) were presented at the meeting. The purpose of fused and multi- modalityimagingistocombineinformationabout anatomy,function,andevenbiochemistrytoyield a “complete” clinical picture. Until recently, fusion imaging remained rela- tivelyinaccessibleformanyclinicians.Theprocess involvedthecostlycoregistrationandsubsequent fusion of two or more images, most often made duringdifferentexaminationsofthesamepatient. With the advent of devices that combine func- tionalandanatomicimaginginonepatientstudy, nuclear medicine is making advances unimag- ined a decade ago. Many observers believe that this capability to see the “whole” patient and the promise of taking this new vision to the molec- ular level may make nuclear medicine the dom- inant area of medical imaging in the next quar- ter of a century. Almost 25% of physicians surveyedbyDr.Wagnerin1999reportedthatthey believednuclearmedicinewouldbecomethelead- ing imaging modality of the future. This per- centage undoubtedly has risen with recent inno- vations in fusion technologies. Hybrid imaging carries with it a second and potentappeal,inthatseveralofthesystemscom- bine modalities that many hospitals and medical centers would not be able to justify as stand- alones. The term “hybrid” itself causes confu- sion in this regard, as some systems focus on coregistration aspects of anatomical and func- tional information, whereas others allow an either/or performance of radioisotope and radi- ological imaging. Still others are referred to as hybrid because they combine two or more pre- existing product lines from one company into a single gantry. IntheUnitedStates,twocompanies,GEMed- icalSystems(Waukesha,WI)andSiemensMed- icalSystems–NuclearMedicineGroup(Hoffman Estates,IL)havedevelopedhybridCT/PETimag- ing equipment for the clinical market.Although othermanufacturersbothintheUnitedStatesand inEuropeareinresearchanddevelopmentphases with hybrid devices, details are not available. GE: The Hawkeye and Beyond InSeptember1999,GEintroduced“functional anatomical mapping” as part of what would become the GE MillenniumVG Hawkeye scan- ner,todayinclinicaluseandknownsimplyasthe “Hawkeye.” Developed through studies at Van- derbilt University (Nashville,TN) and Rambam Medical Center (Haifa, Israel), the technology consists of a CT X-ray tube and linear detector array installed on a GE Millennium VG dual- isotope camera with coincidence imaging capa- bility. From the first, GE marketed the appara- tus as both functional and practical in cancer treatment planning. “We’vealwaysbeeninterestedinhelpingradi- ation oncologists refine their vision of tumors. It was clear that this kind of fusion of tech- niques would provide the functional anatomic mapping that would be helpful to physicians and beneficial to patients,” says Jan Goldstein, GEAmerica’s Manufacturing Manager/Nuclear Medicine/PET. Today, more than 50 Hawkeye units are in operation in the United States, with another 20–25 in other countries. AttheRambamHospital,thefirstclinicalcases withtheHawkeyewereimagedinMay1999.Ora Israel, MD, now chair of the Department of Nuclear Medicine at Rambam, reports that her groupisperforming5–12combinedstudieseach day using different single-photon and -positron NEWSLINE Newsline 11N The GE Millennium VG Hawkeye. (Courtesy of GE Medical Systems)
  4. 4. emittingisotopes.“Ourexperiencehasbeenvery good so far,” she says. “As expected, we began with the use of combined imaging in oncology. We are now assessing its role in cardiology and inwhatappearstobeaveryinterestingandpromis- ing field: the evaluation of infection and inflam- mation. We are also investigating its use for improved quantitation of radiopharmaceutical uptake.”Dr.Israelhasreportedthattheuseofthe Hawkeye has altered patient management in one out of every four oncology patients imaged. Although much of the early work with the Hawkeye was carried out in large teaching hospitals and medical centers, the apparatus has had considerable appeal for smaller institutions that might not be able to afford or justify dedi- cated PET. “The versatility of this apparatus for smaller hospitals is important,” says Dominique Delbeke,MD,ChairofNuclearMedicineatVan- derbilt. “The nuclear medicine physician can image both conventional radiopharmaceuticals, includingSPECTcardiacstudiesandFDGusing SPECT (cardiac dual-isotope single-acquisition 99m Tc sestamibi/FDG studies) and coincidence imaging.”At the Beaumont Hospital inTroy, MI, a Hawkeye was installed in the nuclear medi- cine department just weeks ago. Conrad Nagle, MD, Editor of Newsline and Chief of Nuclear Medicine at the hospital, reports that the deci- sion to acquire the Hawkeye was based on the anticipated benefits of the powerful combina- tion of functional/physiological imaging com- bined with the strength of resolution and supe- rioranatomiclocalizationoftheCTimage.“This combination,” he says, “is likely to result in bet- ter diagnostic information and more precise answers to questions about patients with a variety of clinical problems.” Another hybrid offering by GE is the Posi- trace dual-mode oncology system, which com- bines a dedicated PET camera capable of whole- body FDG imaging with a diagnostic-quality CT scanner for anatomic localization and atten- uationcorrection.AcquiredfromSMVinfall2000, the Positrace is advertised as an “economically priced diagnostic instrument.” SMV previewed the Positrace at the 1999 meeting of the Radio- logical Society of North America (RSNA) and receivedFDAclearanceforclinicaluseinAugust of the following year. GE’smostrecententryinthehybridfieldisthe as-yet-unnamed CT/PET system that combines theGELightspeedmultisliceCTscannerwiththe GEAdvance NXi PET. “The new CT/PET tech- nology is a natural progression for GE, given the success of the GE Hawkeye product, to advance that technology to dedicated PET systems,” said Beth Klein, Vice President and General Man- ager of Global Functional and Molecular Imag- ingatGEMedicalSystems.“Whilenuclearmed- icineandPETarerenownedfordetectinglesions sometimes months before they can actually be seen by CT or MR alone, the ability to pinpoint thelocationofthoselesionshaseludedphysicians foryears.CT/PETtechnologyoffersthepotential to change all this.” Currently, one of these high- end systems is in clinical use in Switzerland. Thecompanyestimatesthat2–3unitswillbeoper- ative in the United States by summer of 2001, as will 15–20 more by year’s end. Versatility remains the hallmark for GE in its hybridplans.Companyspokespersonsemphasize the range of hybrid products offered, from eco- nomical to high-end. The company plans to pre- view different configurations of the Hawkeye at theSNMmeetinginTorontoinJune,accordingto Eric Evenson, GE Marketing Manager, Nuclear Medicine Cameras and Cardiology. “We will be able to configure the machines to the needs of the prospectivecustomer,combiningtheirinstitution’s clinical and throughput needs to provide the most beneficial and cost-effective configuration.” Siemens: Bringing the Biograph to Market “Siemens chose to enter the hybrid imaging fieldwithahigh-endsystem,”accordingtoRandy NEWSLINE 12N THE JOURNAL OF NUCLEAR MEDICINE • Vol. 42 • No. 5 • May 2001 GE’s new (and unnamed) system combining the Lightspeed multislice CT scanner with the Advance NXi system. (Courtesy of GE Medical Systems)
  5. 5. Weatherhead, the company’s VP for Sales and Marketing, Nuclear Medicine and PET. The biograph system integrates Siemens’s premium dedicatedPET(HR+)andSpiralCT(SOMATOM Emotion) technologies with the advanced syngo multimodality computer platform.The products combinedinthisunitwerealreadyintheSiemens productlineandwerejoinedspecificallybecause the company believed that clinicians wanted a system that produces fully diagnostic images in either modality, as well as the benefits of coreg- istration.Theunitwasformallyintroducedtothe imaging public at RSNA 2000, and is targeted at oncology disease management, including stag- ing and therapy planning and monitoring. Thesystemisjustbeginningtoenterthemain- stream market. One prototype has been in clini- cal operation at the University of Pittsburgh for almost three years. Experience with the appara- tus has been promising, says David Townsend, PhD,theprincipalscientistanddirectorofresearch with the biograph, “The results of the studies we performed clearly demonstrated that the anatomical and biological, or functional, infor- mation derived from the prototype PET/CT provides valuable clinical information that per- mits accurate tumor detection and localization and establishes appropriate disease staging.” Siemens reports that in these initial studies, “a significant fraction” of patients imaged with the device had their management changed. Themostlikelyearlymarketsforthebiograph will be among those nuclear medicine groups already doing PET studies with a dedicated unit, saysWeatherhead. “This is a natural solution for placeslikeuniversitiesandinstitutionsthatalready haveaPETbutarelookingfortheadditionalben- efitsofperfectlycoregisteredPETandCTdata.” Likeanumberofothermanufacturers,Siemens is offering a dual-purpose PET/SPECT device, thee.comduet.Suchsystemshavemetwidemar- ketacceptanceintheUnitedStatesandwithgreat interest in Europe. Siemens plans to highlight both the biograph andthee.camduet,alongwithitsfullproductline of nuclear medicine devices, at the June meet- ing of the SNM. Reimbursement: A Shifting Target As of this writing, the Health Care Financing Administration(HCFA)haspostponedadecision that may make a distinction between dedicated and hybrid PET systems in its reimbursement schedules.BeginninginJuly1999,Medicarereim- bursed for limited indications for PET imaging, regardless of whether the images were acquired withadedicatedPETscannerorahybridgamma camera. However, in December 2000, HCFA announced expanded coverage of PET for diag- nosis of six types of cancer (see Gambhir et al. ATabulatedSurveyofFDGPET,thesupplement accompanyingthisissueofTheJournalofNuclear Medicine)butindicatedthatthiscoveragewould be restricted to high-performance PET scanners only.Questionsaroseimmediatelyovertheword- ing and intent of this restriction, and a final clar- ification has not been made.The matter is under review,andHCFAisholdingongoingdiscussions with equipment manufacturers and the nuclear medicinecommunity,withafinalstatementsched- uled by May 4, 2001. Opinionsaremixedontheeffectsofregulation on the success or failure of devices in the clinical environment. Most nuclear medicine physicians surveyed by Newsline believe that the ultimate success or failure of combined modality imag- ing will hinge on clinical results, patient bene- fits, and continued improvements in throughput times and enhanced technologies. But manufac- turersandnuclearmedicinespecialistskeepawary eye on HCFA reimbursement announcements. “Most of the impact has already been quite posi- tive,” says Weatherhead. “Because of announce- ments about expanded coverage and additional expectedcoveredapplications,thenumberofsites expressing interest in these modalities is up dra- matically from two years ago. It’s much easier for institutions to justify this kind of acquisi- tion.” Industry contacts at both Siemens and GE admitted, however, that confusion about reim- bursementprospectsfordedicatedversusnonded- icated PET systems has many institutions NEWSLINE 14N THE JOURNAL OF NUCLEAR MEDICINE • Vol. 42 • No. 5 • May 2001 The Siemens biograph. (Courtesy of Siemens Medical Systems–Nuclear Medicine Group) (Continued on page 22N)
  6. 6. NEWSLINE Newsline 19N A s part of a continued efforttowidenchannels of communication and foster the creation of a vital, global nuclear medicine com- munity, the Society of Nuclear Medicine(SNM)hasjoinedwith several organizations from Europe and Asia to cosponsor seminars and continuing med- ical education courses (CMEs) at the 48th Annual SNM Meet- ing, June 23–27, 2001, inToronto, Ontario.The seven sched- uled cosponsored events are: PET Imaging to MeasureTumor Response Saturday, June 23 Categorical seminar 12:00–5:45 PM Sponsored by the SNM and the European Association of Nuclear Medicine (EANM) Currently,nouniformlyacceptedcriteriaareusedtodefineresponse withPETimaging.TheEuropeanPETcommunity,workingwiththe European Organization for Research and Treatment of Cancer (EORTC), has undertaken a project to define response criteria for FDGPETtobeusedinclinicaltrials.Thegrouphavepublishedtheir preliminary consensus and recommendations in the European Journal of Cancer (1999;35:1773–1782), and several members of the group will be among the participants in the seminar. Presenta- tions will be of interest both to those involved in clinical trials and to those already using PET in clinical practice. Orthopedic Nuclear Medicine: Sunday, June 24 From Pelvis to Foot Continuing education course 4:15–5:45 PM Sponsored by the Association of the Latin American Societies of Nuclear Medicine and Biology (ALASBIMN) This course is intended for professionals already proficient in musculoskeletalnuclearmedicine,suchasnuclearphysicians,nuclear medicine residents, and technologists, who are interested in the cur- rentstatusoforthopedicnuclearmedicineimagingwithspecialempha- sis on benign diseases of the pelvis and lower extremities. Scintigraphy Down Under: Monday, June 25 An Overview of the Differences inAustralian and New Zealand Practices Continuing education course 9:45 AM–1:15 PM SponsoredbytheAustralia-NewZealandSocietyofNuclearMedicine Apanelofthreespeakerswillgiveabriefoverviewofclinicalnuclear medicinepracticesinAustraliaandNewZealand.Thiswillbefollowed International Focus Continues at SNM 2001 T he Society of Nuclear Medicine (SNM) is once again reaching out to the general public as part of its annual meeting activities.A free seminar, “It’sYour Health, Take Control,” will be presented in Toronto on Saturday, June 23, the first day of the SNM 48th annual meeting. The seminar is designed for men and women of all ages who want to learn about diagnosing, preventing, and treating lung cancer, breast cancer, and cardiac disease. Canadian Olympic RowingTeam member Emma Robin- son will be a guest speaker at the seminar. Robinson benefited from nuclear medicine when she was diagnosed with thyroid cancer in 1999. Fully recovered for the 2000 Olympics in Sydney, Australia, Robinson was a member of Canada’s Bronze Medal-winning women’s eight crew and finished fourth in the pair event. She is a third-year medical student at the University of Toronto, a former Canada Scholar, and active in keeping the public informed about health benefits and options. Attendees at this program will learn how nuclear medi- cine helps physicians accurately diagnose, prevent, and treat lung cancer, breast cancer, and cardiac disease—three of the most widespread diseases. The seminar will cover: • how nuclear medicine can help; • what types of tests are available; • at what ages and how often tests should be performed; • what these tests tell physicians; and • how to prevent these illnesses. Among the physicians participating in the morning’s pro- gram are Fotini S. Sampalis, MD, Alexander J. McEwan, MD, and N.D. Greyson, MD. The seminar will be from 8:30AM–12:30 PM in the Mount Sinai Hospital Auditorium. There is no charge to attend the seminar, and it’s a great destination for friends and fam- ily of SNM Annual Meeting attendees. Public Outreach Seminar Planned for Toronto Meeting Toronto Convention Center (Continued on page 36N)
  7. 7. NEWSLINE 20N THE JOURNAL OF NUCLEAR MEDICINE • Vol. 42 • No. 5 • May 2001 NOTIFICATION OF PROPOSED BYLAW CHANGE The Society of Nuclear Medicine (SNM; the Society) Committee on Bylaws has received notice of and reviewed the following proposed amendments to the SNM Bylaws. As required by our Bylaws, notice of these proposals will be communicated to the membership prior to the next meeting of the House of Delegates.The Committee understands that this communication will be via publication in Newsline in the Journal of Nuclear Medicine and through the SNM Web site.The delegates will then discuss and vote on the amendments at the 2001Annual Meeting of the House of Delegates in Toronto, Ontario. The following Bylaws amendments are proposed for a vote at the annual 2001 meeting of the House of Delegates and are published here as notice to the membership. At its annual meeting in June 2000, the House of Delegates instructed the Bylaws Committee to: (1) develop lan- guage to permit and clarify disciplining of members under certain circumstances, and (2) simplify the commission/com- mittee structure by eliminating the “commission” layer and maintaining only “committees.” The following Bylaws amendments are proposed for a vote at the annual 2001 meeting of the House of Delegates and are published here as notice to the membership. 1. Article III, Section 4:Termination is replaced in its entirety by the following: “Section 4: Discipline A. Members may be subject to discipline, including deprivation of membership if they have presented false cer- tificates or false statements of educational attainments or if they have been convicted of a felony in a court of law. B. The Committee on Ethics shall review, either on its own initiative or on written and signed complaint, any case in whichthecircumstanceslistedinSection4:Amayleadtopotentialdiscipline,andmakerecommendationtotheHouse of Delegates on possible action. Such review shall afford the accused member an opportunity for a hearing. C. Recommendations for discipline of a member shall be referred to the House of Delegates, which will take final action by a two-thirds majority vote.” 2. Article XII is amended to remove reference to Commissions and replace those with “Committee.” The list of Standing Committees is trimmed to those ongoing committees important on a continuing basis to the func- tion of the Society. Other present commissions or committees will be continued as Special Committees or subcom- mittees as desired by the House of Delegates.Article XII, Section 1, is replaced by the following: “ARTICLE XII: COMMITTEES Section 1: Description A. The House of Delegates shall have the following Standing Committees as well as such additional Special Com- mittees as may be required by the House to address special topics or subjects. (1) Committee on Chapters (2) Committee on Councils (3) Committee on Education (4) Committee on Ethics (5) Committee on Nominations (6) Committee on Bylaws (7) Committee on Radiopharmaceuticals The Chairpersons of all Committees of the House of Delegates shall serve as consultants to the House of Delegates and to the Board of Directors.”
  8. 8. NEWSLINE 22N THE JOURNAL OF NUCLEAR MEDICINE • Vol. 42 • No. 5 • May 2001 N early 100 physicians, scientists, and Internet spe- cialists from around the world met in Bethesda, MD, at the National Institutes of Health (NIH) on March 15 and 16 to discuss ways in which the Internet can be applied to the practice of nuclear medicine. The meet- ing, entitled “The Internet: the Road to Smart Nuclear Med- icine,” was sponsored jointly by the Society of Nuclear Med- icine (SNM), Johns Hopkins University, and NIH, and marked the first collaboration of the three organizations. Unrestricted educational grants were made by DuPont Phar- maceuticals and Siemens, and additional support came from GE Medical Systems and Capintec. The idea for the two- day symposium originated with Henry N. Wagner, Jr., MD, as part of his efforts to launch SNMGlobal.org, the SNM’sWeb site for the international nuclear medicine com- munity. In opening remarks, he said, “More than anything else, information technology can accelerate and further enhance the increasing fusion of nuclear medicine into the mainstream of medical imaging.”Wagner later told Newsline, “I believe that the Internet is going to revolutionize medi- cine, and, if nuclear medicine people don’t get involved soon, they will be left on the sidelines.” The penalties for being left behind—and the challenges and rewards of embracing new information technologies— were made clear in the presentations that followed. After opening remarks onThursday morning,Wagner set the tone with his talk on “An Internet-based Practice: FromVision to Reality.” Other speakers during the first day addressed the use of the Internet to market health care to the public and referring physicians, picture archiving and communication systemsinnuclearmedicine,InternetinitiativesatNIH,issues of computer networking and connectivity, legal concerns, and image transmission standards. The day also included demonstrations of innovative hardware and software and a wine and cheese reception. Presentations on the second day of the seminar included National Library of Medicine activities in telemedicine and the Internet, an overview of SNM’s Internet strategy, and presentations on how nuclear medicine information systems can and should work within the larger architecture of hospi- tal information systems. Dr. Wagner summarized the central theme of the meet- ing in three words: “just do it.” Rather than waiting for a top- down approach, with hospital administrators identifying desirable factors in new information systems, “nuclear med- icine has an opportunity and responsibility to lead the way to the use of the Internet in medical practice. We have been interpreting images on a computer screen since the late 1960s and have had ‘filmless’departments since that time,” he said. Nuclear medicine, the participants in the meeting made clear, is uniquely positioned for integration into a fruitful and expanding global network. GotoSNMglobal.orgtolearnmoreabouttheinternational network of nuclear medicine, discuss important issues with colleagues from around the world, and find upcoming events with information technology components. SNM Global Hosts Internet Symposium (Continued from page 14N) Hybrid Imaging in Nuclear Medicine wavering at the brink of acquisition decisions they might oth- erwise have made more quickly. The Future: It’s Fusion The combination of functional and anatomical imaging in one patient study puts nuclear medicine in a position to lead medical imaging in the new century. This combination, manybelieve,willbecomeanessential,ratherthananadjunct, element of basic medical practice. GE’s Goldstein says, “I seeatimewhenallimagingequipmentwillhavetheabilityto openupthephysician’svisionandclarifydatabasedonanatom- icalandfunctionalinformation.”Siemens’sWeatherheadnotes thatfortheimmediatefuture,dedicatedPETsystemswillcon- tinue to improve, with significantly reduced scan times, enhanced quality, and across-the-board migration to larger, LSO crystal technology. What the application and acceptance of hybrid imaging modalities make clear is that nuclear medicine is entering a newageofrapidtechnologicaldevelopment,inwhichthetools ofthefieldmaychangerapidlyandradicallywithinshortperi- ods of time. The ultimate goal, however, remains the same: to combine the maximum amount of functional and anatom- icalinformationinwaysthatbenefitpatientsandenhancemed- ical knowledge and practice. Nuclear medicine is well placed to take the lead in providing such information to clin- icians across the spectrum of the medical endeavor.
  9. 9. 24N THE JOURNAL OF NUCLEAR MEDICINE • Vol. 42 • No. 5 • May 2001 C o m m e n t a r yNEWSLINE O ver the last few years, the Nuclear Reg- ulatory Commission (NRC) has imple- mentedtwomajorinitiativesthatstream- linetheregulatoryprocess.Oneinitiativehasbeen toapplythemethodsofbusinessprocessre-engi- neeringtoreducetheadministrativeeffortneeded for renewing byproduct materials licenses (1). Theothermajorinitiativehasbeentorisk-inform regulatoryrequirementstofocusregulatoryactiv- ities by the NRC and its licensees on the higher risk aspects of using radioactive materials (2). These initiatives have resulted in substantial changes to the NRC’s process for renewing licensesforpossessingandusingbyproductmate- rials (3). Two consequences are of particular importancetomedicallicensees.First,ingeneral, theNRChasadopteda10-yeartermforrenewed licenses (4). Second, where a licensee has had a recordofsubstantialnoncompliantbehavior,the NRC may renew a license for a term of less than 10 years (5). Thisarticle,thefirstoftwotohighlighttheeffects of these NRC initiatives, discusses ways in which licensees can simplify the process of renewing an NRC license to use byproduct material and avoid a record of substantial noncompliance that could limit the renewed license period to less than 10 years.Backgroundinformationnecessaryforunder- standing how to take advantage of these changes intheNRC’sprocessisprovidedinanoverviewof boththelicenserenewalprocessandkeyelements of the license renewal application. NRC License Renewal Process Overview ToplacetheNRC’slicenserenewalprocessfor byproduct materials into perspective, it is useful first to overview the Commission’s regulatory philosophyandhowithaschangedrecently.This overview provides insights into the importance the NRC places on the license renewal process and on the principal requirements for byproduct materials licenses. The overview concludes with a catalog of the principal regulatory guid- ance documents that implement the NRC’s reg- ulatory philosophy and requirements. NRC Regulatory Philosophy The NRC’s regulatory attitude toward license renewal is governed by the agency’s overall reg- ulatoryphilosophy.Inthelastfewyears,pressure from Congress, especially the Senate oversight committee, has led the NRC to adopt a kinder, gentler approach to regulation. Greater reliance has been placed on licensees to self-assess their complianceprogramsandtakecorrectiveactions when necessary. Enforcement actions have been cut back commensurately to address only serious noncompliances. Duringthissameperiod,theentirefederalgov- ernment has been reducing budgets, streamlin- ing processes, and increasing efficiency in the delivery of services. Consistent with this gov- ernment-wide re-engineering, the NRC has applied a version of business process re-engi- neering,calledBusinessProcessRedesign(BPR), tosimplifythematerialslicensingprocess.NRC license reviewers have been explicitly instructed to limit their requests for information from licensees(5).Theresulthasbeenasimplerrenewal process that requires licensees to submit sub- stantiallylessinformationthanhadbeenrequired previously.Licenserenewaltermsalsohavebeen extended from 5 to 10 years to reduce regula- tory costs. In addition to these process changes, the NRC also has undergone a major change in the substance of its regulatory philosophy by increasingitsuseofrisk-informed,performance- basedmethodsofregulation.Thischangeinphi- losophy is being applied broadly throughout the federal government. Risk-informed regulation has been embraced by the NRC to reduce prescriptiverequirementsandtofocuslicensees’ compliance activities on actual risks. The result is an NRC license renewal process that focuses on relatively higher risk activities (6). An example of the streamlined licensing process is provided by the treatment of proce- dures. Under the new licensing guidance, most procedures are not required to be submitted to theNRCforreviewandapproval.Rather,alicense How to Renew an NRC License: Practical Pointers for Medical Licensees Part 1 In the last few years, pressure from Congress, especially the Senate oversight committee, has led the NRC to adopt a kinder, gentler approach to regulation. The first of a two-part article on new NRC initiatives and their effects on licensees
  10. 10. 26N THE JOURNAL OF NUCLEAR MEDICINE • Vol. 42 • No. 5 • May 2001 NEWSLINE renewal applicant can simply state that it will adoptandimplementtheproceduresthatarepro- videdintheNRC’sguidance(7).Thissimplified process reflects an NRC determination that it need not review these procedures in advance to have confidence that the licensee will conduct itsprograminamannerconsistentwithadequate protection of public health and safety. Rather, in these cases, postimplementation inspection has been determined by the NRC to be ade- quateforfulfillingitsregulatoryresponsibilities. However, certain aspects of the program and certainproceduresstillrequirepriorNRCreview andapprovalbeforethelicenseisrenewed.These are the program aspects and procedures that the NRChasdeterminedpresentthepotentialforsub- stantial risk and, therefore, require prior review and approval. These program elements include facilities and equipment, radiation safety, and waste management. Accordingly, the license renewal application must contain adequate descriptions of these factors. Importance of License Renewal to the NRC Althoughcommittedtosimplifyingandstream- lining the license renewal process, the NRC believesthattherenewalprocessservesanimpor- tantfunctioninhelpingmeetitsregulatoryoblig- ations. The Commission’s views were clearly expressedinitsrejectionofanNRCstaffproposal to extend all licenses for two years without NRC review, after the licenses had already been extended for five years without review (8). The Commissionstatedthataformallicenserenewal process was necessary in order to review each licensee’s operating performance and safety, health, and environmental programs. License renewal also enables the NRC to supplement inspections as a means of evaluating each licensee’scompliancewithrequirements.Inaddi- tion, license renewal was seen as encouraging licenseestoadoptthelatesttechnologyandprac- tices and to conduct audits to self-evaluate com- pliance,consistentwiththeNRC’soverallchange inphilosophytorelymoreonlicensees’program implementation.Finally,consistentwiththeBPR and cost reduction, license renewal would pro- videtheNRCanopportunitytosimplifyaccrued license amendments, thereby simplifying licensees’ability to comply. NRC Requirements Several NRC regulations apply to byproduct material licensees. Of these, the most important generallyapplicablesubstantiverequirementsare in10CodeofFederalRegulations(CFR)Part20, StandardsforProtectionagainstRadiation.NRC management focuses intently on ensuring that public exposures to radiation are within regula- tory limits and that no member of the public is inadvertentlyexposedtoradiationorradioactive materials. Of the applicable specific requirements, 10 CFR Part 35 is clearly the most important, because it was developed specifically for med- ical users of byproduct materials. Among the components of this rule that are especially important to the NRC are the requirements in the Quality Management Program (QMP) and for securing radioactive materials. Because these regulations are intended to prevent inap- propriate or inadvertent radiation exposures to members of the public, the NRC is espe- cially sensitive to licensees’ compliance with these requirements. Finally, care must be taken to comply with thegenerallyapplicablerequirementsof10CFR 50.7, regarding the completeness and accuracy ofinformation.AllinformationprovidedtoNRC must be complete and accurate in all material respects. “Material” means capable of influenc- ing the NRC as a knowledgable regulator. All information that the NRC requires licensees to keep,suchaswrittendirectives,isalsosubjectto this requirement. Thisrequirementistakenveryseriously,because the NRC must have confidence that it can rely on the information it receives from applicants and licensees. Accordingly, the NRC vigorously enforces this requirement. Civil penalties may be imposedforinadvertentlyprovidinginaccurateor incompleteinformationtotheNRC.Criminalpros- ecutionmaybeinitiatedforwillfulfalsestatements. To appreciate how violations of this require- ment may arise, it is useful to consider an actual recentviolation.Alicenseapplicationstatedthat aspecifiedlicenseerepresentativewouldbephys- ically present when shipments of radioactive materials were received at the licensed facility. TheNRClearnedthatthelicenseewasnotalways presentwhenshipmentswerereceivedandalerted the licensee of the need to honor this commit- ment. Later, during an inspection, the licensee wasaskedifhehadbeenpresentwhenshipments were received after the most recent interaction with the NRC.The licensee neglected to inform theinspectorthathehadnotbeenpresenttoreceive shipmentsaftertheinteractionwiththeNRC.This C o m m e n t a r y Under the new licensing guidance, most procedures are not required to be submitted to the NRC for review and approval.
  11. 11. 28N THE JOURNAL OF NUCLEAR MEDICINE • Vol. 42 • No. 5 • May 2001 NEWSLINE failure to inform the NRC inspector violated 10 CFR 50.7, because the omissions made the licensee’s response materially incomplete. An NRCdecisionontheregulatoryactiontotakefor theearlierfailurestobepresentwhenradioactive material was received clearly was materially affectedbythelicensee’sfailuretotakeadequate corrective actions. NRC LicenseApplication Guidance NRC license application guidance is impor- tant and useful to licensees, because the guid- ance translates the NRC’s philosophy, require- ments, and expectations into specific program elements. NRC guidance to licensees on apply- ing for a license is contained in NUREG-1556, Vol. 9, Consolidated GuidanceAbout Materials Licenses:ProgramSpecificGuidanceAboutMed- ical Use Licenses. Additional specific guid- anceiscontainedinRegulatoryGuideDG-0005, Application for Licenses of Broad Scope, and NUREG-1516, Effective Management of Radioactive Materials Safety Programs at Med- ical Facilities. NUREG-1556 supersedes all previous NRC guidance.The guidance in NUREG-1556 iden- tifies all of the information needed to complete NRC Form 313, Application for Materials License. Section 8 addresses each element in the application form. In particular, the appendices provide model compliance procedures, which, if adopted and implemented, are sure to result in compliance. An applicant’s use of NRC guidance is volun- tary. Guidance does not establish legal require- ments. A licensee may request the NRC staff to accept an alternative method of compliance on showing that the alternative provides an equiva- lent level of safety (9). However, the NRC has broad discretion to determine whether an alternative provides an equivalent level of safety. It is very difficult to challenge an NRC staff determination that an alternative does not meet this criterion. Use of the suggested wording in NUREG- 1556 will expedite NRC review (5).As a prac- tical matter, if the application does not fol- low NRC guidance, the review of a license or license renewal application may take longer than it otherwise would. When a licensee fol- lows its guidance, the NRC is able to quickly apply its checklists, which standardize and sim- plify the review process. When a licensee’s renewal application does not follow the NRC’s guidance, there is a substantial likelihood that NRC review will be delayed by requests for additional information about matters not addressed in the NRC guidance. Despite these considerations, if a licensee determines that the benefits of pursuing a compliance alter- native to the methods in the NRC’s guidance outweigh the costs of obtaining NRC approval of that alternative, then a licensee should pursue that alternative. Specific Aspects of License Renewal Although license renewal involves many details, a few issues are significant enough to warrant inclusion in a license renewal overview. Timely renewal ensures that the license will not expire until the NRC acts on the renewal appli- cation. Explicit acknowledgement of manage- ment’s responsibilities is critical to NRC con- fidence in licensees’compliance. Management also must clearly recognize the limited role of consultants. Finally, certain details must be addressed for a renewal application to be granted readily by the NRC. Timely Renewal Timely renewal is a general principle of administrative law that the NRC has adopted for all license renewals. Timely renewal protects the licensee from delay by providing that a license will continue in effect after its expiration date, as long as the licensee has applied for license renewal by the time spec- ified in the licensing regulations. Timely filing of a renewal application is necessary and sufficient to continue license after the expiration date. For medical licensees, timely renewal is pro- videdforin10CFR30.36(a).Itrequiresarenewal application to be filed at least 30 days before the license expiration date. After a renewal appli- cation has been filed in a timely manner, there is no limit on the license period until the applica- tion is acted on by the NRC. Management Responsibilities TheNRCholdslicenseemanagementrespon- sible for providing the leadership, oversight, andresourcesnecessaryforcompliance.Personal civil enforcement and criminal prosecution can result from management’s failure to honor com- mitments in a license application. For example, astatementinalicenseapplicationthatthesigner hasknowledgeofthelicenseapplicationcontents C o m m e n t a r y Reviewers will concentrate on licensee performance that indicates potential programmatic weaknesses and on major changes in program areas that affect radiation safety.
  12. 12. 30N THE JOURNAL OF NUCLEAR MEDICINE • Vol. 42 • No. 5 • May 2001 NEWSLINE ismaterialinformationtotheNRC.Accordingly, ifthepersonresponsibleforthebyproductmate- rial program signs the renewal application with- out reading it, an enforcement action can result. NRC review of a license renewal application should clearly show how the applicant licensee willcontinuetoimplementitsNRCresponsibil- ities. The application should briefly describe: managementcontrolsandoversightactivitiesfor maintainingcompliancewithNRCrequirements; written management delegations of adequate authority, freedom, and prerogative to the radia- tionsafetyofficer(RSO);and,whereapplicable, how written procedures for interdepartmental and/or interdisciplinary coordination establish effective communication. Role of Consultants Consultantsmaybeusedtohelptopreparethe renewal application and to support the radiation protection program. However, consultants can- not and do not assume management’s responsi- bilities to the NRC. Moreover, licensee man- agement is responsible for consultants’ actions andomissions.Licenseesaresubjecttoenforce- ment for their consultants’ violations, even if those violations were deliberate and licensee management had taken all reasonable steps, includingoversightandtraining,topreventsuch deliberate violations. LicenseApplication Details A license renewal application should include sufficient detail to enable the NRC to find a pro- gram adequate to protect the public health and safety.An initial investment in a sufficient level of detail should avoid potentially costly follow- up questions that also may lead to delay in issuance of the renewed license (10).Although delaymaynotbeimportantiftherenewedlicense will cover the same program as the current license, delay could be costly if it limits the abil- itytoconductnewactivitiesuntilthenewlicense is granted. A team approach to program management should be stressed. Clear roles and responsibili- ties should be described for program managers, the RSO, and the radiation safety committee (RSC). Describe the delegation of authority to the RSO and the training and experience of the byproductmaterialsusersandtheRSO.Theappli- cation must be signed by the program manager who is authorized to bind the institution and can provide the necessary resources. If proprietary information must be included, useanaffidavittoprotectitfromdisclosureunder the Freedom of InformationAct. Address the NRC’s concerns related to the description of facilities and equipment by dis- cussing the programmatic aspects of operations that use large quantities of materials, require preparation steps involving gases, liquids, and volatile radioactive materials, or involve uses of alpha emitters, high-energy photon emit- ters, and high-energy ß-emitters. In describ- ing the radiation protection program, address audit, occupational dose, public dose, contam- ination minimization, operating and emergency procedures, material receipt and accountabil- ity, transportation, and waste management. What the NRC Reviewer Looks For NRCguidancetoitslicensereviewershasbeen combinedandupdatedinNUREG-1556,Vol.20. A survey of that guidance shows that it directs NRCreviewerstofocustheirresourcesonexcep- tional situations. Reviewers will concentrate on licenseeperformancethatindicatespotentialpro- grammatic weaknesses and on major changes in program areas that affect radiation safety (6). Renewal Performance Indicators Prior performance will be assessed against four performance indicators (PIs). They are: enforcement history for the previous five years (including pending as well as escalated enforce- ment by the Office of Enforcement [OE] and ongoing investigations by the Office of Inves- tigations [OI]); loss of material; overexposure; and unauthorized disposal or release of mate- rial. If an enforcement action or OI investiga- tion is pending, a license will not be renewed unless the Director of either OE or OI, as appro- priate, agrees to the renewal (9). NRC Review Level NRC reviewers will structure their reviews of alicenserenewalapplicationinaccordancewith the number of PIs present. Three review levels arepossible:comprehensive,limited,andlimited focused.Thecriteriafordeterminingwhichreview level will be applied are discussed below. Reviewers usually will conduct a compre- hensive review of the renewal application if one or more PIs are present (11). A comprehensive review means that the scope of NRC review will be as extensive as the review of an applica- tion for a new license (12). This implies that a C o m m e n t a r y
  13. 13. 32N THE JOURNAL OF NUCLEAR MEDICINE • Vol. 42 • No. 5 • May 2001 NEWSLINE compliance strategy that avoids the PIs is a cost-effective compliance strategy. If no PIs are present, a limited review usually will be conducted by the NRC (11). A limited review focuses on administrative items, the con- tinuingadequacyofanyfinancialassurance,pro- gram management, organizational structure, key personnelqualifications,andequipmentandfacil- ities (13). Also to be considered is the possible needforanenvironmentalassessment,especially if the program will result in additional allowable exposures to members of the public. In certain cases, as determined by the NRC, it will exercise its discretion to conduct the level of review that it determines is appropriate (11). A limited review may be conducted despite the presenceofaPI,andacomprehensivereviewmay be conducted despite the absence of a PI. For example, where a licensee has had an escalated enforcement action and has responded by tak- ing comprehensive, effective corrective actions, the NRC may determine that the licensee has demonstrated sufficient regulatory awareness tonotrequireacomprehensivereviewofalicense application.Conversely,wherealicenseehashad ahistoryofminorviolationsthatneverrosetothe level of escalated enforcement, the NRC may determine that the licensee presents a regula- tory risk that must be thoroughly investigated before a license is renewed. In specific cases, the NRC staff has been directed to conduct a limited, focused review to givespecialattentiontospecificitems(13).Five circumstances have been identified as possible reasons for such limited, focused review. They are:newauthorizationsnotpreviouslyreviewed; new broad-scope authority or high-risk technol- ogy;changesincontroland/orownership;changes in key staff members responsible for the radia- tionsafetyprogram;andobvioussignificantand/or complex deficiencies in any particular applica- tionarea.BecausethisguidancetotheNRCstaff isclearlybasedontheNRC’sconcernsaboutpub- lic radiation exposures that either exceed reg- ulatory limits or are inadvertent, a licensee may convince the NRC to exercise its discre- tion and not conduct a limited, focused review by demonstrating in the renewal application how the compliance program will address any of the factors that could trigger such a focused review. Thus, a relatively modest investment in a detailed license application may cost effec- tively avoid a more costly limited, focused review of that license application. ––SheldonTrubatch, PhD, JD Foley & Lardner Washington, DC Part 2, which will appear in a future issue of Newsline, will detail a number of cost- effective strategies for meeting new license renewal criteria, including the institution of a variety of self-assessment procedures. REFERENCES 1. U.S.NuclearRegulatoryCommission.MethodologyandFindings of the Nuclear Regulatory Commission’s Materials Licensing Process Redesign. NUREG-1539.Washington, DC: NRC; 1996. 2. U.S. Nuclear Regulatory Commission. Medical uses of byprod- uct material, policy statement revision. Fed Reg. August 3, 2000;65:47654. 3. U.S. Nuclear Regulatory Commission. Consolidated Guidance About Material Licenses. NUREG-1556. Washington, DC: NRC; 1996. 4. U.S.NuclearRegulatoryCommission.Licensetermformedical use licenses. Fed Reg. February 6, 1997;62:5656. 5. U.S. Nuclear Regulatory Commission. Consolidated Guidance AboutMaterialLicenses,GuidanceAboutAdministrativeLicens- ingProcedures.NUREG-1556.Vol.20.Washington,DC:NRC; 1999:Section 4.1. 6. U.S. Nuclear Regulatory Commission. Consolidated Guidance About Material Licenses, GuidanceAboutAdministrative Licens- ing Procedures. NUREG-1556.Vol. 20.Washington, DC: NRC; 1999:Section 4.4. 7. U.S. Nuclear Regulatory Commission. Consolidated Guid- ance About Material Licenses, Program Specific Guidance About Medical Use Licensees. NUREG-1556. Vol. 9. Wash- ington, DC: NRC; 1997. 8. U.S. Nuclear Regulatory Commission. Staff Requirements Memorandum on SECY-00-0121. Washington, DC: NRC; July 13, 2000. 9. U.S. Nuclear Regulatory Commission. Consolidated Guid- ance About Material Licenses, Guidance About Administrative LicensingProcedures. NUREG-1556.Washington, DC: NRC; 1999;20:Section 4.2. 10. U.S. Nuclear Regulatory Commission. Consolidated Guid- ance About Material Licenses, Guidance About Adminis- trative Licensing Procedures. NUREG-1556. Washington, DC: NRC; 1999;20:Section 4.5. 11. U.S. Nuclear Regulatory Commission. Consolidated Guid- ance About Material Licenses, Guidance About Adminis- trative Licensing Procedures. NUREG-1556. Vol. 20. Wash- ington, DC: NRC; 1999;20:Section 4.4.1. 12. U.S. Nuclear Regulatory Commission. Consolidated Guid- ance About Material Licenses, Guidance About Adminis- trative Licensing Procedures. NUREG-1556. Washington, DC: NRC; 1999;20:Section 4.4.3. 13. U.S. Nuclear Regulatory Commission. Consolidated Guid- ance About Material Licenses, Guidance About Adminis- trative Licensing Procedures. NUREG-1556. Washington, DC: NRC; 1999;20:Section 4.4.4. C o m m e n t a r y …a licensee may convince the NRC to exercise its discretion and not conduct a limited, focused review by demonstrating in the renewal application how the compliance program will address any of the factors that could trigger such a focused review.
  14. 14. NRC Part 35 to OMB. The Nuclear Reg- ulatory Commission (NRC) has sent Part 35 to the Office of Management and Budget (OMB) for review. In the filing, the NRC esti- mates the cost of compliance with the new rule at approximately $127 million. In a detailed analysis submitted to OMB, the Society of Nuclear Medicine (SNM) and the American College of Nuclear Physicians (ACNP) have challenged this estimate, pegging first-year costs to the nuclear medicine community at $494 million and recurring annual costs at $127 million. These costs were equated to the pur- chase of 247 dedicated PET scanners in the first year and an additional 63 dedicated PET scanners in each successive year—expendi- tures that would advance the health and wel- fare of the public rather than generating addi- tional bureaucratic reports and records to demonstrate the continued low risk of nuclear medicine. On April 16, the NRC denied an SNM/ACNP petition submitted on January 3 to reduce the regulation of diagnostic nuclear medicine; SNM and ACNP will continue to press this issue with Congress. PET Coverage. The Health Care Financing Administration (HCFA) announced on April 11 that it would be postponing until May 4 a deci- sion on inclusion of coincidence imaging in recently extended PET coverage. The SNM and ACNP have joined with Institute for Clinical PET/AcademyofMolecularImagingandsystem manufacturerstoaskthatrestrictionsannounced intheDecembermemorandumbeeasedandthat coincidenceimagingbeincludedinthenewreim- bursementplan.ActingonbehalfoftheSNMand ACNP, Drs. Abreu, Conti, Gupti, and Lull have conferenced with HCFA representatives, bring- ing to their attention additional data demon- strating that coincidence PET compares favor- ably with dedicated PET. HCFA has announced that the Medicare CoverageAdvisoryCommitteeDiagnosticImag- ing Panel will meet in Baltimore on June 19 to consider additional coverage for PET and breast cancer. SNM andACNP representatives will be presenting to the panel. A Different Kind of Coverage. Newspapers serving more than 11 million readers around the country picked up on the report in the Decem- ber issue of The Journal of Nuclear Medicine (JNM) that PET can be an effective diagnostic toolforidentifyingAlzheimer’sdisease,particu- larlyindistinguishingitfromotherdementias.In additiontoprovidingradiospotsfeaturingnuclear medicineprocedures,theSNMperiodicallypro- duces press releases highlighting important new findings appearing in JNM. CARE Act Introduced. Congresswoman Heather Wilson (R–NM) has reintroduced the ConsumerAssurance of Radiologic Excellence billintothe107thCongress.Firstintroducedlast fall by Congressman Rick Lazio (R–NY), the bill calls for state licensure of all personnel who perform diagnostic imaging examinations and who plan and deliver radiation therapy pro- cedures.Tohighlightthebill’sintroduction,mem- bers of the Alliance for Quality Medical Imag- ing and Radiation Therapy went to Capitol Hill on March 1 to ask members of their congres- sionaldelegationtojoinassponsors.SNMTech- nologist Section President Kristen Waterstram- Rich, President-Elect Mickey Clarke, Government Relations Chair Lynne Roy, and members Lenna Delitis-King and Danny Basso have all made visits to the Hill in March. The Alliance is still seeking a Senate sponsor for the bill. ––William Uffelman Director, SNM PublicAffairs General Counsel, SNM NEWSLINE 34N THE JOURNAL OF NUCLEAR MEDICINE • Vol. 42 • No. 5 • May 2001 PUBLIC AFFAIRS UPDATE
  15. 15. FDA Guidance on Foreign Clinical Studies OnMarch15,theU.S.FoodandDrug Administration (FDA) released a brief guideline statement outlining con- ditions under which data from clinical studies performed outside the United States can be used to support applica- tions for marketing approval. Guidance forIndustryAcceptanceofForeignClin- icalStudies(www.fda.gov/cder/guidance/ index.htm) clarifies existing FDA requirements. In October 2000, the World Medical Association revised similar requirements that form part of the Declaration of Helsinki. The FDA noted that its own document was intended “to clarify that the action of theWorld MedicalAssociation did not change FDA regulations.” The document reaffirmed that FDA regulations permit the acceptance of foreign clinical studies in support of an application for marketing approval of a human drug, biological product, or device if certain conditions are met. Foreign studies performed under an investigational new drug application (IND) or investigational device exemp- tion (IDE) must meet the same require- ments of 21 CFR Part 312 or 21 CFR Part 812, respectively, that apply to U.S. studies conducted under an IND or IDE. Under 21 CFR 312.120(c)(1), the FDA will accept a foreign clinical study not conducted under an IND only if the study conforms to the ethical principles contained in the Declaration of Helsinki (Declaration), as set out in 21 CFR 312.120(c)(4), incorporating the 1989 version of the Declaration, or with the laws and regulations of the country in which the research was conducted, whichever provides greater protection of the human participants. Although the FDA made no changes after the recent amendments to the Declaration of Helsinki, the guidance document concluded with the note that the “FDA is currently reviewing its regulations pertaining to the accep- tance of foreign clinical studies, to determine if it should revise those reg- ulations to incorporate new or modi- fied standards or requirements.” PET Gives New Insights on Dyslexia An international team of Italian, French, and British researchers recently published results of a study using PET to compare the physio- logical presentation of dyslexia with the more variable culture-specific manifestations (Dyslexia: cultural diversity and biological unity. Science. March 16, 2001;291:2165–2167). Dr. E. Paulesu, of the University of Milan Bicocca, Italy, and his coauthors stud- ied 72 individuals, of whom 36 had been labeled dyslexic and 36 as nondyslexic. Each group contained 12 English speakers, 12 French speak- ers, and 12 Italian speakers.The study was undertaken, the authors note, because “the recognition of dyslexia as a neurodevelopmental disorder has been hampered by the belief that it is not a specific diagnostic entity because it has variable and culture- specific manifestations.” While reading, all individuals labeled as dyslexic (regardless of lan- guage spoken) showed the same reduced activity in a region of the left hemisphere, with the maximum peak in the middle temporal gyrus and addi- tional peaks in the inferior and supe- rior temporal gyri and middle occip- ital gyrus.The authors concluded that there is a universal neurocognitive basis for dyslexia. However, differ- ences in languages (orthographies) are believed to account for the fact that some countries have far lower per- centages of individuals identified as dyslexic. Italian, for example, is said to have a “shallow orthography” (or simple language structure), and read- ing is actually easier for Italian speak- ers than for speakers of English. Indi- viduals showing the same levels of reduced activity on PET may, in fact, have radically different manifestations of dyslexia, depending on the lan- guages they speak and read. ICANL and SNM Accreditation Programs to Merge TheboardsofdirectorsoftheSociety ofNuclearMedicine(SNM)andthe IntersocietalCommissionfortheAccred- itation of Nuclear Medicine Laborato- ries (ICANL) have voted to incorpo- rate the SNM accreditation program (purchased from American College of Nuclear Physicians one year ago) into ICANL management and marketing structure. The merging of the two pro- gramswillprovideacomprehensivepro- gramforaccreditingbothnuclearcardi- ologyandnuclearmedicinelaboratories usingon-siteinspections.Thefinalmerg- ingoftheprogramsisplannedfornolater thanJulyof2002,untilwhichtimeSNM will continue to market and promote its current program. Laboratories accred- itedbytheSNM/ACNPprogramwillbe granted accreditation automatically in theneworganization,toprovideaseam- less transition. The SNM is a charter member of ICANL, which was founded four years ago to provide an independent accredit- ing structure for nuclear medicine labo- ratory facilities. To date, it has concen- trated on cardiovascular facilities. The inclusion of nuclear medicine programs will enhance significantly the organiza- tion’sprofilewithinthecommunity.SNM isrepresentedontheICANLboard,asare theAmerican Society of Nuclear Cardi- ology, the SNM Technologist Section, ACNP,andtheAmericanCollegeofCar- diology (ACC). Conjoint Government Affairs Committee Hires Contractors The joint Government Affairs Com- mittee formed by SNM and ACNP several years ago has signed contracts with two prominent industry advocates topromotethelegislativeandregulatory agenda of the nuclear medicine com- munity. Concentrating on opposing the Newsline 35N NEWSLINE N e w s b r i e f s
  16. 16. by descriptions of practices that are unique to this region.Areas cov- eredwillincludepulmonaryimagingusingTechnegas,pediatricdiuretic renographyforassessingrenaltractobstruction,andinfection/inflam- mation imaging using 99mTc stannous colloid-labeled white cells. DifferentiatedThyroid Cancer: Tuesday, June 26 Diagnosis,Treatment, and Follow-Up: ReadWith the Experts Continuing education course 2:30–4:00 PM Sponsored by the EANM Thiscourseisdesignedforphysiciansinvolvedinthediagnosisand treatmentofdifferentiatedthyroidcancer.Participantsshouldbefamil- iarwiththeprinciplesandmethodsofdiagnosisandfollow-upofthy- roid cancer.They also should be familiar with tumor types andTNM classificationofthyroidcancer.Thecourseisdesignedforphysicians with backgrounds in nuclear medicine and thyroid endocrinology. Movement Disorders:A New Role Tuesday, June 26 for Nuclear Medicine and SPECT Continuing education course 2:30–4:00 PM Sponsored by the EANM Thiscoursewillcovertheanatomo-pathologyofthebasalganglia anditsrelationshiptoclinicalpresentationinpatientswithmovement disorders. Parkinson’s disease will be used as the disease model. Thedopaminergicsystemwillbediscussedwithemphasisonrecent advancesinneuroimagingandradioligandsspecificforthepre-synap- ticdopaminetransportersystemandpostsynapticdopamineD2recep- tors.Patternsofradioliganddistributionwillbedescribedandguide- lines for producing an effective clinical report will be given. Quantitative Brain Perfusion Wednesday, June 27 SPECT Imaging for Management ofAcute Stroke Continuing education course 8:00–9:30 AM Sponsored by the Japanese Society of Nuclear Medicine ThiscourseisorganizedasajointprogramwiththeJapaneseSoci- etyofNuclearMedicinetodemonstratenuclearmedicineprocedures thatareperformedroutinelyinJapan. BrainperfusionSPECTimag- ing is widely employed in clinical settings, using three radiotracers currentlyavailableinJapan.Attendeeswilllearnbasictechniquesfor brain perfusion SPECT imaging, as well as clinical applications for cerebrovascular diseases. Inflammatory Joint Diseases Wednesday, June 27 and SpondylitisAnkylosans Continuing education course 9:45–11:15 AM Sponsored by the EANM Cutting-edge issues in the diagnosis and treatment of ankylosing spondilitis and other inflammatory joint diseases will be presented by an international team of experts. removal by the Health Care Financing Administration of coincidence cam- eras from coverage under the current reimbursement policy. They have also promotedtheSNM/ACNPNuclearReg- ulatory Commission (NRC) petition to removethemedicalprogramfromNRC jurisdiction and the Office of Manage- mentandBudget(OMB)reviewofPart 35 regulation. SNM and ACNP are increasing their advocacy activities on behalf of nuclear medicine and its prac- titioners.The firms now under contract include Roy W. Brown Consulting and Mintz, Levin, Cohen, Ferris, Glovsky, and Popeo. SNM Sponsor for Medical Physics Education Programs The Commission on Accreditation of Medical Physics Education Pro- grams, Inc. (CAMPEP) has approved an application for SNM to be recog- nized as an organization that can spon- sor medical physics continuing educa- tion (MPCEC) activities. Previously, SNM could provide credits only for medical physics programs in cospon- sorship with CAMPEP. WFNMB Meeting to Carry AMA PRA Category 1 Credit The World Federation of Nuclear Medicine and Biology (WFNMB), working with SNM staff, has been granted American Medical Associa- tion (AMA) Physician’s Recognition Award category 1 credit for its meet- ing in Santiago, Chile, in October 2002. The meeting will be the first international imaging meeting to be granted Category 1 credit in the five- year history of the AMA accredit- ing program.The accreditation, which requires extensive preparation, is based upon “excellence in content and scope of topics presented, supe- rior organization of the application and corresponding materials, and strict policies surrounding disclosure of commercial support.” Plans for the World Congress, last held in Berlin in 1998, are well along under the stewardship of a distin- guished international committee chaired by Dr. Horacio Amaral, the President of the WFNMB. Dr. Patri- cio Gonzalez, Secretary General of the Federation, is responsible for the scientific program that resulted in the AMA accreditation. Members of the International Scientific Com- mittee include Dr. William Strauss (United States); Dr. Ismael Mena (Chile); Dr. Hans Biersack (Ger- many); Dr. Peter Ell (Great Britain); Dr. Mario Iturralde (Italy); and Dr. Junji Konishi (Japan). 36N THE JOURNAL OF NUCLEAR MEDICINE • Vol. 42 • No. 5 • May 2001 NEWSLINEN e w s b r i e f s (Continued from page 19N) International Focus Continues at SNM 2001