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1 Plicy Medical Plicy Manual Draft Revised Plicy: D Nt Implement Psitrn Emissin Tmgraphy (PET) fr Onclgic Applicatins DESCRIPTION Psitrn Emissin Tmgraphy (PET), als called PET imaging r a PET scan, is a frm f nuclear medicine imaging. PET imaging is based n the use f psitrn emitting radinuclide tracers cupled t rganic mlecules such as glucse, ammnia, r water. The radinuclide tracers simultaneusly emit tw high-energy phtns in ppsite directins that can be simultaneusly detected by a PET scanner. The PET scanner cnsists f multiple detectrs that encircle the area f interest. A variety f tracers are used fr PET scanning including xygen-15, nitrgen-13, carbn-11, and flurine-18. The mst cmmnly used raditracer in nclgy imaging is flurine-18 cupled with flurdexyglucse (FDG). FDG has a metablism related t glucse metablism. It has been cnsidered ptentially useful in cancer imaging, since tumr cells shw increased metablism f glucse. Prpsal is t add wrds r statements in red and delete wrds r statements with strikethrugh. POLICY Psitrn emissin tmgraphy (PET) scans fr the nclgical applicatins listed belw are cnsidered medically necessary if the medical apprpriateness criteria are met: Adrenal Tumrs Anal Cancer Bne Cancers Breast Cancer Castleman s Disease Central Nervus System Tumrs Cervical Cancer Esphageal Cancer Gastric Cancer Gastrintestinal/Pancreatic Neurendcrine Cancers Gastrintestinal Strmal Tumr Head and Neck Cancers Hematpietic Stem Cell Transplantatin Hepatcellular Carcinma/Biliary Tumrs Langerhans Cell Histicytsis (LCH) Leukemia (Chrnic Lymphcytic (CLL) Lung Cancers Lymphmas Medullblastma, Supratentrial Primitive Neurectdermal Tumrs, and Pineblastma Melanmas and ther Skin Cancers Metastatic Cancer, Carcinma f Unknwn Primary Site, & Other Types f Cancer Multiple Myelma and Plasmacytmas Neurblastma Ovarian Cancer Pancreatic Cancer Paraneplastic Syndrmes Prstate Cancer Rhabdmysarcma Salivary Gland Cancer Sft Tissue Sarcmas This dcument has been classified as public infrmatin

2 Plicy Medical Plicy Manual Draft Revised Plicy: D Nt Implement Testicular and Nnepithelial Ovarian Cancer (Germ Cell Cancer) Thracic Cancers (Other than Esphageal and Lung) Thyrid Cancers Transitinal Cell Cancer Wilms Tumr Psitrn emissin tmgraphy (PET) scans fr the fllwing applicatins are cnsidered investigatinal: General Guidelines When imaging lesins less than 8 mm in size Surveillance imaging (unless specifically stated in the criteria) Distant r diffuse metastatic disease Metastatic disease in the central nervus system (CNS) Fllw-up after lcalized therapy (e.g., radifrequency ablatin, emblizatin, steretactic radiatin) Breast When used fr nn-invasive breast cancers When bvius multi-rgan metastatic disease is present PET mammgraphy When used fr surveillance Esphageal When used fr surveillance Gastrintestinal Nn-invasive carcinmas Carcinmas cntained within a plyp Cln cancer that is cmpletely resected and lymph nde negative Anal margin carcinmas T1 gastric cancers Fllwing cmplete resectin f gastrintestinal strmal tumr (GIST) Liver lesins less than 1 cm in individuals withut a prir histry f cnfirmed malignancy When used fllwing interventinal radilgy prcedures invlving liver lesins, such as radifrequency ablatin (RFA) When used fllwing pstperative adjuvant chemtherapy with the fllwing: Resectin has remved all knwn grss disease Markers are nt elevated When used in the setting f bvius multi-rgan metastatic disease Gyneclgic Cancers Endmetrial cancer Vulvar cancer Vaginal cancer Uterine cancers Nn-invasive cervical cancer External genitalia cancer Head and Neck (Squamus cell carcinmas f the head and neck) When used t determine the need fr neck dissectin fr individual with newly diagnsed head and neck cancer This dcument has been classified as public infrmatin

3 Plicy Medical Plicy Manual Draft Revised Plicy: D Nt Implement When used fr restaging f cancers f the head and neck when surgery is the primary treatment mdality (e.g. cmplete resectin/ radical neck dissectin) When cmplete respnse r prgressin is clearly bvius n physical examinatin When used fr salivary gland tumrs When used as a substitute fr panendscpy Leukemia (acute lymphblastic, acute myelid, and chrnic myelid) Lungs When using serial PET scans t evaluate lung ndules When ther imaging mdalities have cnfirmed skeletal disease metastasis frm ther primary sites (i.e. lung, breast, prstate, renal cell and ther urgenital cancers) Metastatic nn-small cell disease utside chest cavity (e.g., malignant pleural/pericardial effusin) When ther imaging shws extensive staged disease in small cell carcinma Fr restaging fr the fllwing: When surgery was the primary treatment and all knwn tumr was resected When tumrs were initially treated with radiatin therapy as the nly treatment mdality Melanma and Other Skin Cancers Fr rutine surveillance in all skin cancers (including melanma) fr asymptmatic individuals Miscellaneus (Carcinmas f unknwn primary site, sft tissue sarcma, generalized lymphadenpathy and mediastinal abnrmalities/ lymphadenpathy, liver lesins, adrenal lesins and neurendcrine lesins) When used fr surveillance and fr rutine bdy imaging f lymph ndes When used fllwing cmplete resectin When used fr generalized lymphadenpathy and mediastinal abnrmalities prir t histlgic diagnsis Prstate Cancer Primary brain tumrs Fr detectin, initial wrk up r staging fr primary brain tumrs Fr the use f FDG-PET in the evaluatin f metastatic depsits and well-differentiated brain tumrs Salivary Gland Cancers Renal Cell Cancer Skin Cancers (Nn-Melanma) Unless specifically addressed within the plicy criteria (e.g., Merkel cell carcinma) Uterine Cancer MEDICAL APPROPRIATENESS Psitrn emissin tmgraphy (PET) fr nclgical applicatins is cnsidered medically apprpriate if ANY ONE f the fllwing are met: Adrenal Tumrs with ANY ONE f the fllwing met: Initial wrkup r initial staging with ALL f the fllwing met: This dcument has been classified as public infrmatin

4 Plicy Medical Plicy Manual Draft Revised Plicy: D Nt Implement Phechrmcytma, paraganglima, r paraganglineurma r adrencrtical carcinma Cntinued suspicin with negative r incnclusive imaging PET results will direct immediate care decisins Restaging r recurrence with ALL f the fllwing met: Cntinued suspicin with negative r incnclusive imaging Anal Cancer with ANY ONE f the fllwing met: Initial wrkup r initial staging with ALL f the fllwing met: Stage II - IV squamus cell carcinma f the anal canal Restaging r recurrence with ALL f the fllwing met: Stage III r IV squamus cell carcinma f the anal canal Bipsy prven recurrence Incnclusive cnventinal imaging Hepatcellular Carcinma (HCC) / Biliary Tumrs (Primary) with ANY ONE f the fllwing met: Initial wrkup r initial staging with ALL f the fllwing met: Primary biliary carcinma (bipsy is nt required; liver lesin with AFP >20 is adequate fr imaging) N evidence f metastatic disease by cnventinal imaging T determine if individual is a surgical candidate Bne Sarcma Chrdma with ANY ONE f the fllwing met: Initial wrkup r initial staging with incnclusive cnventinal imaging Restaging r recurrence with ALL f the fllwing met: Cmpletin f raditherapy r every 2 cycles f chemtherapy Incnclusive cnventinal imaging Bne Cancer - Ewing Sarcma and Primitive Neurectdermal Tumrs with ANY ONE f the fllwing met: Initial staging with ALL f the fllwing met: Plain X-ray has been perfrmed Histlgic diagnsis has been established Treatment respnse with ALL f the fllwing met: Distant bne metastasis with ANY ONE f the fllwing met: After every 2 cycles f chemtherapy End f planned chemtherapy Restaging with ANY ONE f the fllwing met: After apprximately 12 weeks f neadjuvant chemtherapy and prir t lcal cntrl surgery t cnfirm the absence f disease prgressin Fllwing lcal cntrl surgery and planned chemtherapy Surveillance with ALL ANY ONE f the fllwing met: Cnventinal imaging incnclusive r suspicius fr recurrence and PET avidity will determine whether bipsy r cntinued bservatin is apprpriate PET will determine whether bipsy r cntinued bservatin is apprpriate Obvius clinical symptms shw strng evidence suggesting recurrence (PET culd replace cnventinal imaging) Restaging after bipsy-cnfirmed recurrence Bne Cancer - Ostegenic Sarcma with ANY ONE f the fllwing met: Initial staging with ALL f the fllwing met: Plain X-ray has been perfrmed This dcument has been classified as public infrmatin

5 Plicy Medical Plicy Manual Draft Revised Plicy: D Nt Implement Histlgic diagnsis has been established Treatment respnse with ANY ONE f the fllwing met: Distant bne metastasis with ANY ONE the fllwing met: After every 2 cycles f chemtherapy End f planned chemtherapy Restaging with ANY ONE f the fllwing met: After weeks f neadjuvant chemtherapy and prir t lcal cntrl surgery t cnfirm absence f disease prgressin Distant bne metastasis with ANY ONE f the fllwing met: Fllwing lcal cntrl surgery, whle bdy PET/CT every 4 mnths End f planned chemtherapy Breast Cancer with ANY ONE f the fllwing met: Initial wrkup r initial staging when CT and /r bne scan are incnclusive Restaging r recurrence with ALL f the fllwing met: Incnclusive CT, MRI, and/r bne scan fr suspected recurrence Further characterizatin is needed t make treatment decisins Stage IV disease with ALL f the fllwing met: Bne metastasis nly site f Stage IV disease (excluding brain mets) Prir bne scan has nt been perfrmed fr serial cmparisn Carcinma f Unknwn Primary Site with ANY ONE f the fllwing met: Carcinma fund in lymph nde r rgan knwn nt t be primary and ANY ONE f the fllwing studies have failed t demnstrate site f primary: CT Chest and Abdmen/Pelvis with cntrast CT Neck with cntrast if cervical r supraclavicular invlvement CT with cntrast f any ther symptmatic site MRI with and withut cntrast f any ther symptmatic site Diagnstic (nt screening) mammgram and full pelvic exam MRI bilateral breasts if pathlgy cnsistent with breast primary and mammgram is incnclusive Sebaceus carcinma f the skin and ANY ONE f the fllwing studies have failed t demnstrate site f primary: CT Chest and Abdmen/Pelvis with cntrast CT Neck with cntrast if cervical r supraclavicular invlvement CT with cntrast f any ther symptmatic site MRI with and withut cntrast f any ther symptmatic site Axillary adencarcinma if ANY ONE f the fllwing studies have failed t demnstrate site f primary: CT Neck, Chest, and Abdmen with cntrast CT with cntrast f any ther symptmatic site MRI with and withut cntrast f any ther symptmatic site Diagnstic (nt screening) mammgram and full pelvic exam MRI bilateral breasts if pathlgy cnsistent with breast primary and mammgram is incnclusive Castleman s Disease with ANY ONE f the fllwing met: Initial staging with ALL f the fllwing met: Prir CT suggests unicentric disease Surgical resectin being cnsidered PET/CT t cnfirm unicentric disease Restaging r recurrence with ANY ONE ALL f the fllwing met: Indicated fr ANY ONE f the fllwing: This dcument has been classified as public infrmatin

6 Plicy Medical Plicy Manual Draft Revised Plicy: D Nt Implement Multicentric disease Surgically unresected unicentric disease after every 2 cycles f chemtherapy Surgically nn-resected unicentric disease being treated with chemtherapy every 2 cycles with Indicated fr ANY ONE f the fllwing: Suspected recurrence Recurrent B symptms Rising LDH/IL-6/VEGF levels Central Nervus System Tumrs - Lw Grade Glima (WHO histlgic grade f I r II) with ALL f the fllwing met: Initial staging with PET brain metablic imaging with ANY ONE f the fllwing met: Transfrmatin t high grade glima is suspected based n symptms r recent MRI findings Evaluate a brain lesin f indeterminate nature Central Nervus System Tumrs High Grade Glima (WHO histlgic grade f III r IV) with ALL f the fllwing met: Initial staging with PET brain metablic imaging with ANY ONE f the fllwing met: T distinguish radiatin-induced tumr necrsis frm prgressive disease within 18-mnths f cmpleting raditherapy T evaluate incnclusive MRI findings t determine need fr bipsy r change in therapy, including a change frm active therapy t surveillance T evaluate a brain lesin f indeterminate nature Cervical Cancer with ANY ONE f the fllwing met: Initial wrkup r initial staging with ANY ONE f the fllwing met: Stage IB1 r less (<4 cm cnfined t the cervix) if ther advanced imaging studies incnclusive Stage IB2 r higher if radiatin therapy is t be primary treatment mdality Any size cervical cancer with ALL f the fllwing met: Incidentally fund in a hysterectmy specimen Incnclusive cnventinal imaging Restaging r recurrence with ALL ANY ONE f the fllwing met: Incnclusive cnventinal imaging with ANY ONE f the fllwing: Difficult r abnrmal examinatin Elevated LFTs Signs r symptms f recurrence Radiatin r chemtherapy is primary therapy and surgical salvage is treatment ptin Clrectal Cancer Initial wrkup r initial staging with ANY ONE f the fllwing met: Islated metastatic lesin(s) n ther imaging and individual is ANY ONE f the fllwing: Candidate fr aggressive surgical resectin Candidate fr ther lcalized treatment f metastasis fr curative intent Incnclusive cnventinal imaging Restaging r recurrence with ANY ONE f the fllwing met: Pstperative elevated r rising CEA r LFTs with negative recent cnventinal imaging Islated metastatic lesin(s) n cnventinal imaging and individual is ANY ONE f the fllwing: Candidate fr aggressive surgical resectin Candidate fr lcalized treatment t metastasis with curative intent Differentiate lcal tumr recurrence frm pstperative and/r pst-radiatin scarring Esphageal Cancer This dcument has been classified as public infrmatin

7 Plicy Medical Plicy Manual Draft Revised Plicy: D Nt Implement Initial wrkup r initial staging with ALL f the fllwing met: Bipsy prven Prir t start f neadjuvant therapy in preparatin fr surgery N evidence f metastatic disease by cnventinal imaging Restaging r recurrence with ANY ONE f the fllwing met: Cnventinal imaging is incnclusive Salvage surgical candidate with recurrence and n metastatic disease dcumented by cnventinal imaging After cmpletin f radiatin therapy with ALL f the fllwing: Recent CT findings are incnclusive PET findings will alter immediate care decisin making PET imaging dne as early as 6 weeks after cmpletin f radiatin therapy Extrathracic Small Cell Carcinma Metastases with ANY ONE f the fllwing met: Initial staging with ALL ANY ONE f the fllwing met: N evidence f metastatic disease Cnventinal imaging is incnclusive fr determining lcalized vs distant metastatic disease Gastric Cancers with ANY ONE f the fllwing met: Initial wrkup r initial staging with ALL f the fllwing met: Stage equal t r greater than T2 N metastatic disease by cnventinal imaging Restaging r recurrence with incnclusive findings n cnventinal imaging Gastrintestinal Strmal Tumr (GIST) with ANY ONE f the fllwing met: Initial wrkup r initial staging with incnclusive cnventinal imaging Restaging r recurrence with incnclusive cnventinal imaging Treatment respnse with incnclusive cnventinal imaging Head and Neck Cancer Squamus Cell Carcinma with ANY ONE f the fllwing met: Squamus Cell Carcinma Suspected diagnsis with ANY ONE f the fllwing met: T determine a mre favrable site fr bipsy when prir bipsy was nndiagnstic T determine a mre favrable site fr bipsy when a relatively inaccessible site is cntemplated which wuld require invasive surgical interventin fr bipsy attempt Naspharyngeal (NPC) Cancer Initial wrkup r initial staging with ANY ONE f the fllwing met: Knwn stage III r IV disease Naspharyngeal primary site Incnclusive cnventinal imaging (CT, MRI) Prir t start f primary chemraditherapy and have nt undergne definitive surgical resectin T direct laryngscpe/exam under anesthesia fr bipsy Pulmnary ndule(s) 8 mm in size Cervical lymph nde bipsy psitive fr squamus cell carcinma and n primary site identified n CT r MRI Incnclusive findings suggestive f disease utside the head and neck area Restaging r recurrence with ALL ANY ONE f the fllwing met: Fllwing primary chemraditherapy fr Stage III r IV disease (n sner than 12 weeks fllwing radiatin therapy) with ANY ONE f the fllwing met: Evaluatin fr salvage surgery/radical neck dissectin in individuals with measurable residual disease n physical exam r n recent CT r MRI Distinguish active tumr frm radiatin fibrsis Incnclusive cnventinal imaging (CT r MRI) This dcument has been classified as public infrmatin

8 Plicy Medical Plicy Manual Draft Revised Plicy: D Nt Implement Bipsy prven lcal recurrence Hematpietic Stem Cell Transplantatin with ANY ONE f the fllwing met: Pst-Transplant with ANY ONE f the fllwing met: Incnclusive cnventinal imaging at Day +100 Tandem autlgus transplants (2-4 autlgus transplants back-t-back, spaced 6-8 weeks apart) PET permitted fllwing each separate transplant Langerhans Cell Histicytsis (LCH) with ANY ONE f the fllwing met: Multifcal bne invlvement bserved n skeletal survey Bne pain and negative skeletal survey Oher clinical symptms suggesting multisite disease Recurrence evaluatin Leukemia (Chrnic Lymphcytic (CLL) and Small Lymphcytic Lymphma (SLL) with ALL f the fllwing met: Suspected transfrmatin (Richter s) frm a lw grade lymphma t a mre aggressive type with ANY ONE f the fllwing met: New B symptms (e.g., fever, night sweats, unintended weight lss f > 10%) Rapidly grwing lymph ndes Extrandal disease develps Significant recent rise in LDH abve nrmal range Lung Cancer Nn-Small Cell (NSCLC) with ANY ONE f the fllwing met: Suspected r actual diagnsis with ANY ONE f the fllwing met: Evaluate pulmnary ndule measuring 8 mm (0.8 cm) t 30 mm (3 cm) seen n CT r MRI Evaluate pulmnary mass measuring 31 mm (3.1 cm) r greater seen n CT r MRI with ANY ONE f the fllwing met: Prir t bipsy when resectin will be perfrmed instead f bipsy if PET cnfirms limited disease Prir t bipsy if multiple pssible bipsy ptins are present t determine mst favrable site Initial wrkup r initial staging with ANY ONE ALL f the fllwing met: PET was nt perfrmed prir t histlgical diagnsis Indicated fr ANY ONE f the fllwing: All Stage I - IIIB disease Stage IV disease cnfined t the chest regin (pleura/pericardium r slitary site including lung ndules) Cnventinal imaging is incnclusive T cnfirm slitary fcus f metastatic disease (i.e., brain r adrenal) if being cnsidered fr aggressive surgical management Restaging r recurrence with ANY ONE f the fllwing met: Suspected r bipsy prven recurrence lcalized t the chest cavity Newly identified abnrmalities lcalized t chest cavity n cnventinal imaging Incnclusive findings n cnventinal imaging Differentiate tumr frm radiatin scar/fibrsis Lung Cancer Small Cell (SCLC) with ANY ONE f the fllwing met: Early staging with ALL f the fllwing met: Cnfirm limited stage disease (nn-metastatic) Initial staging imaging (CT and MRI) shwed disease limited t the thrax This dcument has been classified as public infrmatin

9 Plicy Medical Plicy Manual Draft Revised Plicy: D Nt Implement Lymphma Anaplastic Large Cell with ANY ONE f the fllwing met: Initial staging r initial diagnsis Clinical suspicin f skull r distal lwer extremity invlvement Treatment respnse as ften as every 2 cycles f chemtherapy Clarify incnclusive findings detected n cnventinal imaging Lymphma Burkitt s with ANY ONE f the fllwing met: Initial staging r initial diagnsis Clinical suspicin f skull r distal lwer extremity invlvement Evaluate treatment respnse, as ften as every cycle f chemtherapy End f chemtherapy and/r end f radiatin therapy evaluatin Evaluate suspected recurrence with incnclusive cnventinal imaging Lymphma - Central Nervus System (als knwn as Micrglima) with ANY ONE f the fllwing met: Initial staging t cnfirm CNS primary when CT results are incnclusive Lymphma Cutaneus (includes Peripheral T-Cell, Primary Cutaneus B Cell, Mycsis Fungides/Sézary Syndrme, Primary Cutaneus CD30+T Cell Lymphprliferative Disrders) with ANY ONE f the fllwing met: Initial staging r initial diagnsis End f chemtherapy and/r radiatin evaluatin Lymphma Diffuse Large B Cell (DLBCL), Grade 3 Fllicular, Grey Zne, Primary Mediastinal B Cell, Pst-Transplant Lymphprliferative Disrder and Viral-Assciated Lymphprliferative Disrder with ANY ONE f the fllwing met: Initial staging r initial diagnsis Clinical suspicin f skull r distal lwer extremity invlvement Treatment respnse as frequently as every tw cycles f therapy End f chemtherapy and/r end f radiatin therapy evaluatin Suspected r bipsy-cnfirmed recurrence Clarify incnclusive findings n cnventinal imaging Lymphma Fllicular (WHO Grade 1-2) with ANY ONE f the fllwing met: Initial staging r initial diagnsis if radiatin therapy is being cnsidered fr Stage I r II disease End f therapy evaluatin Suspected transfrmatin (Richter s) frm a lw grade lymphma t a mre aggressive type with ANY ONE f the fllwing met: New B symptms (e.g., fever, night sweats, unintended weight lss f > 10%) Rapidly grwing lymph ndes Extrandal disease develps Significant recent rise in LDH abve nrmal range Lymphma Hdgkin with ANY ONE f the fllwing: Classical Hdgkin lymphma with ANY ONE f the fllwing met: Initial staging r initial diagnsis Whle bdy PET/CT when there is clinical suspicin f skull r distal lwer extremity invlvement T determine a mre favrable site fr bipsy when a relatively inaccessible site is cntemplated Treatment respnse as frequently as every 2 cycles Treatment respnse with lw risk (stage IA r IIA) mixed cellularity Hdgkin lymphma after cycles 1 and 3 This dcument has been classified as public infrmatin

10 Plicy Medical Plicy Manual Draft Revised Plicy: D Nt Implement End f chemtherapy evaluatin End f radiatin therapy evaluatin (after 12 weeks f cmpletin f radiatin therapy) Surveillance with a single fllw-up PET/CT when end f therapy PET/CT dcuments Deauville 4 r 5 FDG avidity Ndular Lymphcyte-Predminant Hdgkin with ANY ONE f the fllwing met: Initial staging r initial diagnsis Treatment respnse as frequently as every 2 cycles End f chemtherapy evaluatin End f raditherapy evaluatin (after 12 weeks f cmpletin f radiatin therapy) Suspected recurrence Suspected transfrmatin (Richter s) frm a lw grade lymphma t a mre aggressive type with ANY ONE f the fllwing met: New B symptms (e.g., fever, night sweats, unintended weight lss f > 10%) Rapidly grwing lymph ndes Extrandal disease develps Significant recent rise in LDH abve nrmal range Surveillance with a single fllw-up PET/CT if the end f therapy PET/CT dcuments Deauville 4 r 5 FDG avidity Lymphma Mantle Cell with ANY ONE f the fllwing met: Initial staging r initial diagnsis if radiatin therapy is being cnsidered fr Stage I r II disease End f therapy evaluatin Lymphma Marginal Zne & MALT Lymphmas (Mucsa Assciated Lymphid Tissue) with ANY ONE f the fllwing met: Initial staging r initial diagnsis if radiatin therapy is being cnsidered fr Stage I r II disease End f therapy evaluatin Medullblastma, Supratentrial Primitive Neurectdermal Tumrs, and Pineblastma with ANY ONE f the fllwing: PET Brain Metablic Imaging with ANY ONE f the fllwing are met: Distinguish radiatin-induced tumr necrsis frm prgressive disease within 18 mnths f cmpleting raditherapy Evaluate incnclusive MRI findings if ALL ANY ONE f the fllwing are met: T determine need fr bipsy T determine need fr change in therapy, including a change frm active therapy t surveillance Evaluate a brain lesin f indeterminate nature t determine whether bipsy/resectin can be safely pstpned Melanmas and Other Skin Cancers with ANY ONE f the fllwing met: Melanma initial wrk-up r initial staging with ANY ONE f the fllwing met: Stage III (sentinel nde psitive, palpable reginal ndes) Stage IV (metastatic) Mucsal, including lip primary Ocular/rbital primary site Primary melanma site unknwn with ALL f the fllwing met: CT Chest negative CT Abdmen/Pelvis negative Melanma restaging r recurrence with ALL ANY ONE f the fllwing met: Dcumented r clinically suspected recurrence at ANY ONE f the fllwing: This dcument has been classified as public infrmatin

11 Plicy Medical Plicy Manual Draft Revised Plicy: D Nt Implement Primary site In-transit disease Reginal lymph ndes Metastatic site Incnclusive cnventinal imaging Islated metastatic disease based n results f initial cnventinal imaging Merkel Cell carcinma initial wrk-up r initial staging with ALL f the fllwing met: N metastatic disease identified n cnventinal imaging Merkel Cell carcinma restaging r recurrence with ALL f the fllwing met: N metastatic disease n any f the previus imaging studies Other Nn-melanma Skin Cancers initial wrk-up r initial staging with ALL ANY ONE f the fllwing met: Perineural invasin r lcal reginal extensin (i.e., bne, deep sft tissue) invlvement with ALL f the fllwing met: PET perfrmed n primary site Reginal staging f large squamus cell r basal cell carcinmas prir t perative treatment Nrmal size ndes are visualized but may harbr metastatic tumr Skin lesin ptentially a dermal metastasis frm distant primary when cnventinal imaging (CT r MRI) is unable t identify a primary site Other Nn-melanma Skin Cancers restaging r recurrence with ALL f the fllwing met: Recurrence where planned therapy is mre extensive than simple wide lcal excisin with ALL f the fllwing met: Reginal staging f large squamus cell r basal cell carcinmas prir t perative treatment Nrmal size ndes are visualized but may harbr metastatic tumr Metastatic Cancer with ANY ONE f the fllwing met: (when primary cancer is knwn, PET request shuld be reviewed by primary cancer guideline) Adrenal Gland Metastases with ALL f the fllwing met: T cnfirm islated adrenal lesin with ALL f the fllwing are met: N diagnsis-specific guideline available regarding PET imaging T cnfirm slitary islated adrenal metastasis Cnventinal imaging des nt reveal ther metastatic disease Primary tumr site cntrlled Surgical resectin r raditherapy f adrenal metastasis is ptentially curative Bne Metastases (including Vertebral) F-FDG-PET/CT n a case-by-case basis with ALL f the fllwing are met: Bne pain Negative bne scan Negative CT r MRI Brain Metastases when ANY ONE ALL f the fllwing are met: Indicated fr ANY ONE f the fllwing: Slitary Suspected brain metastasis suspected with prir diagnsis f cancer Brain metastasis and n knwn primary tumr Indicated fr ANY ONE f the fllwing Incnclusive cnventinal imaging Cnfirm stable systemic disease r absence f ther metastatic disease Liver Metastases with ANY ONE f the fllwing met: This dcument has been classified as public infrmatin

12 Plicy Medical Plicy Manual Draft Revised Plicy: D Nt Implement T cnfirm slitary metastasis amenable t resectin n cnventinal imaging LFT s and/r tumr markers cntinue t rise with negative CT and MRI results Lung Metastases with ANY ONE f the fllwing met: Lung ndule(s) greater than r equal t 8 mm T cnfirm slitary metastasis amenable t resectin n cnventinal imaging Multiple Myelma and Plasmacytmas with ANY ONE f the fllwing met: Initial wrkup r initial staging with ANY ONE ALL f the fllwing met: Negative r incnclusive cnventinal imaging Indicated fr ANY ONE f the fllwing: Determine if a plasmacytma is slitary Suspicin f extrasseus plasmacytmas Suspected prgressin f malignancy fr ANY ONE f the fllwing: Mnclnal Gammpathy f Unknwn Significance (MGUS) Smldering Myelma (SMM) Ensure member has Stage I ( smldering ) and nt a higher stage Restaging r recurrence with ANY ONE f the fllwing met: MGUS disease with signs/symptms r labs studies suggesting prgressin Negative PET will allw change in management frm active treatment t maintenance r surveillance T determine additinal therapies in refractry disease r nn-secretry disease Neurblastma with ANY ONE f the fllwing met: MIBG-negativity dcumented at initial diagnsis At majr decisin pints such as hematpietic stem cell transplantatin r surgery if MIBG and CT/MRI are incnclusive Individuals currently receiving medicatins that may interfere with MIBG uptake that cannt safely be discntinued prir t imaging, including: Tricyclic antidepressants Selective sertnin reuptake inhibitrs (SSRI s) Neurleptics Antihypertensive drugs Decngestants Stimulants Neurendcrine Cancers with ANY ONE f the fllwing met: Brnchpulmnary r Thymic Carcinid with ANY ONE f the fllwing met: Initial wrkup r initial staging with ANY ONE f the fllwing met: Incnclusive CT r MRI After cmplete resectin if ALL f the fllwing are met: Resectin fails t reslve secretin f pathlgic levels f hrmnes r neurtransmitter cmpunds Nuclear imaging (MIBG, Octretide, r Smatstatin scintigraphy) is negative Restaging r recurrence with negative r incnclusive cnventinal imaging Gastrintestinal/Pancreatic Neurendcrine Cancers with ANY ONE f the fllwing met: Suspected/Diagnsis with ALL f the fllwing met: Cnventinal imaging negative r incnclusive Systemic symptms strngly suggestive f functining neurendcrine tumr Initial wrkup r initial staging with ALL ANY ONE f the fllwing met: Incnclusive CT r MRI This dcument has been classified as public infrmatin

13 Plicy Medical Plicy Manual Draft Revised Plicy: D Nt Implement After cmplete resectin if ALL f the fllwing met: Resectin fails t reslve secretin f pathlgic levels f hrmnes r neurtransmitter cmpunds Negative nuclear imaging (MIBG, Octretide, r Smatstatin scintigraphy) Restaging/recurrence with incnclusive cnventinal imaging Ovarian Cancer with ANY ONE f the fllwing met: Initial wrkup r initial staging with ANY ONE f the fllwing met: Primary peritneal disease with bipsy-prven malignancy cnsistent with varian carcinma Elevated tumr markers with negative r incnclusive CT imaging Restaging r recurrence with ALL ANY ONE f the fllwing met: CT negative r incnclusive and ANY ONE f the fllwing CA-125 cntinues t rise Elevated LFTs Cnventinal imaging failed t demnstrate tumr r if persistent radigraphic mass with rising tumr markers Pancreatic Cancer with ANY ONE f the fllwing met: Initial wrkup r initial staging if n evidence f metastatic disease n CT r MRI Restaging r recurrence with ALL f the fllwing met: incnclusive cnventinal imaging pst neadjuvant chemradiatin (if given as curative therapy) Suspected recurrence Paraneplastic Syndrmes with ANY ONE f the fllwing met: Abnrmality n cnventinal imaging difficult t bipsy Incnclusive cnventinal imaging Primary Peritneal Mesthelima with ANY ONE f the fllwing met: Initial staging with ANY ONE f the fllwing met: N evidence f metastatic disease Incnclusive finding n cnventinal imaging Recurrence r restaging with incnclusive finding n cnventinal imaging Prstate Cancer with ALL f the fllwing met: Recurrence r restaging with ALL f the fllwing met: CT, MRI and bne scan negative fr metastasis C Chline PET/CT scan is requested Indicated fr ANY ONE f the fllwing: Individual with prir radical prstatectmy and ANY ONE f the fllwing: Palpable anastmtic recurrence PSA remains greater than 0.2 after at least 2 PSAs Initial undetectable PSA increasing n 2 cnsecutive PSAs Individual with prir radiatin therapy and ANY ONE f the fllwing: Clinical suspicin f relapsed disease PSA increasing n at least 2 cnsecutive values abve pst-therapy baseline Rhabdmysarcma with ANY ONE f the fllwing met: Initial staging after histlgic cnfirmatin f diagnsis Treatment respnse with ANY ONE f the fllwing met: Respnse assessment prir t lcal cntrl surgery Respnse assessment prir t radiatin therapy This dcument has been classified as public infrmatin

14 Plicy Medical Plicy Manual Draft Revised Plicy: D Nt Implement Evaluatin f residual mass visible n cnventinal imaging as part f end f therapy evaluatin Respnse assessment f disease visible n PET but nt cnventinal imaging When results are likely t result in a treatment change, including a change frm active treatment t surveillance. Surveillance with ANY ONE ALL f the fllwing met: Cnventinal imaging (CT, MRI, US, plain film) incnclusive fr recurrence PET avidity will determine whether bipsy r cntinued bservatin is apprpriate Obvius clinical symptms shw strng evidence suggesting recurrence Salivary Gland with ANY ONE f the fllwing met: Initial wrkup r initial staging with ALL f the fllwing met: Bipsy-prven malignancy Suspicius lung abnrmality is fund n CT chest Sft Tissue Sarcmas with ANY ONE f the fllwing met: Initial wrkup r initial staging with ANY ONE f the fllwing met: Grade f tumr in dubt fllwing bipsy Cnventinal imaging suggests slitary metastasis amenable t surgical resectin Cnventinal imaging incnclusive Planning neadjuvant therapy Prir t surgical resectin fr tumrs greater than 3cm (30mm) Clinical suspicin f skull r distal lwer extremity invlvement Treatment respnse with ANY ONE f the fllwing met: Assess respnse prir t lcal cntrl surgery r radiatin therapy Evaluatin f residual mass visible n cnventinal imaging as part f end f therapy evaluatin Assess respnse f disease visible n PET but nt cnventinal imaging Recurrence r restaging with ANY ONE f the fllwing met: Differentiate tumr frm radiatin r surgical fibrsis Determine respnse t neadjuvant therapy Cnfirm ligmetastatic disease prir t curative intent surgical resectin Surveillance with ALL f the fllwing met: Cnventinal imaging inclusive r suspicius fr recurrence PET avidity will determine if bipsy is apprpriate Testicular, Ovarian and Extragnadal Germ Cell Tumrs with ANY ONE f the fllwing: Restaging r recurrence with ALL f the fllwing met: Seminma with residual mass greater than 3 cm (30mm) CT findings are incnclusive PET findings will alter immediate care decisin making (can be perfrmed as early as 6 weeks after cmpletin f radiatin therapy) Thracic Cancers (Other than Esphageal and Lung) with ANY ONE f the fllwing met: Malignant Pleural Mesthelima with ANY ONE f the fllwing: Initial wrkup r initial staging with ALL f the fllwing met: Cytlgically r pathlgically prven N evidence f metastatic disease r incnclusive cnventinal imaging Restaging with ALL f the fllwing met: Treatment with Fllwing inductin chemtherapy prir t surgical resectin Every 2 cycles fllwing chemtherapy inductin, prir t surgical resectin N evidence f metastatic disease This dcument has been classified as public infrmatin

15 Plicy Medical Plicy Manual Draft Revised Plicy: D Nt Implement Thymic Carcinma with ANY ONE f the fllwing: Suspected r actual diagnsis with ANY ONE f the fllwing met Pulmnary ndule 8 mm (0.8 cm) t 30 mm (3 cm) seen n CT Chest r MRI Chest Pulmnary mass 31 mm (3.1 cm) r greater seen n CT r MRI When resectin will be perfrmed instead f bipsy if PET cnfirms limited disease If multiple pssible bipsy ptins are present and PET will be used t determine mst favrable site Initial wrkup r initial staging with ANY ONE f the fllwing met: All Stage I-IIIB disease Stage IV disease cnfined t chest regin (pleura/pericardium r slitary site including lung ndules) Incnclusive cnventinal imaging Restaging r recurrence with ANY ONE f the fllwing met: Newly identified abnrmalities lcalized t chest cavity n cnventinal imaging Suspected r bipsy prven recurrence lcalized t the chest cavity Incnclusive cnventinal imaging T differentiate tumr frm radiatin scar/fibrsis Thymma with ANY ONE f the fllwing: Initial wrkup r initial staging if incnclusive finding n CT Restaging with ANY ONE f the fllwing met: Incnclusive finding n CT Extensive disease n Fllwing inductin chemtherapy prir t surgical resectin, if n evidence f metastatic disease Thyrid Cancer with ANY ONE f the fllwing met: Anaplastic and Medullary Thyrid Carcinmas with ANY ONE f the fllwing met: Initial wrkup r initial staging if cnventinal imaging incnclusive Restaging r recurrence if cnventinal imaging incnclusive Fllicular, Papillary and Hürthle Cell Carcinmas Restaging r recurrence with ANY ONE f the fllwing met: Negative radiidine scan and rising thyrglbulin level Incnclusive findings n cnventinal imaging Metastatic disease that is ALL f the fllwing: RAI refractry cnventinal imaging is incnclusive Transitinal Cell Cancer with ANY ONE f the fllwing met: Initial wrkup r initial staging with ALL f the fllwing met: Used t determine neadjuvant therapy vs surgery as initial treatment Cnventinal imaging negative r incnclusive Wilms Tumr (unilateral and bilateral) with ANY ONE f the fllwing met: Fr treatment respnse with ALL f the fllwing met: T establish the presence f active disease A majr therapeutic decisin depends n PET avidity IMPORTANT REMINDERS Any specific prducts referenced in this plicy are just examples and are intended fr illustrative purpses nly. It is nt intended t be a recmmendatin f ne prduct ver anther, and is nt intended t represent a cmplete listing f all prducts available. These examples are cntained in the parenthetical e.g. statement. This dcument has been classified as public infrmatin

16 Plicy Medical Plicy Manual Draft Revised Plicy: D Nt Implement We develp Medical Plicies t prvide guidance t Members and Prviders. This Medical Plicy relates nly t the services r supplies described in it. The existence f a Medical Plicy is nt an authrizatin, certificatin, explanatin f benefits r a cntract fr the service (r supply) that is referenced in the Medical Plicy. Fr a determinatin f the benefits that a Member is entitled t receive under his r her health plan, the Member's health plan must be reviewed. If there is a cnflict between the Medical Plicy and a health plan, the express terms f the health plan will gvern. SOURCES evicre healthcare. (2018, May). Clinical Guidelines. Onclgy imaging plicy. Retrieved July 23, evicre healthcare. (2018, May). Clinical Guidelines. Pediatric nclgy imaging plicy. Retrieved July 23, Natinal Cmprehensive Cancer Netwrk. (2017). NCCN Clinical Practice Guidelines in Onclgy (NCCN Guidelines ) Anal carcinma. Natinal Cmprehensive Cancer Netwrk. (2017). NCCN Clinical Practice Guidelines in Onclgy (NCCN Guidelines ) B-cell lymphmas. Natinal Cmprehensive Cancer Netwrk. (2017, May). NCCN Clinical Practice Guidelines in Onclgy (NCCN Guidelines ) Bladder cancer. Natinal Cmprehensive Cancer Netwrk. (2017, August). NCCN Clinical Practice Guidelines in Onclgy (NCCN Guidelines ) Bne cancer. Natinal Cmprehensive Cancer Netwrk. (2017, April). NCCN Clinical Practice Guidelines in Onclgy (NCCN Guidelines ) Breast cancer. Natinal Cmprehensive Cancer Netwrk. (2017, August). NCCN Clinical Practice Guidelines in Onclgy (NCCN Guidelines ) Central nervus system cancers. Natinal Cmprehensive Cancer Netwrk. (2017). NCCN Clinical Practice Guidelines in Onclgy (NCCN Guidelines ) Cervical cancer. Natinal Cmprehensive Cancer Netwrk. (2018). NCCN Clinical Practice Guidelines in Onclgy (NCCN Guidelines ) Chrnic lymphcytic leukemia/small lymphcytic lymphma. Natinal Cmprehensive Cancer Netwrk. (2017, March). NCCN Clinical Practice Guidelines in Onclgy (NCCN Guidelines ) Cln cancer. Natinal Cmprehensive Cancer Netwrk. (2017, Octber). NCCN Clinical Practice Guidelines in Onclgy (NCCN Guidelines ) Esphageal and esphaggastric junctin cancers. Natinal Cmprehensive Cancer Netwrk. (2017, Octber). NCCN Clinical Practice Guidelines in Onclgy (NCCN Guidelines ) Gastric cancer. Natinal Cmprehensive Cancer Netwrk. (2017, May). NCCN Clinical Practice Guidelines in Onclgy (NCCN Guidelines ) Head and neck cancers. This dcument has been classified as public infrmatin

17 Plicy Medical Plicy Manual Draft Revised Plicy: D Nt Implement Natinal Cmprehensive Cancer Netwrk. (2017). NCCN Clinical Practice Guidelines in Onclgy (NCCN Guidelines ) Hdgkin lymphma. Natinal Cmprehensive Cancer Netwrk. (2017, September). NCCN Clinical Practice Guidelines in Onclgy (NCCN Guidelines ) Kidney cancer. Natinal Cmprehensive Cancer Netwrk. (2017, July). NCCN Clinical Practice Guidelines in Onclgy (NCCN Guidelines ) Malignant pleural mesthelima. Natinal Cmprehensive Cancer Netwrk. (2017, Octber). NCCN Clinical Practice Guidelines in Onclgy (NCCN Guidelines ) Melanma. Natinal Cmprehensive Cancer Netwrk. (2018). NCCN Clinical Practice Guidelines in Onclgy (NCCN Guidelines ) Multiple myelma. Natinal Cmprehensive Cancer Netwrk. (2017, June). NCCN Clinical Practice Guidelines in Onclgy. (NCCN Guidelines ). Neurendcrine tumrs. Natinal Cmprehensive Cancer Netwrk. (2017, September). NCCN Clinical Practice Guidelines in Onclgy (NCCN Guidelines ) Nn-small cell lung cancer. Natinal Cmprehensive Cancer Netwrk. (2017). NCCN Clinical Practice Guidelines in Onclgy (NCCN Guidelines ) Occult primary. Natinal Cmprehensive Cancer Netwrk. (2017, August). NCCN Clinical Practice Guidelines in Onclgy (NCCN Guidelines ) Ovarian cancer. Natinal Cmprehensive Cancer Netwrk. (2017, September). NCCN Clinical Practice Guidelines in Onclgy (NCCN Guidelines ) Pancreatic adencarcinma. Natinal Cmprehensive Cancer Netwrk. (2017, February). NCCN Clinical Practice Guidelines in Onclgy (NCCN Guidelines ) Prstate cancer. Natinal Cmprehensive Cancer Netwrk. (2017, September). NCCN Clinical Practice Guidelines in Onclgy (NCCN Guidelines ) Small cell lung cancer. Natinal Cmprehensive Cancer Netwrk. (2017, February). NCCN Clinical Practice Guidelines in Onclgy (NCCN Guidelines ) Sft tissue sarcma. Natinal Cmprehensive Cancer Netwrk. (2016, December). NCCN Clinical Practice Guidelines in Onclgy (NCCN Guidelines ) Testicular cancer. Natinal Cmprehensive Cancer Netwrk. (2017, May). NCCN Clinical Practice Guidelines in Onclgy (NCCN Guidelines ) Thyrid carcinma. EFFECTIVE DATE ID_EC This dcument has been classified as public infrmatin