PET Coding & Coverage: Including NOPR Sequel April 27, Presented by: Denise A. Merlino, MBA, CNMT, FSNMTS,CPC. Agenda

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1 Presented by: Barry Siegel, MD Mallinckrodt Institute of Radiology PET Coding & Coverage: Including NOPR Sequel April 27, 2009 Presented by: Denise A. Merlino, MBA, CNMT, FSNMTS,CPC President, Merlino Healthcare Consulting Corp. SNM Coding Advisor Agenda Basics of Coding & Billing PET & PET/CT Codes Modifiers PET Coverage April 3, 2009 Changes in Medicare National Coverage Determination (NCD) for Oncologic PET National Oncologic PET Registry (NOPR 2009) Questions 2 1

2 Medicare Billing Guidance for PET and PET/CT Medicare-covered PET and PET/CT procedures use AMA CPT Codes PET under CED (aka NOPR) is considered covered by Medicare; however, these claims require the addition of modifiers and/or specific ICD-9 codes in specific locations Medicare Non-covered PET and PET/CT procedures use CMS HCPCS Level II Codes 3 AMA CPT PET Procedures CPT Code Description Positron emission tomography (PET) imaging; limited area (eg, chest, head/neck) Positron emission tomography (PET) imaging; skull base to mid-thigh Positron emission tomography (PET) imaging; whole body The term tumor was removed from the descriptors to allow broader use of the codes and reflect expansion of the use of PET imaging for indications other than tumor imaging. This is a CPT change, NOT a Medicare Coverage change. 4 2

3 SNM Definition of Whole-body PET For PET and PET/CT imaging, historically the term whole-body was used to describe a variety of imaging protocols and most often meant including the region from skull base to mid thigh, which is now coded (CPT 78812, 78815). We recommend that PET and PET/CT whole-body imaging (CPT 78813, 78816) include the region from the skull (vertex) to substantially below the knees, usually extending to the feet F-FDG PET Procedure and Supply Codes CPT /HCPCS Code Description Q0 Positron emission tomography (PET) imaging; limited area (eg, chest, head/neck) Q0 Positron emission tomography (PET) imaging; skull base to mid-thigh Q0 Positron emission tomography (PET) imaging; whole body 6 3

4 AMA CPT PET/CT Procedures Description CPT Code Positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization imaging; limited area (eg, chest, head/neck) Positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization imaging; skull base to mid-thigh Positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization imaging; whole body 7 18 F FDG PET/CT Procedure and Supply Codes CPT /HCPCS Code Q Q Q0 Description Positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization imaging; limited area (eg, chest, head/neck) Positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization imaging; skull base to mid-thigh Positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization imaging; whole body 8 4

5 Neurological PET CPT Codes CPT Code Description Brain imaging, positron emission tomography (PET); metabolic evaluation Brain imaging, positron emission tomography (PET); perfusion evaluation Does NOT currently correspond to any Medicare covered conditions F-FDG PET/CT Procedure and Supply Codes CPT /HCPCS Code Q0 Description Brain imaging, positron emission tomography (PET); metabolic evaluation 10 5

6 Medicare Non-Covered PET Procedures HCPCS Level II G0219 G0235 Description PET imaging whole body; melanoma for noncovered indications PET imaging, any site, not otherwise specified G0252 PET imaging, full and partial-ring PET scanners only, for initial diagnosis of breast cancer and/or surgical planning for breast cancer (e.g. initial staging of axillary lymph nodes) For PET codes that do not currently correspond to any Medicare-covered conditions, providers may choose to obtain a signed ABN from the patient. 11 Medicare Non-Covered PET Procedures HCPCS Level II G0235 Description PET imaging, any site, not otherwise specified The G0235 could be used for any other non-covered Medicare study, such as; (1)a PET study for initial treatment strategy evaluation if the patient has previously had another study done for this purpose for the same cancer, because the new coverage policy only allows for one initial treatment strategy evaluation per patient per cancer. (2)a PET study done for "routine" surveillance of a patient with a previously treated cancer in whom there is no evidence to suggest residual or recurrent disease. (3)Initial treatment strategy for prostate cancer For PET codes that do not currently correspond to any Medicare-covered conditions, providers may choose to obtain a signed ABN from the patient. 12 6

7 Cardiac PET CPT Codes CPT Code Description Myocardial imaging, positron emission tomography (PET), metabolic evaluation Myocardial imaging, positron emission tomography (PET), perfusion; single study at rest or stress Myocardial imaging, positron emission tomography (PET), perfusion; multiple studies at rest and / or stress 13 SNM Billing Guidance If there is an organ- or indication-specific nuclear medicine AMA CPT or CMS HCPCS Level II code, the more specific code takes precedence over the general code. Examples: Brain PET; Cardiac PET; Medicare non-covered indications 14 7

8 CPT Unlisted Codes Nuclear Medicine has Unlisted CPT codes in each section 78X99. CPT states, Select the name of the procedure of service that accurately identifies the service performed. Do not select a CPT code that merely approximates the service. If no such procedure or service exists, then report the service using the appropriate unlisted procedure or service code. 15 Unlisted CPT Procedures CPT Code Description Unlisted musculoskeletal procedure, diagnostic nuclear medicine Unlisted cardiovascular procedure, diagnostic nuclear medicine Unlisted miscellaneous procedure, diagnostic nuclear medicine These unlisted or NOC CPT codes may be considered for use with private payers for procedures not already described by current CPT codes. Examples in 2007 were CPT for PET bone scans, in 2008 and beyond for PET bone scans use For WM and EF with Cardiac PET use CPT For software fusion of PET and CT performed on separate equipment same day or separate day use CPT For Medicare Non-covered procedures use the G HCPCS level II codes. 16 8

9 DO NOT USE with Any Nuclear Medicine Procedures CPT Code Description 3D rendering with interpretation and reporting of computed of computed tomography, magnetic resonance imaging, ultrasound, or other tomographic modality; NOT requiring image post processing on an independent workstation (Use in conjunction with codes(s) for base imaging procedure(s)) (Do not report in conjunction with 70496, 70498, , 71275, 71555, 72159, 72191, 72198, 73206, 73225, 73706, 73725, 74175, 74185, 75635, , 76377, , 0066T, 0067T, 0144T-0151T, 0159T) D rendering with interpretation and reporting of computed of computed tomography, magnetic resonance imaging, ultrasound, or other tomographic modality; requiring image post processing on an independent workstation (Use in conjunction with codes(s) for base imaging procedure(s)) (Do not report in conjunction with 70496, 70498, , 71275, 71555, 72159, 72191, 72198, 73206, 73225, 73706, 73725, 74175, 74185, 75635, , 76377, , 0066T, 0067T, 0144T-0151T, 0159T) 17 Nuclear Medicine Introduction For CPT 78xxx & 79xxx Nuclear Medicine Introduction change: The services listed do not include the radiopharmaceutical or drug. Diagnostic and therapeutic radiopharmaceuticals and drugs supplied by the physician should be reported separately using the appropriate supply code(s), in addition to the procedure code. Providers use HCPCS LEVEL II supply codes for drugs & radiopharmaceuticals with nuclear medicine procedures 18 9

10 Medicare-covered PET Radiopharmaceuticals HCPCS Level II A9526 A9552 Trade / Common Name PET Perfusion Agent PET Metabolic Agent A9555 CardioGen PET Perfusion Agent Description Nitrogen N-13 Ammonia, diagnostic, per study dose, up to 40 millicuries Fluorodeoxyglucose F-18 FDG, diagnostic, per study dose, up to 45 millicuries Rubidium Rb-82, diagnostic, per study dose, up to 60 millicuries Single study one (1) per study dose, multiple studies two (2) doses of Tc labeled or PET MPI Agents. Except Trailblazer. 19 Medicare Non-covered PET Radiopharmaceutical HCPCS Level II A9580 Trade / Common Name Sodium Fluoride Used for PET Bone Imaging Description Sodium fluoride F-18, diagnostic, per study dose, up to 30 millicuries 20 10

11 General Billing Information The PROFESSIONAL (26) component is billed for the physician in the hospital or non-hospital setting. The TECHNICAL (TC) component is billed for the services of technologists, equipment and the cost of supplies in the hospital or non-hospital setting. The GLOBAL( ) amount would be billed by the freestanding non-hospital center or physician office and includes both of the above. 21 CPT Payment Modifiers CPT Modifier 26 Professional Component Tc Technical Component No Modifier on a PET code = Global Payment Identifying Modifiers Description When the physician component is reported separately, the service may be identified by adding modifier 26 to the usual procedure number. Technical component charges are institutional charges and not billed separately by physicians. Use when physician office both owns equipment, employs the technologist and performs the interpretation

12 CPT CCI Edit Modifier Edit Modifiers CPT Modifier 59 Distinct Procedural Service Description Under certain circumstances, it may be necessary to indicate that a procedure or service was distinct or independent from other non-e/m services performed on the same day. Use when PET/CT and Diagnostic CT are both performed on same patient, same day (SDOS) Per CPT Append Modifier 59 to the CT codes 23 HCPCS Level II Modifier NOPR Identifying Modifiers CPT Modifier Description Comments Q0 (Zero) Investigational clinical service provided in a clinical research study that is in an approved clinical research study QR was deleted effective Dec 31, 2007; Q0 (zero) is used for DOS effective January 1, 2008 through July 1, 2009 (implementation date pending for new modifiers waiting CMS transmittal.) 24 12

13 HCPCS Level II Modifier NEW PET Tumor Identifying Modifiers CPT Modifier Description Comments PI (eye) PET tumor init tx strat Positron emission tomography (PET) or PET/Computed Tomography (CT) to inform the initial treatment strategy of tumors that are biopsy proven or strongly suspected of being cancerous based on other diagnostic testing, one per cancer diagnosis Effective date for this modifiers is July 1, 2009; however, we are still waiting for CMS transmittal to define the details of use and an implementation date. Effective for DOS April 3, 2009 claims; Implemented by MACs?? July 3, HCPCS Level II Modifier NEW PET Tumor Identifying Modifiers CPT Modifier Description Comments PS PET tumor subsq tx strategy Positron emission tomography (PET) or PET/Computed Tomography (CT) to inform the subsequent treatment strategy of cancerous tumors when the beneficiaries treating physician determines that the PET study is needed to inform subsequent antitumor strategy Effective date for this modifiers is July 1, 2009; however, we are still waiting for CMS transmittal to define the details of use and an implementation date. Effective for DOS April 3, 2009 claims; Implemented by MACs?? July 3,

14 PENDING CMS Guidance Examples: Medicare-Covered July CODING Retroactive to Claims DOS April 3, 2009 PET/CT Torso Code Physician Read Initial PET Pi Subsequent PET PS Technical Initial PET TC-Pi Subsequent PET TC-PS Global Initial PET Pi Subsequent PET PS 27 PENDING CMS Guidance Examples: Medicare-NOPR-Covered July CODING retroactive to Claims DOS April 3, 2009 PET/CT Torso Code Physician Read Initial PET Pi-Q0 Subsequent PET PS-Q0 Technical Initial PET TC-Pi-Q0 Subsequent PET TC-PS-Q0 Global Initial PET Pi-Q0 Subsequent PET PS-Q

15 Hospitals ONLY on 1450 Claim Form (UB) Hospital Revenue/ICD 9 CM Codes Description 0343 Diagnostic Radiopharmaceutical 0404 PET Procedures V70.7 Examination of participants in clinical trial TC Modifier is not necessary on a UB V70.7 Use in the Second Diagnosis Position (FL 67a on new UB) From Current CMS policy CR CMS Requirement for Ordering & Following Orders for Dx Tests Providers must have orders specific for the requested procedures and these must meet coverage medical necessity criteria 30 15

16 CMS General Signature Requirements Medicare Program Integrity Manual Per , B. Signature Requirements, indicates B. Signature Requirements Medicare requires a legible identifier for services provided/ordered. The method used shall be hand written or an electronic signature (stamp signatures are not acceptable) to sign an order or other medical record documentation for medical review purposes Providers may obtain a verbal order and follow up with the treating physician signature after the PET scan It is the responsibility of the facility to maintain appropriate documentation for a MAC, RAC or OIG audit. 31 ICD-9-CM Coding for Diagnostic Tests Current ICD-9 Codes: International Classification of Diseases, Ninth Revision, Clinical Modification, Sixth Edition Revised Guidelines Effective October 1, 2007: CMS General ICD-9 Web Site

17 ICD-9-CM Coding REASON for the procedure Code to highest level of SPECIFICITY and degree of certainty Tip: Do not give patients diseases without confirmed diagnosis, e.g., biopsy proven ICD Is the April 3 rd NCD effective now? YES Can I continue to submit claims to my Medicare contractor for PET scans for the indications that were already covered prior to the release of the PET final NCD? YES These claims should represent the majority of your PET facility volume Additionally, any PET procedures that previously were covered under NOPR 2006 and continue under NOPR 2009 could be submitted now, with no holding e.g., subsequent treatment stomach Finally, any PET procedures for the newly covered monitoring indications, that were previously covered indications could be submitted with no billing issues now. e.g. head and neck, oral cavity 34 17

18 Are you submitting claims now on the newly covered indications to your Medicare Contractor? A. Yes we are submitting our newly covered indications to our Medicare contractor. B. No, we have decided to hold claims and wait for the CMS claim submission guidance. C. No, we did not perform any of the newly covered indications as yet. D. No, this does not apply to us e.g. we are sales or consultants. 35 So what claims does the SNM recommend we hold pending MAC guidance? Any claims with ICD-9 codes that are now covered in the April 3rd policy for initial treatment, but were not covered before April 3 rd. e.g., initial treatment stomach The reason the Medicare Contractors have not yet updated their LCDs with new ICD-9 codes or with any frequency limits. Additionally, the Medicare Contractors will be given 30 days from the time CMS issues the claims guidance to implement the claims processing changes

19 Are Medicare Advantage plans required to accept the new NCD? Yes, they too are waiting for the Claims Processing Transmittal from CMS. Additionally, they typically have a prior authorization system in place. 37 Presented by: Barry Siegel, MD Mallinckrodt Institute of Radiology PET Coverage Barry A. Siegel, MD Presented by: Denise A. Merlino, MBA, CNMT, FSNMTS,CPC President, Merlino Healthcare Consulting Corp. SNM Coding Advisor 19

20 Medicare Coverage National Coverage Determination (NCD) National Coverage (positive decision) Coverage with Evidence Development (CED) National Non-coverage (negative decision) Not medically necessary = explictly not covered Exclusionary policy (covered indications must be specifically mentioned in the policy or CMS considers it non-covered.) No National Coverage Determination Left to contractor discretion Local Coverage Determinations (LCDs) 39 NCD vs LCD Indications generally defined by NCD Clinical indications Initial treatment strategy vs subsequent treatment strategy Covered vs non-covered vs CED Local policy: carrier discretion in LCD where specifically indicated in NCD or where NCD silent TC procedure pricing (freestanding, not outpatient) DRA negates most of these Tracer pricing RPs are carrier priced CPT to ICD-9 edits Frequency limits Post-pay review 40 20

21 PET NCD: Exclusionary Policy The NCD states in part Except as set forth below in cancer indications listed as "coverage with evidence development", a particular use of PET scans is not covered unless this manual specifically provides that such use is covered. Although this section lists some non-covered uses of PET scans, it does not constitute an exhaustive list of all noncovered uses. e.g., 18 F-fluoride PET bone scans NOT Covered by Medicare e.g., WM and EF with MPI PET NOT Covered by Medicare 41 NCD for PET Non-coverage Specifically Identified Screening for cancer detection Initial treatment strategy evaluation for prostate cancer Breast cancer diagnosis Evaluating regional lymph nodes in breast cancer and melanoma Surveillance of patients with history of cancer 42 21

22 NCD for PET Non-coverage NOT Specifically Identified F-18 fluoride PET bone imaging FDG-PET infection/inflammation imaging PET with other radiopharmaceuticals 43 NCD for PET No Change Brain Pre-surgical evaluation of refractory seizures Dementia for differential diagnosis of FTD vs AD Cardiac Myocardial viability 18 F-FDG Myocardial perfusion 82 Rb, 13 N-ammonia 44 22

23 CMS Final Decision April 3, 2009 New framework differentiates PET into use for: initial treatment strategies (formerly diagnosis and initial staging) subsequent treatment strategies (formerly treatment monitoring and restaging/ detection of suspected recurrence) 45 NCD for PET Initial Treatment Strategy PET is medically necessary when it is used: To avoid an invasive diagnostic procedure To find best site for diagnostic invasive procedure If stage is in doubt after standard workup If PET replaces standard imaging If clinical management will differ depending on stage NOT for screening 46 23

24 NCD for PET Initial Treatment Strategy PET may be covered for diagnosis: to help determine if a suspicious lesion is cancer, e.g., if the lesion is inaccessible for biopsy, if biopsy is contraindicated, or if biopsy has been done with indeterminate results to help find a primary tumor in a patient with pathologically proven (or strongly suspected) metastatic disease after negative results of conventional assessment (CUP) to help find a primary tumor in a patient with a strongly suspected paraneoplastic syndrome after negative results of conventional assessment PET may be covered for initial staging: as a baseline when it is anticipated that PET will likely be used to monitor tumor response during treatment 47 NCD for PET Subsequent Treatment Strategy PET is medically necessary when it is used: If performed during a planned course of treatment when a change in treatment is being considered If performed after completion of treatment To detect residual disease To detect suspected recurrence To assess extent of known recurrence NOT for surveillance of asymptomatic, previously treated patients 48 24

25 NCD for PET Expanded Coverage As part of initial treatment evaluation, a single PET scan will be covered for all cancers with the exception of prostate cancer, breast cancer diagnosis and axillary nodal staging, and melanoma regional nodal staging For subsequent treatment evaluation, expanded coverage for PET in legacy (previously covered) cancers, to include treatment monitoring New coverage for subsequent treatment evaluation of cervical cancer, ovarian cancer, and myeloma 49 NCD for PET Expanded Coverage The CMS NCD for PET published April 3, 2009 is effective today? True False 50 25

26 NCD for PET Expanded Coverage Expanded coverage is significant gain, but: Single-scan limit for initial treatment strategy evaluation is illogical and problematic for: RT planning Evolving cancer 51 NCD for PET Expanded Coverage Does the NCD cover single (SPN) and multiple pulmonary nodules? Use of PET as a diagnostic tool for SPN = diagnosis of lung cancer If can t get tissue first, PET is covered for initial treatment strategy evaluation Use of PET as a diagnostic tool for multiple nodules usually = search for cancer of unknown primary origin with pulmonary metastases 52 26

27 NCD for PET Expanded Coverage Dedicated Oncologic Brain PET Brain PET performed for initial treatment strategy evaluation of primary brain cancer or any other type of cancer (except prostate cancer) is covered Brain PET performed for subsequent treatment strategy evaluation of breast, cervix, colorectal, esophageal, head & neck, lymphoma, melanoma, myeloma, NSCLC, ovarian, or thyroid cancer (meeting the applicable restrictions for the latter) is covered Brain PET performed for subsequent treatment strategy evaluation of a primary brain cancer and all other cancers is covered only under CED 53 CED Coverage with Evidence Development Links coverage and payment with prospective data collection 54 27

28 National Oncologic PET Registry NOPR No Coverage Gap NOPR 2009 operational on April 6, as soon as NCD effective (April 3 rd Friday 6 PM technically) Very similar data collection as for NOPR 2006 Requirement for referring MD signature attesting to data accuracy Additional questions related to treatment monitoring NOPR will work to link to Medicare claims data in collaboration with Agency for Healthcare Research and Quality (AHRQ) looking at actual patient management 56 28

29 Continuation of CED Program (NOPR 2009) For subsequent treatment evaluation (restaging, suspected recurrence or treatment monitoring) for most cancers included in the initial NOPR study, PET will continue to be available only through CED (also necessary for thyroid cancer not meeting current coverage requirement Tg > 10, neg I-131 scan) CED also required for initial treatment strategy of cervical cancer (not meeting current coverage requirements neg CT/MRI for extrapelvic metastasis) and for leukemia 57 Are there New NOPR Forms? There are changes in the registry forms and also in the consent forms. Discard all old patient information sheets and download the new sheets from the NOPR website. Pre-PET and post-pet forms have changed as well 58 29

30 59 NOPR 2009 Educational Materials Appendix III 60 30

31 61 Previous NCD PET claims for date of service (DOS) before April 6, 2009 New NCD PET claims for DOS on or after April 6, 2009 Dx Staging Restaging Treatment Monitoring Initial Rx Subseq. Rx Breast N/C 1 Cover Cover 1 Cover Colorectal Cover Cover Cover CED Cover Cover Esophagus Cover Cover Cover CED Cover Cover Head Neck Cover Cover Cover CED Cover Cover Lymphoma Cover Cover Cover CED Cover Cover Melanoma Cover 2 Cover CED 2 Cover NSCLC Cover Cover Cover CED Cover Cover Thyroid Cover Cover 3 CED Cover 3 or CED 1: Covered for metastatic disease. Non-covered for staging of axillary lymph nodes. 2: Melanoma: Non-covered for initial staging of regional lymph nodes 3: Thyroid: Covered for restaging of follicular cell types 62 31

32 Previous NCD PET claims for date of service (DOS) before April 6, 2009 Dx Staging Restaging Treatment Monitoring Cervix CED Cover/CED Cover/CED CED New NCD PET claims for DOS on or after April 6, 2009 Initial Rx 4 Cover or CED Subseq. Rx Cover Myeloma CED CED CED CED Cover Cover Ovary CED CED CED CED Cover Cover Prostate CED CED CED CED N/C CED All other CED CED CED CED Cover CED solid tumors Leukemia CED CED CED CED CED CED 4: Covered for pretreatment metastases (staging) in newly diagnosed cervical cancer subsequent to conventional imaging that is negative for extra-pelvic metastasis. 63 Timeline Hold claims until all data entered into the Registry Keep for proof elements of NOPR are met Providers Bill Medicare Using Appropriate Claim Form & Codes per the Date of Service & claims instructions No waiting period to submit claim Hospitals Use UB-04/1450 Claim Form Technical Only Non-Hospitals Use 1500 Claim Form Professional/Technical/Global 64 32

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