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CODING SHEET FOR PHYSICIAN & HOSPITAL OUTPATIENT SERVICES MARCH 2006

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Page 1: SIRSPHERES 2006 FINAL CODING SHEET 3-15-06 · PDF fileCT Abdomen MRA Abdomen 3-D Post-Processing ... but only a suggested pathway to allow ... 78811 Tumor imaging, positron emission

CODING SHEET

FOR

PHYSICIAN

&

HOSPITAL OUTPATIENT SERVICES

MARCH 2006

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March 2006

Post-Treatment Follow Up Lab Visits (see page 8) PET Scan (see page 8)

Post-Procedure Observation (See page 7)

Liver Imaging (SPECT)

SIR-Spheres Microspheres Administration

Supervision, Handling & Loading

Place arterial catheter Interstitial radiation source

application

Patient Referral (see page 10) Cancer Center

Medical Oncologists

Interventional Radiology (see page 10)

Consult

Screening Lab Tests See page 13 (Appendix)

PATIENT NOT ELIGIBLE Alternative Treatment

20% or Greater Shunting?

Less than 20% Shunting?

Nuclear Medicine (see page 3)

Tc99 – MAA Scan

Diagnostic Radiology (see pages 1 - 3)

CT Abdomen MRA Abdomen

3-D Post-Processing Baseline PET Angiography

Phase 1: SIR-Spheres Screening

Patient Eligible – (See page 4 )

Schedule Treatment

SIR-Spheres Order 7-10 days prior to treatment

DAY OF TREATMENT (See pages 6 – 7)

Nuclear Medicine/Radiation Oncology(see pages 4 – 5)

Clinical Treatment Planning Medical Radiation Dosimetry

TREATMENT PLAN DOSE CALCULATION (pages 4 - 5)

Phase 2: SIR-Spheres Treatment

SIR-SPHERES MICROSPHERES TREATMENT FLOW CHART

Bilirubin above 2.0 PATIENT NOT ELIGIBLE

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SELECTIVE INTERNAL RADIATION THERAPY (SIRT) SIR-SPHERES TREATMENT CODING

SIR-Spheres microspheres is indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer. The microspheres procedure is performed in the outpatient hospital setting and therefore the possible coding options presented in this guide are applicable to outpatient coding and payment based on Medicare’s 2006 Hospital Outpatient (OPPS) and Physician fee schedule. The coding options listed in this guide are not intended to be a recommendation for coding, but only a suggested pathway to allow institutions and physicians to evaluate their own coding decisions. Not all institutions or physicians will use the codes indicated because of different clinical specialties involved or institutions specific coding practices or insurance payer requirements.

Note: When performing multiple procedures, review current correct coding guidelines carefully. Services that are considered a component of another procedure cannot always be coded and billed separately. Medicare’s Correct Coding Initiative (CCI) is reviewed and updated several times a year. Commercial payer policies vary and should be carefully reviewed. Current Procedural Terminology (CPT) is copyright 2005 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association.

SIR-SPHERES SCREENING PATIENT EVALUATION

2006 OPPS Payment Rate Code Code Description APC/

Status APC

DescriptorAPC

Payment

2006 Medicare Physician Fee Schedule

EVALUATION AND MANAGEMENT SERVICES: OFFICE VISTS & CONSULTATIONS For a complete summary of applicable E&M codes that may apply, see page 10 of this guide or consult your current CPT manual. 99201- 99205

Office or other outpatient visit for the evaluation and management of a new patient

600-602/ V

Clinic Visits $52.37- $87.67

$23.88-$142.87 (Facility) $36.76-$174.33 (Non-Facility)

99211- 99215

Office or other outpatient visit for the evaluation and management of an established patient

600-602/ V

Clinic Visits $52.37- $87.67

$9.10-$ 94.74 (Facility) $21.60-$120.14 (Non Facility)

99241- 99245

Office consultation for new or established patient 600-602/ V

Clinic Visits $52.37- $87.67

$34.49-$184.56 (Facility) $50.40-$223.97 (Non-Facility)

PRE-TREATMENT DIAGNOSTICS: LAB TESTS Screening Lab Tests – See Appendix (page 13 of this guide) for a list of coding options.

PRE-TREATMENT DIAGNOSTICS: RADIOLOGY Selective Catheterizations for Diagnostic Procedure • Select catheterization code based on the most distal catheterization within the vascular family. • If the same vascular access site is used for all same- day services, code the vascular access only once. If separate vascular access

sites are used, code for each site. Refer to your current CPT manual for guidelines on correct coding for selective vascular catheterization(s) 36245 Selective catheter placement, arterial system; each first order

abdominal, pelvic, or lower extremity artery branch, within a vascular family

N N/A N/A $252.40 (Facility)$1,408.27 (Non-Facility)

36246 Selective catheter placement, arterial system; initial second order abdominal, pelvic, or lower extremity artery branch, within a vascular family

N N/A N/A $283.47 (Facility)$1,352.94 (Non-Facility)

36247 Selective catheter placement, arterial system; initial third order or more selective abdominal, pelvic, or lower extremity artery branch, within a vascular family

N N/A N/A $337.67 (Facility) $2,137.80 (Non-Facility)

36248 Selective catheter placement, arterial system; additional second order, third order, and beyond, abdominal, pelvic, or lower extremity artery branch, within a vascular family (List in addition to code for initial second or third order vessel as appropriate)

N N/A N/A $56.09 (Facility)$194.41 (Non-Facility)

APC Status Key: B=Not paid under OPPS; E=Non-covered items and services; H=Device category pass through and brachytherapy sources; K=Non-pass through Drugs, Biologicals, and Radiopharmaceutical Agents; N=Incidental services, packaged into APC rate; S=Significant procedure, not discounted when multiple; T=Procedure, discounted when multiple; X=Ancillary Services; V=Clinic Visit

March 2006 1 This information is provided by Sirtex as a guide for coding services involving SIR-Spheres and is not intended to increase or maximize reimbursement by any payer. We strongly suggest consulting your third-party payer organizations with regard to local coverage, coding and reimbursement policies. Providers assume full responsibility for all reimbursement decisions or actions. Current Procedural Terminology © 2005 American Medical Association. All Rights Reserved.

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PRE-TREATMENT DIAGNOSTICS: RADIOLOGY (continued)

2006 OPPS Payment Rate Code Code Description APC/

Status APC Descriptor APC Payment

2006 Medicare Physician Fee

Schedule

Fluoroscopy 76003 Fluoroscopic guidance for needle placement (eg, biopsy,

aspiration, injection, localization device) N N/A N/A $ 79.96 (Global)

$ 27.66 (Prof)$ 52.30 (Tech)

Chest X-ray – See Appendix (page 13 of this guide) for a list of coding options.

CT Chest 71250 Computed tomography, thorax; without contrast material 0332/S Computerized Axial Tomography

and Computerized Angiography without Contrast

$188.10 $296.74 (Global)$ 60.26 (Prof)$236.48 (Tech)

71260 Computed tomography, thorax; with contrast material(s) 0283/S Computerized Axial Tomography with Contrast Material

$255.43 $347.14 (Global)$ 64.43 (Prof)$282.71 (Tech)

71270 Computed tomography, thorax; without contrast material, followed by contrast material(s) and further sections

0333/S Computerized Axial Tomography and Computerized Angiography

w/o Contrast followed by Contrast

$303.82 $425.59 Global)$ 71.63 (Prof)$353.96 (Tech)

CT Abdomen 74150 Computed tomography, abdomen; without contrast

material 0332/S Computerized Axial Tomography

and Computerized Angiography without Contrast

$188.10 $288.40 (Global)$ 61.77 (Prof)$226.63 (Tech)

74160 Computed tomography, abdomen; with contrast material(s)

0283/S Computerized Axial Tomography with Contrast Material

$255.43 $339.94 (Global)$ 66.32 (Prof)$273.62 (Tech)

74170 Computed tomography, abdomen; without contrast material, followed by contrast material(s) and further sections

0333/S Computerized Axial Tomography and Computerized Angiography

w/o Contrast followed by Contrast

$303.82 $411.57 (Global)$ 72.76 (Prof)$338.80 (Tech)

Ultrasound Abdomen 76700 Ultrasound, abdominal, B-scan and/or real time with

image documentation; complete 0266/S Level II Diagnostic Ultrasound $95.52 $121.65 (Global)

$ 42.45 (Prof)$ 79.20 (Tech)

76705 Ultrasound, abdominal, B-scan and/or real time with image documentation; limited (eg, single organ, quadrant, follow-up)

0266/S Level II Diagnostic Ultrasound $95.52 $ 87.54 (Global)$ 30.69 (Prof)$ 56.85 (Tech)

Bone Scan 78300 Bone and/or joint imaging; limited area 0396/S Bone Imaging $237.57 $132.26 (Global)

$ 32.59 (Prof)$ 99.67 (Tech)

78305 Bone and/or joint imaging; multiple areas 0396/S Bone Imaging $237.57 $189.86 (Global)$ 43.58 (Prof)$146.28 (Tech)

78306 Bone and/or joint imaging; whole body 0396/S Bone Imaging $237.57 $215.64 (Global)$ 45.10 (Prof)$170.54 (Tech)

78315 Bone and/or joint imaging; three phase study 0396/S Bone Imaging $237.57 $244.06 (Global)$ 53.06 (Prof)$191.00 (Tech)

78320 Bone and/or joint imaging; tomographic (SPECT) 0396/S Bone Imaging $237.57 $291.05 (Global)$ 54.57 (Prof)$236.48 (Tech)

APC Status Key: B=Not paid under OPPS; E=Non-covered items and services; H=Device category pass through and brachytherapy sources; K=Non-pass through Drugs, Biologicals, and Radiopharmaceutical Agents; N=Incidental services, packaged into APC rate; S=Significant procedure, not discounted when multiple; T=Procedure, discounted when multiple; X=Ancillary Services; V=Clinic Visit

March 2006 2 This information is provided by Sirtex as a guide for coding services involving SIR-Spheres and is not intended to increase or maximize reimbursement by any payer. We strongly suggest consulting your third-party payer organizations with regard to local coverage, coding and reimbursement policies. Providers assume full responsibility for all reimbursement decisions or actions. Current Procedural Terminology © 2005 American Medical Association. All Rights Reserved.

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PRE-TREATMENT DIAGNOSTICS: RADIOLOGY (continued)

2006 OPPS Payment Rate Code Code Description APC/

Status APC Descriptor APC Payment

2006 Medicare Physician Fee

Schedule

Hepatic Angiogram – Code for each basic examination performed (e.g. the superior mesenteric artery, inferior mesenteric artery and hepatic artery are each basic examinations.) (For selective angiography, each additional visceral vessel studied after basic examination, use 75774.) 75726 Angiography, visceral, selective or supraselective, (with or

without flush aortogram), radiological supervision and interpretation

0280/S Level III Angiography and Venography

$1,215.58 $562.78 (Global)$ 59.12 (Prof)$503.66 (Tech)

75774 Angiography, selective, each additional vessel studied after basic examination, radiological supervision and interpretation (List separately in addition to code for primary procedure)

0279/S Level II Angiography and Venography

$517.67 $522.61 (Global)$ 18.95 (Prof)$503.66 (Tech)

Nuclear Medicine Break Through Scan with TC-99 78201 Liver imaging; static only 0394/S Hepatobiliary Imaging $256.53 $117.86 (Global)

$ 23.12 (Prof)$ 94.74 (Tech)

78202 Liver imaging; with vascular flow 0394/S Hepatobiliary Imaging $256.53 $141.36 (Global)$ 26.53 (Prof)$114.83 (Tech)

A9540 Technetium TC-99m macroaggregated albumin,diagnostic, per study dose, up to 10 millicuries

N N/A N/A N/A

MRA Abdomen 74185 Magnetic resonance angiography, abdomen, with or

without contrast material(s) B Facilities Should Use See C-Codes Below for

Medicare Billing; Private Payers Should be Contacted for their Billing Requirements

$541.56 (Global)$ 93.61 (Prof)$447.95 (Tech)

C8900 MRA with contrast abdominal 0284/S Magnetic Resonance Imaging and Magnetic Resonance

Angiography with Contrast

$371.00 N/A

C8901 MRA without contrast abdominal 0336/S Magnetic Resonance Imaging and Magnetic Resonance Angiography

without Contrast

$349.20 N/A

C8902 MRA without contrast abdominal followed with contrast 0337/S MRI and Magnetic Resonance Angiography without Contrast

Material Followed

$506.26 N/A

Baseline PET 78811 Tumor imaging, positron emission tomography (PET);

limited area (eg, chest, head/neck) 1513/S New Technology - Level XIII

($1100 - $1200) $1,150.00 $82.62 (Prof)

Carrier Decision (Global & Tech)

78812 Tumor imaging, positron emission tomography (PET); skull base to mid-thigh

1513/S New Technology - Level XIII ($1100 - $1200)

$1,150.00 $102.32 (Prof) Carrier Decision (Global & Tech)

S80851 Fluorine-18 fluorodeoxyglucose (f-18 fdg) imaging using dual-head coincidence detection system (non-dedicated pet scan)

N/A Not Applicable to Medicare; Private Payers Should be Contacted for their Billing Requirements 1

A95522 Fluorodeoxyglucose F-18 FDG, diagnostic, per study dose, up to 45 millicuries

1651/H F 18 fdg

Hospital cost-to-

charge ratio4

N/A

OTHER TREATMENT PLANNING SERVICES 77370 Special medical radiation physics consultation 0304/X Level I Therapeutic Radiation

Treatment Preparation $103.09 $139.46

77470 Special treatment procedure (eg, total body irradiation, hemibody radiation, per oral, endocavitary or intraoperative cone irradiation)

0299/S Miscellaneous Radiation Treatment

$343.25 $554.82 (Global)$108.77 (Prof)$446.05 (Tech)

APC Status Key: B=Not paid under OPPS; E=Non-covered items and services; H=Device category pass through and brachytherapy sources; K=Non-pass through Drugs, Biologicals, and Radiopharmaceutical Agents; N=Incidental services, packaged into APC rate; S=Significant procedure, not discounted when multiple; T=Procedure, discounted when multiple; X=Ancillary Services; V=Clinic Visit

March 2006 3 This information is provided by Sirtex as a guide for coding services involving SIR-Spheres and is not intended to increase or maximize reimbursement by any payer. We strongly suggest consulting your third-party payer organizations with regard to local coverage, coding and reimbursement policies. Providers assume full responsibility for all reimbursement decisions or actions. Current Procedural Terminology © 2005 American Medical Association. All Rights Reserved.

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SIR-SPHERES PRE-TREATMENT PRE-TREATMENT EMBOLIZATION

2006 OPPS Payment Rate Code Code Description APC/

Status APC Descriptor APC Payment

2006 Medicare Physician Fee

Schedule

37204 Transcatheter occlusion or embolization (eg, for tumor destruction, to achieve hemostasis, to occlude a vascular malformation), percutaneous, any method, non-central nervous system, non-head or neck

0115/T Cannula/Access Device Procedures

$2,200.75 $996.77

75894 Transcatheter therapy, embolization, any method, radiological supervision and interpretation

0297/S Level II Therapeutic Radiologic Procedures

$303.37 $1,034.22 (Global) $ 68.97 (Prof) $965.25 (Tech)

75898 Angiography through existing catheter for follow-up study for transcatheter therapy, embolization or infusion

0263/X Level I Miscellaneous Radiology Procedures

$101.04 $128.47 (Global) $ 86.20 (Prof) $ 42.06 (Tech)

SIR-SPHERES TREATMENT PLANNING

2006 OPPS Payment Rate Code Code Description APC/

StatusAPC

Descriptor APC Payment

2006 Medicare Physician Fee

Schedule

EVALUATION AND MANAGEMENT SERVICES: OFFICE VISTS & CONSULTATIONS For a complete summary of applicable E&M codes that may apply, see page 10 of this guide or consult your current CPT manual.

99201 - 99205

Office or other outpatient visit for the evaluation and management of a new patient

0600-0602/V

Clinic Visits $52.37- $87.67 $23.88-$142.87 (Facility) $36.76-$174.33 (Non-Facility)

99211 - 99215

Office or other outpatient visit for the evaluation and management of an established patient

0600-0602/V

Clinic Visits $52.37- $87.67 $9.10-$ 94.74 (Facility) $21.60-$120.14 (Non Facility)

99241 - 99245

Office consultation for new or established patient 0600-0602/V

Clinic Visits $52.37- $87.67 $34.49-$184.56 (Facility) $50.40-$223.97 (Non-Facility)

TREATMENT PLANNING - for a complete description of “simple”, “intermediate” and “complex” therapeutic radiology treatment planning, consult your current CPT manual.

77261 Therapeutic radiology treatment planning; simple (single treatment area or simple parallel opposed ports with simple or no blocking)

B N/A N/A $74.66

77262 Therapeutic radiology treatment planning; intermediate (two separate treatment a ea, multipleblocks, or special time dose constraints)

r B N/A N/A $112.56

77263 Therapeutic radiology treatment planning; complex (three or more treatment areas, rotational or special beam considerations, combina ion of therapeuticmodalities).

t

B N/A N/A $167.13

APC Status Key: B=Not paid under OPPS; E=Non-covered items and services; H=Device category pass through and brachytherapy sources; K=Non-pass through Drugs, Biologicals, and Radiopharmaceutical Agents; N=Incidental services, packaged into APC rate; S=Significant procedure, not discounted when multiple; T=Procedure, discounted when multiple; X=Ancillary Services; V=Clinic Visit

March 2006 4 This information is provided by Sirtex as a guide for coding services involving SIR-Spheres and is not intended to increase or maximize reimbursement by any payer. We strongly suggest consulting your third-party payer organizations with regard to local coverage, coding and reimbursement policies. Providers assume full responsibility for all reimbursement decisions or actions. Current Procedural Terminology © 2005 American Medical Association. All Rights Reserved.

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TREATMENT PLANNING (continued)

2006 OPPS Payment Rate Code Code Description APC/

Status APC Descriptor APC Payment

2006 Medicare Physician Fee

Schedule

SIMULATION– if simulation is performed code according to work done

77280 Therapeutic radiology simulation-aided field setting; simple 0304/X Level I Therapeutic Radiation Treatment

Preparation

$103.09 $175.09 (Global)$ 36.38 (Prof)

$ 138.70 (Tech)77285 Therapeutic radiology simulation-aided field setting;

intermediate 0305/X Level II Therapeutic

Radiation Treatment Preparation

$234.09 $ 277.79 (Global)$ 54.57 (Prof)

$ 223.22 (Tech)77290 Therapeutic radiology simulation-aided field setting; complex 0305/X Level II Therapeutic

Radiation Treatment Preparation

$234.09 $ 341.83 (Global)$ 81.10 (Prof)

$ 260.73 (Tech)77295 Therapeutic radiology simulation-aided field setting; three-

dimensional 0310/X Level III Therapeutic

Radiation Treatment Preparation

$826.12 $1,354.46 (Global)$ 236.86 (Prof)

$1,117.60 (Tech)

3-D POST-PROCESSING (for liver volume)

76376 3D rendering with interpretation and reporting of computed tomography, magnetic resonance imaging, ultrasound or other tomographic modality; not requiring image postprocessing on an independent workstation

0340/X Minor Ancillary Procedure $36.52 $ 144.01 (Global)$ 10.99 (Prof)

$ 133.02 (Tech)

76377 3D rendering with interpretation and reporting of computed tomography, magnetic resonance imaging, ultrasound or other tomographic modality; requiring image postprocessing on an independent workstation

0282/S Miscellaneous Computerized Axial

Tomography

$94.82 $ 184.94 (Global)$ 43.20 (Prof)

$ 141.74 (Tech)

DOSIMETRY - for a complete description of “Sources” (intracavitary placement or permanent interstitial placement), consult your current CPT manual

77300 Basic radiation dosimetry calculation, central axis depth dose calculation, TDF, NSD, gap calculation, off axis factor, tissue inhomogeneity factors, calculation of non-ionizing radiation surface and depth dose, as required during course of treatment, only when prescribed by the treating physician

0304/X Level I Therapeutic Radiation Treatment

Preparation

$103.90 $ 85.65 (Global)$ 32.22 (Prof)$ 53.43 (Tech)

77326 Brachytherapy isodose plan; simple (calculation made from single plane, one to four sources/ribbon application, remote afterloading brachytherapy, 1 to 8 sources)

0304/X Level I Therapeutic Radiation Treatment

Preparation

$103.90 $ 143.25 (Global)$ 48.51 (Prof)$ 94.74 (Tech)

77327

Brachytherapy isodose plan; intermediate (multiplane dosage calculations, application involving 5 to 10 sources/ribbons, remote afterloading brachytherapy, 9 to 12 sources)

0305/X Level II Therapeutic Radiation Treatment

Preparation

$234.09 $ 210.71 (Global)$ 72.01 (Prof)

$ 138.70 (Tech)

77328

Brachytherapy isodose plan; complex (multiplane isodose plan, volume implant calculations, over 10 sources/ribbons used, special spatial reconstruction, remote afterloading brachytherapy, over 12 sources)

0305/X Level II Therapeutic Radiation Treatment

Preparation

$234.09 $ 306.59 (Global)$ 108.77 (Prof)$ 197.82 (Tech)

77331 Special dosimetry (eg, TLD, microdosimetry) (specify), only when prescribed by the treating physician

0304/X Level I Therapeutic Radiation Treatment

Preparation

$103.90 $ 64.80 (Global)$ 45.10 (Prof)$ 19.71 (Tech)

APC Status Key: B=Not paid under OPPS; E=Non-covered items and services; H=Device category pass through and brachytherapy sources; K=Non-pass through Drugs, Biologicals, and Radiopharmaceutical Agents; N=Incidental services, packaged into APC rate; S=Significant procedure, not discounted when multiple; T=Procedure, discounted when multiple; X=Ancillary Services; V=Clinic Visit

March 2006 5 This information is provided by Sirtex as a guide for coding services involving SIR-Spheres and is not intended to increase or maximize reimbursement by any payer. We strongly suggest consulting your third-party payer organizations with regard to local coverage, coding and reimbursement policies. Providers assume full responsibility for all reimbursement decisions or actions. Current Procedural Terminology © 2005 American Medical Association. All Rights Reserved.

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DAY OF TREATMENT

2006 OPPS Payment Rate Code Code Description APC/

Status APC Descriptor APC Payment

2006 Medicare Physician Fee

Schedule

HANDLING AND LOADING* (IMPORTANT – SEE NOTE BELOW)

77790 Supervision, handling, loading of radiation source N N/A N/A $ 74.28 (Global)$ 54.57 (Prof)$ 19.71 (Tech)

SIR-SPHERES MICROSPHERES ADMINISTRATION* (IMPORTANT – SEE NOTE BELOW)

77778 Interstitial radiation source application; complex 0651/S Complex Interstitial Radiation Source

Application

$666.21 $ 785.62 (Global)$ 580.59 (Prof)$ 205.03 (Tech)

Q30013 Radioelements for brachytherapy, any type, each N Not Applicable to Medicare; Private Payers should be contacted for their billing requirements 3

C26164 Brachytherapy source, yttrium-90 (This Code is Required for Medicare Claims; Private Payers Should be Contacted for their Requirements)

2616/H Brachytherapy source, yttrium-90

Hospital cost-to-

charge ratio4

S20955 Transcatheter occlusion or embolization for tumor destruction, percutaneous, any method, using yttrium-90 microspheres

N/A Not Applicable to Medicare; Private Payers should be contacted for their billing requirements5

37204 Transcatheter occlusion or embolization (for tumor destruction, to achieve hemostasis, to occlude a vascular malformation) percutaneous, any method, non-central nervous system, non-head or neck

0115/T Cannula/Access Device Procedures

$2,200.75 $996.77

75894 Transcatheter therapy, embolization, any method, radiological supervision and interpretation

0297/S Level II Therapeutic Radiologic Procedures

$303.37 $1,034.22 (Global)$ 68.97 (Prof)$965.25 (Tech)

Revenue Code (used exclusively for hospital claims)

278 Other Implants N/A

*NOTE: CPT code 79445 was a new code effective January 1, 2005. The AMA is currently in the process of clarifying the intent of this code. We recommend checking with your local payers as to their specific requirements pertaining to the use of this code.

79445 Radiopharmaceutical therapy, by intra-arterial particulate administration

0407/S Radionuclide Therapy $230.65 $126.58 (Prof)Carrier Decision (Global & Tech)

APC Status Key: B=Not paid under OPPS; E=Non-covered items and services; H=Device category pass through and brachytherapy sources; K=Non-pass through Drugs, Biologicals, and Radiopharmaceutical Agents; N=Incidental services, packaged into APC rate; S=Significant procedure, not discounted when multiple; T=Procedure, discounted when multiple; X=Ancillary Services; V=Clinic Visit

March 2006 6 This information is provided by Sirtex as a guide for coding services involving SIR-Spheres and is not intended to increase or maximize reimbursement by any payer. We strongly suggest consulting your third-party payer organizations with regard to local coverage, coding and reimbursement policies. Providers assume full responsibility for all reimbursement decisions or actions. Current Procedural Terminology © 2005 American Medical Association. All Rights Reserved.

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DAY OF TREATMENT (continued)

2006 OPPS Payment Rate Code Code Description APC/

Status APC Descriptor APC Payment

2006 Medicare Physician Fee

Schedule

SELECTIVE CATHETERIZATIONS - See your CPT manual for coding guidelines specific to selective vascular catheterization(s)• Select catheterization code based on the most distal catheterization within the vascular family. • If same vascular access site is used for all same-day services, code vascular access only once. If separate vascular access sites

are used, code for each site.

36245 Selective catheter placement, arterial system; each first order abdominal, pelvic, or lower extremity artery branch, within a vascular family

N N/A N/A $252.40 (Facility)$1,408.27

(Non-Facility)

36246 Selective catheter placement, arterial system; initial second order abdominal, pelvic, or lower extremity artery branch, within a vascular family

N N/A N/A $283.47 (Facility)$1,352.94

(Non-Facility)

36247 Selective catheter placement, arterial system; initial third order or more selective abdominal, pelvic, or lower extremity artery branch, within a vascular family

N N/A N/A $337.67 (Facility)$2,137.80

(Non-Facility)

36248 Selective catheter placement, arterial system; additional second order, third order, and beyond, abdominal, pelvic, or lower extremity artery branch, within a vascular family (List in addition to code for initial second or third order vessel as appropriate)

N N/A N/A $56.09 (Facility)$194.41

(Non-Facility)

ANGIOGRAPHY

75726 Angiography, visceral, selective or supraselective, (with or without flush aortogram), radiological supervision and interpretation

0280/S Level III Angiography and Venography

$1,215.14 $562.78 (Global)$ 59.12 (Prof)$503.66 (Tech)

75774 Angiography, selective, each additional vessel studied after basic examination, radiological supervision and interpretation (List separately in addition to code for primary procedure)

0279/S Level II Angiography and Venography

$517.67 $522.61 (Global)$ 18.95 (Prof)$503.66 (Tech)

POST-PROCEDURE OBSERVATION

2006 OPPS Payment Rate Code Code Description APC/

Status APC Descriptor APC Payment

2006 Medicare Physician Fee

Schedule

LIVER IMAGING

78205 Liver imaging (SPECT); 0394/S Hepatobiliary Imaging $256.53 $ 273.62 (Global)$ 37.14 (Prof)

$ 236.48 (Tech)

78206 Liver imaging (SPECT); with vascular flow 0394/S Hepatobiliary Imaging $256.53 $ 279.30 (Global)$ 50.40 (Prof)

$ 228.90 (Tech)

APC Status Key: B=Not paid under OPPS; E=Non-covered items and services; H=Device category pass through and brachytherapy sources; K=Non-pass through Drugs, Biologicals, and Radiopharmaceutical Agents; N=Incidental services, packaged into APC rate; S=Significant procedure, not discounted when multiple; T=Procedure, discounted when multiple; X=Ancillary Services; V=Clinic Visit

March 2006 7 This information is provided by Sirtex as a guide for coding services involving SIR-Spheres and is not intended to increase or maximize reimbursement by any payer. We strongly suggest consulting your third-party payer organizations with regard to local coverage, coding and reimbursement policies. Providers assume full responsibility for all reimbursement decisions or actions. Current Procedural Terminology © 2005 American Medical Association. All Rights Reserved.

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SIR-SPHERES POST-TREATMENT FOLLOW UP

EVALUATION AND MANAGEMENT SERVICES: OFFICE VISTS & CONSULTATIONS For a complete summary of applicable E&M codes that may apply, see page 10 of this guide or consult your current CPT manual.

FOLLOW UP LAB TESTS

Code Code Description Medicare 2006 Clinical Lab Fee Schedule

Electrolyte Panel - use code only if all of these lab tests were done; if all tests are not done, consult your CPT manual and select coding based on actual tests performed.

80048 Basic metabolic panel This panel must include the following: Calcium (82310) Carbon dioxide (82374) Chloride (82435) Creatinine (82565) Glucose (82947) Potassium (84132) Sodium (84295) Urea nitrogen (BUN) (84520)

$ 8.93 – $ 11.83

Comp Metabolic Panel - use code only if all of these lab tests were done; if all tests are not done, consult your CPT manual and select coding based on actual tests performed.

80053 Comprehensive metabolic panel. This panel must include the following: Albumin (82040) Bilirubin, total (82247) Calcium (82310) Carbon dioxide (bicarbonate) (82374) Chloride (82435) Creatinine (82565) Glucose (82947) Phosphatase, alkaline (84075) Potassium (84132) Protein, total (84155) Sodium (84295) Transferase, alanine amino (ALT) (SGPT) (84460) Transferase, aspartate amino (AST) (SGOT) (84450) Urea nitrogen (BUN) (84520)

$ 11.47 – $ 14.77

Hepatic Function Panel - use code only if all of these lab tests were done; if all tests are not done, consult your CPT manual and select coding based on actual tests performed.

80076 Hepatic function panel This panel must include the following: Albumin (82040) Bilirubin, total (82247) Bilirubin, direct (82248) Phosphatase, alkaline (84075) Protein, total (84155) Transferase, alanine amino (ALT) (SGPT) (84460) Transferase, aspartate amino (AST) (SGOT) (84450)

$ 6.41 – $ 11.42

CEA Marker

82378 Carcinoembryonic antigen (CEA) $ 20.28 – $ 26.51

FOLLOW UP PET SCAN

2006 OPPS Payment Rate Code Code Description APC/

Status APC Descriptor APC Payment

2006 Medicare

Physician Fee Schedule

FOLLOW UP PET SCAN 78811 Tumor imaging, positron emission tomography (PET); limited

area (eg, chest, head/neck) 1513/S New Technology - Level

XIII ($1100 - $1200) $1,150.00 $82.62 (Prof)

Carrier Decision (Global & Tech)

78812 Tumor imaging, positron emission tomography (PET); skull base to mid-thigh

1513/S New Technology - Level XIII ($1100 - $1200)

$1,150.00 $102.32 (Prof) Carrier Decision (Global & Tech)

S80851 Fluorine-18 fluorodeoxyglucose (f-18 fdg) imaging using dual-head coincidence detection system (non-dedicated pet scan)

N/A Not Applicable To Medicare; Private Payers should be Contacted for their Billing Requirements 1

A95522 Fluorodeoxyglucose F-18 FDG, diagnostic, per study dose, up to 45 millicuries

1651/H F 18 fdg

Hospital cost-to-charge

ratio4

N/A

APC Status Key: B=Not paid under OPPS; E=Non-covered items and services; H=Device category pass through and brachytherapy sources; K=Non-pass through Drugs, Biologicals, and Radiopharmaceutical Agents; N=Incidental services, packaged into APC rate; S=Significant procedure, not discounted when multiple; T=Procedure, discounted when multiple; X=Ancillary Services; V=Clinic Visit

March 2006 8 This information is provided by Sirtex as a guide for coding services involving SIR-Spheres and is not intended to increase or maximize reimbursement by any payer. We strongly suggest consulting your third-party payer organizations with regard to local coverage, coding and reimbursement policies. Providers assume full responsibility for all reimbursement decisions or actions. Current Procedural Terminology © 2005 American Medical Association. All Rights Reserved.

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MODIFIERS In addition to selecting appropriate CPT codes, billers should pay attention to the use of modifiers. Modifiers should be used in accordance with appropriate procedures. The following modifiers are the most common to the SIR-Spheres microspheres procedure. This list is not all inclusive and is not intended to represent all applicable modifiers. Refer to your current CPT and/or HCPCS manual for a complete list of modifiers, descriptors and instruction.

Modifier Descriptor

-21 Prolonged E&M Service

-22 Unusual Procedural Service

-25 Significant, Separately Identifiable E&M Service by the Same Physician on the Same Day of the Procedure

-26 Professional Component

-50 Bilateral Procedure

-51 Multiple Procedure

-52 Reduced Services

-59 Distinct Procedural Service

-66 Surgical Team

-99 Multiple Modifiers

-LT Left Side

-RT Right Side

Modifiers Approved for Hospital Outpatient Use

-25 Significant, Separately Identifiable E&M Service by the Same Physician on the Same Day of the Procedure

-27 Multiple Outpatient Hospital E&M Encounters on the Same Day

-50 Bilateral Procedure

-52 Reduced Services

-59 Distinct Procedural Service

APC Status Key: B=Not paid under OPPS; E=Non-covered items and services; H=Device category pass through and brachytherapy sources; K=Non-pass through Drugs, Biologicals, and Radiopharmaceutical Agents; N=Incidental services, packaged into APC rate; S=Significant procedure, not discounted when multiple; T=Procedure, discounted when multiple; X=Ancillary Services; V=Clinic Visit

March 2006 9 This information is provided by Sirtex as a guide for coding services involving SIR-Spheres and is not intended to increase or maximize reimbursement by any payer. We strongly suggest consulting your third-party payer organizations with regard to local coverage, coding and reimbursement policies. Providers assume full responsibility for all reimbursement decisions or actions. Current Procedural Terminology © 2005 American Medical Association. All Rights Reserved.

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PATIENT EVALUATION & MANAGEMENT SERVICES The following Evaluation and Management codes are possible coding options for services involving the SIR-Spheres microspheres. See your current CPT manual for complete descriptions and coding options. Curren Procedural Terminology (CPT) is copyright 2005 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, tor related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use.

CODE CODE DESCRIPTION

NEW PATIENT

99201 Office or other outpatient visit for the evaluation and management of a new patient…Physicians typically spend 10 minutes face-to-face with the patient and/or family.

99202 Office or other outpatient visit for the evaluation and management of a new patient…Physicians typically spend 20 minutes face-to-face with the patient and/or family.

99203 Office or other outpatient visit for the evaluation and management of a new patient…Physicians typically spend 30 minutes face-to-face with the patient and/or family.

99204 Office or other outpatient visit for the evaluation and management of a new patient…Physicians typically spend 45 minutes face-to-face with the patient and/or family.

99205 Office or other outpatient visit for the evaluation and management of a new patient…Physicians typically spend 60 minutes face-to-face with the patient and/or family.

ESTABLISHED PATIENT

99211 Office or other outpatient visit for the evaluation and management of an established patient…Typically, 5 minutes are spent performing or supervising these services.

99212 Office or other outpatient visit for the evaluation and management of an established patient…Physicians typically spend 10 minutes face-to-face with the patient and/or family.

99213 Office or other outpatient visit for the evaluation and management of an established patient…Physicians typically spend 15 minutes face-to-face with the patient and/or family

99214 Office or other outpatient visit for the evaluation and management of an established patient… Physicians typically spend 25 minutes face-to-face with the patient and/or family.

99215 Office or other outpatient visit for the evaluation and management of an established patient…Physicians typically spend 40 minutes face-to-face with the patient and/or family.

CONSULTATIONS

99241 Office consultation for a new or established patient… Physicians typically spend 15 minutes face-to-face with the patient and/or family.

99242 Office consultation for a new or established patient…Physicians typically spend 30 minutes face-to-face with the patient and/or family.

99243 Office consultation for a new or established patient…Physicians typically spend 40 minutes face-to-face with the patient and/or family.

99244 Office consultation for a new or established patient… Physicians typically spend 60 minutes face-to-face with the patient and/or family.

99245 Office consultation for a new or established patient… Physicians typically spend 80 minutes face-to-face with the patient and/or family.

March 2006 10 This information is provided by Sirtex as a guide for coding services involving SIR-Spheres and is not intended to increase or maximize reimbursement by any payer. We strongly suggest consulting your third-party payer organizations with regard to local coverage, coding and reimbursement policies. Providers assume full responsibility for all reimbursement decisions or actions. Current Procedural Terminology © 2005 American Medical Association. All Rights Reserved.

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FREQUENTLY ASKED QUESTIONS AND ANSWERS

1. Q: Please explain the “72 hour rule” and how it may relate to the SIR-Spheres microspheres procedure. For example, from a reimbursement perspective, what happens when a patient undergoes the microspheres procedure in the hospital outpatient department and develops complications that require a hospital admission? Does the hospital outpatient department receive reimbursement for the outpatient costs for the microspheres and the rest of the expenses incurred during the outpatient procedure?

A: Private payer policies will vary on this issue. We recommend that the admissions office contact the patient’s private insurance plan to verify coverage under these circumstances.

Medicare policy on this matter is more predictable: if the patient’s ICD-9-CM diagnosis code(s) for the outpatient procedure differ from the admitting principal diagnosis (as determined at the time of discharge) two separate hospital payments may be issued: 1) One for the outpatient procedure (under Medicare’s Outpatient Prospective Payment System, Part B) as determined by the Ambulatory Payment Classification(s) for the administration of the microspheres and related procedures. 2) A separate hospital payment may be issued by the Part A contractor (aka Fiscal Intermediary) for the inpatient procedure(s)/treatment(s) as determined by the appropriate DRG assignment relative to treating the complications.

On the other hand, if the patient’s principal diagnosis (ICD-9-CM) is the same for the hospital outpatient admission as it is for the hospital inpatient discharge, the hospital is paid one payment under Medicare’s hospital prospective payment system as determined by the Diagnosis Related Group (DRG).

If a patient must be admitted due to complications arising from the treatment, the Medicare contractors (Part A and Part B) should both be notified about the change in patient status from outpatient to inpatient as soon the patient’s physician orders an admission. The hospital admissions office will be familiar with this protocol. All complications and comorbidities should be carefully documented in the patient’s medical record.

ADDITIONAL INFORMATION: For additional information, contact your hospital Medicare Compliance Officer and/or your local Medicare contractors (Part A and Part B). You may also refer to the Internet Only Manuals (IOM), Chapter 3, Hospital-Sec 40.3., subsection C, or refer to Transmittal A-03-013 dated February 14, 2003.

2. Q: If a patient has SIR-Spheres microspheres in the outpatient hospital setting and is unable to be discharged prior to 24 hours, will the patient’s stay be considered an inpatient stay?

A: No. The time spent in the hospital does not determine whether a patient’s status is outpatient or inpatient. The status is determined by the judgment of the admitting physician as documented in his/her orders. A patient admitted as an outpatient continues to be an outpatient unless the physician changes that status with a specific order. If, following the normal recovery period for the outpatient procedure, the physician deems that the patient is not ready for discharge, additional time in the hospital would generally be considered outpatient observation time. Outpatient observation allows for additional information to be gathered so the physician can make a decision to discharge the patient or admit the patient as an inpatient. The coding and billing for outpatient observation is separate and in addition to that for the initial admission. Most payers, as a matter of policy, accept physician orders concerning the status of a patient admission or period of observation. As always, the order should be unambiguous and properly document medical necessity. Outpatient observation for more than 48 hours is considered very unusual and may be reviewed by the hospital’s own Peer Review Organization, which has the final say on the status of a patient admission. We recommend being familiar with the policies of the hospital’s Peer Review Organization as well as those of the local Medicare Part B contractor and relevant private payers. CMS Publication 100-2 is a useful reference. NOTE: Medicare rules may not preclude a patient being transferred to another area of the hospital, however, hospital policy may. We recommend discussing these circumstances specifically with your hospital Peer Review Organization (PRO) and or the Medicare Compliance Officer.

March 2006 11 This information is provided by Sirtex as a guide for coding services involving SIR-Spheres and is not intended to increase or maximize reimbursement by any payer. We strongly suggest consulting your third-party payer organizations with regard to local coverage, coding and reimbursement policies. Providers assume full responsibility for all reimbursement decisions or actions. Current Procedural Terminology © 2005 American Medical Association. All Rights Reserved.

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3. Q: Does Medicare reimbursement cover the cost of the SIR-Spheres microspheres?

A: The cost of the microspheres is reimbursed under C2616. Payment is made in addition to the APC(s) associated with the infusion of the microspheres. Payment for the microspheres is hospital specific therefore hospitals will receive different payment amounts. Payment is based on each hospital’s cost-to-charge ratio, reduced to cost, using their historical cost-to-charge ratio. Depending on the hospital’s mark-up (charge) on the microspheres, most hospitals should recover the cost of the device in addition to the associated procedures. The financial department of the hospital is familiar with their cost-to-charge calculations and should be consulted for additional clarification.

4. Q. How much does Medicare allow for the yttrium-90 device?

A: The SIR-Spheres microspheres payment will vary between hospitals depending on their historical cost to charge ratio. Microspheres are payable under C2616, Brachytherapy source, yttrium-90. Payment for C2616 is calculated based on the hospital’s cost for the microspheres, their charge (mark-up) for the microspheres multiplied by their historic cost-to-charge ratio. The formula is as follows: Hospital’s Charge for microspheres x Hospital Specific Cost-to-Charge Ratio = $ Medicare payment for microspheres

5. Q: Do private payers recognize C2616 for SIR-Spheres microspheres?

A: Not generally, however, some payers are beginning to recognize this code. This code is required for Medicare claims for services provided in the hospital outpatient department. Private payers should be contacted for their billing requirements. It is recommended that the microspheres procedure be preauthorized in advance of services so that questions concerning coverage terms and conditions as well as coding are clarified.

6. Q: If the catheterization procedure initiated in the left hepatic artery is discontinued, and moved to the

right hepatic artery, can the physician bill and be paid for both procedures?

A. No. The procedure will be reimbursed as one procedure regardless of complications encountered and extra time involved.

7. Q: If both lobes are treated at the same time, can the physician code for two catheterizations?

A: Yes, the initial catheter placement (36247) is coded in addition to the subsequent (36248).

8. Q: Our claims are paid inconsistently, sometimes even by the same carrier. What can be done about this?

A. The SIR-Spheres microspheres procedure is relatively new and there are multiple steps involved. Until the procedure is better established with payers, clinicians are advised to be very thorough in their documentation and consistent with coding. When possible, preauthorization should be performed to clarify coding, coverage and payment in advance of services.

9. Q: Who can I contact if I have additional reimbursement questions about SIR-Spheres microspheres?

A. For additional reimbursement questions contact your Sirtex Sales Representative or the Sirtex Reimbursement Support E-Hotline at: [email protected].

March 2006 12 This information is provided by Sirtex as a guide for coding services involving SIR-Spheres and is not intended to increase or maximize reimbursement by any payer. We strongly suggest consulting your third-party payer organizations with regard to local coverage, coding and reimbursement policies. Providers assume full responsibility for all reimbursement decisions or actions. Current Procedural Terminology © 2005 American Medical Association. All Rights Reserved.

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March 2006 13 This information is provided by Sirtex as a guide for coding services involving SIR-Spheres and is not intended to increase or maximize reimbursement by any payer. We strongly suggest consulting your

APPENDIX

Code Code Description

PRE-TREATMENT SCREENING LAB TESTS Correct usage of the Organ or Disease Oriented Panels is based on the actual lab tests performed. If all of the lab tests listed within a Panel are not performed, the CPT code describing the Panel cannot be used.

Electrolyte Panel - use code only if all of these lab tests were done; if all tests are not done, consult your CPT manual and select coding based on actual tests performed.

80048 Basic metabolic panel This panel must include the following: Calcium (82310) Carbon dioxide (82374) Chloride (82435) Creatinine (82565) Glucose (82947) Potassium (84132) Sodium (84295) Urea nitrogen (BUN) (84520)

Comp Metabolic Panel – use code only if all of these lab tests were done; if all tests are not done, consult your CPT manual and select coding based on actual tests performed.

80053 Comprehensive metabolic panel. This panel must include the following: Albumin (82040) Bilirubin, total (82247) Calcium (82310) Carbon dioxide (bicarbonate) (82374) Chloride (82435) Creatinine (82565) Glucose (82947) Phosphatase, alkaline (84075) Potassium (84132) Protein, total (84155) Sodium (84295) Transferase, alanine amino (ALT) (SGPT) (84460) Transferase, aspartate amino (AST) (SGOT) (84450) Urea nitrogen (BUN) (84520)

Hepatic Function Panel – use code only if all of these lab tests were done; if all tests are not done, consult your CPT manual and select coding based on actual tests performed.

80076 Hepatic function panel This panel must include the following: Albumin (82040) Bilirubin, total (82247) Bilirubin, direct (82248) Phosphatase, alkaline (84075) Protein, total (84155) Transferase, alanine amino (ALT) (SGPT) (84460) Transferase, aspartate amino (AST) (SGOT) (84450)

CBC with Differential

85025 Blood count; complete (CBC), automated (Hgb, Hct, RBC, WBC and platelet count) and automated differential WBC count

85027 Blood count; complete (CBC), automated (Hgb, Hct, RBC, WBC and platelet count)

PT/PTT

85610 Prothrombin time;

85730 Thromboplastin time, partial (PTT); plasma or whole blood

AFP

82105 Alpha-fetoprotein; serum

LDH

83615 Lactate dehydrogenase (LD), (LDH);

CEA Marker

82378 Carcinoembryonic antigen (CEA)

PRE-TREATMENT RADIOLOGY: CHEST X-RAYS

71010 Radiologic examination, chest; single view, frontal 71015 Radiologic examination, chest; stereo, frontal 71020 Radiologic examination, chest, two views, frontal and lateral; 71021 Radiologic examination, chest, two views, frontal and lateral; with apical lordotic procedure 71022 Radiologic examination, chest, two views, frontal and lateral; with oblique projections 71023 Radiologic examination, chest, two views, frontal and lateral; with fluoroscopy 71030 Radiologic examination, chest, complete, minimum of four views; 71034 Radiologic examination, chest, complete, minimum of four views; with fluoroscopy 71035 Radiologic examination, chest, special views (eg, lateral decubitus, Bucky studies)

third-party payer organizations with regard to local coverage, coding and reimbursement policies. Providers assume full responsibility for all reimbursement decisions or actions. Current Procedural Terminology © 2005 American Medical Association. All Rights Reserved.

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March 2006 14 This information is provided by Sirtex as a guide for coding services involving SIR-Spheres and is not intended to increase or maximize reimbursement by any payer. We strongly suggest consulting your

END NOTES

1 HCPCS code S8085 is used only by some private payers and is not applicable to services provided to Medicare beneficiaries. Private payers should be contacted for their specific coding, coverage and reimbursement requirements.

2 HCPCS code C1775 (described FDG in 2005) was replaced by HCPCS code A9552 effective 1/1 /2006. Private payers should be contacted for their coding, coverage and reimbursement requirements.

3 Yttrium sources should be coded using C2616 when billing Medicare for hospital outpatient services. Some private payers may require use of HCPCS code Q3001 when billing for Yttrium device. Private payers should be contacted for their coding, coverage and reimbursement requirements.

4 The cost of the SIR-Spheres® microspheres is reimbursed under pass through code C2616. Payment for C2616 is specific to Medicare hospital outpatient services only and will be based on each hospital’s charge for the microspheres reduced to cost using their historical cost-to-charge ratio.

5 HCPCS code S2095 is used only by some private payers to describe the SIR-Spheres® microspheres procedure. This code is not applicable to services provided to Medicare beneficiaries. Private payers should be contacted for their specific coding, coverage and reimbursement requirements.

third-party payer organizations with regard to local coverage, coding and reimbursement policies. Providers assume full responsibility for all reimbursement decisions or actions. Current Procedural Terminology © 2005 American Medical Association. All Rights Reserved.

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March 2006 15

SIR-SPHERES MICROSPHERE PRESCRIBING INFORMATION

The SIR-Spheres microsphere is a therapeutic radioactive implant, comprised of beta-emitting yttrium-90 microspheres. The microspheres are approximately 35 microns. The average penetration of the beta particles in tissue is 2.4 mm. The microspheres are suspended in sterile, pyrogen-free water for injection. The vials are shipped in lead shields for radiation protection. Yttrium-90 is a beta emitter with a half-life of ~64 hours. The activity of the microspheres is calibrated to 09:00 hours Sydney time for Australia and Asia, 18:00 USA Eastern Standard Time for the USA and 22:00 Greenwich Mean Time for Europe; and is supplied with an activity of 3 Giga-Becquerels (GBq) or 81 millicuries (mCi). After 14 days, only 2.5% of the original activity remains. Following implant via a hepatic artery catheter, the microspheres become embolized in the microvasculature of liver cancer where they have a local radiotherapeutic effect. Some limited concurrent damage to healthy tissue is caused by radiation that escapes tumor boundaries and from microspheres that fail to become embedded in tumors. Following decay of the yttrium-90, the inert microspheres remain implanted in tissue. Treatment with microspheres exploits a normal physiological process to selectively target the cancerous tissue. Healthy liver tissue receives the overwhelming majority of its blood supply via the portal vein and much less from the hepatic artery. In liver tumors, the reciprocal is true. The consequence of this is that catheterization of the hepatic artery permits the targeting of therapeutic material to liver cancer. INDICATIONS: SIR-Spheres microspheres are indicated for treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) of FUDR (Floxuridine).

CONTRAINDICATIONS: SIR-Spheres microspheres have no therapeutic effect on extrahepatic disease and this must be taken in to account when considering treatment. There are no data on the safety of the microspheres in pregnancy or children. Although less demanding on the patient's resources than some other treatments for liver cancer, it should be recognized that implantation of microspheres is a significant intervention and this must be taken into account when the decision to treat is made. SIR-Spheres microspheres are contraindicated in patient who have:

• Had previous external beam radiation therapy to the liver • Ascites or are in clinical liver failure • Markedly abnormal synthetic and excretory liver function tests (LFT’s) • Tumors amenable to surgical resection for cure • Greater than 20% lung shunting of the hepatic artery blood flow determined by Technetium MAA scan. • Pre-assessment angiogram that demonstrated abnormal vascular anatomy that would result in significant reflux of hepatic

arterial blood to the stomach, pancreas or bowel; • Disseminated or extra-hepatic disease • Been treated with capecitabine within the previous 2 months, or who will be treated with capecitabine at any time

following treatment with SIR-Spheres microspheres • Portal vein thrombosis

WARNINGS:

• Inadvertent delivery of SIR-Spheres microspheres to the gastrointestinal tract or pancreas will cause acute abdominal pain, acute pancreatitis or peptic ulceration. This can be avoided by a performing a pre-procedure angiogram using a greater volume of contrast to adequately visualized all of the aberrant vascular to the stomach, pancreas or GI tract. A post-implantation nuclear scan will verify the placement of the microspheres. This is performed with a gamma camera, which will pick up the secondary Bremsstrahlung radiation for the yttrium-90. If this were to occur the patient should be treated for those conditions according to best standard disease states, including pain relief, gastric acid blocking drugs and intravenous fluids.

• High levels of implanted radiation and /or excessive shunting ( > 20%) to the lung may lead to radiation pneumonities This may be suspected if patients develop a non-productive cough several days or weeks after the implantation of the microspheres and is diagnosed by chest X-ray. Patients should be treated with systemic corticosteroids and supportive care until the condition has subsided

• Excessive radiation to the normal liver parenchyma may result in radiation hepatitis. This can be difficult to diagnose, and may appear many weeks after the implantation of the microspheres. It is suspected if there is unexplained progressive deterioration in liver function. The diagnosis can be confirmed by histologic examination of core liver biopsy. If the diagnosis is made then patients should be treated with systemic corticosteroids and supportive care until the inflammation settles.

This information is provided by Sirtex as a guide for coding services involving SIR-Spheres and is not intended to increase or maximize reimbursement by any payer. We strongly suggest consulting your third-party payer organizations with regard to local coverage, coding and reimbursement policies. Providers assume full responsibility for all reimbursement decisions or actions.

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• Inadvertent delivery of spheres to the gallbladder may result in cholecystites and abdominal pain. The cholecystitis may settle with conservative management, but may require a cholecystectomy for resolution.

• As the patient emits low levels of radiation for several weeks care must be with pregnant women and children in the vicinity.

• Only those clinicians who are properly licensed by the competent authorities to handle and administer radionuclides, and trained in the use of SIR-Spheres microspheres may use the product in an accredited facility

PRECAUTIONS:

• No Studies have been done on the safety and effectiveness of this device on pregnant women, nursing mothers or children

• Due to the radioactivity of this device and the significant consequences of misplacing the microspheres in situ, this product must be implanted by doctors with adequate training in the handling and implantation technique for this device.

• Sirtex recommends a SPECT scan of the upper abdomen be performed immediately after implantation of the spheres. The SPECT scan will detect the Bremsstrahlung radiation for the yttrium-90 to confirm placement of the spheres in the liver

• This product is radioactive. The use of this device is regulated under Title 10 of the Code of Federal Regulations Part 35. These regulations must be followed when handling this device.

• All persons handling, dispensing and implanting this device must be familiar with and abide by all Local, State and Federal regulatory requirements governing therapeutic, radioactive materials. Accepted radiation protective techniques should be used to protect staff when both the isotope and the patient.

• Some patients may experience gastric problems following treatment, use of H-2 blockers, the day before implantation of the spheres and continue as needed after administration to reduce gastric complications

• Many patients experience abdominal pain immediately following the administration of the spheres and pain relief may be required.

• SIR-Spheres microspheres demonstrated a mild sensitization potential when tested dermally in the animal model.

BIBLIOGRAPHY: • Van Hazel, G., et al., Randomised phase 2 trial of SIR-Spheres plus Fluorouracil/Leucovorin chemotherapy versus

Fluorouracil/Leucovorin chemotherapy alone in advanced colorectal cancer. Journal of Surgical Oncology, 2004. 88: p. 78 - 85.

• Gray, B., et al., Randomised trial of SIR-Spheres plus chemotherapy vs chemotherapy alone for treating patients with liver metastases from primary large bowel cancer. Annals of Oncology, 2001. 12: p. 1711 - 1720.

• Stubbs, R. and S. Wickremesekera, Selective internal radiation therapy (SIRT): a new modality for treating patients with colorectal liver metastases. HPB, 2004.6(3): p.133 - 139.

• Stubbs RS, Wickremesekera K et al., Selective Internal Radiation Therapy (SIRT) for the treatment of advanced Colorectal Liver Metastases. Journal of Gastrointestinal Surgery 2003; 7: p. 262-263.

• Gray, B., et al., Treatment of colorectal liver metastases with SIR-Spheres plus chemotherapy. Gastrointestinal Cancer, 2000. 3: p. 249 - 257.

• Stubbs, R. and R. Cannan, Active treatment of colorectal hepatic metastases. New Zealand Family Physician, 1999. 26. • Gray, B., et al., Regression of liver metastases following treatment with yttrium-90 microspheres. Australian and New Zealand

journal of Surgery, 1992. 62: p.105- 110. • Gray, B., et al., Selective internal radiation (SIR) therapy for treatment of liver metastases: measurement of response rate.

Journal of Surgical Oncology, 1989. 42: p. 192 – 196 • Lim, L., Gibbs, P., Yip, D., et al., Prospective study of treatment with selective internal radiation therapy spheres in patients

with unresectable primary or secondary hepatic malignancies. Internal Medicine Journal, 2005; 35: p. 222 – 227. • Murthy, R., Xiong, H., Nunez, R., et al., Yttrium 90 Resin microspheres for the treatment of unresectable colorectal

hepatic metastases after failure of multiple chemotherapy regimens: Preliminary results. Journal of Vascular and Interventional Radiology, 2005; 15: p. 937 – 945.

• Lim, L., et al., A prospective evaluation of treatment with Selective Internal Radiation Therapy (SIR-Spheres) in patients with unresectable liver metastases from colorectal cancer previously treated with 5-FU based chemotherapy. BMC Cancer 2005; 5:132

• Wong, C., et al., Reduction of metastatic load to liver after intraarterial hepatic yttrium-90 radioembolization as evaluated by [18F]Fluorodeoxyglucose positron emission tomographic imaging. Journal of Vascular and Interventional Radiology, 2005. 16: p. 1101 - 1106.

March 2006 16 This information is provided by Sirtex as a guide for coding services involving SIR-Spheres and is not intended to increase or maximize reimbursement by any payer. We strongly suggest consulting your third-party payer organizations with regard to local coverage, coding and reimbursement policies. Providers assume full responsibility for all reimbursement decisions or actions.

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NOTES

March 2006

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Sirtex Medical Inc.

1401 North Western Avenue Suite 100

Lake Forest, IL 60045 Phone: 847.482.9023

Fax: 847.482.9103

www.sirtex.com

Email: [email protected]

is a registered trademark of Sirtex Medical Limited

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