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CONDENSED CODING SHEET

FOR

PRE-TREATMENT EVALUATION

&

MICROSPHERES ADMINISTRATION

JANUARY 2009

SIR-SPHERES MICROSPHERES TREATMENT FLOW CHART

Phase 1: SIR-Spheres Microspheres Pre-Treatment Evaluation

Patient Referral

Phase 2: SIR-Spheres Microspheres Administration

Patient Eligible

Schedule Treatment

Interventional Radiology Radiation Oncology SIR-Spheres Microspheres Order 5-7 business days prior to treatment

Screening Lab Tests Hepatic panel ­ Required for treatment

TREATMENT PLAN DOSE CALCULATION

Radiation Oncology/Nuclear Medicine Treatment Planning Radiation Dosimetry

Bilirubin above 2.0 PATIENT NOT ELIGIBLE Pre-Treatment Mapping Angiography Embolization

DAY OF TREATMENT

Nuclear Medicine Tc99 ­ MAA Scan

SIR-Spheres Microspheres Administration

Place arterial catheter Possible Embolization, Supervision, Handling & Loading Interstitial radiation source application

20% or Greater Shunting?

Less than 20% Shunting?

PATIENT NOT ELIGIBLE Alternative Treatment Diagnostic Radiology CT Abdomen MRA Abdomen ­ if applicable 3-D Post-Processing Baseline PET - if applicable

Post-Procedure Observation

Liver Imaging (SPECT or Planar)

Post-Treatment Follow Up

January 2009

2

SELECTIVE INTERNAL RADIATION THERAPY (SIRT) SIR-Spheres Microspheres PRE-TREATMENT EVALUATION AND SIR-Spheres Microspheres ADMINISTRATION CODING

Coding for administration of SIR-Spheres microspheres can be complex and confusing. There is no consensus or consistency in the coding/billing for the administration of SIR-Sphere microspheres. The following provides SIR-Spheres Microspheres Pre-Treatment Evaluation & Administration suggested coding options. As always, payer policies should be reviewed for coverage & coding guidelines. 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. Correct coding is based on documentation contained in the patient's medical records; therefore the provider should perform the procedure, document the procedure, code the procedure from the documentation, and finally bill the procedure. NOTE: It is important that all providers are in agreement regarding the coding of the microspheres administration and concomitant procedures. Do not use different codes to describe the same service.

FDA LABELED INDICATIONS FOR USE

SIR-Spheres microspheres: Colorectal cancer metastasized to liver in combination with hepatic arterial chemotherapy (FUDR) ­ Full PMA approval

Current Procedural Terminology (CPT) is copyright 2008 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.

PRE-TREATMENT EVALUATION PROCEDURES

Code Code Description 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)

CT Abdomen

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

MRA Abdomen ­ Optional Coding Option for Medicare Outpatient Hospital Use

C8900 74185 78811 78812 S80851 A95522 MRA with contrast abdominal Magnetic resonance angiography, abdomen, with or without contrast material(s) Positron emission tomography (PET); limited area (eg, chest, head/neck) Positron emission tomography (PET); skull base to mid-thigh Fluorine-18 fluorodeoxyglucose (F-18 fdg) imaging using dual-head coincidence detection system (non-dedicated pet scan) Fluorodeoxyglucose F-18 FDG, diagnostic, per study dose, up to 45 millicuries

Coding Option for Private Payer and Physician

PET ­ Optional

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 36246 36247 36248 Selective catheter placement, arterial system; initial second order abdominal, pelvic, or lower extremity artery branch, within a vascular family Selective catheter placement, arterial system; initial third order or more selective abdominal, pelvic, or lower extremity artery branch, within a vascular family 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)

This information is provided as a guide for coding services involving SIR-Spheres microspheres administration and is not intended to increase or maximize reimbursement by 3 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 © 2008 American Medical Association. All Rights Reserved. January 2009

PRE-TREATMENT EVALUATION PROCEDURES

Code 3-D Post-Processing (for liver volume)

76376

Code Description

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

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 75774 Angiography, selective, each additional vessel studied after basic examination, radiological supervision and interpretation

Pre-Treatment Embolization 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 75894 Transcatheter therapy, embolization, any method, radiological supervision and interpretation 75898 Angiography through existing catheter for follow-up study for transcatheter therapy, embolization or infusion Nuclear Medicine Break Through Scan with TC-99

78201 78205 A9540 Liver imaging; static only Liver imaging (SPECT) Technetium TC-99m macroaggregated albumin,diagnostic, per study dose, up to 10 millicuries

Pre-Treatment Planning 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 77263 Therapeutic radiology treatment planning; complex 77470 Special treatment procedure

SIR-Spheres MICROSPHERES ADMINISTRATION - DAY OF TREATMENT

SIR-Spheres Microspheres Administration

Coding Option 1: SIR (Society of Interventional Radiology) recommends the following codes1 :

Additional coding options for day of treatment follow this option:

77778 2 37204

Interstitial radiation source application; complex (billed by authorized user) 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 (billed by interventional radiologist) 75894 Transcatheter therapy, embolization, any method, radiological supervision and interpretation Q3001 or Radioelements for brachytherapy, any type, each C2616* Brachytherapy source, yttrium-90

Coding Option 2

77778 Interstitial radiation source application; complex Q3001 or Radioelements for brachytherapy, any type, each C2616* Brachytherapy source, yttrium-90

Coding Option 3 (not valid for patients enrolled in the Medicare fee-for-service plan)

S2095 75894 Q3001

1 2

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

Transcatheter therapy, embolization, any method, radiological supervision and interpretation Radioelements for brachytherapy, any type, each

In the event of planned bilobar therapy, the 2nd treatment session will require a -58 modifier to account for the fact that treatment of the 2nd lobe is planned as a staged procedure (separate and distinct from the first application of therapy).

Seeking Reimbursement for Yttrium-90 Procedures. IR News. March-April 2007. pg 14. Volume 20, Number 2.

This information is provided as a guide for coding services involving SIR-Spheres microspheres administration and is not intended to increase or maximize reimbursement by 4 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 © 2008 American Medical Association. All Rights Reserved. January 2009

SIR-Spheres MICROSPHERES ADMINISTRATION - DAY OF TREATMENT (continued)

Code Code Description Coding Option 4 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 75894 Transcatheter therapy, embolization, any method, radiological supervision and interpretation Q3001 or Radioelements for brachytherapy, any type, each C2616* Brachytherapy source, yttrium-90 Coding Option 5 79445 Radiopharmaceutical therapy, by intra-arterial particulate administration Q3001 or Radioelements for brachytherapy, any type, each C2616* Brachytherapy source, yttrium-90 Handling and Loading of SIR-Spheres Microspheres

77790

Supervision, handling, loading of radiation source

Day of Treatment ­ Concomitant Procedures

Selective Catheterizations - See CPT Manual For Guidelines Specific To Selective Vascular Catheterization(s). 36245 36246 36247 36248

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

Angiography 75726 75774 75898 78201 78205 76000 Angiography, visceral, selective or supraselective (with or without flush aortogram), radiological supervision and interpretation Angiography, selective, each additional vessel studied after basic examination, radiological supervision and interpretation (List separately in addition to code for primary procedure) Angiography through existing catheter for follow-up study for transcatheter therapy, embolization or infusion Liver imaging; static only Liver imaging (SPECT);

Liver Imaging

Fluoroscopy Fluoroscopy (separate procedure), up to 1 hour physician time, other than 71023 or 71034 (eg, cardiac fluoroscopy) *C2616 is required for Medicare claims; private payers should be contacted for their requirements

This information is provided as a guide for coding services involving SIR-Spheres microspheres administration and is not intended to increase or maximize reimbursement by 5 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 © 2008 American Medical Association. All Rights Reserved. January 2009

ICD-9-CM DIAGNOSIS CODES

ICD-9-CM CODE

197.7

Descriptor

Secondary malignant neoplasm of liver

The appropriate primary cancer should be coded. The following diagnosis code range is specific to colorectal cancer (SIR-Spheres microspheres is approved for colorectal cancer that has metastasized to the liver). If the cancer is other than colorectal cancer that has metastasized to the liver, consult your ICD-9-CM code book for a complete list of codes. 153.0 ­ 153.9 Malignant neoplasm of colon

MICROSPHERES REVENUE CODES

REVENUE CODE

0278

Descriptor

Medical / Surgical Supplies ­ Other Implants

Hospital Charge Master Reminder

Hospital Billing: · The hospital's charge master should reflect the following codes for the microspheres o C2616 (Brachytherapy source, yttrium-90) and/or o Q3001 (Radioelements for brachytherapy, any type, each) for the microspheres. The appropriate code used to bill for the microspheres will depend upon the patient's insurance coverage. NOTE: It is important to consult with the hospital finance department to determine the appropriate charges for the microspheres.

Medicare Billing Forms Reminder

Hospital Billing: · For 2009, all institutional paper claims must use the UB-04 form with a valid National Provider Identifier number. Claims submitted using the UB-92 are unacceptable Physician Billing: · For 2009, all physician claims must be submitted with a valid National Provider Identifier number.

This information is provided as a guide for coding services involving SIR-Spheres microspheres administration and is not intended to increase or maximize reimbursement by 6 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 © 2008 American Medical Association. All Rights Reserved. January 2009

FREQUENTLY ASKED QUESTIONS

Q1. Is SIR-Spheres considered a brachytherapy or radiopharmaceutical device?

A. A brachytherapy device is defined by CMS as a ``seed or seeds (or radioactive source)'' that are themselves radioactive, meaning that the sources contain a radioactive isotope3. Brachytherapy devices require penetration of the skin or surgery to insert the device directly into the interstitial tumor bed. Unlike Radiopharmaceuticals, Brachytherapy devices are not metabolized by the body. SIR-Sphere's microspheres represent a permanent form of brachytherapy that continues to deposit radiation until the resin microspheres have completely decayed.4 The resin microspheres will remain implanted in the patient for the remainder of their life. The term "Radiopharmaceutical" means a radioactive isotope that contains by product material combined with chemical or biological material; and is designed to accumulate temporarily in a part of the body for therapeutic purposes or for enabling the production of a useful image for use in a diagnosis of a medical condition.5 SIR-Spheres microspheres are a permanent Brachytherapy device not a Radiopharmaceutical.

Q2. What is the correct code for SIR-Spheres microspheres infusion and how are other sites coding it?

A. There is no consensus of opinion on the correct coding of the SIR-Spheres microspheres infusion nor is there coding consistency among the sites providing this service. We have listed common coding options. Coding is based on the description of the procedure contained in the medical records. It is imperative that the documentation support the code choice. If the procedure does not clearly describe an interstitial placement, the CPT code describing interstitial placement should not be used to describe the procedure. In addition to following CPT guidelines for coding, Medicare's correct coding initiative as well as payer medical policies should be reviewed for coding guidelines.

Q3. Do certain payers have specific coding requirements for the procedure?

A. Many national and regional payers have coverage policies in place recommending specific procedure code(s). We recommend checking with the payer to determine if a coverage policy is in effect. Note: Many payers have not established specific coding guidelines and assess the claims at the time of the procedure.

Q4. Why are there two codes listed to describe the Yttrium-90 and how is the Yttrium-90 paid?

A. When SIR-Spheres microspheres are administered in the hospital outpatient department to a Medicare beneficiary, Medicare requires hospitals to identify the SIR-Spheres microspheres by using the HCPCS C code, C2616, on the hospital bill. Use of C2616 enables the hospital to receive payment for the SIR-Spheres microspheres from the Medicare program in addition to the payment for the administration procedure. SIR-Spheres microspheres are paid separately because of the 2003 MMA legislation. Medicare payment for the Yttrium-90 is considered a cost-based non-pass-through payment and is based on the hospital's charge listed on the patient's claim submitted to Medicare reduced to cost. The Medicare contractor determines the hospital's cost for the Yttrium-90 by applying the hospital specific cost-to-charge ratio (CCR) to the billed charges. Many private payers prefer the hospital to identify the

microspheres by using code Q3001 on the hospital bill. Private payers should be contacted regarding their coding, coverage and reimbursement requirements.

Q5. Do Medicare and Medicaid provide coverage for yttrium-90 treatments? A. Medicare reimburses providers for Yttrium-90 under HCPCS code C2616. Per the FDA approved package insert, SIRSpheres® is indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery (HAC) FUDR (Floxuridine) chemotherapy. We recommend checking your local Medicare contractor's website to determine if they have issued a local coverage determination (LCD) policy for Yttrium-90. The local Medicare contractor will determine the codes to use when reporting the service.

In regards to Medicaid payment for SIR-Spheres®, the hospital should review their Medicaid fee schedule to determine the level of reimbursement, if any, for C2616. We recommend checking with your state Medicaid agent for more information.

This information is provided as a guide for coding services involving SIR-Spheres microspheres administration and is not intended to increase or maximize reimbursement by 7 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 © 2008 American Medical Association. All Rights Reserved. January 2009

Q6. 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. Medicare 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

Q7. Which private payers have a positive medical directive for SIR-Spheres microspheres?

A. Currently, Aetna, Cigna, HealthNet, Oxrford and United Healthcare have national written medical directives allowing coverage of the treatment. In addition, BCBS of IL, BCBS of NM, BCBS of OK, BCBS of TX, Horizon BCBS, Independence BlueCross, Wellmark and Premera BCBS also have positive written medical directives allowing coverage of the treatment. Many other plans cover the treatment on a case by case basis. Contact your Sirtex Reimbursement Counselor at 888-4-SIRTEX for information specific to your payer health plans.

Q8. How do I indicate to the Medicare contractor I am using the SIR-Spheres microspheres for offlabel use?

A. In general, Medicare contractors require procedures involving off-label use of medical technologies be coded according to the usual coding rules. If there are appropriate listed codes, they should be used to describe the procedure. If not, the appropriate not otherwise classified (NOC) or unlisted procedure codes should be used. Providers concerned about clearly indicating off-label usage may note "off label use" in the remarks/comments section on the hospital claim form, referred to as the UB-04. NOTE: Sirtex Medical Inc.'s SIR-Spheres® microspheres are indicated for the treatment of non-resectable metastatic colorectal cancer in combination with intra-arterial FUDR chemotherapy. Information regarding other disease states or agents in combination with this device is different from the approved USA labeling for SIR-Spheres.

Q9. What diagnosis codes are considered off-label for SIR-Spheres microspheres?

A. All diagnosis codes are considered off-label for SIR-Spheres microspheres except for colorectal cancer metastasized to the liver (ICD-9 diagnosis code 197.7, billed in conjunction with 153.0-154.8).

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. CRF TITLE 42 CHAPTER 7 SUBCHAPTER XVIII Part B § 1395l Section H Society of Interventional Radiology, 2007 March-April Newsletter, Volume 20 number 2 pages 14 -16. Source: CFR TITLE 42 CHAPTER 23 Division A. SUBCHAPTER X § 2160d

3 4 5

This information is provided as a guide for coding services involving SIR-Spheres microspheres administration and is not intended to increase or maximize reimbursement by 8 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 © 2008 American Medical Association. All Rights Reserved. January 2009

NOTES PAGE

This information is provided as a guide for coding services involving SIR-Spheres microspheres administration and is not intended to increase or maximize reimbursement by 9 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 © 2008 American Medical Association. All Rights Reserved. January 2009

Sirtex Medical Inc.

16 Upton Drive #2-4 Wilmington, MA 01887 Phone: 888-474-7839, ext. 717 Fax: 978-229-9585 www.sirtex.com Email: [email protected]

SIR-Spheres® is a registered trademark of Sirtex SIR-Spheres Pty Ltd 10 This information is provided as a guide for coding services involving SIR-Spheres microspheres administration 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 © 2008 American Medical Association. All Rights Reserved. January 2009

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