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Radiation Oncology, SRS, SBRT, Protons. Advanced Concepts Section 10 Pages 1-45 9:00-10:00 010814 Revised for 2/21/201 82 Privileged and Confidential Work Product – Subject to the Attorney – Client Privilege

Radiation Oncology, SRS, SBRT, Protons. Advanced Concepts Section 10 Pages 1-45 9:00-10:00 010814 Revised for 2/21/2014 82 Privileged and Confidential

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Radiation Oncology,SRS, SBRT, Protons. Advanced Concepts

Section 10Pages 1-45

9:00-10:00 010814

Revised for 2/21/201482Privileged and Confidential Work Product – Subject to the Attorney – Client Privilege

Stereotactic treatment is defined as the use of external beam radiation therapy using stereotactic guidance to deliver very precise doses of radiation to a defined tissue volume

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STEREOTACTIC PROCEDURES

Gamma Knife (Radio surgery, SRS)Cyber Knife (SRS, SBRT)Conventional XRT (SRS, SBRT )

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Stereotactic Procedures, SRS

• SRS, Stereotactic Radio Surgery was the original definition of this code.

• SRS is now limited to the cranial vault, and is limited to only one fraction of treatment.

• Treatment may be delivered using a Gamma Knife unit, linear accelerator, Tomotherapy unit, Cyber Knife unit, but Protons are excluded from SRS at this time.

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Stereotactic Procedures, SBRT

• SBRT, Stereotactic Body Treatment may be delivered to the cranial vault or any where in the body, but is restricted to 2-5 fractions to the cranial vault, and 1-5 fractions to the body.

• SRS and SBRT are both calculated using Advanced 3-D Dosimetry, 77295.

• If IMRT 77301, is used for planning, treatment delivery should be 77418.

• Treatment may be delivered using a linear accelerator, Tomotherapy unit, or Cyber Knife unit, but Protons are excluded at this time.

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MANAGEMENT OF CRANIAL LESIONS BY STEREOTACTIC TREATMENT

• Medicare would expect to see 77432 reported one time for a Gamma Knife, or X Knife treatment course consisting of 1 treatment only.

• If the course is to extend longer than one day, but 5 or less, then 77435, Treatment Management up to 5 fractions must be used.

• If the treatment extends beyond 5 fractions, 77427 must be used to report the entire course of treatment.

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Only one of these codes may be reported per session of stereotactic radiation therapy. The codes 77427, 77432, and 77435 may not be used on the same date of service, or during the same course of treatment. THESE CODES ARE MUTUALY EXCLUSIVE CANNOT BE USED SEQUENTIALLY

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3-Dimensional simulation (77295, not 77301) is performed to determine the optimal beam arrangement to deliver treatment to a target volume by Gamma Knife.

Gamma Knife Historical Background

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The patient is fixed into a head frame for total accuracy of localization of the lesion

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The head frame locks in to the Gamma Knife unit for absolute accuracy of set up and treatment. Bill each helmet as a 77334

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Removal of the head Frame• The code 20660 application of stereotactic frame, includes

removal (a separate process) CPT)• This is only a neurosurgery code, in spite of what you may

have been told• 20664 is the application of a cranial halo on the head of a

small child whose skull is unusually thin. (CPT)• 20665 is the removal of this halo, not a stereotactic frame.

(CPT)• The radiation oncologist should not bill 20665 for

stereotactic frame removal, if payment is received, then this is an error in local billing as the description is a legitimist procedure, just the wrong procedure. Any one qualified can remove the stereotactic head frame, but there is no valid charge today for any one. The placement by the neurosurgeon also includes the removal.

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GAMMA KNIFE TECHNICIAL TREATMENT DELIVERY CODE

The code 77371 Gamma Knife one fraction only, complete course of therapy, is used for the technical reimbursement.

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Gamma knife work page and final

narrative of procedure

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ONCOCHART

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History of Dosimetry

Conventional Dosimetry.Basic 3-D planning

Forward Planned IMRTAdvanced 3-D planning

Inverse planned IMRT

The use of forward planned IMRT planning algorithms is the basis of all Advanced 3-D Dosimetry for SRS and SBRT.

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Hospitals must bill for Gamma Knife SRS planning using CPT procedure code 77295Hospital APC ~$1,036.39

Hospitals Must use 77371, 77372 for SRS delivery. THIS IS USUALY A NEGOTIATED RATE Hospital APC 0067 ~$ 5,615.41

APC Rules for Gamma Knife (SRS) Reimbursement

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The use of a linear accelerator (Cyber Knife, X-knife, Tomo therapy, Peacock, Brain Lab, Etc.) for stereotactic radiation therapy uses either an aperture, iris, or micro MLC to collimate the x-ray beam from the accelerator. CPT Technical delivery Code 77372- single FX, or 77373 - 2 to 5 FX, (FSC). (2007, ASTRO, CMS Hospital 2014),

The patient support platform (the treatment couch) may have the capability of moving in various (x, y and z) directions. (Robotic couch)

Each of the megavoltage treatment portals is directed to the area of interest within the brain.

48SRS USING A LINEAR ACCELERATOR

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Brain Lab Micro Multileaf collimator

Removable head frame

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BRAIN LAB STEREOTACTIC PLANING; THIS USES IMRT FORWARD PLANNING ALGORYTHM SOFTWARE, AND SHOULD BE BILLIED AS ADVANCED 3-D77295

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A report is absolutely required for proper documentation of this procedure

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Medicare will not allow 77435 to follow 77432, LIMIT OF ONE PER COURSE.If the procedure is planned to be fractionated 2 to 5 fractions, then it should be reported as 77435 fractionated SRS or SBRT. Average physician payment $601.87 in 2014

All of the ancillary codes associated with either 77432 or 77435 may be reported at the time of setup or subsequent treatment except guidance codes with IGRT.

Fractionated Stereotactic Radiation Therapy Treatment

Management

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G0173--GO340 DELETED 1-1-1477371 single session, Gamma Knife77372 single session, Linac, free standing center, or hospital.77373 2-5 sessions, Linac, free standing center, or hospital, bill for each session as done

If the planning is done using IMRT planning 77301, then treatment should be IMRT 77418 IF YOU TREAT OVER 5 SESSIONS

Stereotactic treatment delivery 51

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SRS/SRT Stereotactic Radiosurgery or Stereotactic Radiation Therapy Treatment; Limited to Contents of the Cranial Vault (Brain)

77371 Single Cranial treatment delivery using multisource photon unit (Gamma Knife)

77432 Single Cranial Treatment Physician Management

77372 Single Cranial treatment delivery using a linear accelerator unit.

77373 2 – 5 treatments delivered using a linear accelerator unit. Per fraction delivered.

77435 2 – 5 treatments physician management (cannot be used to extend billing of treatment management from a single fraction)

RULES AND CODES FOR SRS 52

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Stereotactic Body Radiation Therapy, SBRT.

• SBRT is utilized as the technique of stereotactly treating small localized lesions outside of the cranial vault, anywhere within the body.

• If treatment is being delivered to the cranial vault by means of a linear accelerator, exceeding one fraction, it must be considered SBRT.

• SBRT treatment may be delivered utilizing a linear accelerator, Tomo therapy unit, or Cyberknife.

• Check your LCD for specific rules related to payment for SBRT based on ICD 9.

Privileged and Confidential Work Product – Subject to the Attorney – Client PrivilegeCourtesy ONCOCHART

Notice the detailed and customized clinical comments as part of the statement of medical necessity

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SBRT Stereotactic Body Radiation Therapy Treatment; Limited to the Body Below the Cranial Vault (Brain)

77373 1 – 5 treatments delivered using a linear accelerator unit, Cyber knife, Tomotherapy unit or other x-ray source If treatment extends beyond 5 fractions, Code 77373 should not be used for the case; rather 77418 (IMRT) must be used for all fractions delivered 1-X77373 includes all Image Guided Codes

77435 Physician treatment management 1 – 5 treatmentsIncludes image guidanceIf treatment extends beyond 5 fractions 77435 should not be used for the case. Management will be considered 77427 only.

53RULES AND CODES FOR SBRT

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Medicare reimbursement values, 2014.

77371 GammaKnife, SRS, complete course of treatment of cranial lesion(s), one session multi-sourced cobalt 60, $ negotiated value.77372 SRS complete course of treatment of cranial lesion(s) consisting of one session, linear accelerator $992.79.77373 SBRT linear accelerator, 1-5 TX, stereotactic body radiation therapy, treatment delivery, per fraction to one or more lesions, including image guidance, entire course not to exceed 5 fractions $1188.76.77435 SBRT stereotactic body radiation therapy treatment management, per treatment course, to one or more lesions, including image guidance, entire course not to exceed 5 fractions $601.87.77432 SRS stereotactic radiation treatment management of cranial lesion(s) , complete course of treatment consisting of one session $398.41.

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Stereotactic Radio Surgery (SRS), 77432

What’s it for?The physician’s clinical care during a course of 1 fraction using either the Gamma Knife or X-Knife.

Who normally documents this code?The physician.

When is this code normally billed?The day of the procedure.

What Documentation is suggested for this code?A progress procedure note outlining the course of therapy.

What is the common documentation error identified with this code?No note being documented.

What is the common billing error identified?Billing of this code with conventional therapy or SBRT. (only for SRS)

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Stereotactic Body Radiation therapy (SBRT) 77435

What’s it for?The physician’s clinical care during a course up to 5 fractions using stereotactic body treatment, including the CNS.

Who normally documents this code?The physician.

When is this code normally billed?At the completion of the procedure.

What Documentation is suggested for this code?A progress/procedure note outlining the course of therapy

What is the common documentation error identified with this code?No note being documented.

What is the common billing error identified?Billing of this code with conventional therapy or one fraction SRS.

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IMAGEGUIDED RADIATION THERAPY

IGRT

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COMBINED CT AND LINEAR ACCELERATOR

THE TREATMENT IS IMRT 77418, THE GUIDANCE IS DAILY CONE BEAM CT IMAGING BILLED AS 77014, OR;

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LINEAR ACCELERATOR IMRT USING KILOVOLTAGE X-RAY IMAGING, ON BOARD IMAGING (OBI)77421 STEREOSCOPIC

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ADVANTAGE OF IGRT

• The image is directly referenced to the treatment machine

• All machine parameters are in perfect geometric relationship to the images

• The Physician guides the daily treatment based on “live “images

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BILLING FOR IGRT

• There is no code at this time for IGRT• Without a specific code you cannot

bill for a new procedure• The only choice is to use existing

codes

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• 77427 Physician treatment management• 77418 IMRT treatment delivery• 77421 Fiducial treatment guidance, or• 77014 CT treatment guidance (2014??)

57Available Codes for IGRT

Treatment with SRS or SBRT may still be considered IGRT, but the guidance codes are bundled, and the treatment

cannot be IMRT, 77418

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77421 STEREOSCOPIC GUIDANCE

• MAY USE KV OR MV 90 DEGREE X-RAYS• REQUIRES POSITIONING OR TRACKING

SYSTEM, INFRARED OR SURFACE ANATOMY, FIDUCIAL MARKERS, OR A CONSISTANT DEFINABLE ANATOMIC STRUCTURE

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FIDUCIAL MARKERS FORSTEREOSCOPIC GUIDANCE

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77421 STEREOSCOPIC

X-RAY GUIDANCE

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FORMAT OF STEREOSCOPIC X-RAY GUIDANCE

• Locating the target volume on orthogonal X-Rays with Fiducial markers.

• Locating the target volume on orthogonal X-Rays without Fiducial markers if the target volume or a consistent anatomic structure can be clearly seen on the images.

• To ensure accurate treatment of the target and spare normal tissues.

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SIMULATION IMAGES AND ON TREATMENT KV BEAM SET UP

IMAGES SUPERIMPOSED

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DOCUMENTATION for 77421

If the physician wishes to bill for this procedure, a report must be generated within 24 hrs. of the next performed procedure.

Failure to approve the images and generate

a report prior to the next image could result in denial of payment for the procedure

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BILLING FOR STEREOSCOPIC GUIDANCE, 77421

• The 2014 Medicare value is : • 77421-26 about $ 19.05• 77421-TC about $ 51.37• 77421 about $70.43

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Image Guidance of Radiation Treatment Delivery77421 Stereotactic X-Ray Guidance for Localization of

Target Volume for the Delivery of Radiation Therapy TreatmentsMay be used on a daily basis if clinically indicatedRequires the Direct supervision of a physician.Requires a written report.Requires fiducial alignment using fiducial marker(s) or definable anatomic structure(s) to establish the Isocenter for treatment.

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CONE BEAM CT

• GUIDANCE OF TOMOTHERAPY and OTHER IGRT TECHNIQUES, USE CODE 77014, CT GUIDANCE

• ALL PAYMENT is Bundled with the simulation or treatment delivery.

• No professional billing is recognized in 2014. The professional component of the CT scan is considered bundled into either the simulation or the treatment delivery procedure.

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Privileged and Confidential Work Product – Subject to the Attorney – Client PrivilegeCONE BEAM CT 77014

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77014 CT Guidance of Delivery of Radiation TreatmentsIf used as a Guidance Code some form of treatment machine based CT imagery system must be used.Imaging may be done using the Mega Voltage Treatment Beam or an on-board Kilo Voltage Cone Beam device.The physician must provide Direct Supervision of this procedure. A physician must be present in the Department when the procedure is performed and must be available if corrective action is required. The images may be reviewed after treatment has been delivered; a brief report is required for each image set reviewed.This code is bundled into the Technical Procedure of CT Simulation and treatment delivery and payment is no longer recognized.

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RESPIRATORY GATING

• This is 4-D1, Vertical2, Lateral3, Horizontal4, Motion is the fourth dimension

• Billing code +77293 for simulation.• Billing code 0197T for treatment gating. • 77290-22, (very time intensive)

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Respiratory motion causes

mismatch

Respiratory gating allows

treatment only at match time

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2014 CPT update

• +77293 is a new add-on code describing the physician work and resources involved in acquiring a respiratory correlated 4D CT simulation study for conformal planning.

• Professional payment $98.67• Global payment $410.66• Technical payment $311.99• Add-on codes must be reported in addition to the

primary procedure, 77295 or 77301, and reported on the same date of service.

NIB

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T CODE FOR GATING

• 0197T category III code• Intra fraction localization and tracking of target or

patient motion during delivery of radiation therapy.• 3-D positional tracking, gating, 3-D surface tracking.• Report each fraction of therapy• Hospital packaged• Physician carrier priced. Indicator C in CPT Jan 1, 2009• Still a valid code in 2014.• May be discontinued Jan 2015

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PARTICLE ACCELERATORS63

The concept of a Proton radiation therapy unit was first proposed by physicists in 1946

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WHAT ARE PROTONS?

• Sub-atomic particle with a positive charge• Weigh 2000 times as much as an Electron• Building block of all atoms• All atoms must have at least one Proton

and one Electron (Hydrogen)• As more Protons are added to the

nucleus then Neutrons are also added which creates different elements.

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Proton units in The United States, a timeline

1946-Wilson proposes using protons clinically.1955- the 1st patient is treated at Berkeley.1961- the Harvard cyclotron lab begins treatment.1991-Loma Linda operates the 1st proton gantry.2001-Harvard proton center opens.2002- Indiana University starts proton treatment.2006- MD Anderson, Houston.2006-University of Florida, Jacksonville.2009- procure Oklahoma City.2010- procure Warrenville Illinois [Chicago].2012- Procure Somerset New Jersey [New York City].2013- Mevion Washington University St. Louis.2014- At least 13 proton units proposed or under construction this year.

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Harvard/MGH,MA2001-2009

4270 patients

Loma Linda, CA1990 - 2009

14000 patients

MD Anderson, TX2006-2009

1700 patients

Source: National association for proton therapy

UFPTI, FL2006-2009

1847 patients

UC San Francisco, CA1994 -2009 (Ocular Tumors)1200 patients

ProCure, OK2009

47 patients

UPenn

Hampton

ProCure, WA

ProCure, IL

ProCure, FL

MPRI, IN1993-2009

890 patients

ProCure, NJ

McLaren, MI

UTenn, TN

Mayo, MN

Mayo, AZ

ProCure, MI

Scripps, CA

UCSD, CA

OUHSC, OK

WashU, MO UMaryland, MD

RWJUH, NJ

9 Under construction/in development

4 Mevion

NIPTRC, IL

11 In operation

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Tumor

NIB

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Proton Beam Shaping

Milled brass compensator

s

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Photon Beam Proton Beam

Comparison of single photon versus single proton beams

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TUMOR TUMOR

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Skull base tumor, Single Proton Port64

Privileged and Confidential Work Product – Subject to the Attorney – Client PrivilegeProton treatment of rib lesion

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Proton Plan for a Lung tumor 65

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Pair of opposed

lateral proton ports

Prostate dose 100%

Sharp drop off at 45% for hip joints

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Proton Cranio-spinal Irradiation(Prone Position based)

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NIB

PATIENT SET UP ON TREATMENT TABLE

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Proton Accelerator - CYCLOTRON NIB

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Cyclotron opened for maintenance

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Energy Selection SystemBeam Transport and Switching

System

NIB

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Ion Beam Applications (IBA) Isocentric Gantry65

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Typical IBA 3 room Proton Treatment Installation

230 MeV Cyclotron

3 gantry rooms

fixed beam

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Fixed Beam Treatment Nozzle and Robotic Table65

ProCure

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MEVION (Still River) Proton unit, Single room unit with superconducting cyclotron mounted on gantry,

Gantry rotates through a 180 degree arc, and robotic table allows all possible angles of therapy to be accomplished

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Cyclotron mounted on gantry

Clean clinical environment

Single Room contains allequipment

FDA 510k cleared

Still River Systems – Compact Proton Therapy

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This is a big

machine, But it still fits in one room.

NIB

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- 250 MeV- ~20 tons- Very high B field: 9 T

MEVION1) Barnes

Jewish hospital in

St. Louis, Mo. Now

operational treating patients.

2) University of Oklahoma

in Okla. City, OK.

3) Robert Wood Johnson University, in New Jersey

MEVION is now FDA approved. The first three units are being installed

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Double Scattering, Aperture, and compensator

Two Scatterers

RotatingRange Modulator

Fixed Scatterer

Aperture & CompensatorSecondScatterer

P+

Two Patient specific scattering compensators and an aperture and compensator each of which is billed as a 77334

NIB

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• Varian Medical Systems announced its it’s updated ProBeam proton therapy system received FDA 510(k) clearance.

• The IMPT system gives clinicians more options for delivering the dose precisely in the course of proton therapy treatments.

• The scanning beam technology enables IMPT by modulating dose levels on a spot-by-spot basis throughout the treatment area.

• Irradiations from multiple angles are combined in an optimal manner to improve control of dose distributions.

• Scanning beam technology eliminates the need to utilize external compensators for each beam angle.

Intensity Modulated Proton BeamNIB

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Depth doses of photons, protons, and carbon ions

Pristine (Bragg) peak: Bragg peak by a near-monoenergetic carbon ion beam

NIB

Carbon ion beam

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Proton machines

• Fixed beam physics adapted units• Multiple gantry physics adapted units• Multiple gantry dedicated radiation therapy

units• Single gantry dedicated radiation therapy

units• Single room gantry mounted cyclotron• Next generation IMPT machines, prototype

unit now treating patients in Germany

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ESTIMATED COSTS OF A PROTON FACILITY EQUIPMENT, FACILITY, AND START UP COST

• Single room, single gantry system…..$36,106,125• One gantry, remote cyclotron………..$57,207,027• One gantry, one fixed beam………….$73,708,555• Two gantry, one fixed beam……...….$97,657,456• Three gantry, one fixed beam……....$121,606,359• IMPT added to any unit, added cost...

$30,000,000

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Proton Beam Treatment Delivery

• 77520 Proton Beam Delivery; Simple• 77522 Proton Beam Delivery; Simple,

with compensators• 77523 Proton Beam Delivery; Intermediate• 77525 Proton Beam Delivery; Complex

• 0664 APC For 77520, 77522, • 0419 APC For 77523, 77525,

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PROTON THERAPY REMBURSEMENT

• CMS has allowed each Proton therapy center to be priced locally, due to the small number of operating centers.

• Hospital payment under the APC 0664, and 0667 are still locally negotiated.

• As the Conversion Factor changes, we have no way to predict the payment system, or the values, over the next few years, (for all radiation therapy services)

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Proton ReimbursementHCPCS APC Descripto

r$2014 $2013

77520 0664

Simple w/o comp

$872.37

$1136.61

77522 0664

Simple with comp

$872.37

$1136.61

77523 0667

Intermediate

$1205.27

$682.36

77525 0667

Complex $1205.27

$682.36

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This puts it in perspective

Courtesy of MEVION

NIB

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OTHER CHARGES WITH PROTONS

• 99205 High Intensity Consultation. • 77263-22 Complex Treatment Planning• 77290-22 Complex Simulation(s) at time of setup. • 77290 Simulation as done as pre-plan, • 77300 Basic Dosimetry (often multiple done per port)• 77334 Complex Treatment Devices, blocks,

compensators, degraders, etc• 77321 Special Beam Considerations (Protons)• 77470-22 Special Treatment Procedure (Protons) • 77431-22 Short Week of Radiation Management

(Single Fraction)• 77427 standard week(s) of therapy• 77315 Complex Isodose Plan(s) (Proton Isodose)• 77295 3-D planning• 77336 Physics Support• 77370 Special Physics Report (if documented)

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END

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PRINCIPLES OF BILLING, CODING

AND COMPLIANCE IN RADIATION ONCOLOGY

BMSi 2014END SECTION 10

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END SECTION 10