June 24, 2014 Dr. Bernice Hecker Contractor Medical ... · As our model policy states, “coverage decisions must extend beyond ICD-9 and ICD-10 codes to incorporate additional considerations

June 24, 2014 Dr. Bernice Hecker Contractor Medical Director Noridian Healthcare Solutions, LLC 900 42nd Street S. P.O. Box 6740 Fargo, ND 58108-6740 Re: LCD DL33531- Draft LCD for Intensity Modulated Radiation Therapy (IMRT). Dear Dr. Hecker: The American Society for Radiation Oncology* (ASTRO) appreciates the opportunity to review and provide comments on the Noridian Healthcare Solutions, LLC Jurisdiction E, draft LCD DL33531 on Intensity Modulated Radiation Therapy (IMRT). IMRT Delivery For almost a decade now, ASTRO has published a distinct series of model policies to efficiently communicate correct coverage policies for radiation oncology services. We work to maintain updated information and inform payers of all changes to existing policies. ASTRO’s IMRT Model Policy was most recently revised in 2013 and is enclosed for your review. As a source of information, the draft LCD cites the “American College of Radiology (ACR) Radiation Oncology Carrier Advisory Committee (CAC) Network Model Policy on IMRT, which had also been reviewed and approved by The American Society for Therapeutic Radiation and Oncology (ASTRO) Regulatory Subcommittee and Health Policy and Economic Committee (HPE), received by Noridian May 17, 2005”. Due to the technological advancements made in the past decade, some of the technical requirements in the 2005 ACR Model Policy and draft LCD may be obsolete or inaccurate. For example, the draft LCD states that “delivery of IMRT requires either the use of a multileaf collimator (MLC) … or the use of compensator-based beam modulation treatment.” In addition to these two methods, a number of other technologies, such as helical tomotherapy, can be employed to modulate dose distribution and delivery of IMRT. ASTRO advises against imposing such stringent constraints that are no longer appropriate. * ASTRO is the premier radiation oncology society in the world, with more than 10,000 members who are physicians, nurses, biologist, physicists, radiation therapists, dosimetrists and other health care professionals that specialize in treating patients with radiation therapies. As the leading organization in radiation oncology, the Society is dedicated to improving patient care through professional education and training, support for clinical practice and health policy standards, advancement of science and research, and advocacy. ASTRO publishes two medical journals, International Journal of Radiation Oncology, Biology, Physics (www.redjournal.org) and Practical Radiation Oncology (www.practicalradonc.org); developed and maintains an extensive patient website, www.rtanswers.org; and created the Radiation Oncology Institute (www.roinstitute.com), a non-profit foundation to support research and education efforts around the world that enhance and confirm the critical role of radiation therapy in improving cancer treatment. To learn more about ASTRO, visit www.astro.org.

http://www.redjournal.org/

http://www.practicalradonc.org/

http://www.rtanswers.org/

http://www.roinstitute.com/

http://www.astro.org/

ASTRO Comments – Noridian Draft LCD (DL33531) for IMRT Page 2 The draft LCD also references an outdated ASTRO position on Specifying Patient Specific Treatment Verification in IMRT that was issued in October 2004 and includes a section on ‘patient specific IMRT treatment verification,’ which is partially antiquated. On multiple occasions, the policy references 2D films but many modern IMRT dosimetric systems use more efficient, accurate and reliable electronic detectors. In a 2011 white paper entitled “Safety considerations for IMRT,” ASTRO agreed that a patient specific measurement is essential to proper IMRT delivery. In addition, there are many elements of quality assurance that span the full process of care and are not focused solely on one specific aspect of patient safety. For Noridian’s review and inclusion in the policy, we have attached the extended full report and executive summary of the patient safety white paper that provides detailed information on quality assurance. Lastly, ASTRO does not support Noridian’s claim that “Voluntary breath holding is not considered appropriate and the solution for movement can best be accomplished with gating technology.” ASTRO recommends Noridian remove this language and recognize voluntary breath holding as a valid means by which to control for organ motion. Physicians should provide documentation supporting identification of structures that traverse high- and low-dose regions created by breathing motion when billing for respiratory motion management simulation but voluntary breath hold can be a satisfactory solution to account for organ motion. One recent study demonstrated voluntary deep-inspiratory breath-hold is comparable to deep inspiratory breath-hold with the active breathing coordinator in terms of positional reproducibility and normal tissue sparing for breast cancer patients 1.

IMRT Indications While ASTRO believes the indications outlined in the Noridian draft LCD are generally compatible with our IMRT model policy, we are concerned the draft LCD verbiage is limiting. As our model policy states, “coverage decisions must extend beyond ICD-9 and ICD-10 codes to incorporate additional considerations of clinical scenarios and medical necessity with appropriate documentation.” Irrespective of location, all disease sites that meet the necessary criteria as outlined in the draft LCD can be treated with IMRT. If the draft LCD is implemented as written, IMRT will be limited to an undefined “relatively small fraction” of gynecologic and genitourinary (GU) cases. However, there are data to support the use of IMRT for abdominal or pelvic tumors. In 2010, published data originating from the Quantitative Analysis of Normal Tissue Effects in the Clinic (QUANTEC) Project included an analysis of “Radiation Dose–Volume Effects in the Stomach and Small Bowel” 2. QUANTEC, a collaborative effort of more than 100 radiation oncologists, medical physicists and radiobiologists, analyzed available literature regarding the risk of normal tissue toxicity as related to radiation dose. The analysis demonstrates that a higher radiation dose to a large volume of small bowel is associated with a higher risk of severe toxicity. When the volume of individual small bowel loops receiving more than 15 Gy (V15 absolute) exceeds 120 cc for a patient receiving combined chemotherapy and radiation therapy, the risk of severe (grade 3 or higher) toxicity is in the range of 40 percent, whereas when the V15 is below that threshold, the risk of severe toxicity is in the range of 10 percent or less. Physicians utilize this and other verified clinical information to determine necessity for IMRT treatment.

ASTRO Comments – Noridian Draft LCD (DL33531) for IMRT Page 3 In the case of gynecologic tumors, various studies have shown reduced gastrointestinal (GI) and GU toxicities for patients treated with IMRT compared to non-IMRT delivery 3, 4, 5. In an early retrospective study, Mundt et al. found that compared to 4-field box, IMRT for gynecologic malignancies significantly reduced acute grade 2 GU toxicity from 91 to 60 percent 6. The decision to treat tumors of the abdomen and pelvis with IMRT should not be dependent on the number of cases but rather on the need for IMRT dose constraints. ASTRO recommends Noridian utilize proper review of clinical rationale for the basis of coverage and not limit IMRT for these disease sites. The Noridian draft LCD states, “Indications will include some left breast tumors due to risk to immediately adjacent cardiac and pericardial structures, though it would be only rarely if ever be medically necessary for tumors of the right breast.” While it is not common, there are a limited number of cases of right breast tumors where IMRT would be medically necessary and therefore ASTRO recommends Noridian remove the phrase “if ever” from the aforementioned sentence. We are concerned the draft verbiage does not allow the necessary flexibility for clinical necessity. In summary, ASTRO recommends Noridian utilize the reasonable and medically necessary criteria to determine coverage decisions and not exclude disease sites simply because they may not frequently require IMRT. Additionally, ASTRO recommends the following ICD-9-CM codes be added to the final LCD:

o 153.7 Malignant neoplasm of splenic flexure o 153.8 Malignant neoplasm of other specified sites of large intestine o 227.3 Benign neoplasm pituitary gland and craniopharylngeal duct o 227.4 Benign neoplasm of pineal gland o 227.5 Benign neoplasm of carotid body o 227.6 Benign neoplasm other endocrine glands and related structures o 990 Effects of radiation, unspecified

This code may only be used where prior radiation therapy to the site is the governing factor necessitating IMRT in lieu of other radiotherapy. An ICD diagnosis code of the anatomic diagnosis must also be used.

IMRT Coding Effective January 1, 2014, providers can no longer separately report CT guidance, represented by CPT® code 77014 (Computed tomography guidance for placement of radiation therapy fields), when reporting simulation services represented by codes 77280-77290 and code 77295 (Therapeutic radiology simulation-aided field setting; 3-dimensional). The inclusion of CT guidance within the simulation service reflects current practice in which acquiring the necessary images and data is integral to the process of care. Therefore we recommend Noridian remove the following statement from the draft policy: “CT and other imaging are separately coded (e.g. 77014), when necessary and performed.”

Also effective January 1, 2014, a new add-on code was introduced into the radiation oncology code set. CPT code +77293 (Respiratory motion management simulation) describes the physicians work and resources involved in simulating a patient using multi-slice CT scan

ASTRO Comments – Noridian Draft LCD (DL33531) for IMRT Page 4 acquisition and subsequent reconstruction of target volumes that incorporate the breathing-related motion of the tumor and normal tissues. This code must be reported with either 77295 (Three-dimensional radiotherapy plan, including dose-volume histograms) or 77301 (Intensity modulated radiotherapy plan, including dose-volume histograms for target and critical structure partial tolerance specifications) on the same date of service and cannot be billed as a stand-alone code. We recommend Noridian include +77293 in the LCD list of CPT/HCPCS codes.

ASTRO published coding guidance articles on our website to inform members and payers of these coding changes. The articles are enclosed for your reference. Additionally, ASTRO recently mailed Noridian complimentary copies of the ASTRO/ACR Guide to Radiation Oncology Coding 2010: 2014 Supplement, which include these changes. The draft LCD requires that documentation for clinical treatment planning meet “The ASTRO/ACR Guide to Radiation Oncology Coding 2005.” The 2005 coding guide contains outdated information and should no longer be used as a source of information. ASTRO will be publishing a new revised coding guide next year to accurately reflect current coding information, including important coding changes that will go into effect January 2015.

Thank you for your consideration of our comments. Should you have any questions or wish to discuss IMRT and our recommendations further, please contact ASTRO’s Assistant Director of Health Policy, Anne Hubbard, at (703) 839-7394 or via email at [email protected]. Sincerely, Laura I Thevenot Chief Executive Officer cc: Arthur Lurvey, MD Richard Whitten, MD, MBA, FACP Enclosures: ASTRO IMRT Model Policy Safety Considerations for IMRT (full report) Safety Considerations for IMRT: Executive Summary Coding Guidance Article on Respiration Motion Management (+77293) Coding Guidance Article on Computed Tomography Guidance for Placement of Radiation Therapy Field (77014) References:

1. Bartlett FR, Colgan RM, Carr K, et al. The UK HeartSpare Study: randomised evaluation of voluntary deep-inspiratory breath-hold in women undergoing breast radiotherapy. Radiotherm Oncol. 2013; 108(2): 242-247.

2. Kavanagh BD, Pan CC, Dawson LA, Das SK, Li XA, Ten Haken RK, Miften M. Radiation dose-volume effects in the stomach and small bowel. Int J Radiat Oncol Biol Phys. 2010; 76(3 Suppl): S101-107.

mailto:[email protected]

ASTRO Comments – Noridian Draft LCD (DL33531) for IMRT Page 5

3. Mundt AJ, Mell LK, Roeske JC. Preliminary analysis of chronic gastrointestinal toxicity in gynecology patients treated with intensity-modulated whole pelvic radiation therapy. Int J Radiat Oncol Biol Phys. 2003; 56(5): 1354-1360.

4. Brixey CJ, Roeske JC, Lujan AE, et al. Impact of intensity-modulated radiotherapy on acute hematologic toxicity in women with gynecologic malignancies. Int J Radiat Oncol Biol Phys. 2002; 54(5): 1388-1396.

5. Chen MF, Tseng CJ, Tseng CC, et al. Clinical outcome in posthysterectomy cervical cancer patients treated with concurrent Cisplatin and intensity-modulated pelvic radiotherapy: comparison with conventional radiotherapy. Int J Radiat Oncol Biol Phys. 2007; 67(5): 1438-1444.

6. Mundt AJ, Lujan AE, Rotmensch J, et al. Intensity-modulated whole pelvic radiotherapy in women with gynecologic malignancies. Int J Radiat Oncol Biol Phys. 2002; 52(5): 1330-1337.

This Model Policy1 addresses coverage for Intensity Modulated Radiation Therapy (IMRT).

DESCRIPTION Intensity Modulated Radiation Therapy (IMRT) is a technology for delivering highly conformal external beam radiation to a well-defi ned treatment volume with radiation beams whose intensity varies across the beam. IMRT is particularly useful for delivering a highly conformal radiation dose to targets positioned near sensitive normal tissues.

TREATMENT

IMRT Treatment Planning

IMRT treatment plans are tailored to the target volumes and are geometrically more accurate than conventional or three-dimensional conformal radiation therapy plans. IMRT planning defi nes the necessary fi eld sizes, gantry angles and other beam characteristics needed to achieve the desired radiation dose distribution.

IMRT treatment planning (i.e., inverse treatment planning) is a multi-step process:

1. Imaging: Three-dimensional image acquisition of the target region by simulation employing CT, MR, PET scanners or similar image fusion technology is an essential prerequisite to IMRT treatment planning. If respiratory or other normal organ motion is expected to produce signifi cant movement of the target region during radiotherapy delivery, the radiation oncologist may additionally elect to order multi-phasic treatment planning image sets to account for motion when rendering target volumes.

2. Contouring: Defi ning the target and avoidance structures is in itself a multi-step process:

a. The radiation oncologist reviews the three-dimensional images and outlines the treatment target on each slice of the image set. The summation of these contours defi nes the Gross Tumor Volume (GTV). For multiple image sets, the physician may outline separate GTVs on each image set

to account for the eff ect of normal organ motion upon target location and shape. Some patients may not have GTVs if they have had previous treatment with surgery or chemotherapy, in which case treatment planning will be based on CTVs as described below.

b. The radiation oncologist draws a margin around the GTV to generate a Clinical Target Volume (CTV) which encompasses the areas at risk for microscopic disease (i.e., not visible on imaging studies). Other CTVs may be created based on the estimated volume of residual disease. For multiple image sets, the physician may draw this margin around an aggregate volume containing all image set GTVs to generate an organ-motion CTV, or Internal Target Volume (ITV).

INTENSITY MODULATED RADIATION THERAPY (IMRT)

Model Policies

1 ASTRO model policies were developed as a means to effi ciently communicate what ASTRO believes to be correct coverage policies for radiation oncology services. The ASTRO Model Policies do not serve as clinical guidelines and they are subject to periodic review and revision without notice. The ASTRO Model Policies may be reproduced and distributed, without modifi cation, for noncommercial purposes.

CPT Copyright 2012 American Medical Association. All rights reserved.

Approved 11-13-13

c. To account for potential daily patient set-up variation and/or organ and patient motion, a fi nal margin is then added to create a Planning Target Volume (PTV).

d. Nearby normal structures that could potentially be harmed by radiation (i.e., “organs at risk”, or OARs) are also contoured.

3. Radiation Dose Prescribing: The radiation oncologist assigns specifi c dose requirements for the PTV which typically includes a prescribed dose that must be given to at least 90-95% of the PTV. This is often accompanied by a minimum acceptable point dose within the PTV and a constraint describing an acceptable range of dose homogeneity. Additionally, PTV dose requirements routinely include dose constraints for the OARs (e.g., upper limit of mean dose, maximum allowable point dose, and/or a critical volume of the OAR that must not receive a dose above a specifi ed limit). A treatment plan that satisfi es these requirements and constraints should maximize the potential for disease control and minimize the risk of radiation injury to normal tissue.

4. Dosimetric Planning and Calculations: The medical physicist or a supervised dosimetrist calculates a multiple static beam and/or modulated arc treatment plan to deliver the prescribed radiation dose to the PTV and simultaneously satisfy the normal tissue dose constraints by delivering signifi cantly lower doses to nearby organs. Dose-volume-histograms are prepared for the PTV and OARs. Here, an arc is defi ned as a discrete complete or partial rotation of the linear accelerator gantry during which there is continuous motion of the multi-leaf collimator to deliver an optimized radiation dose distribution within the patient. The essential feature of an IMRT plan is that it describes the means to deliver treatment utilizing non-uniform beam intensities. Each radiation beam or arc is, in eff ect, a collection of numerous “beamlets,” each with a diff erent level of radiation intensity; the summation of these “beamlets” delivers the characteristic highly conformal IMRT dose distribution. The physicist and dosimetrist perform basic dose calculations on each of the modulated beams or arcs. These patient specifi c monitor unit computations verify through an independent second dose calculation method the accuracy of the calculations.

5. Patient Specifi c Dose Verifi cation: The calculated beams or arcs are then delivered either to a phantom or a dosimetry measuring device to confi rm that the intended dose distribution for the patient is physically verifi able and that the intensity modulated beams or arcs are technically feasible. Additional information can be found in the ASTRO QA White Paper (General Reference #13), which critically evaluates guidance and literature on the safe delivery of IMRT, with a primary focus on recommendations to prevent human error and methods to reduce or eliminate mistakes or machine malfunctions that can lead to catastrophic failures.

Documentation of all aspects of the treatment planning process is essential.

IMRT Treatment Delivery

The basic requirement for all forms of IMRT treatment delivery is that the technology must accurately produce the calculated dose distribution described by the IMRT plan. IMRT treatment delivery may be accomplished via various combinations of gantry motion, table motion, slice-by-slice treatment (tomotherapy) and multi-leaf collimator (MLC) or solid compensators to modulate the intensity of the radiation beams or arcs.

The highly conformal dose distribution produced by IMRT results in sharper spatial dose gradients than conventional or three-dimensional conformal radiation therapy. Consequently, small changes in patient position or target position within the body can cause signifi cant changes in the dose delivered to the PTV and to the organs at risk; thus reproducible patient immobilization is required for precision IMRT. Imaging techniques such as stereoscopic kilovoltage or megavoltage X-ray, ultrasound, or cone beam or megavoltage CT scan (collectively referred to as Image Guided Radiation Therapy or IGRT) may be utilized to account for daily motion of the PTV to accurately deliver thetreatment.

Page 2INTENSITY MODULATED RADIATION THERAPY (IMRT)


Documentation Requirements

Documentation in the patient’s medical records must support:

1. The reasonable and necessary requirements as outlined under the “Indications and Limitations of Coverage and/or Medical Necessity” section of this policy.

2. The prescription which defi nes the goals and requirements of the treatment plan, including the specifi c dose constraints to the target and nearby critical structures.

3. A note of medical necessity for IMRT by the treating physician.

4. Signed IMRT inverse plan that meets prescribed dose constraints for the planning target volume (PTV) and surrounding normal tissue.

5. The target verifi cation methodology must include the following: a. Documentation of the clinical treatment volume (CTV) and the planning target volume (PTV). b. Documentation of immobilization and patient positioning.

6. Independent basic dose calculations of monitor units have been performed for each beam before the patient’s fi rst treatment.

7. Documentation of fl uence distributions (re-computed and measured in a phantom or dosimetry measuring device) is required.

8. Documentation supporting identifi cation of structures that traverse high-and low-dose regions created by respiration is indicated when billing for respiratory motion management simulation.

INDICATIONS AND LIMITATIONS OF COVERAGE AND/OR MEDICAL NECESSITY

Indications For Coverage

As IMRT technology was introduced and the appropriate clinical applications were being established, earlier versions of this model policy identifi ed specifi c disease sites for which IMRT was considered a standard option. The maturation and dissemination of IMRT capabilities with improved clinical outcomes has expanded to the point that a defi nitive list of “approved sites” driven solely by diagnosis codes (ICD-9 or ICD-10) is no longer suffi cient. However, it is important to note that normal tissue dose volume histograms (DVHs) or dosimetry must be demonstrably improved with an IMRT plan to validate coverage. Therefore, coverage decisions must extend beyond ICD-9 and ICD-10 codes to incorporate additional considerations of clinical scenario and medical necessity with appropriate documentation. For some anatomical sites such as nasopharynx, oropharynx, hypopharynx, larynx (except for early true vocal cord cancer), prostate, anus and central nervous system, IMRT should be considered standard of care, but for other sites, documentation of benefi t is required.

IMRT is considered reasonable and medically necessary in instances where sparing the surrounding normal tissue is of added clinical benefi t to the patient. Examples of reasons why IMRT might be advantageous include the following:

1. The target volume is in close proximity to one or more critical structures and a steep dose gradient outside the target must be achieved to avoid exceeding the tolerance dose to the critical structure(s).

2. A decrease in the amount of dose inhomogeneity in a large treatment volume is required to avoid an excessive dose “hotspot” within the treated volume to avoid excessive early or late normal tissue toxicity.


3. A non-IMRT technique would substantially increase the probability of clinically meaningful normal tissue toxicity.

4. The same or an immediately adjacent area has been previously irradiated, and the dose distribution within the patient must be sculpted to avoid exceeding the cumulative tolerance dose of nearby normal tissue.

IMRT off ers advantages as well as added complexity over conventional or three-dimensional conformal radiation therapy. Before applying IMRT techniques, a comprehensive understanding of the benefi ts and consequences is required. In addition to satisfying at least one of the four selection criteria noted above, the radiation oncologist’s decision to employ IMRT requires an informed assessment of benefi ts and risks including:

• Determination of patient suitability for IMRT allowing for reproducible treatment delivery.• Adequate defi nition of the target volumes and organs at risk.• Equipment capability, including ability to account for organ motion when a relevant factor.• Physician and staff training.• Adequate quality assurance procedures.

On the basis of the above conditions demonstrating medical necessity, disease sites that frequently support the use of IMRT include the following:

• Primary, metastatic or benign tumors of the central nervous system including the brain, brain stem and spinal cord.

• Primary or metastatic tumors of the spine where the spinal cord tolerance may be exceeded with conventional treatment or where the spinal cord has previously been irradiated.• Primary, metastatic, benign or recurrent head and neck malignancies including, but not limited to those

involving: • Orbits, • Sinuses, • Skull base, • Aero-digestive tract, and • Salivary glands.• Thoracic malignancies.• Abdominal malignancies when dose constraints to small bowel or other normal tissue are exceeded and prevent administration of a therapeutic dose.• Pelvic malignancies, including prostatic, gynecologic and anal carcinomas.• Other pelvic or retroperitoneal malignancies.

The fi nal determination of the appropriateness and medical necessity for IMRT resides with the treating radiation on-cologist who should document the justifi cation for IMRT for each patient.

Note: Diagnosis codes are based on the current ICD-9-CM and ICD-10-CM codes that are eff ective at the time of the Model Policy publication. Any updates to ICD-9-CM or ICD-10-CM codes will be reviewed by ASTRO, and coverage should not be presumed until the results of such review have been published/posted. These ICD diagnosis codes may support medical necessity under this Model Policy.


System Site ICD-9 Codes ICD-10 Codes

Head and Neck Lip 140.0 - 140.9 C00.0 - C00.9Tongue 141.0 - 141.9 C01 - C02.9Major salivary glands 142.0 - 142.9 C07 - C08.9Gum 143.0 - 143.9 C03.0 - C03.9Floor of mouth 144.0 - 144.9 C04.0 - C04.9Other parts of the mouth

145.0 - 145.9 C05.0 - C06.9

Oropharynx 146.0 - 146.9 C09.0 - C10.9Nasopharynx 147.0 - 147.9 C11.0 - C11.9Hypopharynx 148.0 - 148.9 C12 - C13.9Nasal cavities, middle ear and accessory sinuses

160.0 - 160.9 C30.0 - C31.9

Larynx 161.0 - 161.9 C32.0 - C32.9Digestive Organs and

Peritoneum

Esophagus 150.0 - 150.9 C15.3 - C15.9Stomach 151.0 - 151.9 C16.0 - C16.9Small intestine 152.0 - 152.9 C17.0 - C17.9Colon 153.0 - 153.9 C18.0 - C18.9Rectum, rectosigmoid, anus

154.0 - 154.8 C19 - C21.8

Liver, intrahepatic bile ducts

155.0 - 155.2 C22.0 - C22.9

Gallbladder, extrahepatic bile ducts

156.0 - 156.9 C23 - C24.9

Pancreas 157.0 - 157.9 C25.0 - C25.9Retroperitoneum, peritoneum

158.0 - 158.9 C45.1C48.0 - C48.8

Respiratory and

Intrathoracic Organs

Trachea, bronchus and lung

162.0 - 162.9 C33 - C34.92

Pleura 163.0 - 163.9 C38.4 C45.0

Thymus, heart and mediastinum

164.0 - 164.9 C37 - C38.8C45.2

ICD-9-CM and ICD-10-CM Codes that may be Associated with Medical Necessity



Bone, connective

tissue and skin

Bone 170.0 - 170.9 C40.00 - C41.9Connective and other soft tissue

171.0 - 171.9 C47.0 - C49.9

Skin 172.0 - 173.99 C43.0 - C44.99D03.0 - D03.9

Kaposi’s sarcoma 176.0 - 176.9 C46.0- C46.9Merkel cell carcinoma 209.31 - 209.75 C4A.0 - C4A.9

D3A.00 - D3A.8C7B.00 - C7B.1

Breast Female breast 174.0 - 174.9233.0

C50.011 - C50.019C50.111 - C50.119C50.211 - C50.219C50.311 - C50.319C50.411 - C50.419C50.511 - C50.519C50.611 - C50.619C50.811 - C50.819C50.911 - C50.919D05.00 - D05.92

Male breast 175.0 - 175.9 C50.021 - C50.029C50.121 - C50.129C50.221 - C50.229C50.321 - C50.329C50.421 - C50.429C50.521 - C50.529C50.621 - C50.629C50.821 - C50.829C50.921 - C50.929

Genitourinary organs Cervix 180.0 - 180.9 C53.0 - C53.9Uterus 179

182.0 - 182.8C55C54.0 - C54.9

Ovary and adnexa 183.0 - 183.9 C56.1 - C57.4Other female genital organs

184.0 - 184.9 C51.0 - C52 C57.7 - C57.9

Prostate 185 C61Testis 186.0 - 186.9 C62.00 - C62.90Penis and other male genital organs

187.1 - 187.9 C60.0 - C60.9C63.00 - C63.9

Bladder 188.0 - 188.9 C67.0 - C67.9Kidney 189.0 - 189.9 C64.1 - C66.9

C68.0 - C68.9



Other sites Eye 190.0 - 190.9 C69.00 - C69.92Brain, other parts of nervous system

191.0 - 192.9 C70.0 - C72.9

Endocrine glands 193 194.0 - 194.9

C73C74.00 - C75.9

Benign neoplasms of brain, cranial nerves and meninges

225.0 - 225.2 D32.0 - D33.3

Benign neoplasms of pituitary, pineal, aortic body and other paraganglia

227.3 - 227.6 D35.2 - D35.6

Malignant neoplasm

of other and

ill-defi ned sites

Various regions 195.0 - 195.8 C76.0 - C76.8C45.7

Secondary and

unspecifi ed malignant

neoplasm of lymph

nodes

Lymph node metastases

196.0 - 196.9 C77.0 - C77.9

Secondary malignant

neoplasm of

respiratory, digestive

and other specifi ed

sites

Metastatic disease other than lymph node metastases

197.0 - 199.1 C78.00 - C80.1C45.9

Lymphatic and

hematopoietic tissue

Non-Hodgkin’s lymphoma

200.00 - 200.88 202.00 - 202.98

C82.00 - C86.6C91.40 - C91.42C96.AC96.0 - C96.9C96.Z

Hodgkin’s lymphoma 201.00 - 201.98 C81.00 - C81.99Multiple myeloma 203.00 C90.00

Reirradiation Various regions 990* T66.XXXA*

*ICD-9-CM 990 or ICD-10-CM T66.XXXA (Eff ects of Radiation, Unspecifi ed) may only be used where prior radiation therapy to the site is the governing factor necessitating IMRT in lieu of other radiotherapy. An ICD diagnosis code for the anatomic diagnosis must also be used.


Limitations of Coverage

IMRT is not considered reasonable and medically necessary unless at least one of the criteria listed in the “Indications of Coverage” section of this policy is present.

Clinical scenarios that would not typically support the use of IMRT include:

1. Where IMRT does not off er an advantage over conventional or three-dimensional conformal radiation therapy techniques that deliver good clinical outcomes and low toxicity.

2. Clinical urgency, such as spinal cord compression, superior vena cava syndrome or airway obstruction.

3. Palliative treatment of metastatic disease where the prescribed dose does not approach normal tissue tolerances.

4. Inability to accommodate for organ motion, such as for a mobile lung tumor.

5. Inability of the patient to cooperate and tolerate immobilization to permit accurate and reproducible dose delivery.

PHYSICIANS’ CURRENT PROCEDURAL TERMINOLOGY (CPT®)/HCPCS Note: CPT is a trademark of the American Medical Association (AMA)

CPT®/HCPCS codes

CPT Code for IMRT Treatment Planning

77301 Intensity Modulated Radiation Therapy (IMRT) plan, including dose-volume histograms for target and critical structure partial tolerance specifi cations.

This code is typically reported only once per course of IMRT. +77293 Respiratory motion management simulation (List separately in addition to code for primary procedure).

This is an add-on code and cannot be billed on its own. It should be billed with either CPT code 77295 or 77301.

CPT Code for Collimator-based IMRT Treatment Delivery

77418 Intensity Modulated Radiation Therapy (IMRT) delivery, single or multiple fi elds/arcs, via narrow spatially and temporally modulated beams, binary, dynamic MLC, per treatment session

Use with dynamic multileaf collimators. Do not use for compensator-based treatment delivery; report using 0073T instead.

CPT Code for Compensator-based IMRT Treatment Delivery

0073T Compensator-based beam modulation treatment delivery of inverse planned treatment using three or more high resolution (milled or cast) compensator convergent beam modulated fi elds, per treatment session

This code is a temporary CPT Category III code that should be used for tracking purposes.

CPT copyright 2012 American Medical Association. All rights reserved.


Medical Radiation Physics, Dosimetry and Treatment Devices

Basic Radiation Dosimetry

Basic radiation dosimetry is a separate and distinct service from IMRT planning and should be reported accordingly. The radiation dose delivered by each IMRT beam must be individually calculated and verifi ed before the course of radiation treatment begins. Thus, multiple basic dosimetry calculations (up to 10) are typically performed and reported on a single day. Supporting documentation should accompany a claim for more than ten (10) calculations on a single day.

CPT® Code for IMRT Dosimetry 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

This code can generally be billed once for each IMRT beam or arc up to a limit of ten. This code is used to report dosimetry calculations that arrive at the relationship between monitor units (or time) and dose, and the physician’s verifi cation, review and approval. The documentation should contain the independent check of each fi eld, separate from the computer-generated IMRT plan.

Treatment Devices

There are several categories of treatment devices used in conjunction with the delivery of IMRT radiotherapy. Immobilization treatment devices are commonly employed to ensure that the beam is accurately on target. In addition, the radiation oncologist is responsible for the design of treatment devices that defi ne the beam geometry. The beam or arc aperture, the dose constraints per beam, the couch and gantry angles for each beam position or arc start/stop location, and the coverage requirements all must be evaluated in order to guide the generation of the multi-leaf collimator (MLC) segments. CPT® code 77338 was established to report multileaf collimator (MLC) design and construction for IMRT. It captures the physician work associated with design and fabrication of the device, the practice expense associated with staff (physicists and dosimetrists) and the equipment used to design, analyze and fabricate the device. While 77334 was previously billed once for each gantry angle, 77338 is billed only once per IMRT plan. There is no separate accounting for gantry angles or other beam arrangements. CPT code 77334 may be used in the IMRT process of care to report the immobilization device constructed at time of the simulation. Additional IMRT plans during a course of care merit additional reporting of 77338.

CPT Codes for IMRT Treatment Devices

77332 Treatment devices, design and construction; simple Simple treatment devices include simple multi-use shaped blocks, bolus and passive, multiuse devices.

77333 Treatment devices, design and construction; intermediate Intermediate treatment devices include pre-cast or pre-made standard-shaped blocks, stents, and special bolus and bite blocks.

77334 Treatment devices, design and construction; complexComplex treatment devices include custom-fabricated cast blocks, immbolization devices, wedges, compensators and eye shields.

77338 Multi-leaf collimator (MLC) device(s) for intensity modulated radiation therapy (IMRT), design and construction per IMRT plan

Report once per IMRT plan.



Image-Guided Radiation Therapy

Image Guided Radiation Therapy (IGRT) utilizes imaging technology to modify treatment delivery to account for changes in the position of the intended target. IGRT is indicated for use in conjunction with IMRT for patients whose tumors are located near or within critical structures and/or in tissue with inherent setup variation. Thus, although IGRT is a distinct service, it may be used and documented along with IMRT treatment delivery (77418) when necessary. This service must be performed by a radiation oncologist, medical physicist or trained radiation therapist under the direct supervision of the radiation oncologist.

CPT® Codes for IGRT

76950 Ultrasonic guidance for placement of radiation therapy fi elds Used with ultrasound-based 2 and 3D systems.

77014 Computed tomography guidance for placement of radiation fi elds Used with CT-based systems (i.e., integrated cone beam CT, CT/linear accelerator on rails, tomotherapy).

77421 Stereoscopic x-ray guidance for localization of target volume for the delivery of radiation therapy Used with stereoscopic X-ray-based systems (i.e., kV X-rays or MV X-rays: EPID (electronic portal imaging device) with fi ducial markers).

0197T Intra-fraction localization and tracking of target or patient motion during delivery of radiation therapy (eg. 3D positional tracking, gating, and 3D surface tracking), each fraction of treatment Used with implanted radiofrequency transponders and for 3D Surface tracking.

ADDITIONAL INFORMATION

Coding Guidelines

The following CPT® codes are components of IMRT planning (CPT code 77301) and therefore should not be separately coded or billed on the same day of service as 77301. They may, however, be billed as needed, for medically necessary simulation and treatment planning during the course of IMRT treatment (i.e. with code 77418).

CPT® Code CPT Code Descriptor Criteria for Level

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

The work of 3D image reconstruction is part of the process of care of 3D treatment planning and should not be reported using CPT codes 76376 or 76377

77014 Computed tomography guidance for placement of radiation therapy fi elds

IGRT-specifi c guidelines: Used with CT-based systems (i.e., integrated cone beam CT, CT/linear accelerator on rails, tomotherapy).



77295 Three-dimensional radiotherapy plan, including dose-volume histograms

One or more of the following exists: • Volume of interest lies in close proximity to normal structures that must be protected. • Volume of interest can only be defi ned by MRI or CT. • Multiple or conformal portals are necessary to cover the volume of interest with close margins to protect immediately adjacent structures. • Beam’s eye view of multiple portals must be established for conformal treatment delivery. • An immediately adjacent area has been irradiated, and abutting portals must be established with high precision. • Three-dimensional reconstruction of the tumor volume, and the critical structure volume in brachytherapy cases, is used to develop dose-volume histograms for the tumor and critical structures.

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

Explanation of medical necessity may be required.


The following list of codes should also not be reported on the same date of service as IMRT planning (77301). They may, however, correctly be used, as needed, for medically necessary simulation and treatment planning during the course of IMRT treatment (i.e. with code 77418).

CPT® Code CPT Code Descriptor Criteria for Level

77280 Therapeutic radiology simulation-aided fi eld setting, simple

Single treatment area

77285 Therapeutic radiology simulation-aided fi eld setting, intermediate

Two separate treatment areas

77290 Therapeutic radiology simulation-aided fi eld setting, complex

Any one of these factors present:• Three or more treatment areas• Any number of treatment areas if any of the following are involved:

• Particle• Rotation or arc therapy • Complex blocking• Custom shielding blocks • Brachytherapy simulation • Hyperthermia probe verifi cation• Any use of contrast materials



77305 Teletherapy, isodose plan (whether hand or computer calculated); simple

One or two parallel opposed unmodifi ed ports directed to a single area of interest.

77310 Teletherapy, isodose plan (whether hand or computer calculated); intermediate

Three or more treatment ports directed to a single area of interest.

77315 Teletherapy, isodose plan (whether hand or computer calculated); complex

Mantle or inverted Y, tangential ports, the use of wedges, compensators, complex blocking, rotational beam or special beam considerations.


General

1. ASTRO/ACR Guide to Radiation Oncology Coding 2010. Fairfax, Virginia: American Society for Radiology Oncology (ASTRO) and American College of Radiology (ACR); 2010.

2. Bortfeld T, Schmidt-Ulrich R, De Neve W, Wazer DE. Image-Guided IMRT. Berlin, Germany: Springer; 2006.

3. Chao KSC, Apisarnthanarax S, Ozyigit G. Practical Essentials of Intensity Modulated Radiation Therapy. 2nd edition. Philadelphia, PA: Lippincott Williams & Wilkins; 2005.

4. DeVita VT, Hellman S, Rosenberg SA. Radiation Oncology. Cancer, Principles & Practice of Oncology. 9th edition. Philadelphia, PA: Lippincott William & Wilkins; 2011: 297-306.

5. Guerrero Urbano MT, Nutting CM. Clinical use of intensity-modulated radiotherapy: part I. Br J Radiol. 2004; 77(914): 88-96.

6. Guerrero Urbano MT, Nutting CM. Clinical use of intensity-modulated radiotherapy: part II. Br J Radiol. 2004; 77(915): 177-182.

7. Gunderson LL, Tepper, JE. Conformal Therapy and Intensity-Modulated Radiation Therapy: Treatment Planning, Treatment Delivery, and Clinical Results. Clinical Radiation Oncology. 3rd edition. Philadelphia, PA: Saunders; 2012: 287-316.

8. Halperin, EC, Perez, CA, Brady, LW. Intensity-Modulated Radiation Treatment Techniques and Clinical Applications. Principles and Practice of Radiation Oncology, 5th edition. Philadelphia, PA: Lippincott William & Wilkins; 2008: 239- 262.

9. Hartford AC, Galvin JM, Beyer DC, et al. American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guidelines for Intensity-Modulated Radiation Therapy (IMRT). Am J Clin Oncol. 2012; 35(6): 612-617.

10. Hoppe, RT, Phillips TL, Roach M. Three-Dimensional Conformal Radiotherapy and Intensity-Modulated Radiotherapy. Leibel and Phillips Textbook of Radiation Oncology, 3rd edition. Philadelphia, PA: Saunders; 2010: 170-192.

11. McCormick B, Hunt M. Intensity-modulated radiation therapy for breast: is it for everyone? Semin Radiat Oncol. 2011; 21: 51-54.

12. Mell LK, Mehrotra AK, Mundt AJ. Intensity-modulated radiation therapy use in the U.S., 2004. Cancer. 2005; 104(6): 1296-1303.

13. Moran JM, Dempsey M, Eishbruch A, et al. Safety consideration for IMRT: Executive Summary. Pract Radiat Oncol. 2011; 1: 190-195.

14. Mundt AJ, Roeske JC. Intensity Modulated Radiation Therapy. Hamilton, Ontario: BC Decker; 2005.

Anus

15. Bazan JG, Hara W, Hsu A, et al. Intensity-modulated radiation therapy versus conventional radiation therapy for squamous cell carcinoma of the anal canal. Cancer. 2011; 117(15): 3342-3351.

16. Call JA, Haddock MG, Quevedo JF, et al. Intensity-modulated radiotherapy for squamous cell carcinoma of the anal canal: effi cacy of a low daily dose to clinically negative regions. Radiat Oncol. 2011; 6: 134.

17. Defoe SG, Beriwal S, Jones H, et al. Concurrent Chemotherapy and Intensity-modulated Radiation Therapy for Anal Carcinoma - Clinical Outcomes in a Large National Cancer Institute-designated Integrated Cancer Centre Network. Clin Oncol (R Coll Radiol). 2012; 24(6): 424-431.

18. Devisetty K, Mell LK, Salama JK, et al. A multi-institutional acute gastrointestinal toxicity analysis of anal cancer patients treated with concurrent intensity-modulated radiation therapy (IMRT) and chemotherapy. Radiother Oncol. 2009; 93(2): 298-301.

19. Hodges JC, Das P, Eng C, et al. Intensity-modulated radiation therapy for the treatment of squamous cell anal cancer with para-aortic nodal involvement. Int J Radiat Oncol Biol Phys. 2009; 75(3): 791-794.

20. Kachnic LA, Tsai HK, Coen JJ, et al. Dose-painted intensity-modulated radiation therapy for anal cancer: a multi-institutional report of acutetoxicity and response to therapy. Int J Radiat Oncol Biol Phys. 2012; 82(1): 153-158.

21. Milano MT, Jani AB, Farrey KJ, et al. Intensity-modulated radiation therapy (IMRT) in the treatment of anal cancer: toxicity and clinical outcome. Int J Radiat Oncol Biol Phys. 2005; 63(2): 354-361.

22. Pepek JM, Willett CG, Wu QJ, et al. Intensity-modulated radiation therapy for anal malignancies: a preliminary toxicity and disease outcomes analysis. Int J Radiat Oncol Biol Phys. 2010; 78(5): 1413-1419.

23. Saarilahti K, Arponen P, Vaalavirta L, et al. The eff ect of intensity-modulated radiotherapy and high dose rate brachytherapy on acute and late radiotherapy-related adverse events following chemoradiotherapy of anal cancer. Radiother Oncol. 2008; 87(3): 383- 390.

24. Salama JK, Mell LK, Schomas DA, et al. Concurrent chemotherapy and intensity-modulated radiation therapy for anal canal cancer patients: a multicenter experience. J Clin Oncol. 2007; 25(29): 4581-4586.

25. Zagar TM, Willett CG, Czito BG. Intensity-modulated radiation therapy for anal cancer: toxicity versus outcomes. Oncology (Williston Park). 2010; 24(9): 815-23, 828.

Breast

26. Barnett GC, Wilkinson JS, Moody AM, et al. Randomized controlled trial of forward-planned intensity modulated radiotherapy for early breast cancer: interim results at 2 years. Int J Radiat Oncol Biol Phys. 2012; 82(2): 715-723.

27. Beckham WA, Popesscu CC, Patenaude VV, et al. Is multi-beam IMRT better than standard treatment for patients with left-sided breast cancer? Int J Radiat Onc Biol Phys. 2007; 69(3): 918-924.

28. Bhatnagar AK, Beriwal S, Heron DE, et al. Initial outcomes analysis for large multicenter integrated cancer network implementation of intensity modulated radiation therapy for breast cancer. Breast J. 2009; 15(5): 468-474.

29. Bhatnagar AK, Brandner E, Sonnik D, et al. Intensity modulated radiation therapy (IMRT) reduces the dose to the contralateral breast when compared to conventional tangential fi elds for primary breast irradiation. Breast Cancer Res Treat. 2006; 96(1): 41-46.

30. Bhatnagar AK, Heron DE, Deutsch M, et al. Does breast size aff ect the scatter dose to the ipsilateral lung, heart, or contralateral breast in primary breast irradiation using intensity-modulated radiation therapy (IMRT)? Am J Clin Oncol. 2006; 29(1): 80-84.

REFERENCES

The medical literature regarding Intensity Modulated Radiation Therapy is extensive. The following list comprises a compliation of selected peer reviewed publications from the last 10 years reporting clinical outcomes in patients treated with IMRT, organized by disease site.

31. Coles CE, Moody AM, Wilson CB, et al. Reduction of radiotherapy-induced late complications in early breast cancer: the role of intensity-modulated radiation therapy and partial breast irradiation. Part I--normal tissue complications. Clin Oncol (R Coll Radiol). 2005; 17(1): 16-24.

32. Coles CE, Moody AM, Wilson CB, et al. Reduction of radiotherapy induced late complications in early breast cancer: the role of intensity modulated radiation therapy and partial breast irradiation. Part II: Radiotherapy strategies to reduce radiation-induced late eff ects. Clin Oncol (R Coll Radiol). 2005; 17: 98–110.

33. Correa CR, Litt HI, Hwang WT, et al. Coronary artery fi ndings after left- sided compared with right-sided radiation treatment for early-stage breast cancer. J Clin Oncol. 2007; 25(21): 3031-3037.

34. Cozzi L, Fogliata A, Nicolini G, et al. Clinical experience in breast irradiation with intensity modulated photon beams. Acta Oncol. 2005; 44(5): 467-474.

35. Dayes I, Rumble R, Bowen J, et al. Intensity-modulated radiotherapy in the treatment of breast cancer. Clin Oncol (R Coll Radiol). 2012; 24(7): 488-498.

36. De Neve W, De Gersem W, Madani I. Rational Use of Intensity-Modulated Radiation Therapy: The Importance of Clinical Outcome. Sem Radiat Oncol. 2012; 22(1): 40–49.

37. Donovan E, Bleakley N, Denholm E, et al. Randomised trial of standard 2D radiotherapy (RT) versus intensity modulated radiotherapy (IMRT) in patients prescribed breast radiotherapy. Radiother Oncol. 2007; 82(3): 254-264.

38. Freedman GM, Anderson PR, Bleicher RJ, et al. Five-year local control in a phase II study of hypofractionated intensity modulated radiation therapy with an incorporated boost for early stage breast cancer. Int J Radiat Oncol Biol Phys. 2012; 84(4): 888-893.

39. Freedman GM, Anderson PR, Li J, et al. Intensity modulated radiation therapy (IMRT) decreases acute skin toxicity for women receiving radiation for breast cancer. Am J Clin Oncol. 2006; 29(1): 66-70.

40. Freedman GM, Li T, Nicolaou N, et al. Breast intensity-modulated radiation therapy reduces time spent with acute dermatitis for women of all breast sizes during radiation. Int J Radiat Oncol Biol Phys. 2009; 74: 689–694.

41. Harsolia A, Kestin L, Grills I, et al. Intensity-modulated radiotherapy results in signifi cant decrease in clinical toxicities compared with conventional wedge-based breast radiotherapy. Int J Radiat Oncol Biol Phys. 2007; 68(5): 1375-1380.

42. Keller LMM, Sopka DM, Li T, et al. Five-year results of whole breast intensity modulated radiation therapy for treatment of early stage breast cancer: The Fox Chase Cencer Center experience. Int J Radiat Oncol Biol Phys. 2012; 84(4): 881-887.

43. Leonard C, Carter D, Kerscher J, et.al. Prospective trial of accelerated partial breast intensity-modulated radiotherapy. Int J Radiat Oncol Biol Phys. 2007; 67(5): 1291-1298.

44. Lewin AA, Derhagopian R, Saigal K, et al. Accelerated partial breast irradiation is safe and eff ective using intensity-modulated radiation therapy in selected early-stage breast cancer. Int J Radiat Oncol Biol Phys. 2012; 82(5): 2104-2110.

45. McDonald MW, Godette KD, Butker EK, et al. Long-term outcomes of IMRT for breast cancer: a single-institution cohort analysis. Int J Radiat Oncol Biol Phys. 2008; 72(4): 1031-1040.

46. Pignol J, Olivotto I, Rakovitch E, et al. Phase III randomized study of intensity modulated radiation therapy versus standard wedging technique for adjuvant breast radiation therapy. Int J Radiat Oncol Biol Phys. 2006; 66(3 Suppl): S1.

47. Pignol JP, Olivotto I, Rakovitch E, et al. A multicenter randomized trial of breast intensity-modulated radiation therapy to reduce acute radiation dermatitis. J Clin Oncol. 2008;

Central Nervous System

48. Milker-Zabel S, Zabel-du Bois A, Huber P, et al. Intensity-modulated radiotherapy for complex-shaped meningioma of the skull base: long-term experience of a single institution. Int J Radiat Oncol Biol Phys. 2007; 68(3): 858-863.

49. Narayana A, Chang J, Yenice K, et al. Hypofractionated stereotactic radiotherapy using intensity-modulated radiotherapy in patients with one or two brain metastases. Stereotact Funct Neurosurg. 2007; 85(2-3): 82-87.

50. Narayana A, Yamada J, Berry S, et al. Intensity-modulated radiotherapy in high-grade gliomas: clinical and dosimetric results. Int J Radiat Onc Biol Phys. 2006; 64(3): 892-897.

51. Paravati AJ, Heron DE, Landsittel D, et al. Radiotherapy and temozolomide for newly diagnosed glioblastoma and anaplastic astrocytoma: validation of Radiation Therapy Oncology Group- Recursive Partitioning Analysis in the IMRT and temozolomide era. J Neurooncol. 2011; 104(1): 339-349.

52. Pirzkall A, Debus J, Haering P, et al. Intensity modulated radiotherapy (IMRT) for recurrent, residual, or untreated skull-base meningiomas: preliminary clinical experience. Int J Radiat Oncol Biol Phys. 2003; 55(2): 362-372.

53. Reddy K, Damek D, Gaspar L, et al. Phase II trial of hypofractionated IMRT with temozolamide for patients with newly diagnosed glioblastoma multiforme. Int J Radiat Oncol Biol Phys. 2012; 84(3): 655-660.

54. Schroeder TM, Chintagumpala M, Okcu MF, et al. Intensity-modulated radiation therapy in childhood ependymoma. Int J Radiat Oncol Biol Phys. 2008; 71(4): 987-993.

55. Wang SJ, Choi M, Fuller CD, et al. Intensity-modulated Radiosurgery for patients with brain metastases: a mature outcomes analysis. Technol Cancer Res Treat. 2007; 6(3): 161-168.

56. Yamada Y, Lovelock M, Bilsky MH. Image-guided intensity-modulated radiation therapy of spine tumors. Curr Neurol Neurosci Rep. 2006; 6: 207-211.

Cervix

57. Ahmed R, Kim RY, Duan J, et al. IMRT Dose escalation for positive para-aortic lymph nodes in patients with locally advanced cervical cancer while reducing the dose to bone marrow and other organs at risk. Int J Radiat Oncol Biol Phys. 2004; 60(2): 505-512.

58. Albuquerque K,Giangreco D, Morrison C, et al. Radiation-related predictors of hematologic toxicity after concurrent chemoradiation for cervical cancer and implications for bone marrow-sparing pelvic IMRT. Int J Radiat Oncol Biol Phys. 2011; 79(4): 1043-1047.

59. Beriwal S, Gan GN, Heron DE, et al. Early clinical outcome with concurrent chemotherapy and extended-fi eld, intensity-modulated radiotherapy for cervical cancer. Int J Radiat Oncol Biol Phys. 2007; 68(1): 166-171.

60. Chen CC, Lin JC, Jan JS, et al. Defi nitive intensity-modulated radiation therapy with concurrent chemotherapy for patients with locally advanced cervical cancer. Gynecol Oncol. 2011; 122(1): 9-13.


61. Chen MF, Tseng CJ, Tseng CC, et al. Clinical outcome in posthysterectomy cervical cancer patients treated with concurrent Cisplatin and intensity-modulated pelvic radiotherapy: comparison with conventional radiotherapy. Int J Radiat Oncol Biol Phys. 2007; 67(5): 1438-1444.

62. Du XL, Tao J, Sheng XG, et al. Intensity-modulated radiation therapy for advanced cervical cancer: a comparison of dosimetric and clinical outcomes with conventional radiotherapy. Gynecol Oncol. 2012; 125(1): 151-157.

63. Esthappan J, Chaudhari S, Santanam L,et al. Prospective clinical trial of positron emission tomography/computed tomography image-guided intensity-modulated radiation therapy for cervical carcinoma with positive para-aortic lymph nodes. Int J Radiat Oncol Biol Phys. 2008; 72(4): 1134-1139.

64. Hasselle MD, Rose BS, Kochanski JD,et al. Clinical outcomes of intensity-modulated pelvic radiation therapy for carcinoma of the cervix. Int J Radiat Oncol Biol Phys. 2011; 80(5): 1436-1445.

65. Kidd EA, Siegel BA, Dehdashti F, et al. Clinical outcomes of defi nitive intensity modulated radiation therapy with fl uorodeoxyglucose-positron emission tomography simulation in patients with locally advanced cervical cancer. Int J Radiat Oncol Biol Phys. 2010; 77: 1085–1091.

66. Macdonald DM, Lin LL, Biehl K, et al. Combined intensity-modulated radiation therapy and brachytherapy in the treatment of cervical cancer. Int J Radiat Oncol Biol Phys. 2008; 71(2): 618-624.

67. Simpson DR, Song WY, Moiseenko V, et al. Normal tissue complication probability analysis of acute gastrointestinal toxicity in cervical cancer patients undergoing intensity modulated radiation therapy and concurrent cisplatin. Int J Radiat Oncol Biol Phys. 2012; 83(1): e81-e86.

68. Van de Bunt L, van der Heide UA, Ketelaars M, et al. Conventional, conformal, and Intensity-modulated radiation therapy treatment planning of external beam radiotherapy for cervical cancer: The impact of tumor regression. Int J Radiat Oncol Biol Phys. 2006; 64(1): 189-196.

Esophagus

69. Kole T, Aghayere O, Kwah J, et al. Comparison of heart and coronary artery doses associated with intensity-modulated radiation therapy versus three- dimensional conformal radiotherapy for distal esophageal cancer. Int J Radiat Oncol Biol Phys. 2012; 83(5): 1580-1586.

70. La TH, Minn AY, Su Z, et al. Multimodality treatment with intensity modulated radiation therapy for esophageal cancer. Dis Esophagus. 2010; 23(4): 300-308.

71. Lin SH, Wang L, Myles B, et al. Propensity score-based comparison of long-term outcomes with 3-dimensional conformal radiotherapy vs intensity-modulated radiotherapy for esophageal cancer. Int J Radiat Oncol Biol Phys. 2012; 84(5): 1078-1085.

72. Mayo CS, Urie MM, Fitzgerald TJ, et al. Hybrid IMRT for treatment of cancers of the Lung and Esophagus. Int J Radiat Oncol Biol Phys. 2008; 71(5): 1408- 1418.

73. Wang SL, Laio Z, Vaporciyan AA, et al. Investigation of clinical and dosimetric factors associated with postoperative pulmonary complications in esophageal cancer patients treated with concurrent chemo radiotherapy followed by surgery. Int J Radiat Oncol Biol Phys. 2006; 64(3): 692-699.

Gynecologic

74. Ferrigno R, Santos A, Martins LC, et al. Comparison of conformal and intensity modulated radiation therapy techniques for treatment of pelvic tumors. Analysis of acute toxicity. Radiat Oncol. 2010; 5: 117.

75. Georg P, Georg D, Hillbrand M, et al. Factors infl uencing bowel sparing in intensity modulated whole pelvic radiotherapy for gynaecological malignancies. Radiother Oncol. 2006; 80(1): 19-26.

76. Lujan AE, Mundt AJ, Yamada SD, et al. Intensity-modulated radiotherapy as a means of reducing dose to bone marrow in gynecologic patients receiving whole pelvic radiotherapy. Int J Radiat Oncol Biol Phys. 2003; 57(2): 516-521.

77. Mundt AJ, Mell LK, Roeske JC. Preliminary analysis of chronic gastrointestinal toxicity in gynecology patients treated with intensity-modulated whole pelvic radiation therapy. Int J Radiat Oncol Biol Phys. 2003; 56(5): 1354-1360.

78. Salama JK, Mundt AJ, Roeske J, et al: Preliminary outcome and toxicity report of extended-fi eld, intensity-modulated radiation therapy for gynecologic malignancies. Int J Radiat Oncol Biol Phys. 2006; 65: 1170- 1176.

79. Vandecasteele K, Tummers P, Makar A, et al. Postoperative intensity-modulated arc therapy for cervical and endometrial cancer: A prospective reportr on toxicity. Int J Radiat Oncol Biol Phys. 2012; 84 (2): 408-414.

Head and Neck

80. Arcangeli G, Benassi M, Giovinazzo G, et al. Analysis of Salivary Flow and Dose–Volume Modeling of Complication Incidence in Patients With Head-and-Neck Cancer Receiving Intensity- Modulated Radiotherapy. Int J Radiat Oncol Biol Phys. 2009; 73(4): 1252-1259.

81. Bhide S A, Bidmead A M, Clark C H, et al. Pre-trial quality assurance process for an intensity modulated radiation therapy (IMRT) trial: PARSPORT, a UK multicentre Phase III trial comparing conventional radiotherapy and parotid sparing IMRT for locally advanced head and neck cancer. Br J Radiol. 2009; 82: 585-594.

82. Chan K, Gomez DR, Gomez J, et al.. Intensity-Modulated Radiotherapy in Postoperative Treatment of Oral Cavity Cancers. Int J Radiat Oncol Biol Phys. 2009; 73(4): 1096-1103.

83. Chao KS, Ozyigit G, Blanco AI, et al. Intensity-modulated radiation therapy for oropharyngeal carcinoma: impact of tumor volume. Int J Radiat Oncol Biol Phys. 2004; 59(1): 43-50.

84. Chen AM, Farwell DG, Luu Q, et al. Intensity-modulated radiotherapy is associated with improved global quality of life among long-term survivors of head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2012; 84(1): 170-175.

85. Chua DT, Sham JS, Leung LH, et al. Re-irradiation of nasopharyngeal carcinoma with intensity-modulated radiotherapy. Radiother Oncol. 2005; 77(3): 290-294.

86. Clavel S, Nguyen DHA, Fortin B, et al. Simultaneous integrated boost using intensity-modulated radiotherapy compared with conventional radiotherapy in patients treated with concurrent carboplatin and 5-fl uorouracil for locally advanced oropharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2012; 82(2): 582-589.


87. Doornaert P, Langendijk JA, Leemans RC, et al. Intensity-Modulated Radiotherapy Reduces Radiation-Induced Morbidity and Improves Health-Related Quality of Life: Results of a Nonrandomized Prospective Study Using a Standardized Follow-Up Program. Int J Radiat Oncol Biol Phys. 2009; 74(1): 1-8.

88. Duprez F, Madani I, Morbée L, et al. IMRT for sinonasal tumors minimizes severe late ocular toxicity and preserves disease control and survival. Int J Radiat Oncol Biol Phys. 2012; 83(1): 252-259.

89. Eisbruch A, Harris J, Garden A, et al. Multi-institutional trial of accelerated hypofractionated intensity-modulated radiation therapy for early-stage oropharyngeal cancer (RTOG 00-22). Int J Radiat Oncol Biol Phys. 2010; 76(5): 1333-1338.

90. Eisbruch A, Kim HM, Feng FY, et al. Chemo-IMRT of oropharyngeal cancer aiming to reduce dysphagia: swallowing organs late complication probabilities and dosimetric correlates. Int J Radiat Oncol Biol Phys. 2011; 81(3): e93-e99.

91. Feng FY, Kim HM, Lyden TH, et al. Intensity-Modulated radiotherapy of head and neck cancer aiming to reduce dysphagia: early dose-eff ect relationships for the swallowing structures. Int J Radiat Oncol Biol Phys. 2007; 68(5): 1289-1298.

92. Graff P, Lapeyre M, Desandes E, et al. Impact of intensity-modulated radiotherapy on health-related quality of life for head and neck cancer patients: matched-pair comparison with conventional radiotherapy. Int J Radiat Oncol Biol Phys. 2007; 67(5): 1309-1317.

93. Habl G, Jensen AD, Potthoff K, et al. Treatment of locally advanced carcinomas of head and neck with intensity-modulated radiation therapy (IMRT) in combination with cetuximab and chemotherapy: the REACH protocol. BMC Cancer. 2010; 10: 651.

94. Jabbari S, Kim HM, Feng M, et al. Matched case-control study of quality of life and xerostomia after intensity-modulated radiotherapy or standard radiotherapy for head-and-neck cancer: Initial report. Int J Radiat Oncol Biol Phys. 2005; 63(3): 725-731.

95. Kam MK, Leung SF, Zee B, et al. Prospective randomized study of intensity-modulated radiotherapy on salivary gland function in early-stage nasopharyngeal carcinoma patients. J Clin Oncol. 2007; 25(31): 4873-4879.

96. Klem ML, Mechalakos JG, Wolden SL, et al. Intensity-modulated radiotherapy for head and neck cancer of unknown primary: toxicity and preliminary effi cacy. Int J Radiat Oncol Biol Phys. 2008; 70(4): 1100-1107.

97. Kwong DL, Pow EH, Sham JS, et al. Intensity-modulated radiotherapy for early-stage nasopharyngeal carcinoma: a prospective study on disease control and preservation of salivary function. Cancer. 2004; 101(7): 1584-1593.

98. Kwong DL, Sham JS, Leung LH, et al. Preliminary results of radiation dose escalation for locally advanced nasopharyngeal carcinoma. Int J Radiat Onc Biol Phys. 2006; 64( 2): 374-381.

99. Lauve A, Morris M, Schmidt-Ullrich R, et al. Simultaneous integrated boost intensity-modulated radiotherapy for locally advanced head- and-neck squamous cell carcinomas: II--clinical results. Int J Radiat Oncol Biol Phys. 2004; 60(2): 374-387.

100. Lee N, Xia P, Fischbein NJ, et al. Intensity-modulated radiation therapy for head-and-neck cancer: the UCSF experience focusing on target volume delineation. Int J Radiat Oncol Biol Phys. 2003; 57(1): 49-60.

101. Lee NY, de Arruda FF, Puri DR, et al. A comparison of intensity-modulated radiation therapy and concomitant boost radiotherapy in the setting of concurrent chemotherapy for locally advanced oropharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2006; 66(4): 966-974.

102. Lin A, Kim HM, Terrell JE, et al. Quality of life after parotid-sparing IMRT for head-and-neck cancer: a prospective longitudinal study. Int J Radiat Oncol Biol Phys. 2003; 57(1): 61-70.

103. Lu TX, Mai WY, Teh BS, et al. Initial experience using intensity-modulated radiotherapy for recurrent nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2004; 58(3): 682-687.

104. Madani I, Bonte K, Vakael L, et al. Intensity-Modulated Radiotherapy for Sinonasal Tumors: Ghent University Hospital Update. Int J Radiat Oncol Biol Phys. 2009; 73(2): 424-432.

105. McMillan AS, Pow EH, Kwong DL, et al. Preservation of quality of life after intensity-modulated radiotherapy for early-stage nasopharyngeal carcinoma: results of a prospective longitudinal study. Head Neck. 2006; 28(8): 712-722.

106. Miah AB, Bhide SA, Guerrero-Urbano MT, et al. Dose-escalated intensity-modulated radiotherapy is feasible and may improve locoregional control and laryngeal preservation in laryngo-hypopharyn geal cancers. Int J Radiat Oncol Biol Phys. 2012; 82(2): 539-547.

107. Milano MT, Vokes EE, Kao J, et al. Intensity-modulated radiation ` therapy in advanced head and neck patients treated with intensive chemoradiotherapy: preliminary experience and future directions. Int J Oncol. 2006; 28(5): 1141-1151.

108. Montejo ME, Shrieve DC, Bentz BG, et al. IMRT with simultaneous integrated boost and concurrent chemotherapy for locoregionally advanced squamous cell carcinoma of the head and neck. Int J Radiat Oncol Biol Phys. 2011; 81(5): e845-e852.

109. Nutting CM, Morden JP, Harrington KJ, et al. Parotid-sparing intensity modulated versus conventional radiotherapy in head and neck cancer (PARSPORT): a phase 3 multicentre randomised controlled trial. Lancet Oncol. 2011; 12(2): 127-136.

110. Nutting CM, Rowbottom CG, Cosgrove VP, et al. Optimization of radiotherapy for carcinoma of the parotid gland: a comparison of conventional, three-dimensional conformal, and intensity- modulated techniques. Radiother Oncol. 2001; 60(2): 163-172.

111. Ozyigit G, Yang T, Chao KS. Intensity-modulated radiation therapy for head and neck cancer. Curr Treat Options Oncol. 2004; 5(1): 3-9.

112. P.M. Braam, C.H. Terhaard, J.M. Roesink et al. Intensity-modulated radiotherapy signifi cantly reduces xerostomia compared with conventional radiotherapy. Int J Radiat Oncol Biol Phys. 2006; 66: 975-980.

113. Pacholke HD, Amdur RJ, Morris CG, et al. Late xerostomia after intensity-modulated radiation therapy versus conventional radiotherapy. Am J Clin Oncol. 2005; 28(4): 351-358.

114. Parliament MB, Scrimger RA, Anderson SG, et al. Preservation of oral health-related quality of life and salivary fl ow rates after inverse-planned intensity-modulated radiotherapy (IMRT) for head- and-neck cancer. Int J Radiat Oncol Biol Phys. 2004; 58(3): 663-673.

115. Pow EH, Kwong DL, McMillan AS, et al. Xerostomia and quality of life after intensity-modulated radiotherapy vs. conventional radiotherapy for early-stage nasopharyngeal carcinoma: initial report on a randomized controlled clinical trial. Int J Radiat Onc Biol Phys. 2006; 66(4): 981-991.

116. Puri DR, Chou W, Lee N. Intensity-modulated radiation therapy in head-and-neck cancers: dosimetric advantages and update of clinical results. Am J Clin Oncol. 2005; 28(4): 415-423.


117. Qiu S, Lin S, Tham IWK, et al. Intensity-modulated radiation therapy in the salvage of locally recurrent nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2012; 83(2): 676-683.

118. Saarilahti K, Kouri M, Collan J, et al. Intensity modulated radiotherapy for head and neck cancer: evidence for preserved salivary gland function. Radiother Oncol. 2005; 74(3): 251-258.

119. Saarilahti K, Kouri M, Collan J, et al. Sparing of the submandibular glands by intensity modulated radiotherapy in the treatment of head and neck cancer. Radiother Oncol. 2006; 78(3): 270-275.

120. Schoenfeld JD, Sher DJ, Norris CM, et al. Salivary gland tumors treated with adjuvant intensity-modulated radiotherapy with or without concurrent chemotherapy. Int J Radiat Oncol Biol Phys. 2012; 82(1): 308-314.

121. Setton J, Caria N, Romanyshyn J, et al. Intensity-modulated radio therapy in the treatment of oropharyngeal cancer: An update of the Memorial Sloan-Kettering Cancer Center experience. Int J Radiat Oncol Biol Phys. 2012; 82(1): 291-298.

122. Shoushtari A, Saylor D, Kerr K, et al. Outcomes of patients with head- and-neck cancer of unknown primary origin treated with intensity-modulated radiotherapy. Int J Radiat Oncol Biol Phys. 2011; 81(3): e83-e91.

123. Sulman E, Schwartz D, Le T, et al. IMRT Reirradiation of head and neck cancer: Disease control and morbidity outcomes. Int J Radiat Onc Biol Phys. 2009; 73(2): 399-409. 124. Villenueve H, Després P, Fortin B, et al. Cervical lymph node metastases from unknown primary cancer: A single-institution experience with intensity-modulated radiotherapy. Int J Radiat Oncol Biol Phys. 2012; 82(5): 1866-1871.

125. Wiegner E, Daly M, Murphy J, et al. Intensity-modulated radiotherapy for tumors of the nasal cavity and paranasal sinuses: clinical outcomes and patterns of failure. Int J Radiat Oncol Biol Phys. 2012; 83(1): 243-251.

126. Yao M, Dornfeld KJ, Buatti JM, et al. Intensity-modulated radiation treatment for head-and-neck squamous cell carcinoma--the University of Iowa experience. Int J Radiat Onc Biol Phys. 2005; 63(2): 410-421.

127. Zwicker F, Roeder F, Thieke C, et al. IMRT reirradiation with concurrent cetuximab immunotherapy in recurrent head and neck cancer. Strahlenther Onkol. 2011; 187(1): 32-38.

Liver

128. Kalapurakal JA, Pokhrel D, Gopalakrishnan M, et al. Advantages of Whole-liver Intensity Modulated Radiation Therapy in Children With Wilms Tumor and Liver Metastasis. Int J Radiat Oncol Biol Phys. 2012 Jul 4 [epub ahead of print].

129. Kuo YC, Chiu YM, Shih WP, et al. Volumetric intensity-modulated Arc (RapidArc) therapy for primary hepatocellular carcinoma: comparison with intensity-modulated radiotherapy and 3-D conformal radiotherapy. Radiat Oncol. 2011; 6: 76.

Lung

130. Choi Y, Kim JK, Lee HS, et al. Impact of intensity-modulated radiation therapy as a boost treatment on the lung-dose distributions for non- small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2005; 63(3): 683-689.

131. Jiang ZQ, Yang K, Komaki R, et al. Long-term clinical outcome of intensity-modulated radiotherapy for inoperable non-small-cell lung cancer: The MD Anderson experience. Int J Radiat Oncol Biol Phys. 2012; 83(1): 332-339.

132. Loo SW, Smith S, Promnitz DA, et al. Synchronous bilateral squamous cell carcinoma of the lung successfully treated using intensity- modulated radiotherapy. Br J Radiol. 2012; 85(1009): 77-80.

133. Murshed H, Liu HH, Liao Z, et al. Dose and volume reduction for normal lung using intensity-modulated radiotherapy for advanced-stage non- small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2004; 58(4): 1258-1267.

134. Rosenzweig KE, Zauderer MG, Laser B, et al. Pleural intensity-modulated radiotherapy for malignant pleural mesothelioma. Int J Radiat Oncol Biol Phys. 2012; 83(4): 1278-1283.

135. Sura S, Gupta V, Yorke E, et al. Intensity-modulated radiation therapy (IMRT) for inoperable non-small cell lung cancer: the Memorial Sloan- Kettering Cancer Center (MSKCC) experience. Radiother Oncol. 2008; 87(1): 17-23.

136. Yom SS, Liao Z, Liu HH, et al. Initial evaluation of treatment-related pneumonitis in advanced-stage non-small-cell lung cancer patients treated with concurrent chemotherapy and intensity-modulated radiotherapy. Int J Radiat Onc Biol Phys. 2007; 68(1): 94-102.

Lymphoma

137. Allan DS, Fox GW, Gerig LH, et al.Total scalp radiation using image-guided IMRT for progressive cutaneous T cell lymphoma. Br J Radiol. 2009; 82: e122-e125.

138. Goodman KA, Toner S, Hunt M, et al. Intensity-modulated radiotherapy for lymphoma involving the mediastinum. Int J Radiat Oncol Biol Phys. 2005; 62(1): 198-206.

139. Koeck J, bo-Madyan Y, Lohr F, et al. Radiotherapy for early mediastinal Hodgkin lymphoma according to the German Hodgkin Study Group (GHSG): The roles of intensity modulated radiotherapy and involved-node radiotherapy. Int J Radiat Oncol Biol Phys. 2012; 83(1): 268-276.

140. Lu NN, Li YX, Wu RY, et al. Dosimetric and clinical outcomes of involved-fi eld intensity-modulated radiotherapy after chemotherapy for early-stage Hodgkin’s lymphoma with mediastinal involvement. Int J Radiat Oncol Biol Phys. 2012; 84(1): 210-216.

141. Wang H, Li YX, Wang WH, et al. Mild toxicity and favorable prognosis of high-dose and extended involved-fi eld intensity-modulated radio therapy for patients with early-stage nasal NK/T-cell lymphoma. Int J Radiat Oncol Biol Phys. 2012; 82(3): 1115-1121.

Ovary

142. Rochet N, Kieser M, Sterzing F, et al. Phase II study evaluating consolidation whole abdominal intensity-modulated radiotherapy (IMRT) in patients with advanced ovarian cancer stage FIGO III--the OVAR-IMRT-02 Study. BMC Cancer. 2011; 11: 41.


Pancreas

143. Abelson J, Murphy J, Minn A, et al. Intensity-modulated radiotherapy for pancreatic adenocarcinoma. Int J Radiat Oncol Biol Phys. 2012; 82(4):e595-601. Ben-Josef E, Shields AF, Vaishampayan U, et al. Intensity-modulated radiotherapy (IMRT) and concurrent capecitabine for pancreatic cancer. Int J Radiat Oncol Biol Phys. 2004; 59(2): 454-459.

144. Milano MT, Chmura SJ, Garofalo MC, et al. Intensity-modulated radio therapy in treatment of pancreatic and bile duct malignancies: toxicity and clinical outcome. Int J Radiat Oncol Biol Phys. 2004; 59(2):445-453.

145. Nakamura A, Shibuya K, Matsuo Y, et al. Analysis of dosimetric parameters associated with acute gastrointestinal toxicity and upper gastrointestinal bleeding in locally advanced pancreatic cancer patients treated with gemcitabine-based concurrent chemoradio therapy. Int J Radiat Oncol Biol Phys. 2012; 84(2): 369-375.

146. Yovino S, Maidment B, Herman J, et al. Analysis of local control in patients receiving IMRT for resected pancreatic cancer. Int J Radiat Oncol Biol Phys. 2012; 83(3): 916-920.

Prostate

147. Afonso SL, Stefano ES, Viani GA. Higher-Than-Conventional Radiation Doses in Localized Prostate Cancer Treatment: A Meta- analysis of Randomized, Controlled Trials. Int J Radiat Oncol Biol Phys. 2009; 74(5): 1405-1418.

148. Alicikus ZA, Yamada Y, Zhang Z, et al. Ten-year outcomes of high-dose, intensity-modulated radiotherapy for localized prostate cancer. Cancer. 2011; 117(7): 1429-1437.

149. Al-Mamgani A, Heemsbergen W, Peeters S.et al. Role of Intensity-Modulated Radiotherapy in Reducing Toxicity in Dose Escalation for Localized Prostate Cancer. Int J Radiat Oncol Biol Phys. 2009; 73(3): 685-691.

150. Alongi F, Fiorino C, Cozzarini C, et al. IMRT signifi cantly reduces acute toxicity of whole-pelvis irradiation in patients treated with postoperative adjuvant or salvage radiotherapy after radical prostatectomy. Radiother Oncol. 2009; 93(2): 207-212.

151. Brabbins D, Martinez A, Yan D, et al. A dose escalation trial with the adaptive radiotherapy process as a delivery system in localized prostate cancer: analysis of chronic toxicity. Int J Radiat Oncol Biol Phys. 2005; 61(2): 400-408.

152. Cahlon O, Hunt M, Zelefsky MJ. Intensity-modulated radiation therapy: supportive data for prostate cancer. Semin Rad Oncol. 2008; 18(1): 48-57.

153. Chung H, Xia P, Chan L, et al. Does image-guided radiotherapy improve toxicity profi le in whole pelvic-treated high-risk prostate cancer? Comparison between IG-IMRT and IMRT. Int J Radiat Onc Biol Phys. 2009; 73(1): 53-60.

154. Eade TN, Horwitz EM, Ruth K, et al. A Comparison of acute and chronic toxicity for men with low-risk prostate cancer treated with intensity-modulated radiation therapy or 125I permanent implant. Int J Radiat Onc Biol Phys. 2008; 71(2): 338-345.

155. Fonteyne V, Lumen N, Villeirs G, et al. Clinical results after high-dose intensity-modulated radiotherapy for high-risk prostate cancer. Adv Urol. 2012; 2012: 368528.

156. Forsythe K, Blacksburg S, Stone N, et al.. Intensity-modulated radiotherapy causes fewer side eff ects than three-dimensional con formal radiotherapy when used in combination with brachytherapy for the treatment of prostate cancer. Int J Radiat Oncol Biol Phys. 2012; 83(2): 630-635.

157. Jani A, Su A, Milano MT. Intensity-modulated versus conventional pelvic radiotherapy for prostate cancer: analysis of acute toxicity. Urology. 2006; 67: 147-151.

158. Lim TS, Cheung PC, Loblaw DA, et al. Hypofractionated Accelerated radiotherapy using concomitant intensity-modulated radiotherapy boost technique for localized high-risk prostate cancer: acute toxicity results. Int J Rad Onc Bio Phys. 2008; 72(1): 85-92.

159. Myrehaug S, Chan G, Craig T, et al. A Treatment Planning and Acute Toxicity Comparison of Two Pelvic Nodal Volume Delineation Techniques and Delivery Comparison of Intensity-Modulated Radiotherapy Versus Volumetric Modulated Arc Therapy for Hypofractionated High-Risk Prostate Cancer Radiotherapy. Int J Radiat Oncol Biol Phys. 2012; 82(4): e657-e662.

160. Pederson AW, Fricano J, Correa D, et al. Late toxicity after intensity- modulated radiation therapy for localized prostate cancer: an exploration of dose-volume histogram parameters to limit genitourinary and gastrointestinal toxicity. Int J Radiat Oncol Biol Phys. 2012; 82(1): 235-241.

161. Pollack A, Hanlon AL, Horwitz EM, et al. Dosimetry and preliminary acute toxicity in the fi rst 100 men treated for prostate cancer on a randomized hypofractionation dose escalation trial. Int J Radiat Oncol Biol Phys. 2006; 64(2): 518-526.

162. Quon H, Cheung PCF, Loblaw DA, et al. Quality of life after hypofractionated concomitant intensity-modulated radiotherapy boost for high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2012; 83(2): 617-623.

163. Sharma NK, Li T, Chen DY, et al. Intensity-modulated radiotherapy reduces gastrointestinal toxicity in patients treated with androgen deprivation therapy for prostate cancer. Int J Radiat Oncol Biol Phys. 2011; 80(2): 437-444.

164. Zelefsky MJ, Chan H, Hunt M, et al. Long-term outcome of high dose intensity modulated radiation therapy for patients with clinically localized prostate cancer. J Urol. 2006; 176(4 Pt 1): 1415-1419.

165. Zelefsky MJ, Kollmeier M, Cox B, et al. Improved Clinical Outcomes with High-Dose Image Guided Radiotherapy Compared with Non- IGRT for the Treatment of Clinically Localized Prostate Cancer. Int J Radiat Oncol Biol Phys. 2012; 84(1): 125-129.

166. Zelefsky MJ, Yamada Y, Kollmeier M, et al. Long-term outcome following three-dimensional conformal/intensity-modulated external-beam radiotherapy for clinical stage T3 prostate cancer. Eur Urol. 2008; 53(6): 1172-1179.

167. Zietman AL, DeSilvio ML, Slater JD, et al. Comparison of conventional dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: a randomized controlled trial. JAMA. 2005; 294(10): 1233-1229.


Rectum

168. Arbea L, Martinez-Monge R, Diaz-Gonzalez JA, et al. Four-week neoadjuvant intensity-modulated radiation therapy with concurrent capecitabine and oxaliplatin in locally advanced rectal cancer patients: A validation phase II trial. Int J Radiat Oncol Biol Phys. 2012; 83(2): 587-593.

169. Aristu J, Arbea L, Rodriguez J, et al. Phase I-II trial of concurrent capecitabine and oxaliplatin with preoperative intensity-modulated radiotherapy in patients with locally advanced rectal cancer. In. J Radiation Oncology Biol Phys. 2008; 71(3): 748-755.

170. Freedman G, Meropol N, Sigurdson E, et al. Phase I trial of preoperative hypofractionated intensity-modulated radiotherapy with incorporated boost and oral capecitabine in locally advanced rectal cancer. Int J Radiat Oncol Biol Phys. 2007; 67(5): 1389-1393.

171. Gasent Blesa JM, Garde Noguera J, Laforga Canales JB. Phase II Trial of Concomitant Neoadjuvant Chemotherapy with Oxaliplatin and Capecitabine and Intensity-Modulated Radiotherapy (IMRT) in Rectal Cancer. J Gastrointest Cancer. 2012; 43(4): 553-561.

172. Gunnlaugsson A, Kjellen E, Nilsson P, et al. Dose-volume relationships between enteritis and irradiated bowel volumes during 5-fl uorouracil and oxaliplatin based chemoradiotherapy in locally advanced rectal cancer. Acta Oncol. 2007; 46: 937–944.

173. Samuelian JM, Callister MD, Ashman JB, et al. Reduced acute bowel toxicity in patients treated with intensity-modulated radiotherapy for rectal cancer. Int J Radiat Oncol Biol Phys. 2012; 82(5): 1981-1987.

174. Tho L, Glegg M, Patterson J, et al. Acute small bowel toxicity and preoperative chemoradiotherapy for rectal cancer: investigating dose-volume relationships and role for inverse planning. Int J Radiat Oncol Biol Phys. 2006; 66(2): 505-513.

Stomach

175. Chakravarty T, Crane C, Ajani J, et al. Intensity-modulated radiation therapy with concurrent chemotherapy as preoperative treatment for localized gastric adenocarcinoma. Int J Radiat Oncol Biol Phys. 2012; 83(2): 581-586.

176. Minn AY, Hsu A, La T, el al. Comparison of intensity-modulated radiotherapy and 3-dimensional conformal radiotherapy as adjuvant therapy for gastric cancer. Cancer. 2010; 116(16): 3943-3952.

Testis

177. Zilli T, Boudreau C, Doucet R, et al. Bone marrow-sparing intensity- modulated radiation therapy for Stage 1 seminoma. Acta Oncol. 2011; 50 (4): 555-562.

Uterus

178. Beriwal S, Jain SK, Heron DE, et al.Dosimetric and toxicity comparison between prone and supine position IMRT for endometrial cancer. Int J Radiat Oncol Biol Phys. 2007; 67(2): 485–489.

179. Beriwal S, Jain SK, Heron DE, et al. Clinical outcome with adjuvant treatment of endometrial carcinoma using intensity-modulated radiation therapy. Gynecol Oncol. 2006; 102(2): 195-199.

180. Bouchard M, Nadeau S, Gingras L, et al.Clinical Outcome of Adjuvant Treatment of Endometrial Cancer Using Apeture-Based Intensity Modulated Radiation Therapy. Int J Radiat Oncol Biol Phys. 2008; 71(5): 1343-1350. (doi:10.1016/j.ijrobp.2007.12.004)


181. Jhingran A, Winter K, Portelance L, et al. A Phase II Study of Intensity Modulated Radiation Therapy to the Pelvis for Postoperative Patients With Endometrial Carcinoma: Radiation Therapy Oncology Group Trial 0418. Int J Radiat Oncol Biol Phys. 2012; 84(1): e23-28.

182. Lian J, Mackenzie M, Joseph K, et al. Assessment of extended-fi eld radiotherapy for stage IIIC endometrial cancer using three-dimensional conformal radiotherapy, and helical tomography. Int J Radiat Oncol Biol Phys. 2008; 70(3): 935-943.

183. Veldeman L, Madani I, Hulstaert F, et al. Evidence behind use of intensity-modulated radiotherapy: a systematic review of comparative clinical studies. Lancet Oncol. 2008; 9(4): 367-375.

184. Wong E, D’Souza D, Chen J, et al. Intensity-modulated arc therapy for treatment of high-risk endometrial malignancies. Int J Radiat Oncol Biol Phys. 2005; 61(3): 830-841.

185. Zwahlen DR, Ruben JD, Jones P, et al. Eff ect of intensity modulated pelvic radiotherapy on second cancer risk in the postoperative treatment of endometrial and cervical cancer. Int J Radiat Oncol Biol Phys. 2009; 74(2): 539–545.

Vulva

186. Beriwal S, Coon D, Heron D,et al. Peroperative intensity-modulated radiotherapy and chemotherapy for locally advanced vulvar carcinoma. Gynecol Oncol. 2008; 109(2): 291-295.

187. Beriwal S, Heron DE, Kim H, et al. Intensity modulated radiotherapy for the treatment of vulvar carcinoma: a comparative dosimetric study with early clinical outcome. Int J Radiat Oncol Biol Phys. 2006; 64(5): 1395-1400.

Practical Radiation Oncology (2011)

SUPPLEMENTAL MATERIAL

Safety Considerations for IMRT

Jean M. Moran, Ph.D.,* Melanie Dempsey, M.S.,† Avraham Eisbruch, M.D.,*

Benedick A. Fraass, Ph.D.*, James M. Galvin, D.Sc.,‡ Geoff rey S. Ibbott, Ph.D.,§ and

Lawrence B. Marks, M.D.#

*Department of Radiation Oncology, University of Michigan, Ann Arbor, MI; † Department of Radia-tion Sciences, School of Allied Health Professions, Virginia Commonwealth University, Richmond, VA; ‡Department of Radiation Oncology, Thomas Jefferson University Hospital, Philadelphia, PA; §Radia-tion Physics, UT M.D. Anderson Cancer Center, Houston, TX; and #Department of Radiation Oncology, University of North Carolina, Chapel Hill, NC

Reprint requests to: Jean M. Moran, Ph.D.Associate Professor, Associate Division Director for Clinical Physics, Department of Radiation Oncology, University of Michigan Medical Center, Ann Arbor, MI 48109-0010Phone: 734-936-2062, Fax: 734-936-7859, [email protected]

This document was prepared by the IMRT experts invited by the Multidisciplinary Quality As-surance Subcommittee of the Clinical Affairs and Quality Committee of the American Society for Radiation Oncology (ASTRO) as a part of ASTRO’s Target Safely Campaign. The IMRT white paper was reviewed by 8 experts from the fi eld of IMRT. In December 2010, it was posted for public comments for 4 weeks. We received comments from physicians, physi-cists, therapists, and representatives from radiation therapy manufacturers, including general and specifi c comments from the American Association of Physicists in Medicine (AAPM). All the comments were reviewed and discussed by the entire writing group and appropriate revisions were incorporated in the paper with group consensus. ASTRO white papers present scientifi c, health, and safety information and may to some extent refl ect scientifi c or medical opinion. They are made available to ASTRO members and to the public for educational and informational purposes only. Any commercial use of any content in this white paper without the prior written consent of ASTRO is strictly prohibited. Adherence to this white paper will not ensure successful treatment in every situation. Further-more, this white paper should not be deemed inclusive of all proper methods of care or exclusive of other methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding the propriety of any specifi c therapy must be made by the physician and the patient in light of all circumstances presented by the individual patient. ASTRO assumes no liability for the information, conclusions, and fi ndings contained in its white papers. This white paper was prepared on the basis of information available at the time the Writing Group was conducting its research and discussions on this topic. There may be new developments that are not refl ected in this white paper and that may, over time, be a basis for ASTRO to consider revisiting and updating the white paper.

2 JM Moran et al Practical Radiation Oncology: July 2011

Confl ict of Interest Notifi cation:

Before initiation of this white paper, all members of the White Paper Writing Group were required to complete disclosure statements. These statements are maintained at ASTRO Headquarters in Fairfax, VA and pertinent disclosures are published with the report. The ASTRO COI Disclosure Statement seeks to provide a broad disclosure of outside interests. Where a potential confl ict is detected, remedial measures to address any potential confl ict are taken and will be noted in the disclosure statement. Dr. Jean Moran has received a research grant, paid to the University of Michigan, from Varian Medical Systems. Dr. Avraham Eisbruch is a Chair of an independent review committee assessing the complications of investigational protocol at Amgen. Dr. Geoffrey Ibbott has received a research grant, paid to the University of Texas M. D. Anderson Can-cer Center, from Varian Medical Systems, and is a consultant with the Young Ricchiuti Caldwell and Heller Law Firm LLC. Dr. Benedick Fraass serves on the Varian Patient Safety Council. He receives no compensation or reimbursement for this work. The Writing Group Chair ensured that the white paper was built by consensus to deliberately minimize any potential confl icts of interest. ASTRO has reviewed these disclosures and determined that they do not present a confl ict with respect to these Writing Group mem-bers’ work on this White Paper. Safety Considerations for IMRT

1. Introduction1.1 Scope of this Document on Patient Safety for IMRT1.2 Background Information on IMRT2. Safety Concerns3. Supporting a Culture of Safety: Environmental Considerations3.1 Department Environment3.2 Standard Operating Procedures for IMRT3.3 Process Time Considerations4. IMRT Guidance for Quality Assurance Experience: Technical Considerations4.1 Existing Guidance Documents for IMRT4.2 Establishing and Monitoring an IMRT Program4.3 Needs for Additional Guidance4.4 Checklists for the IMRT Process4.5 Additional Safety Concerns5. Collaboration between Users and Manufacturers to Improve IMRT Safety6. Summary

Table 1. Key Components of an IMRT SystemTable 2. Example Distribution of Responsibilities in the IMRT Planning and

Delivery ProcessTable 3. Example Problems in the Planning and Delivery Process for IMRT and

Possible Remedial ActionsTable 4. Recommendations to Guard against Catastrophic Failures for IMRT Table 5. Summary of Guidance Documents on IMRT

Figure 1. An example abbreviated diagram of the process (boxes) and review (ovals) steps for IMRT planning for an individual patient

Appendix 1. Example Workfl ow for IMRTAppendix 2. Example Checklists for IMRT

Safety Considerations for IMRT 3Practical Radiation Oncology: July 2011

1. Introduction

1.1 Scope of this Document on Patient Safety for IMRT

This report on intensity-modulated radiation therapy (IMRT) is part of a series of white papers addressing patient safety commissioned by the American Soci-ety for Radiation Oncology’s (ASTRO) Target Safely Campaign. The document was approved by the ASTRO Board of Directors on February 14, 2011 and has been endorsed by the American Association of Physicists in Medicine (AAPM), American Association of Medi-cal Dosimetrists (AAMD), and the American Society of Radiologic Technologists (ASRT). The document has also been reviewed and accepted by the American College of Radiology’s Commission on Radiation Oncology. This report is related to other reports of the ASTRO white paper series on patient safety, still in preparation, especially those on peer review and on image-guided radiation therapy (IGRT) since both of these areas have implications on the practice of IMRT. There are sec-tions of this document that defer to guidance that will be published by those groups in future reports. We respect-fully acknowledge that there is a larger body of work on quality assurance and quality control principles within the medical community at large (1,2,3) and within radia-tion oncology (4,5). In addition, a number of internation-al agencies actively support patient safety such as the World Health Organization (WHO), the International Commission on Radiological Protection (ICRP), the European Society of Therapeutic Radiology and On-cology (ESTRO) and the International Atomic Energy Agency (IAEA). Many of the quality control/assurance issues pertinent for IMRT are also pertinent for broader clinical practice, and will likely be addressed in a later paper. However, because this is the fi rst report in the series, some of these more “generic concerns”, that are not limited to IMRT, are herein included. IMRT provides increased capability to conform iso-dose distributions to the shape of the target(s), thereby reducing dose to some adjacent critical structures. This promise of IMRT is one of the reasons for its widespread use. However, the promise of IMRT is counterbalanced by the complexity of the IMRT planning and delivery processes, and the associated risks. The New York Times reported on serious accidents in-volving both IMRT and other radiation treatment modali-ties (6,7). This report provides an opportunity to broadly address safe delivery of IMRT, with a primary focus on recommendations for human error prevention and meth-ods to reduce the occurrence of errors or machine mal-functions that can lead to catastrophic failures or errors.

1.2 Background Information on IMRT

Treatment planning and delivery of IMRT require

use of specialized software and hardware. Table 1 de-fi nes example documentation, software, and hardware that are the key components of an IMRT program. Regardless of the delivery technique, an institution with an IMRT program requires a full treatment team, proper equipment, and proper procedures to safely care for radiation therapy patients. It is crucial to have in-dividuals with proper credentials and training specifi c to radiation therapy for the simulation, treatment plan-ning, QA, and delivery processes. For IMRT, the roles of the treatment team members are described in detail in a report from the IAEA.(8) The IMRT team members discussed in this report include radiation oncologists, medical physicists, dosimetrists (or treatment planners), radiation therapists, and administrative staff. Special at-tention should be paid to the roles of the physician and physicist; both board certifi ed medical specialists who share responsibility for IMRT quality. The physician has the overall responsibility for the IMRT program. The physicist is responsible for commissioning the entire IMRT program (hardware and software), maintaining software/equipment for treatment planning and deliv-ery, overseeing (typically with the help of the equip-ment manufacturer) training of individuals who use the software and delivery equipment, overseeing treatment planning and quality assurance of individual treatment plans, and monitoring the accuracy of the treatment delivery throughout an individual patient’s treatment course. 2. Safety Concerns

This document presents tools and techniques that can be used by individual clinics to reassess and strengthen the safety of their IMRT programs. Due to the complex-ity of IMRT delivery, we believe it is unsafe for IMRT to be delivered in emergent situations that would en-courage staff to skip the needed quality assurance steps. And yet, given the pressures that every clinic is under, and the desire to meet multiple needs, it can be diffi cult to ensure support for this approach. Hazards within an IMRT program can be broadly categorized as environ-mental or technical. Environmental concerns, that can affect all patient treatments, include things such as the lack of standard operating procedures, haste (such as in-adequate time to perform all steps in a process), habitua-tion, incomplete understanding or misuse of procedures/equipment, an inadequate QA program, and a lack of continuing staff education. While these hazards are not unique to IMRT, their impact may be large due to the complexity of IMRT. Therefore, a portion of this report is also devoted to creating and supporting a culture of safety to address environmental concerns whose affect are not limited to IMRT. Technical concerns that affect safety include things such as inadequate commissioning of the clinical IMRT


Clear communication from physician to dosimetrist/physicist regarding desired treatment planning goals including target doses and normal tissue limits.(21)

Software used to create the representation of the patient, defi ne volumes for treatment and avoidance, position and shape beams for planning, optimize the intensities (weights) of small beamlets, and calculate dose. For IMRT, cost or objective functions (these may be points on a dose-volume histogram) are specifi ed to best meet the written treatment direc-tive. IMRT treatment planning is typically an iterative process that requires interactions between physicians, dosimetrists, and physicists.(18,19) The TPS may use a fl uence-based approach by creating larger segments from the small beamlets to achieve more effi cient dose delivery.

For fl uence-based systems, the fl uence is converted into a series of segments or sequences as a function of time (and monitor units) which can be delivered by the treatment machine. The number of MLC segments may range from 5 to greater than 100 for a given fi eld. Ap-proximations in the TPS modeling may result in differences between the optimized and actual delivered fl uence. This can be a challenging issue during the planning and delivery process.(18,19,20)

The treatment data are transferred from the TPS to the TMS for delivery. Verifying the correctness and integrity of all data, as well as confi rming the deliverability of the leaf sequences to be used, are among the most critical steps to be confi rmed in the IMRT QA process.(18,19,15) Lack of transfer of the MLC fi les is a known cause of a catastrophic failure.

The TMS is used to deliver the patient treatment. This system has a record of the treatment plan to be delivered, the number of fractions, etc and it also tracks the delivery dates, dose, and other associated information. Use of the patient information stored in the TMS is an important part of a pre-treatment QA program.

Because of the complexity of IMRT planning and delivery, pre-treatment patient-specifi c quality assurance has been recommended in guidance documents from ASTRO, ACR, and AAPM.(18,19,26,15)

Equipment for IMRT typically includes multiple complementary detectors and phantoms to verify the accuracy of the data transfer and dose calculations. Some centers may also have monitor unit check software for treatment fi eld calculations, and this capability is often used in combination with measurements.

Many systems utilize the gamma analysis technique to compare calculations and measure-ments.(28) Users typically specify the number of points that are expected to satisfy the cri-teria for dose (in Gy or in %) and distance (in mm) for agreement when they establish their program.

The linear accelerator needs to be capable of accurately delivering intensity modulated treat-ments. For gantry-based systems using an arc delivery technique (e.g.VMAT), additional information regarding the accuracy of the gantry information at multiple delivery points need to be validated as well. For these systems, derivation of the delivery information as de-scribed for leaf sequencing above would also include verifi cation that the gantry sequences, leaf positions, dose delivery, and time information are correct and registered (in time and MU) correctly. Guidelines for commissioning and pre-treatment QA for VMAT treatment plans are currently under development.

Table 1. Key Components of an IMRT System

Component Description

Written treatment directive

Treatment planning system (TPS)

Conversion of desired fl uence into a fi eld consisting of segments

Plan transfer to the treatment management system

Treatment management system (TMS)

Patient specifi c pre-treatment quality assurance (QA)

Equipment for pre-treatment QA

Analysis software

Linear accelerator for treatment delivery


Table 2. Example Distribution of Responsibilities in the IMRT Planning and Delivery Process.

Physician Dosimetrist* Physicist Therapist

Decides to use IMRT Primary

Primary Advisory Advisory

Patient positioning Supervisory Supervisory or advisory

Advisory Primary

Registration of image datasets

Approval Primary or secondary

Primary or secondary

Primary or secondary

Segmentation of images (e.g. contouring)

Targets, certain structures, also approves/reviews other’s segmentations

Normal tissues, expanded volumes

Specifi es dose constraints

Primary Advisory Advisory

Calculate dose Primary Supervisory or advisory

Review treatment plan and 3D doses

Primary Primary (compare to physician requests)

Advisory (Final review)

Secondary

Perform and evaluate patient-specifi c pre-treatment QA†

Advisory Primary

Treat patient Supervisory Advisory Supervisory Primary

Monitor patient for effects to treatment‡

Primary Advisory

Monitor accuracy of delivery

Primary (review and approve portal images, and pre- treatment dosimetry measurements)

Primary beam parameters, monitor units, doses)

Primary

* This refers to the individual performing the treatment planning. † See text in section 4 for more detail.‡ Nurses and mid-level providers also assist in monitoring the patient during the course of therapy and may provide additional information to the physician regarding the patient’s progress.


program, inadequate validation of the accuracy of treat-ment delivery parameters, improper use of one or more parts of the planning and delivery process, and an inad-equate investigation of discrepancies between treatment plan parameters and QA results. One source of increased risk with IMRT is the large number of monitor units per treatment.(9) Compared to non-IMRT treatments, the monitor units can be increased by about a factor of 3 or more depending on the modula-tion and delivery effi ciency. This may increase the risk of catastrophic dose delivery error in some circumstanc-es. Another potential risk is the shape and orientation of the beams, and the resultant dose distribution, relative to critical structures. If steep dose gradients are placed at the edge of targets and/or normal tissues, the accu-racy of set-up may be critical. Proper use and frequency of imaging techniques (e.g. IGRT) are helpful to verify patient positioning and will be presented in the IGRT Safety White Paper. IMRT treatment planning and delivery involves a full treatment team (see Table 2 with an example distribution of the roles for the team members). Some clinics distrib-ute effort differently; e.g. a physicist may perform IMRT treatment planning instead of a dosimetrist. Regardless of the distribution of effort, care should be taken to have a mechanism in place for independent review of each patient’s plan, data transfer, and QA results. For exam-ple, a dosimetrist may be responsible for reviewing and downloading the plan before the physicist performs ad-ditional pre-treatment quality assurance checks. Clinics with limited physics/dosimetry staff should arrange 1) for peer review of their overall IMRT quality program and 2) especially for independent review of patient-specifi c IMRT QA. For example, AAPM Task Group Report 103 describes a mechanism for components of peer review.(10)

The process of IMRT treatment planning and deliv-ery is complex (see Appendix 1 for detailed listing of the main process steps for IMRT planning and delivery). All individuals described as part of the IMRT team in this re-port play a critical role in assuring that each patient re-ceives the correct treatment. Some of the tasks common-ly ascribed to the different team members, each with the ability to prevent or detect catastrophic failures for IMRT, are listed below. The tasks listed include broad program-matic issues, as well as patient-specifi c items.

Attending Physician:

• Oversees the process that guarantees that each pa-tient receives the correct treatment for the correct treatment site, as documented in the patient’s chart and verifi ed by imaging. This oversight includes verifi cation of the correct treatment prescription, segmentation of target volumes, image registra-tion, treatment plan, and image guidance strategy

(See IGRT White Paper for more details).• For any IMRT QA failures, oversees decision to

delay patient treatment, begin treatment with a simpler plan, or other approach.

• Monitors the patient for any unexpected or early treatment side effects and communicates with the physicist, dosimetrist, and therapists in such situa-tions.

Medical Physicist:

• Responsible for the clinical commissioning and use of the treatment planning, treatment manage-ment, and treatment delivery systems.

• Designs the quality assurance system, QA checks, and performs or supervises the routine QA checks of equipment and software. Verifi es that equip-ment and procedures perform within pre-defi ned tolerance values.

• Oversees or performs the patient-specifi c pre-treatment IMRT QA measurements, reviews the results, and communicates with the team regarding the results. Defi nes the criteria for pass vs. failure of the IMRT patient-specifi c QA. Defi nes for the team the dosimetric implications of discrepancies between the anticipated and measured beam data.

Medical Dosimetrist:

• Verifi es correct patient, treatment site, and correct image datasets from simulation (and other studies if appropriate).

• Creates a treatment plan per the physician-defi ned clinical goals. This is often an iterative process requiring feedback from physicians and medical physicists.

• Verifi es that the treatment plan is reviewed (e.g. for target coverage and normal tissue exposure), and highlights for the physician the areas where the plan failed to meet the desired dose goals.

• Notifi es the physicists of any software problems during the planning, data transfer, or review. If this occurs, individuals should stop at that point in the process and further immediate investigation is needed by the physicist.

• Enters the approved plan information into the pa-tient’s chart and the treatment management system.

Radiation Therapists:

• Prior to commencing a course of treatment: Review the approved treatment plan information, review in-structions and directives for internal consistency and logic, and that the other team members have com-pleted and provided formal approval for their tasks (e.g. patient-specifi c pre-treatment physics QA).


unambiguous/robust hand-offs (and means of commu-nication) between personnel. The amount of work in-volved also demonstrates the importance of timely peer review at key points in the process. Key items from Ap-pendix 1 (and the list above) were used to create check-lists that can be considered for pre-IMRT time-outs (see Appendix 2). These checklists should be customized in accordance with the assignment of tasks and workfl ow in individual clinics.

3. Supporting a Culture of Safety for IMRT: Environmental Considerations

3.1 Department Environment

This section addresses safety concerns involving the environment in the department. The departmental lead-ership establishes the foundation for patient safety and teamwork. They can minimize the likelihood of cata-strophic failures through a variety of elements. While these elements are not unique to IMRT, we believe that they are crucial for ensuring a safe radiation therapy program, especially since IMRT requires additional equipment, personnel, and procedures for safety.

• The members of the department must trust

each other.(1)

• Strong administrative support for safety:

Administrators help set the tone within the depart-ment by openly supporting error-prevention and taking responsibility for supplying necessary resources (e.g. equipment), training, and personnel (e.g. adequate staff-ing levels) while providing suffi cient time to complete necessary quality assurance and controls. At this time, regulations do not specify the training requirements for non-physician personnel involved in IMRT. Efforts are underway by national organizations to update the re-quirements for staffi ng for IMRT and other techniques. Until those reviews/documents are available, we recom-mend that treatment units be staffed with at least two therapists at all times (one to focus on the patient during delivery and one to focus on the treatment console), and that all IMRT plans be independently verifi ed/reviewed by a second physicist/dosimetrist prior to plan export to the machine. For physicians, peer review of treatment volumes and plans (to be addressed in a separate docu-ment in the white paper series) is valuable along with continuing education activities such as expert work-shops on image segmentation. Administration should also provide funding and time for periodic independent peer review(10) of the quality assurance program.

• Prior to each treatment session: Confi rm that the patient prescription is still valid (e.g. physician has not changed the treatment plan or closed the course). The ASRT Radiation Therapy guide rec-ommends the performance of a time-out prior to “beam on” to verify the correct patient and correct isocenter for each treatment delivery.(11)

• Prior to initial treatment and as prescribed thereaf-ter: Obtain and review appropriate images. Seek approval per department standard operating proce-dure (SOP).

• During treatment: monitor treatment conditions and patient for inconsistencies or irregularities.

• Notifi es the physicists of any machine or soft-ware problems when they arise during treatment. If a problem occurs, the therapists should stop at that point in the treatment delivery. The physicist should review the machine and software status and determine if it is safe to resume treatment.

Administrators:

• Provide adequate resources for personnel, equip-ment, and time for commissioning an IMRT sys-tem.

• Support the time required for personnel to develop standard operating procedures.

• Support continuing education on IMRT for all per-sonnel.

• Provide support for individuals to be able to halt any procedures that are deemed unsafe.

Additional Personnel:

Other personnel also contribute to the care and safety of IMRT patients, e.g. nurses and physician’s assistants working with physicians; physics assistants working with medical physicists; and trainees in all areas work-ing with their corresponding certifi ed or licensed spe-cialist. In addition, good communication between the department’s information technology (IT) personnel, the manufacturer’s service engineers, and the physicists is crucial for maintaining the correct versions of software and ensuring that necessary upgrades occur and are test-ed prior to clinical use.(12) The IAEA guidance document on the roles and responsibilities for IMRT also specifi es supervision responsibilities and is an excellent reference for each department to use in defi ning the roles and su-pervisory requirements for IMRT.(8) The tasks above are only a sampling of the many tasks required by each team member. Appendix 1 provides a detailed listing of the tasks, by team member, and in ap-proximate chronologic order. When the steps for IMRT are considered sequentially, the process includes 54 pro-cess steps and 15 hand-offs between the personnel. This illustrates the critical need for clearly defi ned roles, and


• Event tracking, review, investigation:

To improve error prevention and remediation of events(any unplanned/undocumented deviation from the depart. ment’s standard process or the patient’s ex-pected treatment), the team should discuss potential and actual sources of errors and document all events that oc-cur. All catastrophic or signifi cant errors, or substantial near misses, should be reviewed in a timely fashion by the team and treatments should be halted if necessary. Additional resources may be required to appropriately document and evaluate such events.

• Appropriate personnel and training:

All personnel involved in the process of patient care with IMRT should have adequate training, access to con-tinuing education, and certifi cation (and/or a license or appropriate oversight by a licensed or certifi ed individual as defi ned in ACR guidance documents).(13,14)Educational programs organized by national and international radia-tion therapy organizations often include training specifi c to IMRT. To evaluate the adequacy of commission-ing, personnel should have time to 1) read and follow guidance documents such as TG119(15) which describes tests that compare local IMRT QA measurements with published results and (2) participate in an independent evaluation using a phantom test such as those that have been designed by the Radiological Physics Center (RPC) for IMRT. When participating in an independent audit, IMRT tasks should be performed by the same personnel who would perform the task for a patient.

• Use of Standard Operating Procedures:

Standard operating procedures (SOPs) that contain a clear description of tasks and checks that are specifi -cally aimed at avoiding catastrophic failures are an es-sential element of error prevention. Such SOPs should include a time frame for completion of tasks and checks. This report includes example checklists for IMRT that can be adapted to be part of a SOP. Standard operat-ing procedures are discussed in greater detail in Section 3.2.

• Defi ned Roles and Responsibilities for Team

Members:

As noted in Section 3.2, each clinic should have pol-icies that clearly defi ne the roles and responsibilities of the personnel involved in IMRT.

• Strong Communication among Team Members:

Team members must have the opportunity to regu-larly interact with each other during the planning and

delivery process. For example, a physicist needs to be available immediately for any problems that may arise with the software or equipment during the treatment de-livery to review error messages and to verify that the equipment is safe to use before the therapists resume a patient’s treatment. Also, there are situations when it is extremely valuable for a dosimetrist or a physicist to be in the treatment room during the initial patient setup to explain the details of the location of the treatment unit isocenter, when photographs and/or drawings may be insuffi cient. Similarly, locating IMRT-planning and physician-work areas close to each other will facilitate such interactions. Extra caution should be taken with “remote planning” since clear communication is more diffi cult. Administration should encourage and allow adequate time for open communication among team members who must feel comfortable challenging each other; without reprisals. In addition, individuals must be able to freely question each step of the process. Such open communication is needed for inter-team discus-sions about problems that may arise during the planning/delivery of IMRT (see Table 3 for examples).

• ACR/ASTRO Practice Accreditation

To better support safety in radiation therapy, we rec-ommend that departments become accredited through the joint ACR/ASTRO practice accreditation process, which includes a systematic review of a department’s procedures and the adequacy of the training for person-nel. During the independent review process, the depart-ment’s SOPs for each treatment procedure along with sample checklists can serve as an effi cient and effective mechanism for determining the facility’s ability to miti-gate errors such as possible catastrophic patient errors. With respect to IMRT, comprehensive evaluation should include a review of the department’s (1) accelerator QA program for IMRT, (2) patient-specifi c pre-treatment QA program, (3) SOP and timelines for IMRT, (4) communica-tion mechanisms between members of the IMRT team, (5) review of documentation for a randomly chosen pa-tient case (written directive for simulation and treatment planning, prescription, treatment plan, QA, and delivery records) and (6) an assessment of whether or not the pro-cedures and department culture are aimed at avoiding catastrophic errors and supporting patient safety. Currently, 9% of US radiation oncology departments are accredited by the ASTRO/ACR program. While the number of institutions accredited at this time is low, in-dependent reviews of quality assurance programs that are provided through accreditation and other external peer review methods are invaluable. It will take some time to increase the number of institutions participating in accreditation.


Table 3. Example problems in the planning and delivery process for IMRT and possible remedial actions.

Stage Example

Problem

Example Communication Flow Possible Action

From: To:

Simulation Patient not posi-tioned adequately

Dosimetrist upon review of patient setup contacts therapists and physician

Therapist, physician

Adjust positioning and re-simu-late; review frequency and type of image guidance; avoid or mitigate with routine dosimetrist participation at simulation

Treatment Planning

Segmentation error

Peer physician Treating phy-sician

Replanning may be needed. Can reduce the occurrence of error by earlier peer review

Treatment Planning

Treatment plan does not meet con-straints

Dosimetrist/Physicist

Physician, physicist

Physician needs to redefi ne trade-offs and provide revised prescription information to the dosimetrist; physician may need to consult with the patient regarding trade-offs; physicist may assist in redesigning the plan

Pre-treatment QA

IMRT QA failed Physicist Whole team including physician

Review causes for failure: Is it a new technique? Was the technique thoroughly tested? Is anything different? What is the root cause of the problem? Is target volume vs critical struc-ture geometry more challeng-ing than typical cases for this disease site?

During Treat-ment Course

Patient showing unusual early ef-fects to radiation

Physician; therapist Other caregiv-ers, dosime-trist and physicist, physician

Review treatment plan and QA; review patient set-up (e.g. positioning, beam placement); verify accuracy of data in RV; review possible confounding clinical factors (e.g. medication use, chemotherapy)

During Treat-ment Course

Immobilization device no longer fi ts snuggly (e.g. loose head mask)

Therapist Physician, do-simetrist

Assess anatomic changes, and dosimetric effects: possible re-simulation/ immobilization


• Continuous Quality Improvements

Departments should continually evaluate the adequacy of their programs. Administration should maintain records of staff continuing education credits for IMRT and other procedures and should regularly support individuals in receiving the appropriate educa-tion. National organizations should evaluate the formal requirements for IMRT-specifi c re-education.

3.2 Standard Operating Procedures for IMRT

Part of the foundation of a safe and high quality IMRT program is the creation of standard operating procedures (SOPs). It is important for each institution to custom-ize procedures to refl ect their institutional processes and resources when creating a program that explicitly incor-porates patient safety. We believe that SOPs help improve patient safety. In our daily lives, we have become insensitive to situ-ations where software or a device may not work and by habit we simply restart the software or the device and try again. However, in the context of delivery radiation therapy, this approach can be dangerous. For example, if error messages are encountered during transfer of infor-mation to the treatment management system, it is critical for the physicist to be called and for a full investigation of the transferred information (and an assessment of the system) to occur. We believe that SOPs that empower individuals to halt treatment or planning when a problem is encountered can be used to empower individuals to stop in the midst of a problem, to take the time to under-stand the problem, and to decide upon the best course of action. In the midst of a situation where adequate time is not allowed for performing all of the necessary QA steps prior to treatment, time pressures may stand in the way of identifying and resolving problems. One of the root causes of inadequate commissioning of IMRT systems may be tied to the clinical pressures to create an IMRT program as quickly as possible. A program can be more complex when IMRT is com-bined with other techniques such as respiratory motion management, dynamic delivery, real-time adaptive tech-niques and/or daily image guidance. Thus, similar to complex procedures used in many other medical special-ties, implementation of and adherence to detailed policies and procedures are necessary to avoid both quality errors and catastrophic failures. The use of a checklist can rigor-ously enforce adherence to the procedures as documented in the IMRT SOP (see example checklist, Appendix 2).

The IMRT SOP document should:

• Be a written document that requires adherence to the clearly stated procedures for IMRT planning, verifi cation, and delivery.

• Describe the check, double-check, and testing pro-cedures designed to minimize catastrophic failures.

• Explicitly identify at each step the dependence of the work on the quality of the previous step. Figure 1 shows an example IMRT planning and treatment process with communication paths among mem-bers of the department.

• Specify the timeline for completion of quality as-surance checks as well as actions to be taken when measured values fall outside of tolerances. Patient-specifi c QA for IMRT plans should be performed before a patient begins treatment with a given treat-ment plan.

• Specify how the treatment management system will be used and how user rights need to be set. For example, therapists need access permissions to view the treatment plan and prescription informa-tion but should not have software permission to edit this information. Special attention should be paid to the user rights for acquiring or over-riding treat-ment couch (and other) equipment positions since the potential for a catastrophic failure exists if the patient is treated in the wrong position. Tolerance tables should be specifi ed in the system to be sensi-tive to errors in the patient’s position when using indexed immobilization equipment. The function of these features may be specifi c to the treatment planning and treatment management system ven-dors and software versions.

• Designate procedures when a change is needed in the plan of a patient already under treatment. These procedures should include the necessary QA processes that are followed for new plans.

• Be specifi c to the clinic’s operations and equip-ment. Although recommendations are given here, the exercise of developing SOPs tailored to the workfl ow and organization of each institution is extremely valuable.

• Defi ne a standard process and the necessary docu-mentation for situations where a physician wants to end treatment of a particular plan immediately. Team members should be informed of any changes with respect to a patient’s treatment, and adequate time should be allowed for review and performance of necessary QA if a new plan will be generated.

• Be continually evaluated and updated as often as necessary. SOPs require support and engagement from administration, physicians, dosimetrists,theapists, and physicists.


Figure 1. An abbreviated diagram of the process (boxes) and review (ovals) steps for IMRT planning for an individual patient. Each color (or shade) repre-sents member of the treatment team.*Peer review will be addressed in detail in a report of the white paper series on patient safety.

MD: Consult and Decision to treat with IMRT

MD + Simulator Therapist (with Dosimetrist/Physicist as needed):Patient Immobilization and Simulation

MD + Dosimetrists: Segmentation

MD: Written Directive to Dosimetrist

MD Review/Approval of Segmentation

Peer Review (e.g. Volumes, Doses, etc.)*

Dosimetrist: Create Treatment Plan using MD’s Directive

MD Review/Approval of Treatment Plan

Physicist Review of Treatment Plan

Dosimetrist: Download Approved Treatment Plan to Treatment Management System

Physicist Review of Download Treatment Plan and IMRT Pre-Treatment QA

Therapist Review of Treatment Plan and Patient Set-Up Before Day 1

Therapists Set-up Patient for Daily Treatment (with Dosimetrist/Physicist as needed)

MD: Monitors Patient during Treatment Course

Physicist: Reviews at Start and at least Every 5 Fractions the Quality of Patient Treatment

3.3 Process Time Considerations

Each clinic needs to determine an adequate time for its IMRT process from the time of initial consult through the start of the patient treatment. Figure 1 shows the com-plexity of the IMRT process (in abbreviated form) as a series of process steps and review steps by members of the IMRT team. It should be noted that if there is a change in the patient geometry that requires a new simu-

lation, the entire process must be restarted. Risks may also increase if inadequate time is allotted for, and in between, the various steps (e.g. image segmentation, written directive, planning, patient-spe-cifi c QA). Each clinic should defi ne in its SOP a recom-mended timeline for the various steps. Image segmenta-tion is a critical, somewhat subjective, and often time consuming, step that is frequently a bottle-neck in this process. Therefore, the timeline should refl ect the time needed for radiologist input, image registration, and peer review of image segmentation.(16,17) The time allotted to planning cannot begin until these image-segmentation-related steps are completed. Given the complexities, delays at any step may require that the patient’s treat-ment be rescheduled. Pre-treatment QA should occur at least a day before the commencement of treatment to allow time to investigate potential problems. To the ex-tent possible, the fi rst treatment of new patients should be performed when all members of the IMRT team are readily available, in case questions arise.

4. IMRT: Guidance for Quality Assurance: Technical Considerations

4.1 Existing guidance documents for IMRT QA

The complexity of IMRT planning and delivery has led to the creation of guidance documents on quality assurance aspects of IMRT from radiation therapy or-ganizations (see Table 5 for summary).(18,19,20,15,14) These earlier IMRT QA documents emphasized establishing a quality IMRT program and did not explicitly concen-trate on the potential for catastrophic failures in IMRT delivery. Several documents suggested that some QA efforts could be decreased or even eliminated after the accumulation of a stated amount of experience. In this work, we acknowledge that certain types of catastrophic failures resulting from human error and/or equipment (hardware or software) malfunction might not be pre-dictable based on past experience. In some situations, periodic testing alone may be inadequate for identifying these types of problems. Therefore, this report revisits the processes and tasks performed by the IMRT team involved in IMRT with special attention to patient safety and to minimizing the potential for catastrophic failures

4.2 Establishing and Monitoring an IMRT QA

Program

The requirements for establishing an IMRT program have been defi ned by AAPM guidance documents.(18,19) The key elements of these reports that directly affect the safety considerations being addressed here are train-ing, commissioning of an IMRT system, establishing an IMRT program, and monitoring that program.


Table 5 Summary of Guidance Documents on IMRT.

First author (sponsoring

organization(s)) Year

Focus Items of note that are not addressed

Ezzell et al. (AAPM) 2003 Types of IMRT delivery; QA consider-ations; machine QA and pre-treatment QA; staff training and education

This was an early report; there was limited detail on individual aspects of IMRT.

Galvin et al (ASTRO and AAPM) 2004 Specifi c to tasks of individuals on the treatment team; included details for commissioning MLC-based IMRT; dose prescriptions; challenges and tradeoffs in IMRT planning.

Permitted changes in IMRT QA program; permitted changes in monitor units for QA, this technique is now discouraged due to implica-tions in leaf sequencing and quality questions in commissioning.

ACR Practice Guideline for IMRT 2007 Describes qualifi cations and members of the IMRT treatment team; describes ele-ments of QA program

Does not consider potential for data transfer errors; does not provide examples of forms for practice.

ESTRO Guidelines for the Verifi cation of IMRT (ed. Mijnheer, Georg)

Comprehensive review of dosimetry and techniques for pre-treatment quality as-surance. Different approaches to QA are described as a function of the hardware and software systems.

It does not address catastrophic failures.

IAEA 2008 Review of transition from 2-D RT to 3D CRT and IMRT; defi nes personnel training requirements and increased needs for per-sonnel and specialized equipment to sup-port a program; includes a self-assessment questionnaire for institutions.

Ezzell et al (AAPM Task Group 119) 2009

Describes a series of tests and results for different combinations of software and delivery systems.

These tests are useful for assessing quality once the system is fully commissioned.

Holmes et al (ASTRO) 2009 Recommendations for documenting IMRT treatments

Low et al (AAPM Task Group 120) [TBD]

Describes dosimeters and analysis tech-niques for IMRT, including limitations of different techniques.

Describes how to get the proper data for commissioning a system and for doing pre-treatment QA measurements. It does not defi ne what tests need to be done.

This document Describes standard operating procedures, checklists, and concerns with respect to avoiding catastrophic failures for IMRT.

Lacks detail with respect to specifi c tests. Reference is made to previous documents with respect to commissioning an IMRT program.

ICRU 83 - 2010 Describes prescribing, recording, and reporting IMRT patient doses


4.2.1 Training

Administrators should allow time and provide fi nan-cial support for training with new equipment, prior to the use of the equipment for patient treatments. Per-sonnel who will use the planning and delivery systems should be trained, typically by the vendors. Individu-als who receive vendor training can be responsible for training others in the department. They should also fol-low up with the vendor directly on any questions that came up during this stage. If the systems are provided by multiple vendors, specialized training and testing of the inter-operability of the systems is necessary. Inter-operability tests are frequently conducted by the physi-cist. The physicist may need additional support from one or more vendors and from the department’s IT per-sonnel if there are concerns about the communication pathways for data. When starting a new program, it can be valuable for members of the treatment team to visit an institution that has similar equipment and software and to learn about that institution’s implementation of IMRT and standard operating procedures. Dosimetrists and physicists should be trained in how to use the planning system features for IMRT that in-clude the optimization system, and tools for reviewing IMRT fi elds and plans. Physicians should provide do-simetrists and physicists with clear guidance on the de-sired goals for treatment planning on a site-by-site basis. This information can be further developed into a treat-ment directive for standard treatments.(21) The dosime-trists and physicists should work together in converting this information into a series of cost functions for testing and use of the treatment planning system. The physician should review all plans at this stage to provide feedback on whether or not the plans are acceptable. Dosime-trist, physicists, and physicians should review the output of the system to look at differences from their typical 3DCRT plans. During training, therapists should learn about how the IMRT delivery technique is different from conformal delivery and should receive instruction on how to verify correct functioning of equipment such as by watching monitor displays of leaf motion during delivery. All per-sonnel should understand the changes in fi eld shaping, motion of leaves for delivery, and the increase in moni-tor units. Additional safety cues such as differences in the chirping or rapid pulsing sound of the accelerator for conformal compared to IMRT fi elds and differences in the display in the treatment management system should also be noted and evaluated for each delivery. For indi-viduals with no IMRT experience, the physicist can help support initial training that begins with the setup and irradiation of phantoms using treatment plans that are representative of those the therapists will be using for patient treatments. All personnel should be instructed about the potential hazards in IMRT.

4.2.2 Commissioning an IMRT System

When commissioning the treatment planning part of any delivery system, the guidance of AAPM Task Group 53 should be followed.(22) For example, the fundamen-tal functionality and accuracy of the treatment planning system such as contouring, spatial accuracy, dose vol-ume histograms, and dose calculations should be as-sessed. The guidance documents by Ezzell et al(18) and Galvin et al(19) describe additional tests that are neces-sary for IMRT commissioning. For example, the treat-ment planning system should be tested for a range of fi eld sizes and amounts of modulation (and therefore dose gradients). The commissioning should include the \smallest fi eld allowed for IMRT (e.g. 1x1 cm2, depend-ing on limitation set in the planning system). For the especially-challenging measurements of small fi elds, institutions are encouraged to contact the RPC to com-pare their measurements to the average measurements for other institutions. Additionally, the departmental administrator should purchase the special dosimetry equipment needed for this task and make sure there is adequate time to com-mission it for clinical use. The resulting treatment plans should be transferred to the treatment management sys-tem for delivery evaluation to better understand approxi-mations made in the leaf sequencing algorithm. With respect to the machine, the mechanical limits of the delivery equipment need to be determined and baseline values should be measured for tests such as the reproducibility and accuracy of leaf positioning, posi-tioning of the MLC as a function of the gantry angle, etc.(23) Baseline functioning of the mechanical and dosimet-ric systems should be studied and assessed over time to verify that the system functions correctly. As part of commissioning, the physicist should de-termine that quality treatment plans can be created with the IMRT treatment planning system and then success-fully verifi ed with the QA program. At this stage, it is appropriate that the accuracy of calculations be evalu-ated at multiple depths in a phantom and with differ-ent detector systems. It is crucial that a comprehensive set of tests are made with the treatment planning sys-tem, transferred with the methods to be used clinically, and delivered with the treatment management system (TMS). Plans that are developed by dosimetrists during the training stage can be used for delivery system tests. The commissioning should include measurement of full treatment plans for multiple patients to verify the dose in a phantom.(18) During commissioning, measurements should be made for individual fi elds and for the com-posite or full delivery. Tests can also be performed with anthropomorphic phantoms. The commissioning measurements for the treatment planning and delivery systems must be made with the proper equipment. AAPM TG-120 notes that multiple


tested by performing an IMRT credentialing test such as using the RPC head and neck phantom (for centers involved in NCI-sponsored trials) or a test from the MD Anderson Dosimetry Laboratory. In addition, institu-tions may wish to invite another professional to visit their site and review their program.

4.2.3 Establishing a QA Program

As part of clinical implementation, it is necessary to create a periodic quality assurance program for the treatment planning system and the delivery system. Pre-treatment QA measurements should not be used as a substitute for rigorous and periodic equipment QA. The information obtained during commissioning should be used to establish the baseline performance of the treatment planning system and delivery system. For the treatment planning system, monthly tests can include the use of checksums to compare the data fi les to those of the original commissioned version of the system. A component of the system checks are end-to-end tests which are described in detail in Section 4.3. Elements of the periodic QA required for IMRT delivery systems are described in the report of AAPM Task Group 142.(23) For example, the leaf position accuracy for all leaves can be visually verifi ed by using fi lm or a detector with adequate spatial resolution to measure the results of stepping all leaves across the fi eld with beam delivery for a narrow gap at regular intervals.(25) TG142 recom-mends that this type of test (also known as the picket fence test) is performed weekly for machines used to deliver IMRT. The leaf position accuracy is critical because of the dependence of the resulting distribution on the accuracy of gap between opposed leaves.(25) The physicist is responsible for creating a QA program that is consistent with the desired accuracy needed for the IMRT program. We believe there is a need for more explicit guidance from professional radiation therapy organizations with respect to IMRT QA methods and criteria for agreement. During this phase, the clinical tolerance limits for the pre-treatment QA program should be determined and documented in the treatment procedure. There should be clear criteria for a pass or fail of the IMRT patient-specifi c IMRT QA technique. A procedure should be developed for investigating plans that fail QA, and for documenting identifi ed problems and how they were ad-dressed. When creating the pre-treatment QA program, the QA system should be tested to make sure that errors that would be considered unacceptable can be detected by the program. The initial IMRT commissioning and clinical QA testing must be performed with detailed analysis. In addition, a series of measurements should be repeated to assess the reproducibility of the treatment delivery.

measurements systems are required for commissioning and establishing a QA program.(24) For example, ioniza-tion chambers are typically used for absolute dose verifi -cation whereas diodes or other high resolution detectors are required for measurements in the penumbra region.(24) The highest resolution measurement system should be used for the individual fi eld measurements during commissioning to verify that the planned gradients can be reliably delivered. During commissioning, institutions should develop methods for handling incomplete IMRT treatments.

• First, the ability of the treatment management system to record an incomplete treatment under a range of scenarios (e.g. beam off through software/hardware failure) should be established.

• Second, the ability of an interrupted treatment to be completed should be evaluated by assessing the delivery on a phantom.

• Third, personnel should be trained on how to han-dle the situation where a therapist may need to re-sume treatment shortly after an interruption.

• When a treatment cannot be completed, the institu-tion should have a policy to defi ne who should be notifi ed, and who should determine if/when treat-ment is to be resumed. Typically, this decision is made by the physician and physicist. For inter-ruptions due to a machine fault, the physicist must verify that the equipment can be used safely prior to the resumption of patient treatments. This may include the performance of necessary QA checks of the affected systems.

• If the patient has moved since the interruption, it may be necessary to re-image the patient before completing the treatment in order to minimize the possibility of an overlap or under-lap of the modu-lated dose distribution.

It is invaluable to perform these measurements for representative cases as a function of body site prior to clinical release of IMRT. Situations where sub-optimal results were obtained should be documented and cor-rected if possible. If the problem cannot be corrected, software safeguards should be put in place to prevent the use of the system in a way that may lead to poor agreement between calculations and measurements. The potential limitations of the systems to be used for pre-treatment quality assurance should also be assessed for different types of treatment plans.(24) For example, some treatment plans with targets simultaneously receiv-ing different dose levels may require a different QA ap-proach, detector, and/or phantom shape if it is diffi cult to identify a region of uniform dose for verifi cation of the distribution.(24) In addition, institutions may want to perform the test suite of TG119 to compare the commis-sioning results to those obtained in that report.(15) The adequacy of the commissioning can be independently


4.2.4 Pre-treatment IMRT QA program

The current guidance from ACR and ASTRO for IMRT patient-specifi c quality assurance recommends verifi cation of the IMRT treatment plan parameters and the use of dosimetric measurements to verify the accura-cy of the dose delivery.(26) Due to safety considerations, these tests for acceptability should always be performed prior to the start of the patient’s treatment with any given plan. The pre-treatment QA program must be appropriate for the treatment planning and delivery systems. The physicist must verify that the IMRT detector, analysis system, and agreement criteria for routine QA are ca-pable of picking up different types of errors such as: in-correct dose per fraction (if doses are scaled, the system will not catch this), incorrect leaf positioning, and other incorrect delivery parameters.(24) For example, Kruse found that some combinations of 2D detectors and crite-ria were insensitive to clinically-relevant differences.(27) Ideally, the same fi les to be used for the patient delivery should be used for the quality assurance measurements. When this is not possible due to limitations in the treat-ment management system, additional checks should be performed such as comparison of the monitor units and resulting fl uence distributions at the treatment unit be-tween the QA and patient fi elds, or recalculation of the beams for the measured fi eld and the patient fi eld. There is variation in practice among institutions with respect to the content of pre-treatment IMRT QA programs along with the equipment and software used. When creating and/or modifying an IMRT QA program, there are several situations where users should be cau-tious.

For the measurement component, the program is

weakened:

• if the wrong detector is selected such as one with too poor resolution or inadequate spacing for the gradients in the intensity maps;

• if QA failures are approached solely by repeating measurements at multiple different positions in the dose distribution until a point passes rather than identifying the root cause; or

• by the application of too generous dose/distance criteria for agreement.

For calculational methods, users are cautioned that:

• some methods do not check the accuracy of the data transfer to the treatment management system;

• some methods use poor algorithms which make them inadequate for dosimetric verifi cation of complex geometries.

Many institutions use the Gamma-index method to simultaneously evaluate dosimetric and spatial param-

eters.(28) If the parameters are set too broadly, the QA method may be unable to identify suboptimal plans. With respect to criteria for agreement, for the pre-treatment patient specifi c IMRT QA checks reported in TG119, institutions defi ned a region which was either 10% of the maximum dose or delineated by the jaw set-tings, and a criteria of 3% dose/3mm distance criterion .(15) The criteria that provide adequate safety can depend upon the delivery technique and the capabilities of the measurement equipment (such as the spatial resolu-tion of the detectors). Further, these constraints are all somewhat arbitrary. The impact of failing to meet these constraints on the clinical 3D dose distribution, and the anticipated clinical outcome, is not explicitly addressed with these methods. Until formal guidance is available, we recommend that users establish acceptance criteria that they have determined will identify plans that should fail the QA check. For example, users should deliber-ately create plans with known errors such as the incor-rect fl uence for regions of high or low dose across the irradiated volume and/or critical structures, plans with one fi eld with a rotated collimator or an incorrect fl u-ence distribution, and other discrepancies that should be identifi ed by the QA method. For treatment plans that exceed the institution’s pass criteria, the QA results should be reviewed and additional investigation such as recalculation of the estimated delivered dose should be done to assess the potential impact on the patient’s treatment. In other situations, there may be diffi culties with the patient geometry, especially when combined with treatment plans treating multiple regions to differ-ent doses. When additional investigation is performed, the physicist and physician should document the review, especially for situations where the treatment plan is used because the discrepancy is not expected to have a clini-cal impact. Regardless of the approach used, patient safety re-quires that the integrity and accuracy of the information used for treatment delivery is verifi ed. The relationship between the delivery segments, fractional monitor units, and total number of monitor units must be verifi ed along with the accuracy of the calculation. The approach and acceptance criteria should be documented in the institu-tion’s standard operating procedures and followed for all patients. Further guidance is needed from national organiza-tions on the content of pre-treatment IMRT QA pro-grams, the appropriate dose/distance criteria (as a func-tion of the QA method), and the role of calculation-based methods in such programs.

4.2.5 Monitoring the IMRT Program

Once an IMRT program is underway, the physicist should review the results for each patient. If failures are identifi ed, the physicist may need to review the commis-


surement with the ion chamber, the chamber can then be removed to produce images of the end of the drill hole using the treatment beam. This step verifi es the positioning of the treatment fi elds as dictated by the planning process. Skipping the CT-simulation and treat-ment planning steps and using stored information, the procedure can be easily repeated at any time to verify the integrity of the treatment delivery process. By copying a patient’s treatment plan to the phantom geometry, the end-to-end test approach can be adapted for patient-specifi c testing. Delivering a treatment plan to a phantom is known as a composite delivery.(15) This test verifi es the accuracy of a particular treatment plan in the phantom geometry and can detect data-corruption problems. However, the sensitivity of this approach to detect errors depends on the type, resolution, size of the active volume, and sensitivity of the detectors.(24)

4.3 Need for Additional Guidance

As noted earlier, independent audits (e.g. by peer re-view or some other mechanisms) are useful to evaluate the adequacy of the commissioned radiation therapy de-livery system. This is true for verifi cation of the linear accelerator output under basic calibration conditions (e.g. a fi xed 10x10 cm2 fi eld for a specifi c setup), spe-cialized techniques (e.g. IMRT, stereotactic approach-es), and specialized localization and/or imaging tech-niques. Independent audits have been provided by the RPC since 1968 for institutions participating in clinical trials funded by the National Cancer Institute (NCI). This independent evaluation of an IMRT planning and delivery system assesses the adequacy of commission-ing, the skill set of the personnel, and the institution’s QA process for testing the software and delivery sys-tems. As IMRT was incorporated into clinical trials, the RPC developed an anthropomorphic head and neck phantom, with inserts simulating two targets and an or-gan at risk, to assess IMRT accuracy.(29) When an insti-tution receives the phantom, personnel fi ll the phantom with water, place the insert with enclosed dosimeters into the top of the phantom, and then have the phantom go through the radiation therapy department’s IMRT process from CT scanning through treatment planning, target localization, pre-treatment quality assurance, and fi nally delivery. For each part of the process, the tasks should be performed by those individuals who perform those tasks for patient treatments. The phantom is re-turned to the RPC who determines the actual doses de-livered to the phantom via thermoluminescent dosim-eters (to measure a point) and fi lm (for two dimensional measurements across the target and organ-at-risk) within the phantom. These measurements are compared to the intended doses as defi ned by the institution’s treatment planning system.

sioning data to determine if there have been any changes in the software or hardware that affect the planning or delivery. For example, the motion of multileaf col-limator leaves can be affected by adjustments made to the physical MLC or settings at the treatment unit. The physicist is also responsible for updating the program as new guidance becomes available. When software or hardware changes occur, the physicist is responsible for further testing. Some of these tests are described in Sec-tion 4.2.6 on End-to-End Tests. Retraining of personnel may also be needed. Maintenance on the accelerator should be document-ed. Prior to release of the equipment for clinical use, service reports should be reviewed by a designated qual-ifi ed medical physicist and any necessary additional ac-tions such as equipment tests to verify proper function-ing should be performed. Periodic tests of the treatment planning system are also required and testing is required prior to clinical use for any software upgrades.

4.2.6 Complete System End-to-End Testing

End-to-end tests are essential to minimize the possi-bility of catastrophic failures. These tests help to verify the accuracy of the entire chain (from CT simulation to dose delivery), for both conformal and IMRT, and should be performed (at a minimum) during commis-sioning prior to clinical use of a new technique. Ide-ally, these tests should use a phantom, with a detector (to measure dose), that is CT-scanned and then imported into the treatment planning system. The end-to-end tests should be repeated any time a signifi cant hardware component or software ver-sion has been changed to confi rm that communication paths between systems are intact. The results should be documented and can be used as a reference for sys-tem performance. The dose delivered by the plan to an ion chamber and the dose gradient across the individual fi elds should be documented for IMRT. Due to the safety concerns of ensuring the right target can be treated with the right dose for a given plan, a lo-calization test from the CT simulation through delivery is described. The simplest phantom for end-to-end tests is a plastic block with a drilled hole designed to hold an ionization chamber. This block phantom should be scanned with the CT-simulator and the isocenter can be set at a reference point that is easily identifi ed on the CT images (e.g. at the end of the drilled hole). Beams can be planned on this phantom, transferred to the treatment management system with associated images for align-ment, and then delivered, with the planned dose com-pared to the delivered dose serving as an overall metric of quality. For delivery, the phantom is positioned on the treatment couch using an IGRT system or reference marks on the phantom, and the ionization chamber is inserted to the very end of the drill hole. After mea-


In an RPC analysis of 752 phantom irradiations be-tween 2001 and 2009, approximately 78% of the irradia-tions met the generous criteria of 7% agreement in dose and/or 4 mm with respect to the dose gradient for the measured points and planes.(30) More than 350 institu-tions failed to meet the irradiation criteria on the fi rst attempt and were advised to repeat the phantom irra-diation. These results show the marked variation in the quality of the individual institution’s implementation of IMRT when evaluated independently. The overall fail-ure rate for these tests has been ≈ 20-25%. Failure rates for IMRT based on the thoracic and pelvic phantoms are similarly ≈ 20-30%. There is room for improvement. An investigation of these IMRT head and neck phan-tom irradiation failures has shown that some are due to incorrect positioning of the phantom/couch. However, failures were also caused by inadequate commissioning of the treatment planning system that can affect patient treatments.(31) For example, failure was also caused by the use of fi eld segments of small dimensions or small fl uence, for which the uncertainty in leaf position or dose delivery can be relatively large.(18) Since a modulated fi eld is composed of multiple smaller fi elds, errors in the smaller fi elds can have a cumulative effect in degrading the quality of the IMRT delivery. Other failures have been due to beam modeling errors such as inaccurate penumbra, beam and MLC characterization, as well as inaccurate leaf positioning or leaf movement synchro-nization. Incorrect entry of output factor or percentage depth dose data into the treatment planning system has been identifi ed as another cause. This demonstrates the importance of assessing the adequacy of commissioning of IMRT and of training that includes understanding and following the published guidance documents on IMRT. Use of an independent assessment of IMRT delivery on a phantom was shown to be effective at highlighting IMRT process implementation errors. The RPC also noted that many patient-specifi c IMRT QA procedures may be inadequate to detect some errors. For example, some would obtain multiple measurements with a single ionization chamber in different positions for their composite (or “hybrid”) delivery. This is of concern because it may lead to a situation where multiple errors are not detected since they may “cancel each other out.” Further, when there was a disagreement between a measurement and the calculation, some simply repeated a single measurement instead of investigating whether the discrepancy was indicative of a deeper problem (as would be prudent). The RPC also found a range of insti-tutional tolerances for IMRT. The TG119-defi ned cri-teria of 3% and 3 mm dose and distance values, where the evaluated points were defi ned as those greater than 10% of the maximum or the region defi ned by the jaws(15), are not uniformly adhered to. This is a potential concern since different QA techniques have different sensitivi-ties. Further, the TG119 criteria might not be adequate

for highly modulated fi elds.(27) The methods for evalu-ation and the criteria for acceptability are an area that needs further and more rigorous recommendations to improve the safety and quality of IMRT delivery. We recommend that IMRT QA criteria be established using tests of the most highly modulated fi elds that are seen in the local clinic, which may be more demanding than those in the TG 119 test suite. 4.4 Checklists for the IMRT Process

There is a growing body of literature on the use of checklists for improving patient safety.(32) For example, in a large study of 3,733 patients in eight hospitals, sur-gical checklists reduced the rates of post-surgery deaths (from 1.5% to 0.8%) and inpatient complications (from 11.0% to 7.0%).(33) Checklists have been also been used in some radiation therapy procedures. For example, AAPM Task Group 42 on Stereotactic Radiosurgery recommends using a treatment procedure checklist “to minimize the risk of misadministration or injury.”(34)

In a team environment, checklists can be used to verify that each team member performed their required roles. Appendix 2 provides example checklists for members of the IMRT team following the fl ow of a pa-tient from simulation through delivery. It is expected that each institution will need to develop its own check-lists, especially since the processes and personnel may vary according to that institution’s practice and software and hardware. A sign-off sheet can be used so that it is clear who performed a given step, and that pre-requisite steps are performed before subsequent steps. Table 4 summarizes the primary recommendations, tasks, and assigned personnel to guard against catastrophic failures for IMRT, primarily for MLC-based delivery systems. These recommendations have been compiled from the situations that were considered to be the riskiest points in the IMRT process or where missing information could adversely affect patient care.

5. Collaboration between Users and Manufacturers to Improve IMRT Safety Improvements in IMRT equipment/methods to en-hance patient safety are needed and would be facilitated by collaborative efforts between manufacturers, users, and regulatory agencies such as the Food and Drug Ad-ministration. The members of each of these three groups hold important information about RT patient safety, but none of the groups have complete control over solving the problem of catastrophic errors. Manufacturers should introduce new IMRT treatment delivery equipment, approaches and features only after it is clear that necessary equipment and clinical QA pro-cedures are clearly described for the user. The equip-ment QA component consists of the testing procedures


Table 4. Recommendations to Guard against Catastrophic Failures for IMRT

Recommended Tests and

Procedures

Person who

Performs Tasks

Primary Review

Responsibility

Second Review

Half a procedure if the operator is unclear about what is being done.

All All All

Verify the patient information, treat-ment site, and prescription

All All All

Verify correct positioning of the high dose region of isodose plan relative to targets

Dosimetrist Physician Physicist

Verify the recording of reference and shift information from the planning scan in patient chart (electronic or paper)

Dosimetrist PhysicistTherapist

Assess pre-treatment localization/portal images with respect to corresponding reference images before fi rst treatment; physician determines frequency of IGRT techniques(4)

Dosimetrist exports reference images from treatment plan-ning system

Physician Therapist

Verify that the correct version of the patient’s treatment plan is approved, sent to treatment management system, and used for patient-specifi c QA

Dosimetrist exports from the treatment planning system

Physicist Therapists confi rm against prescription for each treatment; physician prescrip-tion should specify the physician approved plan

Before the fi rst treatment or for any change in treatment, perform patient-specifi c QA to guarantee that data transfer between systems is correct before patient treatment begins

Physicist, dosime-trist, therapist or physics assistant

Physicist Therapists confi rm that only fully ap-proved plans are used for treatment

Perform a complete chart check includ-ing review of information in treatment management system prior to the start of any treatment and after any change in treatment before changes are used for treatment.Visually review fi eld aper-tures in treatment management system Perform a check of dose to verify TPS calculation (measurement or calcula-tion using DICOM export of data from RTP system)

Physicist Therapist

Perform a time out prior to treatment delivery.

Therapist Second therapist


Perform a check of treatment parameters before start of and during fi rst treatment against a fi xed version of the treatment plan Includes visual verifi cation of fi eld apertures during fi rst treatment and after any change in treatment. At each fraction, verify motion of leaves (if MLC delivery) and total monitor units

Dosimetrist exported from TPS; verifi ed by physi-cist


Perform end-to-end testing to guaran-tee transfer of data among all systems involved in imaging, planning and dose delivery (periodically and after any software or hardware changes)

Physicist, therapist or physics assistant

Physicist Second physicist to review

used for acceptance testing and quality control of the manufacturers’ equipment. The clinical QA component consists of the tests used during commissioning and for periodic QA. In some cases it is necessary to devise new approaches for both QA components that are un-like the procedures used for the predicate device upon which FDA 510(k) approval was based. Clinical QA procedures are typically developed by medical physi-cists, but this task cannot be completed without access to and familiarity with the new equipment. Therefore, successful development of new procedures requires a combined effort of the manufacturer and a team of physicists, typically expert users. Initially, the manu-facturer guarantees that the necessary information for QA is available to the early adopters of the new equip-ment. Then for safe adoption of new technologies in a variety of settings, the manufacturer has the respon-sibility to test, document, and provide reasonable QA procedures for equipment to users. This section outlines specifi c examples of improve-ment possibilities, grouped into four main categories. Many of these examples are applicable to other meth-ods of radiotherapy in addition to IMRT.

A) Improved methods to directly and independent-

ly verify/validate patient plan and treatment data

on the treatment machine prior to, during, and

after radiation delivery:

1. Pre-treatment QA for IMRT: patient parameters in the treatment management system (not copies) should be used for QA measurements and calcula-tions.

2. Tools/devices should be developed that will make the IMRT QA more effi cient, e.g. further devel-opment of fl at panel detectors to perform pre-treatment QA dosimetry, and possibly daily QA of each treatment delivery. Some centers have

developed their own techniques to improve QA effi ciency. Vendors should make strong efforts to evaluate and adapt these methods and make them available to their entire user community.

3. Plan QA completion/approval status should be re-corded, and automatically demoted if the plan is subsequently modifi ed with the ability to enforce blocking treatment if not approved.

4. Prior to loading a patient’s plan for each day’s treatment, the software should display the correct patient, target site(s) to be treated, and cumulative dose to a reference point(s) so that the patient’s dose target can be explicitly reviewed by the thera-pists prior to delivering additional dose.

5. Tools should be developed for therapists to verify that treatment fi elds and monitor units have been reviewed and are correct prior to delivery.

6. Graphics of the motions of all dynamic compo-nents (e.g. MLC, gantry etc) should be depicted in real-time during treatment delivery, such that they cannot be minimized or hidden.

7. Creation and storage of trajectory (e.g. MLC) log fi les during delivery to allow comparison for QA validation including providing access to the log fi les and making software tools available for asso-ciated analysis during a subsequent review.

8. Real-time trajectory information should be used to stop treatment if the delivery is out of an expected range, and provide information to the operator, including an immediate alert if treatment is stopped.

9. Development and implementation of real time methods (such as use of EPIDs) or other detectors to predict/detect potential overdose of a treatment delivery that can be interlocked with the linear accelerator to halt an incorrect treatment.


B) Provision of safety measures in the IMRT work-

fl ow such as communication features, checklists,

data integration and tracking.

1. Systems should allow incorporation of checklists, time out functions and communication logs within electronic medical records and the treatment man-agement systems. There should be an option of a “forced time out”, with customizable items, within the treatment management system.

2. Checklists should be interactive and modifi able such that their utility can be maximized in the en-vironment in which they are being used.

3. Systems should permit the grouping/naming of plans (including descriptions), and especially, a clear designation for an approved plan. Since IMRT planning is often iterative, with multiple beams and plans being generated, some uniform convention (customizable to the institution) to the naming of beams and plans, with automatic nam-ing of items, would be helpful.

4. The physician should be able to specify a fi nal approval of the treatment plan and prescription that sets the treatment plan status to be enabled for delivery.

5. Treatment management systems should have only one approved version of the treatment plan that cannot be changed at the treatment unit, to be used as a reference that is directly traceable to the in-formation reviewed before treatment, used for pre-treatment QA, and approved by the treatment team.

6. Systems should have a robust method of dealing with privileges associated with the modifi cation of couch and other parameters in the treatment plan.

7. The electronic record (including the informa-tion in the treatment management system) should retain display and retain information that was dem-onstrated to be valuable through the earlier paper chart and manual treatment processes used histori-cally.

8. There should be an improved audit trail in the system, and a mechanism for analyzing the data and using that information to refi ne treatment processes.

9. When a physician needs to change a plan, there should be an automatic communication through the treatment management system to other team members about the change. The plan status should change to unapproved for treatment and all mem-bers should be able to easily identify the change in status on the machine schedule.

10. A vendor’s maintenance logs or other automatic mechanisms should be routinely used to no-tify physicists of any and all equipment repairs, replacements, and/or software changes. This could

improve communication among team members and reduce the possibility of errors.

C) Integration of IMRT sub-systems and QA

procedures

1. There should be improved communication and development between manufacturers of hardware, treatment planning systems, and users. This is es-pecially important for modeling approximations of the hardware system.

2. Improved methods are required between software systems to assure that tumor-targeting based on CT imaging translates to accurate positioning of the patient on the treatment unit. Image guidance is an important component of verifying that the pa-tient is in the correct treatment position. However, the desire for imaging may introduce unintended errors if the table needs to be shifted (away from the correct treatment position) for imaging (e.g. due to clearance). In this setting, the therapist needs to remember to return the patient to correct position before treatment, and systems to auto-matically assess positioning would be particularly helpful.

3. Patient safety can be enhanced by implementation of safe system defaults (e.g. when data is not pres-ent, the software defaults to a “safe setting”).

4. The introduction of new IMRT treatment planning methods and treatment delivery approaches may require the development of new QA procedures. Development of such QA procedures should be a shared responsibility and collaborative effort between the end-users and manufacturers. The involvement of the end-user may be in both the concept and development, but defi nitely in clini-cal implementation, testing and validation. The manufacturer should collaborate with end-users in such development, and should provide the nec-essary understanding and knowledge of the new technology so that an effective approach can be developed. Then, manufacturers should update the other users by providing information about newly developed QA methods and providing all users with the newly developed software.

D) Human Factors

Software and hardware that is used for IMRT plan-ning and delivery should be created and structured to maximize the probability that it is used as intended. For example, attention should be paid to human factors en-gineering principles (e.g. software interfaces should use clear, consistent and unambiguous graphics). Where possible, automation, forcing functions, and standard-ization should be used to assure that tasks are performed


as desired. Opportunities to “hard-wire” redundancies and double checks might be helpful for particularly-crit-ical steps. IMRT is not performed in a vacuum. Rath-er, it occurs in the context of diverse clinical practice. Thus, design of IMRT-specifi c products should at least consider how their implementation might affect, and be affected by, other realities within the existing clinical environment. For example, the user-machine interface of a single system may seem clear and logical when con-sidered in isolation. However, if that interface is funda-mentally different from other interfaces that the user is also using, the inconsistency can raise safety concerns. The preceding list is not meant to be exhaustive, but rather to provide some examples of the broad opportu-nities for improvements in existing systems. Some of these suggestions are applicable to only specifi c ven-dor’s products and others are more general. Overall, successful improvements to existing/future systems will require joint efforts by the users, vendors and regulators. The prioritization, implementation, testing and commer-cial release of any improvements should be a partnership between users, manufacturers, and regulators. Improved methods of communication are required between with users and vendors to facilitate these efforts. Joint educa-tional programs where the users and vendors continue to educate each other might also be helpful.

6. SUMMARY

The many factors noted in this report that can impact IMRT safety can be broadly divided into environmental and technical factors, and are summarized as follows.

6.1 Environmental factors

IMRT is time and resource intensive. Administra-tion needs to provide ample support for the technologi-cal tools themselves (e.g. hardware and/or software), as well as the time needed to implement/commission these tools. Resources need to support initial and ongoing ef-forts towards staff education and maintenance. IMRT requires a team of adequately skilled and credentialed personnel who work well together and who have the sup-port of hospital and departmental leadership.

• The roles of all team members should be adequate-ly defi ned.

• Guidance documents on IMRT should be followed. All staff should have opportunities and time for training on new equipment and for continuing edu-cation on IMRT.

• Clinics must have a culture of safety which admin-istration plays a key role in supporting.

• Standard Operating Procedures are needed to de-fi ne the tasks, responsible persons, and methods to assure appropriate and timely QA. Examples are provided in this report to be adapted to individual clinics. These should be regularly monitored and reviewed prior to implementation of new tech-niques.

• Checklists should be developed by each clinic to verify key QA components. (The examples herein are provided as a guide for institutions to create their own checklists.) Each clinic should review its processes, update its procedures, and consider using sign off sheets for the most critical steps of the IMRT planning and delivery process. The ex-amples in this report are for illustration purposes only.

• Timely treatment is important, but undue pressure and real-time changes to the treatment plan can lead to errors. A “forced time out” can be used to assure adequate time to perform reviews/QA at key points in the process. Adequate time needs to be allowed to perform patient-specifi c pre-treatment QA and verify the treatment plan is acceptable before a plan is used for patient treatment. Team members need to acknowledge that initiation of treatment may need to be delayed to allow time for necessary quality assurance checks and subsequent investigations of problems.

6.2 Technical factors aff ecting patient safety

include:

• A specifi c QA program is needed to maintain the specialized software and hardware that are re-quired for IMRT planning and delivery.

• The adequacy of the commissioning of a program should be assessed with peer review and indepen-dent audits.

• Complete system end-to-end tests play a valuable role in maintaining a safe program. These tests can be part of annual QA for the program, performed any time equipment is upgraded, or more frequent-ly if needed.

• Patient-specifi c pre-treatment QA is considered necessary for a safe IMRT program (and should be documented in the SOP). The QA methods used should verify the integrity of the data transfer from the treatment planning system to the treat-ment management system and the accuracy of the dose to be delivered. The physicist is responsible for making sure the correct tools and methods are used.

• More guidance is needed on the essential compo-nents of an IMRT QA program, including pre-treat-ment QA methods and specifi cation of the accept-ability criteria for IMRT treatment plans. There is


a wide variation of methods used in practice. The development of new QA tools is an area where fu-ture collaboration with manufacturers may be es-pecially benefi cial.

The recommendations in this report are intended to provide guidance to aid clinics in avoiding catastroph-ic errors and to improve the safety and quality of care for patients receiving IMRT. It is expected that there will be further developments with respect to the evalu-ation of IMRT programs for accreditation, and that new guidance documents, such as the forthcoming report by AAPM on quality assurance approaches (Task Group 100) will continue to enhance the quality and safety of IMRT use.

Acknowledgements:

We thank the reviewers who took on the challenge of providing a comprehensive review on an earlier draft of this document. These reviewers provided their re-sponses within a limited timeframe to support the time-liness of the report. Their comments and suggestions were invaluable. We respectfully acknowledge Gary Ezzell, PhD, Anne Greener, MS, Joseph Hanley, PhD, Daniel Low, PhD, Jeff Michalski, MD, Jatinder Palta, PhD, Arthur Pinkerton, Warren Suh, MD, and Michael Sharpe, PhD. We also thank the many reviewers who took the time to comment during the public comment period. All comments were reviewed and further chang-es were incorporated as determined to be appropriate. Finally, we thank Anushree Vichare, M.B.B.S, M.P.H, of ASTRO who supported our writing group throughout the process.

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7. Bogdanich W. As Technology Surges, Radiation Safeguards Lag. The New York Times. January 26, 2010:A1.

8. International Atomic Energy Agency. Transition from 2-D radio-therapy to 3-D conformal and intensity modulated radiotherapy. Vienna, Austria: International Atomic Energy Agency; 2008.

9. Galvin JM, Chen XG, Smith RM. Combining multileaf fi elds to modulate fl uence distributions. Int J Radiat Oncol Biol Phys. 1993;27:697-705.

10. Halvorsen PH, Das IJ, Fraser M et al. AAPM Task Group 103 report on peer review in clinical radiation oncology physics. J Appl Clin Med Phys. 2005;6(4):50-64.

11. American Society of Radiologic Technologists. The Practice Standards for Medical Imaging and Radiation Therapy. Albu-querque, NM: American Society of Radiologic Technologists; 2010.

12. Siochi RA, Balter P, Bloch CD, et al. Information technology re-source management in radiation oncology. J Appl Clin Med Phys. 2009;10:3116.

13. American College of Radiology. ACR Technical Standard for the Performance of Radiation Oncology Physics for External Beam Therapy. Reston, VA: American College of Radiology; 2004.

14. Hartford AC, Palisca MG, Eichler TJ, et al. American Society for Therapeutic Radiology and Oncology (ASTRO) and American College of Radiology (ACR) Practice Guidelines for Intensity-Modulated Radiation Therapy (IMRT). Int J Radiat Oncol Biol Phys. 2009;73:9-14.

15. Ezzell GA, Burmeister JW, Dogan N, et al. IMRT commission-ing: multiple institution planning and dosimetry comparisons, a report from AAPM Task Group 119. Med Phys. 2009;36:5359-5373.

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18. Ezzell, GA, Galvin JM, Low D, et al. Guidance document on de-livery, treatment planning, and clinical implementation of IMRT: report of the IMRT Subcommittee of the AAPM Radiation Ther-apy Committee. Med Phys. 2003;30:2089-2115.

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24. Low DA, Moran JM, Dempsey JF, et al. Dosimetry Tools and Techniques for IMRT. Med Phys. 2011;38:1-26.

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27. Kruse JJ. On the insensitivity of single fi eld planar dosimetry to IMRT inaccuracies. Med Phys. 2010;37:2516-2524.

28. Low DA and Dempsey JF. Evaluation of the gamma dose distri-bution comparison method. Med Phys. 2003;30:2455-2464.

29. Molineu A, Followill DS, Balter PA, et al. Design and imple-mentation of an anthropomorphic quality assurance phantom for intensity-modulated radiation therapy for the Radiation Therapy Oncology Group. Int J Radiat Oncol Biol Phys. 2005;63:577-583.

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Appendix 1.

Table 1: Example Workfl ow for IMRT. The fl ow of work and steps may vary by individual clinic.

Task

Number

Physician Simulation

Therapist

Dosimetrist Physicist Treatment

Therapist

1 Verify the medical necessity of IMRT.

2 Pre-CT/simulation, provide simulator therapist:

a. Patient name and identifi ca-tion number

b. Treatment site and laterality

c. Instructions for simulation

3 Oversee simulation process including immobilization, positioning, placement and communication with thera-pists, dosimetrists, physicists about special requests.

4 Prior to patient’s appointment, review: a. Patient name and

identifi cation b. Treatment site and

laterality c. Physician directive for

simulation and treatment site to assess proper equip-ment and positioning

5 Position patient following standard procedures for treated body site: a. Verify patient is comfort-

able b. Verify positioning is

reproducible

6 Verify isocenter or reference marks are properly placed based per physician guiance.

7If there are ad-ditional questions regarding the patient setup, communicate with the physician, dosimetrist and/or physicist prior to or during the simula-tion.


Task

Number Physician Simulation

Therapist


Therapist

8 Document

positioning with photographs and text information (e.g. equipment used and settings if adjustable).

9 Segmentation (e.g. contouring) of target volumes.

10 Specify/approve the CTV and PTV expansions. PTV expansion should be consistent with frequency and type of image guidance.

11 Specify desired doses for targets and limits to normal structures. Clarify priorities where structures overlap (e.g. PTV with normal struc-ture) and where goals will confl ict.

12 Document that risk/benefi t trade-offs were discussed with patient.

13 Prior to patient’s appointment, review: a. Patient name and

identifi cation; b. Treatment site and

laterality; c. Physician directive

for simulation and treatment site to assess proper equipment and positioning.

14 Review datasets for integrity (complete-ness), dates, and labeling of: a. Primary imaging

dataset for treat-ment planning;

b. Secondary imag-ing datasets.


Task

Number


Therapist


Therapist

15 Review treatment planning guidelines from physician, including: a. Prescription

(total dose, fraction size, fractionation, bolus, etc.);

b. Target volumes; c. Treatment objec-

tives and dose constraints in the treatment direc-tive.

16 Review patient in-formation from the simulator therapists to assess: a. If positioning/ immobilization is reasonable and consistent with anticipated beam orientations b. Position of isocenter or refer-ence marks from simulation

17 Perform image segmentation (e.g. contouring): a. Normal tissues; b. Create expanded

volumes for CTV, PTV, and organs at risk as directed by the physician;

c. For regions where normal tissues are not segmented, defi ne areas of unspecifi ed normal tissue if appropriate to minimize doses to other tissues;

d. Notify physician, physicist, or other dosimetrist that volumes are ready for review.

18 Approve segmenta-tion (contours) cre-ated by dosimetrist including expanded CTV and PTV if appropriate.


Task

Number


Therapist


Therapis

19 Have the treatment vol-umes reviewed by another physician as part of peer review.

20 Review placement of beams and isocenter. a. Document if the

treatment isocenter is identical to the anticipated isocen-ter at the time of CT simulation;

b. If not, document the necessary shift from planning (or reference point) to the treatment isocenter, and create new “set-up beams”.

21 Perform treatment planning and optimi-zation.

22 Communicate with physicist that the treatment plan is ready for an initial review for plan ac-ceptability and deliv-erability issues. The physicist should note any concerns regard-ing: dose gradients, beam modulation, and deliverability of fi elds.

23Perform an initial review of the plan for reasonableness.

24 Prepare treatment plan for physician review.

25 Verify that planned dose distribution meets guid-ance specifi ed in the di-rective and/or is clinically acceptable (i.e. assesses correctness of trade-offs made in planning.)


Task

Number


Therapist


Therapist

26 Write treatment prescription: Review treatment planning guide-lines from physi-cian, including: a. Prescription

(total dose, fraction size, fractionation, bolus, etc.);

b. Target volumes; c. Treatment

objectives and dose constraints in treatment directive

d. Frequency/type of imaging.

27 Review: a. Patient name and

identifi cation; b. Treatment site and

laterality; c. Physician directive

for simulation and treatment site to assess proper equipment and positioning.

28 Review datasets for integrity (completeness), dates, and labeling of: a. Primary imaging

dataset for treatment planning;

b. Secondary imaging datasets.

29 Review treatment plan.

30 Verify that treatment plan meets the physi-cian’s dose constraints specifi ed in directive.

31 Set table, collimator, and gantry tolerances to pre-established level to consider treatment site and immobilization device/technique.


Task

Number


Therapist


Therapist

32 Transfer treatment plan and DRRs to treatment management system after physician has approved and signed plan.

33 Prepare documentation for therapists: e.g. isocenter set-up, and other considerations for delivery of the treatment plan.

34 Notify the physicist or other personnel that plan is ready for pre-treatment quality assurance.

35 Prepare/oversee the creation/calculation of the approved treatment plan on the phantom QA geometry. Use the dose per fraction specifi ed for plan delivery.

36 Verify integrity of information transferred to treatment manage-ment system for patient plan and QA plan, including: correct transfer of gantry, collimator, table, and jaw positions, and calculated monitor units etc.

37 Perform or oversee quality assurance checks of the treat-ment plan for the full delivery with proper gantry angles and for individual fi elds. Note any potential concerns for delivery of patient treatment.

38 Verify the accuracy of monitor units.

39 Document pre-treatment checks performed in patient chart.


Task

Number


Therapist


Therapist

40 Communicate failure of QA at any step to full treatment team. Patient treatment may need to be delayed.

41 Investigate and document causes of failures.

42 Prior to patient’s appointment review: a. Patient name and

identifi cation; b. Treatment site

and laterality; c. Physician

directive for simulation and treatment site to assess proper equipment and positioning.

43 Verify physician’s treatment prescrip-tion and treatment plan are signed and match information in treatment man-agement system.

44 Verify patient’s pre-treatment QA was performed and approved by physics.

45 At time of treat-ment appointment, a. Confi rm signed

treatment plan and prescription are still approved for treatment;

b. Position/ immo-bilize patient as documented;

c. Have a second therapist verify that the patient is set-up correctly;

d. Perform the specifi ed imag-ing;

e. Have im-ages approved as specifi ed by department protocol.


Task

Number


Therapist


Therapist

46 For each beam, verify treatment parameters in the treatment management sys-tem are consistent with the approved treatment plan.

47 Verify patient is always in the proper position before turning the beam on for each fi eld or auto-fi eld sequence.

48 During treatment, each therapist should take on a specifi c role.

49 Designate a therapist to watch the console for real-time outputs.

50 Designate another therapist to monitor the patient via video/audio devices.

51 If additional devices (e.g. respiratory motion manage-ment or other real-time infor-mation) are used, determine if a third therapist is needed to do special procedure monitoring.

52 Document the completion of each treatment delivery. Note any deviances from the standard treatment and com-municate with full team.

53 At a minimum, on a weekly ba-sis, monitors the accuracy of the treatment includ-ing reproducibil-ity of positioning, correct treatment plan informa-tion (parameters, monitor units), and use of beam modifi ers; e.g. bolus, use of IMRT, etc.

54 During treatment course, review patient imaging for reproducibility of positioning and monitor patient’s progress.


Appendix 2.

Example Checklists 1. Master Checklist of Overall Process:

□ Begin with a team that has adequate training and credentials in radiation therapy

□ Develop standard operating procedures (SOP) for all aspects of programo Criteria for IMRT documentedo Create checklists at critical steps where errors

could be made that affect the patient’s safety or degrade patient quality

□ Estimate a standard timeline from simulation to planning to QA to patient starto Allow adequate time for all steps without un-

due pressureo Request additional tools or resources (staff)

from administration if there is a lack of resources

□ Notify team members of problems at any stepso It may be necessary to delay the patient start

with an IMRT plano Halt a procedure if the operator is unclear

about what is being done

2. Physician checklist:

1. Review information regarding previous radiation treatment

2. Specify details for simulation3. Verify image registration4. Image segmentation: Verify segmentation of target

volumes and normal structures (motion consid-ered?)

5. Verify prescription dose and fraction size6. Target coverage: Verify target DVH’s meets/ex-

ceeds desired7. Normal tissue: Verify normal tissue DVH’s at/be-

low desired8. View 3D dose distribution to assess for

a. Dose in unspecifi ed regions (e.g. beams from unusual orientations)b. Assess dose gradients near target/normal-

tissue interfacesc. Gross target and normal tissue exposures

9. Confi rm desired set-up techniques, image guid-ance, motion control for needed accuracy

3. Simulator therapist checklist:

1. Understand diagnosis and treatment goals as they relate to patient setup

2. Confer with physician, dosimetrist and/or physicist prior to simulation to determine appropriate patient positioning and immobilization

3. Note if patient positioning is comfortable and reproducible

4. Place markers on skin during scanning as needed, including markers denoting previously-irradiated sites

5. Ensure that scanned volume is consistent with that requested

6. View images to verify completeness and that need-ed anatomy is not “cut off”

7. Provide documentation/imaging to dosimetry and treatment machines

4. Dosimetrist/physicist checklist for treatment planning:

1. Confer with treatment team prior to simulation/treatment planning to understand treatment goals and appropriate patient positioning and immobili-zation

2. Confi rm imported data set(s) with regard to date, modality, and patient

3. Perform image registration/segmentation of normal structures

4. Verify written prescription 5. Create optimal treatment plan while achieving

desired dose objectives for both target and organs at risk

6. Evaluate the dosimetric impact of previous treat-ment on the current treatment

7. Check labeling of all targets and critical structures to avoid ambiguities a possible confusion

8. Designate/name fi nal approved plan according to department criteria

9. Communicate with physicist regarding plan QA10. Verify plan attributes in treatment management

system (pt setup, tx parameters, isocenter place-ment, reference images)

11. Communicate with radiation therapists regarding approved plan to include image guidance, motion control or other special instructions


5. Example physicist checklist

Pre-treatment:

1. Review a. Patient identifi cation number and nameb. Treatment site and lateralityc. Diagnosis/ treatment location/intent

2. Review treatment plan to verify that the treatment plan meets the physician’s dose constraints as spec-ifi ed in the directive

3. Prepare/oversee the creation/calculation of the approved treatment plan for the QA geometry using the dose per fraction specifi ed for patient delivery

4. Perform or oversee the pre-treatment quality assur-ance checks including:a. Verify integrity of the information transferred

to the treatment management system for the patient plan and the QA plan, including cor-rect transfer of gantry, collimator, table, and jaw positions, and calculated monitor units etc.

b. Verify correctness of MLC leaf positions, sequences, and fractional monitor units

c. Verify the accuracy of monitor units used for the patient dose calculation

5. If pre-treatment QA fails, communicate to the full treatment team that the treatment plan cannot be used for patient treatment and that the patient treat-ment may need to be delayed.

6. Investigate and document any causes of failures7. Review that the patient continues to receive the

correct treatment at least on a weekly basis

6. Example treatment therapist checklist:

Pre-RT course

1. Verify written prescription/consent2. Review patient setup, image guidance and motion

control 3. Review approved treatment plan, verify delivery

type is IMRT (DMLC/SMLC), and verify docu-mentation of QA

4. Obtain and review appropriate images; seek approval per department SOP

5. Perform time out (correct patient, correct site, cor-rect plan) prior to treatment delivery

6. Alert physicist to unusual machine behavior; paus-es/stops treatment if necessary

Prior to/during each fraction

1. Perform time out (correct patient, correct site, cor-rect plan) prior to treatment delivery

2. Verify that imaging is within specifi ed constraints, proceed per department protocol

3. Note changes in patient status, concerns about re-producibility, or intra-fraction motion

4. Verify that machine motions are correct and leaves move for IMRT fi elds

RESPIRATORY MOTION MANAGEMENT SIMULATION: CPT® CODE +772932014 Coding Update: New Add-on Code.

Coding GuidanceJ A N U A R Y 2 014

Beginning January 1, 2014, a code to describe respiratory

management at simulation became eff ective.

With the creation of CPT® code +77293, (Respiratory motion

management simulation (List separately in addition to code for

primary procedure)) the concept of an add-on code has been

introduced into the radiation oncology code set. An add-on code

can only be billed in addition to the primary code; it cannot be

billed as a stand-alone code. It is designated by a plus (+) symbol,

which is found in front of the code.

Th is new code describes the physician work and resources

involved in acquiring a respiratory correlated or ‘4-D’ CT

simulation study for conformal planning. Th e plus (+) symbol in

front of the code number indicates that this is an add-on code.

Add-on codes are never performed independently and must be

reported in addition to the primary procedure. In the case of

+77293, it must always be billed with either CPT code 77295 or

77301 on the same date of service, even though the work may

take place over many days.

CPT® CODE DESCRIPTION

+77293 Respiratory motion management simulation (List separately in addition to code for primary procedure)

77295* Th ree-dimensional radiotherapy plan, including dose-volume histograms

77301 Intensity modulated radiotherapy plan, including dose-volume histograms for target and critical structure

partial tolerance specifi cations

Th e work involved in +77293 includes physicians, therapists,

dosimetrists and physicists and has both a professional and a

technical component. Th e work is performed both in the

simulator and in dosimetry. Th e add-on code +77293 is part of

the simulation and isodose planning process, not part of

treatment delivery.

*CPT code 77295 has been moved to the Medical Radiation, Physics, Dosimetry, Treatment Devices and Special

Services subsection of the CPT book (CPT codes 77300-77370) to represent the work of physics and dosimetry planning

rather than the work performed in the simulation. Th e descriptor has been revised to refl ect this change.

ASTRO Coding Guidance PAGE 2

RESPIRATORY MOTION MANAGEMENT SIMULATION Respiratory motion management simulation describes the

physician work involved in simulating a patient using motion

(respiratory) tracking of a mobile target volume. Simulation

CPT® codes 77280-77290 assume a static target and

acquisition of a single data set. Increasingly, simulation is

performed with motion management to inform fi eld and portal

design with precise knowledge about respiratory movement of

target tissues and organs at risk. Motion management requires

multiple scans and fusion of those scans with motion

(respiratory) tracking and is performed along with base

simulation and a chosen computer planning process.

Respiratory motion management simulation is typically

performed when there is a need to account for the breathing-

related motion of thoracic or abdominal tumors that will be

targeted with radiation therapy. Th e work involves acquisition

and review of multiple additional CT images that allow for a full

accounting of breathing-related tumor motion. Th erefore, the

service is performed in addition to the simulation code. Th e work

represented by respiratory motion management simulation is also

distinct from the work of the treatment planning process.

Since the work of motion management is identical for 3-D

conformal and IMRT patients, it can be billed in conjunction

with either CPT code 77295 or 77301. CPT code +77293 is an

add-on code; therefore, it cannot be billed on its own and must

always be billed with either CPT code 77295 or 77301.

Th e add-on code +77293 can only be billed once. If the patient is

receiving treatment with gating or other respiratory motion

tracking during the treatment, 0197T should be used.

PERFORMING RESPIRATORY MOTION MANAGEMENT SIMULATIONMotion management is performed after CT simulation.

Proper breathing is required by the patient in order to acquire

appropriate images. Th e patient is coached on achieving a

reproducible breathing pattern, typically using a respiratory

sensor as a guide. Respiratory excursion inhibiting devices

(abdominal compression, etc.) may also be used to minimize

respiratory motion or enhance breathing pattern regularity.

External fi ducial markers may be used and oriented on the

patient by the physician. Th e respiratory monitoring system is

then adjusted for the optimum anatomic position to yield the

most appropriate signal strength and the best correlation with

the anticipated tumor motion. Internal fi ducial markers may have

been previously placed but are not considered a necessary part

of the process. CT scout images and adjustments are made to

achieve the desired alignment. Upper and lower borders for

scanning are selected based on the location of the primary

lesion and the involved lymph nodes. Field of view is reviewed to

ensure inclusion of all relevant tissues and skin markers on the

image set.

Four-dimensional CT images are then obtained with the

real-time recording of a respiratory signal simultaneously with

multiple CT images acquired at each axial position in the patient

to capture the entire respiratory cycle at each CT slice position.

Simultaneously, a measure of the patient’s respiratory

motion is acquired using a respiratory sensor, correlated with

each CT slice acquisition phase and stored for later use in the

4-D reconstruction. Th is multi-image technique, which is known

as over-sampling, is performed to obtain a suffi cient number of

CT slices over superior/inferior extent of the patient anatomy, so

that there are enough images to achieve respiratory sorting with

acceptable spatial and temporal accuracy. Over-sampled images

from the CT dataset are sorted into several phases, or bins, based

on the information obtained from the respiratory signal, such as

peak exhale, mid exhale, peak inhale and mid inhale. Generally

up to 10 respiratory-binned CT slices are reconstructed at each

CT slice position. A complete set of image bins acquired over a

respiratory cycle constitutes the 4-D CT dataset.

Th e multiple data sets are then processed and reconstructed

before being transferred to a physician workstation for review.

Th e binned images are reviewed by the physician for consistency

and absence of data gaps and respiratory motion consistency. If

the patient’s respiration pattern was suboptimal, the acquisition

process will be repeated. Th ese binned images are then further

processed into maximum intensity projection and/or minimum

intensity projections. Th e complete set of 4-D images to modify

GTVs over the full range of the previously acquired 3-D dataset

is used to create the motion compensated treatment volume(s).

Clinical circumstances must warrant the use of this service. Th e

following examples are illustrative of when it would be

appropriate to report motion management. Examples include

lung cancers or upper abdominal tumors ( e.g., hepatic or

pancreatic cancers) in which the motion from respiration may

cause signifi cant movement of the intended target volume during

diff erent phases of the respiratory cycle.

ASTRO Coding Guidance PAGE 3

REFERENCES:ASTRO/ACR Guide to Radiation Oncology Coding 2010

(including 2014, 2013, 2012 and 2011 updates). Fairfax, VA and

Reston, VA: American Society for Radiation Oncology and the

American College of Radiology; 2010.

American Medical Association Code Manager® 2014

DOCUMENTATIONComplete documentation is essential when reporting an add-on

code. Documentation should include both the medical

necessity of reporting CPT® code +77293 as well as that the

work the code describes was done. Th e documentation needs to

be more extensive than just part of the simulation note since it

is part of the isodose planning process. Physicians should work

with their staff to ensure that proper documentation has been

completed.

Since the work that is included in +77293 occurs over several

days and involves the therapists, the dosimetrist, the physicist

and the physician, the information that could support the code

would appear in several documents. Th e simulation note would

also document physician review of respiratory motion

management set-up and use at the time of simulation. Th e

treatment plan document would indicate that the physician

created an ITV that covered the target volume in all phases of

respiratory motion.

Add-on codes are to be refl ected as a separate claim line on

electronic claim submission. Add-on codes should be listed

separately in addition to the primary procedure code. Th is code is

only charged once per 3-D or IMRT plan and should be

reported on the same day as the primary planning code (77295 or

77301).

Note: Th is new code describes the work involved in simulating a

patient using motion (respiratory) tracking of a mobile target

volume. Similar to imaging services, CMS will not provide

separate technical payment for the new respiratory management

service (+77293) in the hospital outpatient environment.

www.practicalradonc.org

Practical Radiation Oncology (2011) 1, 190–195

Special Article

Safety considerations for IMRT: Executive summaryJean M. Moran PhDa,⁎, Melanie Dempsey MSb, Avraham Eisbruch MDa,Benedick A. Fraass PhD c, James M. Galvin DSc d,Geoffrey S. Ibbott PhDe, Lawrence B. Marks MD f

aDepartment of Radiation Oncology, University of Michigan, Ann Arbor, MichiganbDepartment of Radiation Sciences, School of Allied Health Professions,Virginia Commonwealth University, Richmond, VirginiacDepartment of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, CaliforniadDepartment of Radiation Oncology, Thomas Jefferson University Hospital, Philadelphia, PennsylvaniaeRadiation Physics, UT M.D. Anderson Cancer Center, Houston, TexasfDepartment of Radiation Oncology, University of North Carolina, Chapel Hill, North Carolina

Received 19 April 2011; accepted 27 April 2011

Outline of the full report (available online only at www.practicalradonc.org).

1. Introduction1.1 Scope of this Document on Patient Safety for

IMRT1.2 Background Information on IMRT

2. Safety Concerns3. Supporting a Culture of Safety: Environmental

Considerations3.1 Department Environment

Supplementary material for this article (doi:10.1016/j.prro.2011.04.008) caConflicts of interest: Before initiation of this white paper all members of the

These statements are maintained at the American Society for Radiation Oncolopublished with the report. The ASTRO Conflict of Interests Disclosure Statemenconflict is detected, remedial measures to address any potential conflict are tareceived a research grant, paid to University of Michigan, from Varian Mreview committee assessing the complications of investigational protocol aUniversity of Texas M. D. Anderson Cancer Center, from Varian Medical SystemFirm LLC. Dr. Benedick Fraass serves on the Varian Patient Safety Council. HGroup Chair ensured that the white paper was built by consensus to delibMultidisciplinary Quality Assurance (QA) Subcommittee, as well as the Writingpresent a conflict with respect to these Writing Group members’ work on this

⁎ Corresponding author. Associate Professor, Associate Division DirectorMichigan, Ann Arbor, MI 48109-0010.

E-mail address: [email protected] (J.M. Moran).

1879-8500/$ – see front matter © 2011 American Society for Radiation Oncodoi:10.1016/j.prro.2011.04.008

3.2 Standard Operating Procedures for IMRT3.3 Process Time Considerations

4. IMRT Guidance for Quality Assurance Experience:Technical Considerations4.1 Existing Guidance Documents for IMRT4.2 Establishing and Monitoring an IMRT

Program4.3 Needs for Additional Guidance4.4 Checklists for the IMRT Process4.5 Additional Safety Concerns

n be found at www.practicalradonc.org.White Paper Task Group were required to complete disclosure statements.gy (ASTRO) Headquarters in Fairfax, VA and pertinent disclosures aret seeks to provide a broad disclosure of outside interests. Where a potentialken and will be noted in the disclosure statement. Dr. Jean Moran hasedical Systems. Dr. Avraham Eisbruch is a Chair of an independentt Amgen. Dr. Geoffrey Ibbott has received a research grant, paid to thes, and is a consultant with the Young Ricchiuti Caldwell and Heller Law

e receives no compensation or reimbursement for this work. The Writingerately minimize any potential conflicts of interest. The Chair of theGroup Chair, reviewed these disclosures and determined that they do notwhite paper.for Clinical Physics, Department of Radiation Oncology, University of

logy. Published by Elsevier Inc. All rights reserved.

http://dx.doi.org/10.1016/j.prro.2011.04.008

http://www.practicalradonc.org/article/S1879-8500(11)00162-7/fulltext

mailto:[email protected]

http://dx.doi.org/10.1016/j.prro.2011.04.008



Safety considerations for IMRT 191Practical Radiation Oncology: July-September 2011

5. Collaboration between Users and Manufacturers toImprove IMRT Safety

6. Summary

Table 1. Key Components of an IMRT SystemTable 2. Example Distribution of Responsibilities in

the IMRT Planning and Delivery ProcessTable 3. Example Problems in the Planning and

Delivery Process for IMRT and PossibleRemedial Actions

Table 4. Recommendations to Guard against Cata-strophic Failures for IMRT

Table 5. Summary of Guidance Documents on IMRT

Figure 1. An example abbreviated diagram of theprocess (boxes) and review (ovals) steps forIMRT planning for an individual patient

Appendix 1. Example Workflow for IMRTAppendix 2. Example Checklists for IMRT

Introduction

This executive summary briefly describes the overallgoals and content of the report on safety considerations forintensity modulated radiation therapy (IMRT) and isintentionally limited in length and content. Please see thefull report published electronically at www.practicalradonc.org. This abridged version is not intended to replace the fulllength report but rather to highlight key recommendationsof the report. Background information for those lessfamiliar with IMRT is limited to the full report.

Scope of this document on patient safety for IMRT

This report is part of a series of white papers addressingpatient safety commissioned by the American Society forRadiation Oncology (ASTRO) Board of Directors as partof ASTRO's Target Safely Campaign. The full lengthdocument was approved by the ASTRO Board ofDirectors on February 14, 2011 and has been endorsedby the American Association of Physicists in Medicine,American Association of Medical Dosimetrists, and theAmerican Society of Radiologic Technologists. Thedocument has also been reviewed and accepted by theAmerican College of Radiology’s Commission on Radi-ation Oncology. These organizations have a long historyof supporting efforts toward improving patient safety inthe United States.

This report is related to other reports of the ASTROwhite paper series on patient safety, still in preparation,especially those on peer review and on image-guidedradiation therapy, since both of these areas haveimplications on the practice of IMRT. There are sections

of the report that defer to guidance that will be publishedby those groups in future reports. Because this is the firstreport in the safety series, some of the concerns included inthis report are not limited to IMRT.

IMRT provides increased capability to conform isodosedistributions to the shape of the target(s), thereby reducingdose to some adjacent critical structures. This promise ofIMRT is one of the reasons for its widespread use.However, the promise of IMRT is counterbalanced by thecomplexity of the IMRT planning and delivery processes,and the associated risks.

The New York Times reported on serious accidentsinvolving both IMRT and other radiation treatmentmodalities.1,2 The full length report broadly addressessafe delivery of IMRT, with a primary focus onrecommendations for human error prevention and methodsto reduce the occurrence of errors or machine malfunctionsthat can lead to catastrophic failures or errors.

The full treatment team should be composed ofindividuals with proper credentials and training specificto radiation therapy for the simulation, treatment planning,quality assurance (QA), and delivery processes. Additionaltraining specific to IMRT is important. See the full lengthreport (section 1.2, available online only at www.practicalradonc.org) for a description of the responsibili-ties of IMRT team members, including radiation oncolo-gists, medical physicists, dosimetrists (or treatmentplanners), radiation therapists, and administrative staff.Special attention should be paid to the roles of thephysician and physicist; both board certified medicalspecialists who share responsibility for IMRT quality.

Safety concerns

Tools and techniques that can be used by individualclinics to reassess and strengthen the safety of their IMRTprograms are presented in the full length document. Due tothe complexity of IMRT delivery, we believe it is unsafefor IMRT to be delivered in emergent situations that wouldencourage staff to skip the needed QA steps. And yet,clinical pressures can make it difficult to ensure support forthis approach.

Hazards within an IMRT program can be broadlycategorized as environmental or technical. Environmentalconcerns that can affect all patient treatments include thelack of standard operating procedures, haste, habituation,incomplete understanding or misuse of procedures orequipment, an inadequate QA program, and a lack ofcontinuing staff education. While these hazards are notunique to IMRT, their impact may be greater due to thecomplexity of IMRT. Technical concerns that affect safetycan include inadequate commissioning of the clinicalIMRT program, inadequate validation of the accuracy oftreatment delivery parameters, improper use of one ormore parts of the planning and delivery process, and an





MD: Consult and Decision to Treat with IMRT

MD + Simulator Therapists (with Dosimetrist/Physicist as needed):Patient Immobilization and Simulation

192 J.M. Moran et al Practical Radiation Oncology: July-September 2011

inadequate investigation of discrepancies between treat-ment plan parameters and QA results.

The responsibilities of members of the treatment teamare defined in the report (see Table 2 in the full document;available online only at www.practicalradonc.org). Also,specific example process steps are presented for workflow(Appendix 1 in full document; available online only atwww.practicalradonc.org) and checklists (Appendix 2;available online only at www.practicalradonc.org), whichmay address ways to prevent or detect catastrophicfailures for IMRT. The 54 process steps and 15 hand-offsbetween the personnel in the example workflow illustratethe critical need for clearly defined roles, and unambig-uous or robust hand-offs (and means of communication)between personnel.

MD + Dosimetrists: Segmentation

MD: Review/Approval ofSegmentation

MD: Written Directive to Dosimetrist

MD Review/Approval ofTreatment Plan

Peer Review (e.g. Volumes, Doses, etc.)*

Dosimetrist: Create Treatment Plan usingMD’s Directive

Physicist Review ofTreatment Plan

Dosimetrist: Download Approved Treatment Plan to Treatment Management System

Physicist Review of Downloaded TreatmentPlan and IMRT Pre-Treatment QA

Therapist Review of TreatmentPlan and Patient Set-Up Before Day 1

Therapists Set-Up Patient for Daily Treatment (withDosimetrist/Physicist as needed)

MD: Monitors Patientduring Treatment Course

Physicist: Reviews at start andat least every 5 Fractions the Quality

of Patient Treatment

Figure 1 An abbreviated diagram of the process (boxes) andreview (ovals) steps for intensity modulated radiation therapyplanning for an individual patient. Each color (or shade)represents member of the treatment team. *Peer review will beaddressed in detail in a report of the white paper series onpatient safety.

Supporting a culture of safety for IMRT:environmental considerations

The departmental leadership establishes the foundationfor patient safety and teamwork. While these elements arenot unique to IMRT, we believe that they are crucial forensuring a safe radiation therapy program, especially sinceIMRT requires additional equipment, personnel, andprocedures for safety. The following considerations(discussed in detail in the full length document availableonline only at www.practicalradonc.org) are important forcreation of a culture of safety:

• Department members must trust each other3

• Administration must provide strong support forsafety

• Event tracking, review, investigation, and follow-upfor events and near misses

• Appropriately qualified personnel and ongoingtraining

• Use of standard operating procedures (SOPs)• Defined roles and responsibilities for team members• Strong communication among team members• American College of Radiology /ASTRO practiceaccreditation

• Continuous quality improvements.

Each institution should customize procedures to reflecttheir own processes and resources but should have a basisfounded in national or international guidance documents(section 4) to create a program that explicitly incorporatespatient safety. SOPs should be written and shouldempower individuals to halt planning or treatmentwhen a problem is encountered, allowing for properinvestigation into the problem, and then a decisionregarding the best course of action to maintain patientsafety. In the midst of a situation where adequate time isnot allowed for performing all of the necessary QA stepsprior to treatment, time pressures may stand in the way of

identifying and resolving problems. The SOP should notpermit staff to skip QA steps.

Implementation of and adherence to detailed policiesand procedures are necessary to avoid both quality errorsand catastrophic failures. Details of what should beincluded in an IMRT SOP are in the full length document(available online only at www.practicalradonc.org).

Figure 1 shows the complexity of the IMRT processas a series of process steps and review steps by members






Table 4 Recommendations to guard against catastrophic failures for IMRT

Recommended tests and procedures Person who performs task Primary reviewresponsibility

Second review

Halt a procedure if the operator is unclear about what isbeing done.

All All All

Verify the patient information, treatment site, and prescription. All All All

Verify correct positioning of the high dose region ofisodose plan relative to targets.

Dosimetrist Physician Physicist

Verify the recording of reference and shift information fromthe planning scan in patient chart (electronic or paper).

Dosimetrist Physicist Therapist

Assess pretreatment localization/portal images with respectto corresponding reference images before first treatment;physician determines frequency of IGRT techniques.

Dosimetrist exportsreference images fromtreatment planning system

Physician Therapist

Verify that the correct version of the patient's treatmentplan is approved, sent to treatment management system,and used for patient-specific QA.

Dosimetrist exports fromthe treatment planningsystem

Physicist Therapists confirmagainst prescriptionfor each treatment;physician prescriptionshould specifythe physicianapproved plan

Before the first treatment or for any change in treatment,perform patient-specific QA to guarantee that datatransfer between systems is correct before patienttreatment begins.

Physicist, dosimetrist,therapist or physicsassistant

Physicist Therapists confirmthat only fullyapproved plans areused for treatment

Perform a complete chart check including review ofinformation in treatment management system prior tothe start of any treatment and after any change intreatment before changes are used for treatment.Visually review field apertures in treatmentmanagement system.

Perform a check of dose to verify TPS calculation(measurement or calculation using DICOM exportof data from RTP system).

Physicist Therapist

Perform a time out prior to treatment delivery. Therapist Secondtherapist

Perform a check of treatment parameters before start ofand during first treatment against a fixed version of thetreatment plan.Includes visual verification of field apertures duringfirst treatment and after any change in treatment.

At each fraction, verify motion of leaves (if MLCdelivery) and total monitor units.

Dosimetrist exported fromTPS; verified by physicist


Perform end-to-end testing to guarantee transfer of dataamong all systems involved in imaging, planning anddose delivery (periodically and after any software orhardware changes).

Physicist, therapist, orphysics assistant

Physicist Second physicistto review

Perform a time out prior to treatment delivery. Therapist Secondtherapist

Perform a check of treatment parameters before start of andduring first treatment against a fixed version of thetreatment plan.Includes visual verification of field apertures duringfirst treatment and after any change in treatment.

Dosimetrist exported fromTPS; verified by physicist


(continued on next page)


Table 4 (continued)

Recommended tests and procedures Person who performs task Primary reviewresponsibility

Second review

At each fraction, verify motion of leaves(if MLC delivery) and total monitor units.

Perform end-to-end testing to guarantee transfer of dataamong all systemsinvolved in imaging, planning and dose delivery(periodically and after any software or hardware changes).

Physicist, therapist,or physics assistant

Physicist Second physicist toreview

IGRT, image-guided radiation therapy; IMRT, intensity modulated radiation therapy; MLC, multileaf collimator; QA, quality assurance; TPS, treatmentplanning system.

194 J.M. Moran et al Practical Radiation Oncology: July-September 2011

of the IMRT team. There are numerous situations (eg, achange in the patient geometry) that can lead to restartingthe process from the beginning, which can causepressures to skip or short-circuit QA procedures. Risksmay also increase if inadequate time is allotted for, and inbetween, the various steps (eg, image segmentation,written directive, planning, patient-specific QA). The fulllength report discusses many of these time considerations(with respect to safety) in detail.

IMRT guidance for quality assuranceexperience: technical considerations

A summary of the existing guidance documents forIMRT is presented in the full length document (text andTable 5 available online only at www.practicalradonc.org). These earlier IMRT QA documents emphasizedestablishing a quality IMRT program and did not explicitlyconcentrate on the potential for catastrophic failures inIMRT delivery. In fact, several documents suggested thatsome QA efforts could be decreased or even eliminatedafter the accumulation of a stated amount of experience. Inthis work, we acknowledge that certain types of cata-strophic failures resulting from human error and equip-ment (hardware or software) malfunction might not bepredictable based on past experience. In some situations,periodic testing alone may be inadequate for identifyingthese types of problems.

The processes and tasks performed by the IMRT teamare addressed with special attention to patient safety and tominimizing the potential for catastrophic failures. The fulllength document (available online only at www.practical-radonc.org) includes a detailed discussion of the followingwith respect to patient safety and quality:

4.2.1 Training4.2.2 Commissioning an IMRT system4.2.3 Establishing a QA program4.2.4 Pretreatment IMRT QA program4.2.5 Monitoring the IMRT program

Each institution should have clear criteria for a pass orfail of the IMRT patient-specific IMRT QA technique.

There is interinstitutional variation in the content ofpretreatment IMRT QA, as well as the equipment andsoftware used. There is no formal consensus on thedesired or required level of agreement between theplanned or expected calculation and the measured datafor patient-specific IMRT QA. Also, the impact of failingto meet a given set of criteria on these patient-specificmeasurements is often not explicitly addressed (eg,remeasure the fields, generate an alternate plan, estimatethe clinical impact qualitatively, etc). Therefore, furtherguidance is needed from national organizations in each ofthese areas.

Until formal guidance is available, we recommendthat users establish acceptance criteria that they havedetermined will identify plans that should fail the QAcheck. For example, users should deliberately createplans with known errors such as the incorrect fluence forregions of high or low dose across the irradiated volumeor critical structures, plans with one field with a rotatedcollimator and/or an incorrect fluence distribution, andother discrepancies that should be identified by the QAmethod. The IMRT QA criteria should be establishedusing tests of the most highly modulated fields that areseen in the local clinic.

The full length report includes a summary of theprimary recommendations, tasks, and assigned personnelto guard against catastrophic failures for IMRT, primarilyconcentrating on multileaf collimator-based deliverysystems since they are the most common (Table 4).

Collaboration between users andmanufacturers to improve IMRT safety

Improvements in IMRT equipment and methods toenhance patient safety are needed and would be facilitatedby collaborative efforts between manufacturers, users, andregulatory agencies such as the United States Food andDrugAdministration. The full length report includes a detailed listof possible improvements, including the following:

A. Methods to directly and independently verify orvalidate patient plan and treatment data on the






treatment machine prior to, during, and after radiationdelivery.

B. Provision of safety measures in the IMRT workflowsuch as communication features, checklists, dataintegration and tracking.

C. Integration of IMRT sub-systems andQAproceduresD. Human interaction with equipment

Successful improvements to existing and future sys-tems will require joint efforts by the users, vendors, andregulators. The prioritization, implementation, testing, andcommercial release of any improvements should be apartnership between users, manufacturers, and regulators.

Summary

IMRT is time and resource intensive. Environmentaland technical concerns need to be addressed to improvepatient safety. Timely treatment is important, but unduepressure and real-time changes to the treatment plan canlead to errors. The report suggests use of a “forced timeout” to assure adequate time to perform reviews and QA atkey points in the process. Team members need toacknowledge that initiation of treatment may need to bedelayed to allow time for necessary QA checks andsubsequent investigations of problems.

The recommendations in the full length report areintended to provide guidance to aid clinics in avoidingcatastrophic errors and to improve the safety and quality ofcare for patients receiving IMRT. It is expected that therewill be further developments with respect to the evaluationof IMRT programs for accreditation, and that newguidance documents will continue to enhance the qualityand safety of IMRT use.

Acknowledgments

This document was prepared by the MultidisciplinaryQuality Assurance Subcommittee of the Clinical Affairs andQuality Committee of the American Society for RadiationOncology as a part of ASTRO's Target Safely Campaign.

The IMRT white paper was reviewed by 8 expertsfrom the field of intensity modulated radiation therapy. InDecember 2010, the IMRT white paper was posted forpublic comments for 4 weeks. We received commentsfrom physicians, physicists, therapists, and representa-tives from radiation therapy manufacturers, includinggeneral and specific comments from the AmericanAssociation of Physicists in Medicine. All the commentswere reviewed and discussed by the entire writing group

and appropriate revisions were incorporated into thepaper with group consensus.

ASTRO white papers present scientific, health, andsafety information, and may to some extent reflectscientific or medical opinion. They are made available toASTRO members and to the public for educational andinformational purposes only. Any commercial use of anycontent in this white paper without the prior writtenconsent of ASTRO is strictly prohibited.

Adherence to this white paper will not ensure successfultreatment in every situation. Furthermore, this white papershould not be deemed inclusive of all proper methods ofcare or exclusive of other methods of care reasonablydirected to obtaining the same results. The ultimatejudgment regarding the propriety of any specific therapymust be made by the physician and the patient in light of allcircumstances presented by the individual patient. ASTROassumes no liability for the information, conclusions, andfindings contained in its white papers.

This white paper was prepared on the basis ofinformation available at the time the writing group wasconducting its research and discussions on this topic.There may be new developments that are not reflectedin this white paper and that may, over time, be a basisfor ASTRO to consider revisiting and updating thewhite paper.

We thank the reviewers who took on the challenge ofproviding a comprehensive review of an earlier draft ofthis document. These reviewers provided their responseswithin a limited time frame to support the timeliness of thereport. Their comments and suggestions were invaluable.We respectfully acknowledge Gary Ezzell, PhD, AnneGreener, MS, Joseph Hanley, PhD, Daniel Low, PhD, JeffMichalski, MD, Jatinder Palta, PhD, Arthur Pinkerton,Warren Suh, MD, and Michael Sharpe, PhD. We alsothank the many reviewers who took the time to commentduring the public comment period. All comments werereviewed and further changes were incorporated asdetermined to be appropriate. Finally, we thank AnushreeVichare, MBBS, MPH, of ASTRO, who supported ourwriting group throughout the process.

References

1. Bogdanich W. Radiation offers new cures, and ways to do harm.New York Times. 2010:A1.

2. Bogdanich W. As technology surges, radiation safeguards lag.New York Times. 2010:A1.

3. Kohn LT, Corrigan J, DonaldsonMS. To err is human: building a saferhealth system. Washington, DC: National Academics Press. 2000.

COMPUTED TOMOGRAPHY GUIDANCE FOR PLACEMENT OF RADIATION THERAPY FIELDS (77014)

Coding GuidanceM A R C H 2 014

Eff ective January 1, 2014, providers will no longer separately

report CT guidance, represented by CPT® code 77014

(Computed tomography guidance for placement of radiation

therapy fi elds), when reporting simulation services represented

by CPT codes 77280-77290 and CPT code 77295 (Th erapeutic

radiology simulation-aided fi eld setting; 3-dimensional). Th e

codes have been revised to refl ect current practice, and it has

been determined that the use of CT guidance is integral to the

simulation procedure and should no longer be reported

separately. Th e value of the professional and technical

components of CT guidance is now captured within the

simulation service.

GUIDANCE FOR REPORTING CPT® CODE 77014 WITH SIMULATION CODESSince the development of the simulation codes, there have been

signifi cant changes in the process of care for physician and other

qualifi ed health care professionals, as well as the nature of the

equipment utilized. For example, fl uoroscopic simulators have

largely been replaced with dedicated CT scanners and related

work stations. As a result, CPT code 77014 is now included

in the simulation codes. At the time of simulation, CPT code

77014 may not be reported by the provider in either the

freestanding or the hospital setting.

In 2014, CPT code 77295 has been reassigned and is now

grouped under Medical Radiation Physics, Dosimetry,

Treatment Devices and Special Services rather than simulations.

Nevertheless, this same rule of not reporting CPT code 77014

when reporting CPT code 77295 also applies.

Th e inclusion of CT guidance within the simulation service is

documented in the defi nition of simulation, which was added

to the 2014 CPT book. Th e defi nition states, “Simulation is the

process of defi ning relevant normal and abnormal target

anatomy, and acquiring the images and data necessary to develop

the optimal radiation treatment process for the patient1.”

CPT code 77014 is also used to describe work associated with

the IGRT process using a cone beam CT during the patient

treatment session. Th at use of CPT code 77014 remains valid for

the year 2014.

1American Medical Association. CPT 2014: Professional Edition.

CPT® CODE DESCRIPTION IGRT-SPECIFIC GUIDELINES SUPERVISION REQUIREMENTS

77014 Computed tomography

guidance for placement of

radiation therapy fi elds

Used with CT-based systems (i.e.,

integrated cone beam CT, CT/linear

accelerator on rails, tomotherapy).

Direct

2014 Coding Update: CT Guidance Not Reported Separately with Simulation