L28892-LCD

LCD/NCD Portal

Automated World Health

Local Coverage Determination (LCD) for Intensity Modulated Radiation Therapy (IMRT) (L28892)

Contractor Information

Contractor Name

First Coast Service Options, Inc. opens in new window

Contractor Number 09101

Contractor Type MAC - Part A

LCD Information

Document Information

LCD ID Number L28892

LCD Title

Intensity Modulated Radiation Therapy (IMRT)

Contractor's Determination Number A77301

Primary Geographic Jurisdiction opens in new window Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 02/16/2009 Original Determination Ending Date

Revision Effective Date

For services performed on or after 10/05/2009 Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:

• Title XVIII of the Social Security Act, Section 1862 (a)(7), (This section excludes routine physical examinations).

• Title XVIII of the Social Security Act, Section 1862 (a)(1)(A), (This section allows coverage and payment for only those services considered medically reasonable and necessary).

• Title XVIII of the Social Security Act, Section 1833 (e), (This section prohibits Medicare payment for any claim which lacks the necessary information to process the claim).

• CMS Manual System, Pub 100-4, Medicare Claims Processing Manual, Chapter 13, Sections 20 and 90, (These sections discuss payment conditions for radiology services).

• Transmittal 132, Change Request 3154, March 30, 2004-07-08, (Allows compensator-based IMRT technology [Effective 04/01/2004]).

Indications and Limitations of Coverage and/or Medical Necessity

Intensity Modulated Radiation Therapy (IMRT) is a computer-based method of planning for, and delivery of patient specific, spatially modulated beams of radiation to solid tumors within a patient. IMRT planning and delivery uses an approach for obtaining the highly conformal dose distributions needed to irradiate complex targets positioned near, or invaginated by, sensitive normal tissues, thus improving the therapeutic ratios. IMRT delivers a more precise radiation dose to the tumor while sparing the surrounding normal tissues by using non- uniform radiation beam intensities determined by various computer-based optimization techniques.

The decision process for using IMRT requires an understanding of accepted practices that take into account the risks and benefits of such therapy compared to conventional treatment techniques. While IMRT technology may empirically offer advances over conventional or three-dimensional conformal radiation, a comprehensive understanding of all consequences is required before applying this technology.

IMRT is not a replacement therapy for conventional radiation therapy methods. Medicare will consider IMRT reasonable and necessary when at least one or more of the following five conditions is documented:

1. The target volume is in close proximity to critical structures that must be protected.

2. The volume of interest must be covered with narrow margins to adequately protect immediately adjacent structures.

3. An immediately adjacent area has been previously irradiated and abutting portals must be established with high precision.

4. The target volume is concave or convex, and critical normal tissues are within or around that that convexity or concavity.

5. Dose escalation is planned to deliver radiation doses in excess of those commonly utilized for similar tumors with conventional treatment.

The most common sites that currently support the use of IMRT include:

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

• Primary metastatic tumors of the spine where spinal cord tolerance may be exceeded by conventional treatment

• Primary, metastatic or benign lesions to the head and neck area including orbits, sinuses, skull base, aerodigestive tract and salivery glands.

• Carcinoma of the prostate

• Selected cases of thoracic and abdominal malignancies

• Selected cases of left breast tumors due to risk to immediately adjacent cardiac and pericardial structures, and selected right breast cases in larger volume breasts and larger chest wall separation distances.

• Other pelvic and retroperitoneal tumors that meet the requirements for medical necessity

• Reirradiation that meets the requirements for medical necessity.

Patient-Specific IMRT Treatment Verification

Per the American Society for Therapeutic Radiology and Oncology (ASTRO)/The American College of Radiology (ACR) Guidelines, verification of the patient treatment plan includes documentation of all of the elements associated with implementation as well as images of treatment portals and physical dose measurements. Each facility may derive its own means to document and ensure communication of the exact details required to achieve daily, ongoing correlation between the image-based IMRT plan and dose delivery. However, the following critical information must be contained in the treatment verification elements. Documentation must exist that the

qualified medical physicist has appropriately commissioned the IMRT planning and delivery system, has authorized the system for clinical use, and has established the quality assurance (QA) program to monitor the IMRT planning and delivery systems. This documentation is generally not contained in individual patients’ medical records. There are various valid commissioning and performance monitoring protocols for IMRT planning and delivery systems. Qualified medical physicists should refer to the appropriate American Association of Physicists

in Medicine (AAPM) recommendations or ACR practice guideline for IMRT.

Use of Clinical Treatment Planning in IMRT (CPT Code 77263) Prior to the Specific IMRT Treatment Plan (77301)

Clinical treatment planning includes interpretation of special testing, tumor localization, treatment volume determinations, treatment time/dosage determinations, choice of treatment modality(ies), selection of

appropriate treatment devices and other procedures such as concurrent or sequential chemotherapy or surgery. A separate charge for clinical treatment planning may be appropriately claimed when based on separately documented work itemizing the specific services provided. Review of records, pathology reports and/or imaging studies are typically part of the basis for claiming either a higher-level E/M service preceding treatment planning, or as a component of this code, but this same work should not be counted as a basis for both services. The need for IMRT should justify complex treatment planning

Use of Simulation-Aided Field Setting in IMRT (CPT Code 77290)

Simulation-aided field setting complex (CPT code 77290) during a course of IMRT is appropriate for the initial setup of the patient where an immobilization device may be constructed, isocenter(s) and volume of interest are determined, and CT or other imaging is obtained for subsequent reconstruction of target(s) and critical structure(s). Documentation should include patient positioning and immobilization device, target verification, possible utilizing radiographic studies and a description of the physician’s work.

Use of Intensity Modulated Radiotherapy Plan (CPT Code 77301), Including Dose Volume Histograms for Target and Critical Structure Partial Tolerance Specification

Intensity-modulated radiotherapy plan (CPT code 77301) is a separate and distinct step in the process of care whose product is the computerized plan developed by the physician, medical physicist and dosimetrist, and is required for the delivery of IMRT. Only one unit of CPT code 77301 (Radiotherapy dose plan, IMRT) can be billed per course of therapy, even if there is a planned “cone down” treatment feature or change in field size. In that case, coding for conventional treatment should be used. A second unit of CPT code 77301 can only be billed if changes in patient anatomy during treatment requires repeat planning CT scanning. Such a change must be documented. Similarly, CPT code 77295 (Set radiation therapy field) cannot be billed during the same course of treatment unless required by a change in patient anatomy.

Documentation for IMRT planning must include the following:

• Review (signed and dated) by the radiation oncologist of the CT or MRI based images of the target and all critical structures with representative isodose distributions that characterize the three-dimensional dose.

• Radiation oncologist review of dose-volume histograms for all targets and critical structures.

• Description of the number and location of each treatment step/rotation or portal to accomplish the treatment plan.

• Documentation of dosimetric verification of treatment setup and delivery, signed by both the radiation oncologist and the medical physicist.

• For compensator-based IMRT, the unique compensator design should be documented for east step or portal.

Use of 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 (CPT Code 77300) in IMRT

Basic radiation dosimetry is a separate service from CPT code 77301 (Radiation dose plan, IMRT). CPT code 77300 (Radiation therapy dose plan) is used to report dosimetry calculations that arrive at the relationship between monitor units (or time) and dose, and the physician’s verification, review and approval of this. The documentation should contain the independent check for each field, separate from the computer-generated IMRT plan.

Use of Teletherapy Isodose Plan in IMRT (CPT Codes 77305–77321)

A claim for a separate teletherapy isodose plan during a course of IMRT is appropriate only when the claim applies to another modality (e.g., an accompanying “boost” with external beam).

Use of Brachytherapy Isodose Plan in IMRT (CPT Codes 77326–77328)

A claim for a separate brachytherapy isodose plan during a course of IMRT is appropriate only when the claim applies to a separate, accompanying brachytherapy modality.

Use of Special Dosimetry in IMRT (CPT Code 77331)

Dosimetry performed as part of plan verification is part of the work and practice expense of CPT code 77301 and cannot be billed separately.

Use of Treatment Devices (e.g., “Blocks”) in IMRT (CPT Codes 77332–77334)

Medicare would not expect to see providers billing frequently for the design and construction of devices that are separate and distinct from the “device” derived from the computerized IMRT plan. The Correct Coding Initiative (CCI) bundles the device CPT codes 77332–77334 into CPT code 77301. In cases where these separate devices are billed, the medical record must clearly demonstrate the medical necessity and rationale for the service.

When a provider designs and constructs a treatment or immobilization device separate and distinct from the “device” derived from the computerized IMRT plan, the provider may then report 77332-77334, as appropriate, with modifier - 59. The medical record must have documentation to support this use of modifier -59. A treatment device could also be appropriate where it applies to another modality (e.g. an accompanying “boost” with external beam).

Additionally, to compensate for the physician work and practice expense (largely physicist and dosimetrist) associated with the calculations, review and oversight necessary for the multileaf collimator, a claim for “Treatment Device” may be made for each gantry stop, up to a maximum of six, using the professional-service- only modifier (-26). It is not appropriate to bill a Treatment Device for these services without the professional- service-only modifier, since the large portion of the technical component is being paid in the treatment delivery code. Using the professional-service-only modifier likely undervalues the practice expense component somewhat and correspondingly may over value the work expense component for these services, but the net effect would be to allow a reasonably fair and functional way to value these services until more specific, updated codes are developed.

Use of Continuing Medical Physics Consultation in IMRT (Weekly Physics QA: CPT Code 77336)

Continuing medical physics is appropriate for the weekly continuing medical physics process and reports the work and oversight of the medical physicist in the care of the IMRT patient. It is not appropriately reported for work associated with the creation of the IMRT plan.

Use of Special Medical Radiation Physics Consultation in IMRT (CPT Code 77370)

A claim for special medical radiation physics consultation during a course of IMRT is appropriate only where the need for and use of the consultation are carefully documented and occur at a time other than that necessary as a part of IMRT planning (e.g., a special physics assessment requested when already into a course of therapy). A medical physics consultation could also be appropriate where it applies to another modality (e.g., an accompanying “boost“with external beam).

Use of Other Radiation Treatment Delivery on the Same Day as IMRT Treatment Delivery (CPT Codes 77418, 0073T)

Radiation treatment delivery CPT codes 77401–77416, 77422–77423 and 0082T may not be used on the same date of service as IMRT treatment delivery (CPT code 0073T or 77418). These other delivery codes may be used prior to or subsequent to an IMRT treatment course for treatment with a different modality.

Radiation Treatment Management (CPT Code 77427)

Radiation treatment management (CPT code 77427) is reported by the physician for the weekly (defined as five- fraction) management of patients receiving radiation therapy, including IMRT.

Use of “Special Treatment Procedure” in IMRT (CPT Code 77470)

A claim for “special treatment procedure” (e.g., total body irradiation, hemibody radiation, per oral, endocavitary or intraoperative cone irradiation) would not be appropriate for services that are a necessary part of IMRT planning, but might rarely be appropriate during a course of IMRT when the respective treatment is being delivered as a separate therapy. Providers are cautioned that the use of this code implies a special treatment procedure with moderate physician work and very considerable practice expense (such as in Total Body Irradiation (TBI)). This service is not to be claimed for much less significant “special procedures” that would more appropriately use CPT code 77499 or are a regular variant of IMRT or regular combination with IMRT.

Image Guided Radiation Therapy (IGRT) Codes (CPT codes 76950,77014,77421)

IGRT is a form of adaptive radiation therapy, which utilizes imaging technology to guide action(s) that modifies the treatment in reference to the intended target, In IGRT, the external beam radiation treatment setup is accomplished with direct visualization of the target volume, implanted fiducial markers or adjacent anatomical structures. These guidance images are compared to the designated target(s) as delineated on the treatment isodose plan. An adjustment may then be required to achieve an accurate concordance of dose distribution with the original plan. IGRT is used in patients whose tumors are directly adjacent to critical structures and where conventional means of targeting are deemed to be inadequate. IGRT must be performed by the radiation oncologist, medical physicist or trained radiation therapist under the supervision of the radiation oncologist. The physician must supervise and review the procedure, as the guidance may show a shift beyond standard tolerances.

The current supervision requirements for the technical component of the IGRT procedure codes are as follows: CPT code 76950 requires general supervision, CPT code 77014 requires direct supervision and CPT code 77421 requires direct supervision.

General supervision means the procedure is furnished under the physician’s overall direction and control, but the physician’s presence is not required during the performance of the procedure.

Direct supervision in the office setting means the physician must be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the procedure. It does not mean that the physician must be present in the room when the procedure is performed.

Personal supervision means a physician must be in attendance in the room during the performance of the procedure.

Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

012x Hospital Inpatient (Medicare Part B only) 013x Hospital Outpatient

085x Critical Access Hospital

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

0333 Radiology - Therapeutic and/or Chemotherapy Administration - Radiation Therapy

CPT/HCPCS Codes

77301 INTENSITY MODULATED RADIOTHERAPY PLAN, INCLUDING DOSE-VOLUME HISTOGRAMS FOR TARGET AND CRITICAL STRUCTURE PARTIAL TOLERANCE SPECIFICATIONS

77418 INTENSITY MODULATED TREATMENT DELIVERY, SINGLE OR MULTIPLE FIELDS/ARCS, VIA NARROW SPATIALLY AND TEMPORALLY MODULATED BEAMS, BINARY, DYNAMIC MLC, PER TREATMENT SESSION

COMPENSATOR-BASED BEAM MODULATION TREATMENT DELIVERY OF INVERSE PLANNED TREATMENT 0073T USING 3 OR MORE HIGH RESOLUTION (MILLED OR CAST) COMPENSATOR CONVERGENT BEAM

MODULATED FIELDS, PER TREATMENT SESSION

ICD-9 Codes that Support Medical Necessity

Medicare is establishing the following limited coverage for CPT/HCPCS codes 0073T, 77301 and 77418:

Covered for:

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MALIGNANT NEOPLASM OF BASE OF TONGUE - MALIGNANT NEOPLASM OF TONGUE UNSPECIFIED

MALIGNANT NEOPLASM OF PAROTID GLAND - MALIGNANT NEOPLASM OF SALIVARY GLAND UNSPECIFIED

MALIGNANT NEOPLASM OF ANTERIOR PORTION OF FLOOR OF MOUTH - MALIGNANT NEOPLASM OF FLOOR OF MOUTH PART UNSPECIFIED

MALIGNANT NEOPLASM OF CHEEK MUCOSA - MALIGNANT NEOPLASM OF MOUTH UNSPECIFIED

MALIGNANT NEOPLASM OF TONSIL - MALIGNANT NEOPLASM OF OROPHARYNX UNSPECIFIED SITE

MALIGNANT NEOPLASM OF SUPERIOR WALL OF NASOPHARYNX - MALIGNANT NEOPLASM OF NASOPHARYNX UNSPECIFIED SITE

MALIGNANT NEOPLASM OF POSTCRICOID REGION OF HYPOPHARYNX - MALIGNANT NEOPLASM OF HYPOPHARYNX UNSPECIFIED SITE

MALIGNANT NEOPLASM OF PHARYNX UNSPECIFIED - MALIGNANT NEOPLASM OF ILL- DEFINED SITES WITHIN THE LIP AND ORAL CAVITY

MALIGNANT NEOPLASM OF CERVICAL ESOPHAGUS - MALIGNANT NEOPLASM OF ESOPHAGUS UNSPECIFIED SITE

MALIGNANT NEOPLASM OF CARDIA - MALIGNANT NEOPLASM OF STOMACH UNSPECIFIED SITE

MALIGNANT NEOPLASM OF HEPATIC FLEXURE - MALIGNANT NEOPLASM OF COLON UNSPECIFIED SITE

MALIGNANT NEOPLASM OF RECTOSIGMOID JUNCTION - MALIGNANT NEOPLASM OF OTHER SITES OF RECTUM RECTOSIGMOID JUNCTION AND ANUS

MALIGNANT NEOPLASM OF LIVER PRIMARY - MALIGNANT NEOPLASM OF LIVER NOT SPECIFIED AS PRIMARY OR SECONDARY

MALIGNANT NEOPLASM OF GALLBLADDER - MALIGNANT NEOPLASM OF BILIARY TRACT PART UNSPECIFIED SITE

MALIGNANT NEOPLASM OF HEAD OF PANCREAS - MALIGNANT NEOPLASM OF PANCREAS PART UNSPECIFIED

MALIGNANT NEOPLASM OF RETROPERITONEUM - MALIGNANT NEOPLASM OF PERITONEUM UNSPECIFIED

MALIGNANT NEOPLASM OF NASAL CAVITIES - MALIGNANT NEOPLASM OF ACCESSORY SINUS UNSPECIFIED

new window MALIGNANT NEOPLASM OF GLOTTIS - MALIGNANT NEOPLASM OF LARYNX UNSPECIFIED

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MALIGNANT NEOPLASM OF TRACHEA - MALIGNANT NEOPLASM OF BRONCHUS AND LUNG UNSPECIFIED

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MALIGNANT NEOPLASM OF PARIETAL PLEURA - MALIGNANT NEOPLASM OF PLEURA UNSPECIFIED

MALIGNANT NEOPLASM OF THYMUS - MALIGNANT NEOPLASM OF MEDIASTINUM PART UNSPECIFIED

MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF HEAD FACE AND NECK - MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE SITE UNSPECIFIED

MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST - MALIGNANT NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE

MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE BREAST - MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE BREAST

179 MALIGNANT NEOPLASM OF UTERUS-PART UNS

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MALIGNANT NEOPLASM OF ENDOCERVIX - MALIGNANT NEOPLASM OF CERVIX UTERI UNSPECIFIED SITE

MALIGNANT NEOPLASM OF CORPUS UTERI EXCEPT ISTHMUS - MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF BODY OF UTERUS

MALIGNANT NEOPLASM OF OVARY - MALIGNANT NEOPLASM OF UTERINE ADNEXA UNSPECIFIED SITE

MALIGNANT NEOPLASM OF VAGINA - MALIGNANT NEOPLASM OF FEMALE GENITAL ORGAN SITE UNSPECIFIED

185 MALIGNANT NEOPLASM OF PROSTATE

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MALIGNANT NEOPLASM OF TRIGONE OF URINARY BLADDER - MALIGNANT NEOPLASM OF BLADDER PART UNSPECIFIED

MALIGNANT NEOPLASM OF KIDNEY EXCEPT PELVIS - MALIGNANT NEOPLASM OF URINARY ORGAN SITE UNSPECIFIED

MALIGNANT NEOPLASM OF EYEBALL EXCEPT CONJUNCTIVA CORNEA RETINA AND CHOROID - MALIGNANT NEOPLASM OF EYE PART UNSPECIFIED

MALIGNANT NEOPLASM OF CEREBRUM EXCEPT LOBES AND VENTRICLES - MALIGNANT NEOPLASM OF BRAIN UNSPECIFIED SITE

MALIGNANT NEOPLASM OF CRANIAL NERVES - MALIGNANT NEOPLASM OF NERVOUS SYSTEM PART UNSPECIFIED

193 MALIGNANT NEOPLASM OF THYROID GLAND

194.1 MALIGNANT NEOPLASM OF ADRENAL GLAND

194.2 MALIGNANT NEOPLASM OF PARATHYROID GLAND

194.5 MALIGNANT NEOPLASM OF CAROTID BODY

194.6 MALIGNANT NEOPLASM OF AORTIC BODY AND OTHER PARAGANGLIA

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MALIGNANT NEOPLASM OF HEAD FACE AND NECK - MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES

198.3 SECONDARY MALIGNANT NEOPLASM OF BRAIN AND SPINAL CORD

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HODGKIN'S PARAGRANULOMA UNSPECIFIED SITE - HODGKIN'S DISEASE UNSPECIFIED TYPE INVOLVING LYMPH NODES OF MULTIPLE SITES

NODULAR LYMPHOMA UNSPECIFIED SITE - OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE INVOLVING LYMPH NODES OF MULTIPLE SITES

225.1 BENIGN NEOPLASM OF CRANIAL NERVES

225.2 BENIGN NEOPLASM OF CEREBRAL MENINGES

227.3 BENIGN NEOPLASM OF PITUITARY GLAND AND CRANIOPHARYNGEAL DUCT

227.4 BENIGN NEOPLASM OF PINEAL GLAND

227.6 BENIGN NEOPLASM OF AORTIC BODY AND OTHER PARAGANGLIA

233.0 CARCINOMA IN SITU OF BREAST

747.81 CONGENITAL ANOMALIES OF CEREBROVASCULAR SYSTEM

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity N/A

XX000 Not Applicable

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

Medical record documentation maintained by the provider must indicate the medical necessity for IMRT, and include all of the following for IMRT planning and delivery:

• The treatment plan/prescription must define the goals and requirements of the treatment, including the specific dose constraints for the target(s) and nearby critical structures.

• A statement by the treating physician documenting the special need for performing IMRT on the patient in question, rather than performing conventional or three-dimensional treatment planning and delivery. The physician must address the other organs at risk and/or adjacent critical structures.

• Radiation oncologist review of dose-volume histograms for all targets and critical structures.

• Description of the number and location of each treatment step/rotation or portal to accomplish the treatment plan.

• Documentation of dosimetric verification of treatment setup and delivery, signed by both the radiation oncologist and the medical physicist.

• For compensator-based IMRT, the unique compensator design should be documented for east step or portal.

Other procedures performed during the episode of care must have documentation that supports the professional and technical components as applicable by identifying the place of service, the date of service, the supervising

physician, and proof of work.

Appendices

Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or medical standards of practice. When services are performed in excess of established parameters, they may be subject to review for medical necessity.

Procedures billed should be consistent with CPT code descriptors and Medicare valuation. The frequency of such procedures in the episode of care and the units on a given day must meet standards of care.

Sources of Information and Basis for Decision

American College of Radiology, American Society for Therapeutic Radiology and Oncology (2001). Model Policy on Intensity Modulated Radiation Therapy. Fairfax, VA. Author. This source supports the appropriate indication for use.

American Society Therapeutic Radiation Oncology/American College Radiology Guide to Radiation Oncology Coding. (2007).

American Society Therapeutic Radiation Oncology/American College Radiology Guide to Radiation Oncology Coding. (2008 Supplement).

Bradley, J., Graham, M., Winter, K., Purdy, J., Komaki, R., Roa, W., Ryu, J., Bosch, W., & Emami, B. (2005). Toxicity and outcome results of RTOG 9311: A phase I-II dose-escalation study using three-dimensional conformal radiotherapy in patients with inoperable non-small-cell lung carcinoma. Int . J. Radiation Oncology Bio. Phys., 61(2), 318-328.

Chen, M., Hayman, J., Haken, R., Tatro, D., Fernando, S., & Kong, F. (2006). Long-term results of high-dose conformal radiotherapy for patients with medically inoperable T1-3N0 non-small-cell lung cancer: is low incidence of regional failure due to incidental nodal irradiation. Int . J. Radiation Oncology Bio. Phys., 64(1), 120-126.

Freedman, G., Li, T., Nicolaou, N. Chen, Y., Ma, C., & Anderson, P. (2009). Breast intensity-modulated radiation therapy reduces time spent with acute dermatitis for women of all breast sizes during radiation. Int. J. Radiation Oncology Biol. Pys., 74(3), 689-694.

Intensity-Modulated Radiotherapy Collaborative Working Group. (2001). Intensity-modulated radiotherapy: current status and issues of interest. International Journal of Radiation Oncology, Biology, Physics, 54(4), 880- 914. This source supports the appropriate indication for use.

Mell, L., Schomas, D., Salama, J., Devisetty, K., Aydogan, B., Miller, R., Jani, A., Kindler, H., Mundt, A., Roeske, J., & Chmura, S. (2008).Association between bone marrow dosimetric parameters and acute hematologic toxicity in anal cancer patients treated with concurrent chemotherapy and intensity-modulated radiotherapy. Int . J. Radiation Oncology Bio. Phys., 70(5), 1431-1437.

Milano, M., Chmura, S., Garofalo, M., Rash, C., Roeske, J., Connell, P., Kwon, O., Jani, A., & Heimann, R. (2004). Intensity-modulated radiotherapy in treatment of pancreatic and bile duct malignancies: Toxicity and clinical outcome. Int . J. Radiation Oncology Bio. Phys., 59(2), 445-453.

Nutting, C.M., Convery, D.J., Cosgrove, V.P., et al. (2000). Reduction of small and large bowel irradiation using an optimized intensity modulated pelvic radiotherapy technique in-patients with prostate cancer. International Journal of Radiation Oncology, Biology, Physics, 48 (3), 649-656. This source supports the appropriate indication for use.

Pirzkall, A., Carol, M., Lohr, F., et al. (2000). Comparison of intensity modulated radiotherapy with conventional conformal radiotherapy for complex-shaped tumors. International Journal of Radiation Oncology, Biology, Physics, 48(5), 1371-1380. This source supports the appropriate indication for use.

Salama, J., Mell, L., Schomas, D., Miller, R., Devisetty, K., Jani, A., Mundt, A., Roeske, J., Liauw, S., & Chmura,

S. (2007). Concurrent chemotherapy and intensity-modulated radiation therapy for anal canal cancer patients: A multicenter experience. Journal of Clinical Oncology, 25(29), 4581-4586.

Shu, H.G., Lee, T, Vigneault, E., et al. (2001). Toxicity following high-dose 3-dimensional and intensity- modulated radiation therapy for clinically localized prostate cancer. Urology, 57(1), 102-107. This source provides a description of services and provides indications for the appropriate use.

Sura, S., Gupta, V., Yorke, E., Jackson, A., Amols, H., & Rosenzweig, K. (2008). Intensity-modulated radiation therapy (IMRT) for inoperable non-small cell lung cancer: The Memorial Sloan-Kettering Cancer Center (MSKCC) experience. Radiotherapy and Oncology.87, 17-23.

Trailblazer LCD

Xia, P., Fu, K., Wong, G., et al. (2000). Comparison of treatment plans involving intensity modulated

radiotherapy for nasopharyngeal carcinoma. International Journal of Radiation Oncology, Biology, Physics, 48 (2), 329-337. This source supports the appropriate indication for use.

Yom, S., Liao, Z., Liu, H., Tucker, S., Hu, C., Wei, X., Wang, X., Wang, S., Mohan, R., Cox, J., & Komaki, R. (2007). 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. Radiation Oncology Bio.

Phys., 68(1), 94-102.

Zelefsky, M. J., Fuks, Z., et al (2000). Clinical experiences with intensity modulated radiation therapy (IMRT) in prostate cancer. Radiotherapy Oncology, 55(3), 241-249. This source supports the appropriate indication for use.

Advisory Committee Meeting Notes This policy does not reflect the sole opinion of the contractor or contractor medical director. Although the final decision rests with the contractor, this policy was developed in cooperation

with advisory groups, which includes representatives from oncologist and radiology societies.

Start Date of Comment Period 06/01/2009

End Date of Comment Period 07/15/2009

Start Date of Notice Period 08/20/2009

Revision History Number 1

Revision History Explanation Revision Number:1 Start Date of Comment Period:06/01/2009

Start Date of Notice Period:08/20/2009 Revised Effective Date: 10/05/2009

LCR A2009-076

August 2009 Bulletin

Explanation of Revision: LCD revised in the following sections: ‘Indications and Limitations of Coverage and/or Medical Necessity’ section; revisions include: Statement added to specify that indications will include some left breast tumors due to risk to immediately adjacent cardiac and pericardial structures, and selected right breast cases in larger volume breasts and larger chest wall separation distances. The following new sections have been added under ‘Indications and Limitations of Coverage and/or Medical Necessity’ section: ‘Patient-Specific IMRT Treatment Verification’, ‘Use of Clinical Treatment Planning in IMRT (CPT Code 77263) Prior to the Specific IMRT Treatment Plan (CPT Code 77301)’, ‘Use of Simulation-Aided Field Setting in IMRT (CPT Code 77290)’, ‘Use of Intensity Modulated Radiotherapy Plan (CPT Code 77301), Including Dose Volume Histograms for Target and Critical Structure Partial Tolerance Specification’, ‘Use of 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 (CPT Code 77300) in IMRT’, ‘Use of Teletherapy Isodose Plan in IMRT (CPT codes 77305

-77321)’, ‘Use of Brachytherapy Isodose Plan in IMRT (CPT Codes 77326-77328)’, ‘Use of Special Dosimetry in IMRT (CPT Code 77331)’, ‘Use of Treatment Devices (e.g., “Blocks”) in IMRT (CPT Codes 77332-77334)’, ‘Use of Continuing Medical Physics Consultation in IMRT (Weekly Physics QA: CPT Code 77336)’, ‘Use of Special Medical Radiation Physics Consultation in IMRT (CPT Code 77370)’, ‘Use of Other Radiation Treatment Delivery on the Same Day as IMRT Treatment Delivery (CPT Codes 77418, 0073T)’, ‘Radiation Treatment Management (CPT Code 77427)’, ‘Use of “Special Treatment Procedure” in IMRT (CPT Code 77470)’, ‘Image Guided Radiation Therapy (IGRT) Codes (CPT codes 76950, 77014, 77421)’. The ‘ICD-9 Codes that Support Medical Necessity’ section has been revised to add ICD-9 codes for CPT/HCPCS codes 0073T, 77301 and 77418. The ‘Documentation Requirements’ section has been revised to include requirements for IMRT planning and delivery. The ‘Utilization Guidelines’ section has also been revised and the ‘Sources of Information and Basis for Decision’ section has been updated. The “Coding Guidelines” have been retired. The effective date of this revision is based on date of

service.

Revision Number:Original

Start Date of Comment Period:N/A Start Date of Notice Period:12/04/2008 Revised Effective Date:02/16/2009

LCR A2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the fiscal intermediary predecessors of First Coast Service Options, Inc. (COSVI and FCSO).

For Florida (00090) this LCD (L28892) replaces LCD L3013 as the policy in notice. This document (L28892) is effective on 02/16/2009.

8/1/2010 - The description for Bill Type Code 12 was changed 8/1/2010 - The description for Bill Type Code 13 was changed 8/1/2010 - The description for Bill Type Code 85 was changed

8/1/2010 - The description for Revenue code 0333 was changed

11/21/2010 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:

0073T descriptor was changed in Group 1

77301 descriptor was changed in Group 1 77418 descriptor was changed in Group 1

Reason for Change