LCD : Intensity Modulated Radiation Therapy (IMRT) (L13228)

LCD for Intensity Modulated Radiation Therapy (IMRT) (L13228)

Contractor Information

Contractor Name

BlueCross BlueShield of Tennessee (Riverbend Government Benefits Administrator)

Contractor Number

00390

Contractor Type

LCD Information

LCD ID Number

L13228

LCD Title

Intensity Modulated Radiation Therapy (IMRT)

Contractor's Determination Number

L13228

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2007 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

CMS National Coverage Policy

Title XVIII of the Social Security Act, Section 1862 (a)(1)(A). This section excludes coverage of items or services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Title XVIII of the Social Security Act, Section 1862 (a)(7). This section prohibits Medicare payment for any expenses on items and services incurred for routine physical examinations.

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

Primary Geographic Jurisdiction

New Jersey
Tennessee

Secondary Geographic Jurisdiction

Alaska
Alabama
Arkansas
Arizona
California
Colorado
Connecticut
Florida
Georgia
Hawaii
Iowa
Idaho
Illinois
Indiana
Kansas
Kentucky
Louisiana
Massachusetts
Maryland
Maine
Michigan
Minnesota
Missouri
Mississippi
North Carolina
North Dakota
Nebraska
New Jersey
New Mexico
Nevada
New York
Ohio
Oklahoma
Oregon
Pennsylvania
Rhode Island
South Carolina
Tennessee
Texas
Utah
Virginia
Vermont
Washington
Wisconsin
West Virginia
Wyoming

Oversight Region

Region IV

Original Determination Effective Date

For services performed on or after 09/30/2003

Original Determination Ending Date

Revision Effective Date

For services performed on or after 04/25/2006

Revision Ending Date

Indications and Limitations of Coverage and/or Medical Necessity

CMS National Coverage Policy References

Intensity Modulated Radiation Therapy (IMRT) is a form of external beam irradiation utilizing three-dimensional conformal therapy. It includes:

CT image-based computer modeling to plan therapy and;
An intensity modulated delivery system containing a dynamic multi-leaf collimator to deliver multiple beams of highly focused radiation doses.

IMRT uses computers to modify the intensity of the beam across each individual field with the use of moving collimators. Conventional treatment with multi-leaf collimation (MLC) utilizes static positions of the collimator leaves whereas IMRT allows the dynamic motion of the various collimator leaves during each session of therapy.

IMRT is not a replacement therapy for conventional and 3D conformal radiation therapy methods in every situation. IMRT is indicated to treat tumors that have close proximity to vital organs and structures if those adjacent structures would be significantly exposed to collateral damage using conventional techniques. It is particularly suited to the treatment of irregularly shaped tumor volumes and in the high dose treatment of tumors whose location next to normal organs would otherwise have prohibited that higher dose treatment.

As no randomized trials currently support specific indications of IMRT, coverage will be applied to neoplasms that have shown benefit based on use and research from Centers of Excellence. IMRT is therefore an acceptable modality and WILL BE assumed to be medically necessary for the treatment of:

1. Primary malignant lesions of the central nervous system;

2. Secondary malignant neoplasms of the central nervous system;

3. Primary benign lesions of the central nervous system;

4. Malignant lesions of the head and neck (excluding skin lesions lacking any of the JUSTIFYING CONDITIONS noted below);

5. Malignant lesions of the prostate;

6. Unresectable retroperitoneal sarcoma and extremity sarcoma;

7. Lung cancer and upper abdominal/peri-diaphragmatic (hepato-biliary or mesothelioma) cancers that have unacceptable motion with breathing;

8. Pancreatic and adrenal tumors.

The routine use of IMRT will be considered INVESTIGATIONAL for other indications, including breast cancer, colon cancer, and metastatic cancer to the vertebral bodies. However IMRT MAY BE still considered reasonable and necessary WITH SUPPORTING MEDICAL DOCUMENTATION when at least one of the following JUSTIFYING CONDITIONS exist:

1. Vital organs/structures are in close proximity such that accuracy and extremely high precision are required beyond that available with conventional radiation therapy.

2. Tumor volume has been previously irradiated and immediately adjacent portals must be established with high precision.

3. Gross Tumor Volume (GTV) margins are irregular and in close proximity to critical structures that must be protected to avoid unacceptable morbidity.

4. Only the IMRT method would decrease the probability of grade 2 or grade 3-radiation toxicity compared to conventional radiation in greater than 15 percent of radiated similar cases.

An advance beneficiary notice should be signed when a provider/supplier deems services exceed the accepted standard of medical practice and is not medically necessary.

Coverage Topic

Radiation Therapy (Inpatient)
Radiation Therapy (Outpatient)

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.

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-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
0073T	COMPENSATOR-BASED BEAM MODULATION TREATMENT DELIVERY OF INVERSE PLANNED TREATMENT USING THREE OR MORE HIGH RESOLUTION (MILLED OR CAST) COMPENSATOR CONVERGENT BEAM MODULATED FIELDS, PER TREATMENT SESSION

ICD-9 Codes that Support Medical Necessity

141.0 - 141.9	MALIGNANT NEOPLASM OF BASE OF TONGUE - MALIGNANT NEOPLASM OF TONGUE UNSPECIFIED
142.0 - 142.9	MALIGNANT NEOPLASM OF PAROTID GLAND - MALIGNANT NEOPLASM OF SALIVARY GLAND UNSPECIFIED
144.0 - 144.9	MALIGNANT NEOPLASM OF ANTERIOR PORTION OF FLOOR OF MOUTH - MALIGNANT NEOPLASM OF FLOOR OF MOUTH PART UNSPECIFIED
145.0 - 145.9	MALIGNANT NEOPLASM OF CHEEK MUCOSA - MALIGNANT NEOPLASM OF MOUTH UNSPECIFIED
146.0 - 146.9	MALIGNANT NEOPLASM OF TONSIL - MALIGNANT NEOPLASM OF OROPHARYNX UNSPECIFIED SITE
147.0 - 147.9	MALIGNANT NEOPLASM OF SUPERIOR WALL OF NASOPHARYNX - MALIGNANT NEOPLASM OF NASOPHARYNX UNSPECIFIED SITE
148.0 - 148.9	MALIGNANT NEOPLASM OF POSTCRICOID REGION OF HYPOPHARYNX - MALIGNANT NEOPLASM OF HYPOPHARYNX UNSPECIFIED SITE
149.0 - 149.9	MALIGNANT NEOPLASM OF PHARYNX UNSPECIFIED - MALIGNANT NEOPLASM OF ILL-DEFINED SITES WITHIN THE LIP AND ORAL CAVITY
150.0 - 150.9	MALIGNANT NEOPLASM OF CERVICAL ESOPHAGUS - MALIGNANT NEOPLASM OF ESOPHAGUS UNSPECIFIED SITE
155.0 - 155.2	MALIGNANT NEOPLASM OF LIVER PRIMARY - MALIGNANT NEOPLASM OF LIVER NOT SPECIFIED AS PRIMARY OR SECONDARY
156.0 - 156.9	MALIGNANT NEOPLASM OF GALLBLADDER - MALIGNANT NEOPLASM OF BILIARY TRACT PART UNSPECIFIED SITE
157.0 - 157.9	MALIGNANT NEOPLASM OF HEAD OF PANCREAS - MALIGNANT NEOPLASM OF PANCREAS PART UNSPECIFIED
158.0 - 158.9	MALIGNANT NEOPLASM OF RETROPERITONEUM - MALIGNANT NEOPLASM OF PERITONEUM UNSPECIFIED
160.0 - 160.9	MALIGNANT NEOPLASM OF NASAL CAVITIES - MALIGNANT NEOPLASM OF ACCESSORY SINUS UNSPECIFIED
161.0 - 161.9	MALIGNANT NEOPLASM OF GLOTTIS - MALIGNANT NEOPLASM OF LARYNX UNSPECIFIED
162.0 - 162.9	MALIGNANT NEOPLASM OF TRACHEA - MALIGNANT NEOPLASM OF BRONCHUS AND LUNG UNSPECIFIED
163.0 - 163.9	MALIGNANT NEOPLASM OF PARIETAL PLEURA - MALIGNANT NEOPLASM OF PLEURA UNSPECIFIED
171.2	MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF UPPER LIMB INCLUDING SHOULDER
171.3	MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF LOWER LIMB INCLUDING HIP
173.3	OTHER MALIGNANT NEOPLASM OF SKIN OF OTHER AND UNSPECIFIED PARTS OF FACE
173.4	OTHER MALIGNANT NEOPLASM OF SCALP AND SKIN OF NECK
185	MALIGNANT NEOPLASM OF PROSTATE
190.0 - 190.9	MALIGNANT NEOPLASM OF EYEBALL EXCEPT CONJUNCTIVA CORNEA RETINA AND CHOROID - MALIGNANT NEOPLASM OF EYE PART UNSPECIFIED
191.0 - 191.9	MALIGNANT NEOPLASM OF CEREBRUM EXCEPT LOBES AND VENTRICLES - MALIGNANT NEOPLASM OF BRAIN UNSPECIFIED SITE
192.0 - 192.9	MALIGNANT NEOPLASM OF CRANIAL NERVES - MALIGNANT NEOPLASM OF NERVOUS SYSTEM PART UNSPECIFIED
194.0	MALIGNANT NEOPLASM OF ADRENAL GLAND
194.3	MALIGNANT NEOPLASM OF PITUITARY GLAND AND CRANIOPHARYNGEAL DUCT
194.4	MALIGNANT NEOPLASM OF PINEAL GLAND
195.0	MALIGNANT NEOPLASM OF HEAD FACE AND NECK
197.0	SECONDARY MALIGNANT NEOPLASM OF LUNG
197.6	SECONDARY MALIGNANT NEOPLASM OF RETROPERITONEUM AND PERITONEUM
197.7	MALIGNANT NEOPLASM OF LIVER SECONDARY
198.3	SECONDARY MALIGNANT NEOPLASM OF BRAIN AND SPINAL CORD
198.4	SECONDARY MALIGNANT NEOPLASM OF OTHER PARTS OF NERVOUS SYSTEM
198.7	SECONDARY MALIGNANT NEOPLASM OF ADRENAL GLAND
225.0	BENIGN NEOPLASM OF BRAIN
225.1	BENIGN NEOPLASM OF CRANIAL NERVES
225.2	BENIGN NEOPLASM OF CEREBRAL MENINGES
225.9	BENIGN NEOPLASM OF NERVOUS SYSTEM PART UNSPECIFIED
227.3	BENIGN NEOPLASM OF PITUITARY GLAND AND CRANIOPHARYNGEAL DUCT
227.4	BENIGN NEOPLASM OF PINEAL GLAND
237.0	NEOPLASM OF UNCERTAIN BEHAVIOR OF PITUITARY GLAND AND CRANIOPHARYNGEAL DUCT
237.1	NEOPLASM OF UNCERTAIN BEHAVIOR OF PINEAL GLAND
237.2	NEOPLASM OF UNCERTAIN BEHAVIOR OF ADRENAL GLAND
237.5	NEOPLASM OF UNCERTAIN BEHAVIOR OF BRAIN AND SPINAL CORD
237.6	NEOPLASM OF UNCERTAIN BEHAVIOR OF MENINGES

Diagnoses that Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity

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

Diagnoses that DO NOT Support Medical Necessity

General Information

Documentation Requirements

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

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

2. A statement by the treating physician (either in the medical record or supplementing it) documenting the special need for performing IMRT on the patient, rather than performing conventional or three-dimensional treatment planning and delivery.

Appendices

Utilization Guidelines

Sources of Information and Basis for Decision

Other contractor’s policy (First Coast Service Options, Inc. and Empire Medicare Services).

Program Memorandum A-02-026. March 28, 2002.

American Medical Association. CPT codes.

Bibliography:

1.Ajay K. Bhatnager, MD, et al., “Intensity-Modulated Radiation Therapy (IMRT) Reduces the Dose to the Contralateral Breast When Compared to Conventional Tangential Fields for Primary Breast Irradiation: Initial Report,” The Cancer Journal, Volume 10, Number 6 November/December 2004 2004 Jones and Bartlett Publishers, Inc.

2.Martin Keisch,MD and Frank Vicini MD, “Applying Innovations in Surgical and Radiation Oncology to Breast Conservation Therapy,” The Breast Journal, Volume 11, Suppl. 1, 2005 S24-S29. 2005 Blackwell Publishing, Inc.
3.FA Vicini, et al., “Optimizing Breast Cancer Treatment Efficacy with Intensity-Modulated Radiotherapy”, International Journal of Radiation Oncology, Biology, Physics, Volume 54, December 1, 2002 pp. 1336-44 Available from http://search.epnet.com/login.aspx?direct=true&db=cmedm&an=12459355

4.Janet Gordils-Perez, RN, MA, OCN, Robin Rawlins-Duell, RN, BSN, OCN, and Joanne Frankel Kelvin, RN, MSN, AOCN “Advances in Radiation Treatment of Patients with Breast Cancer,” Clinical Journal of Oncology Nursing, November/December 2003 Volume 7, Number 6, 631.

5. M.T. Guerrero Urbano, MRCPI, FRCR and C. M. Nutting, MRCP, FRCR, MD
“Clinical use of Intensity-Modulated Radiotherapy: part II” The British Journal of Radiology, March 2004, 181 Ó2004 The British Institute of Radiology

6.James D. Cross, M.D., National Medical Director, Cover Letter and Aetna IMRT Policy, January 2006.

7.Riverbend GBA Local Coverage Determination, “Intensity Modulated Radiation Therapy (IMRT)” L13228, Revised 04/24/2006

8. E.A. Krueger, B.A. Fraass, L.J. Pierce, “Clinical Aspects of Intensity-Modulated Radiotherapy in the treatment of Breast Cancer,” Seminars in Radiation Oncology, July 2002 pp. 250-259 Available from
http://search.epnet.com/login.aspx?direct=true&db=cmedm&an=12118390

9. Maurice Tubiana and Francois Eschwege, “Conformal Radiotherapy and Intensity Modulated Radiotherapy, Acta Oncologica Vol. 39, 50.5, pp 555-567, 2000 ©Taylor & Francis 2000

10. G. M. Freedman, et al., “Intensity Modulated radiation Therapy (IMRT) decreases Acute Skin Toxicity for Women Receiving radiation for Breast Cancer,“ American Journal of Clinical Oncology, February 2006, Volume 29(1), pp 66-70 ©2006 EBSCO Publishing Available from: http://search.epnet.com/login.aspx?direct=true&db=cmedm&an=16462506

11. J.S. Li, et al., “Clinical Implementation of Intensity-Modulated Tangential Beam Irradiation for Breast Cancer”, Medical Physics May 2004, Volume 31(5), pp. 1023-31. ©2006 EBSCO Publishing Available from: http://search.epnet.com/login.aspx?direct=true&db=cmedm&an=15191288

12.L. Olofsson, et al., “Intensity Modulated Radiation Therapy with Electrons using Algorithm Based Energy/Range Selection Methods”, Radiotherapy and Oncology; Journal of the European Society for Therapeutic Radiology and Oncology, November 2004, Volume 73(2), pp 223-31. ©2006 EBSCO Publishing Available at:
http://search.epnet.com/login.aspx?direct=true&db=cmedm&an=15542170

13. W Xiong, et al., “Optimization of combined Electron and Photon Beams for Breast Cancer”, Physics in Medicine and Biology May 21, 2004, Volume 49 (10), pp. 1973-89. ©2006 EBSCO Publishing Available at: http://search.epnet.com/login.aspx?direct=true&db=cmedm&an=15214536
14. Cancer Care Network, 7th Edition, 2005, Chapter 14 ©CCN 2005

15. Radiation Oncology, 2006 Edition, 181. American Medical Association Copyright @ 2005, Coding Strategies, Inc.

16.“Intensity Modulated Radiation Therapy (IMRT) (77301 and 77418)” Chapter Thirteen, pp. 71-75, ©2004 American Medical Association, All Rights Reserved.

17.A.K. Bhatnagar, et al., “Does Breast size affect the scatter dose to the ipsilateral lung, heart, or contralateral breast in primary breast irradiation using intensity-modulated radiation therapy (IMRT)?” American Journal of Clinical Oncology, February 2006 29(1):80-4 Available at www.pubmed.gov

18.M.L. Cavey, et al., “Dosimetric comparison of Conventional and Forward-planned Intensity Modulated Techniques for Comprehensive Locoregional Irradiation of Post-mastectomy Left Breast Cancers”, Medical Dosimetry; Official Journal of the American Association of Medical Dosimetrists 2005 Summer; Volume 30(2), pp. 107-116 ©EBSCO Publishing Available at: http://search.epnet.com/login.aspx?direct=true&db=cmedm&an=15922178

19.M. Guerrero, et al., “Simultaneous Integrated Boost for Breast Cancer using IMRT: a Radiobiological and Treatment Planning Study”, International Journal of Radiation Oncology, Biology, Physics August 1 2004, Volume 59 (5), pp. 1513-1522) 2006 ©EBSCO Publishing Available at:
http://search.epnet.com/login.aspx?direct=true&db=cmedm&an=15275739

20.A.K. Bhatnagar, et al., “Intensity-Modulated Radiation Therapy (KIMRT) reduces the Dose to the Contralateral Breast when Compared to Conventional Tangential Fields for Primary Breast Irradiation: Initial Report”. Cancer J. 2005 May-June;11(3). 252. Available at: www.pubmed.gov

21.J. G. Li, et al., “Breast-Conserving Radiation Therapy using Combined Electron and Intensity-Modulated Radiotherapy Technique”, Radiotherapy and Oncology: Journal of the European Society for Therapeutic Radiology and Oncology, July 2000, Volume 56 (1), pp 65-71. ©2006 EBSCO Publishing. Available at:
http://search.epnet.com/login.aspx?direct=true&db=cmedm&an=10869757

22. L.L. Kestin, et al., “Intensity Modulation to Improve Dose Uniformity with tangential Breast Radiotherapy: Initial Clinical Experience”, International Journal of Radiation Oncology, Biology, Physics, December 1, 2000, Volume 48 (5), pp. 1559-1568. ©2006 EBSCO Publishing. Available at:
http://search.epnet.com/login.aspx?direct=true&db=cmedm&an=11121662

23.C.S. Chui, et al., “A Simplified Intensity Modulated Radiation Therapy Technique for the Breast”, Medical Physics April 2002, Volume 29 (4), pp. 522-529Available at: http://search.epnet.com/login.aspx?direct=true&db=cmedm&an=11991123

24.Noridian Administrative Services, LLC, Medicare Part B, LCD L14577 “Intensity Modulated Radiation Therapy (IMRT)"

D3 Advanced Radiation Planning Services IMRT

IMRT. Varian Medical Systems. IMRT

IMRT. Cancer Treatment Centers of America. IMRT

Advisory Committee Meeting Notes

Public Open Meeting to discuss the draft policy was held 06/05/2003.

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 appropriate specialties as well as provider (facility) representatives.

Start Date of Comment Period

05/02/2003

End Date of Comment Period

06/15/2003

Start Date of Notice Period

08/14/2003

Revision History Number

L13228c

Revision History Explanation

04/25/2006 Bibliography added.

04/24/2006 CPT code 0073T was added to Group 1

11/07/2004 - The description for CPT/HCPCS code 77418 was changed in group 1

11/01/2005 - Added ICD-9 codes 141.0-141.9, 150.0-150.9, 161.0-161.9 to group 1

This LCD was converted from an LMRP on 12/8/2005

10/02/2007 - Frequently Asked Questions restored to Appendices.

03/18/2008 - Removed unprintable/bad characters as per email dated 02/28/2008 from CMS.

03/19/2008 - Frequently Asked Questions removed from Appendices