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FUTURE RETIREMENT Local Coverage Determination (LCD)

Intensity Modulated Radiation Therapy (IMRT)

L36773

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
First Coast Service Options, Inc.	A and B MAC	09101 - MAC A	J - N	Florida
First Coast Service Options, Inc.	A and B MAC	09102 - MAC B	J - N	Florida
First Coast Service Options, Inc.	A and B MAC	09201 - MAC A	J - N	Puerto Rico Virgin Islands
First Coast Service Options, Inc.	A and B MAC	09202 - MAC B	J - N	Puerto Rico
First Coast Service Options, Inc.	A and B MAC	09302 - MAC B	J - N	Virgin Islands

LCD Information

Document Information

LCD ID
L36773

LCD Title
Intensity Modulated Radiation Therapy (IMRT)

Proposed LCD in Comment Period
N/A

Source Proposed LCD
DL36773

Original Effective Date
For services performed on or after 11/07/2016

Revision Effective Date
For services performed on or after 07/31/2019

Revision Ending Date
N/A

Retirement Date
ANTICIPATED 12/19/2024

Notice Period Start Date
09/22/2016

Notice Period End Date
11/06/2016

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.

Copyright © 2024, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the AHA copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution, or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

CMS National Coverage Policy

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for Intensity Modulated Radiation Therapy (IMRT). Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for Intensity Modulated Radiation Therapy (IMRT) and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site.

Internet Only Manual (IOM) Citations:

CMS IOM Publication 100-04, Medicare Claims Processing Manual,
- Chapter 4, Section 200.3 Billing Codes for Intensity Modulated Radiation Therapy (IMRT) and Stereotactic Radiosurgery (SRS), Section 200.3.1 Billing for IMRT Planning and Delivery
- Chapter 13, Section 70.5 Radiation Physics Services
CMS IOM Publication 100-08, Medicare Program Integrity Manual,
- Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD

Social Security Act (Title XVIII) Standard References:

Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.
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 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Intensity Modulated Radiation Therapy (IMRT) is a computer-based method of planning for, and delivery of generally narrow, patient specific, spatially and often temporally 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 that are determined by various computer-based optimization techniques.

The computer based optimization process is referred to as ‘inverse planning'. Inverse planning develops a dose distribution based on the input of specific dose constraints for the planned treatment volume (PTV) and nearby clinical structures and is the beginning of the IMRT treatment planning process. The gross tumor volume (GTV), the PTV and surrounding normal tissues must be identified by a contouring procedure and the optimization must sample the dose with a grid spacing of 1 centimeter or less.

Covered Indications:

IMRT is clinically indicated when highly conformal dose planning is required. IMRT planning may be clinically indicated when one or more of the following conditions are present:

An immediately adjacent area has been previously irradiated and abutting portals must be established with high precision.
Dose escalation is planned to deliver radiation doses in excess of those commonly utilized for similar tumors with conventional treatment.
The target volume is concave or convex, and the critical normal tissues are within or around that convexity or concavity.
The target volume is in close proximity to critical structures that must be protected.
The volume of interest must be covered with narrow margins to adequately protect immediately adjacent structures.

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

Primary, metastatic or benign tumors of the central nervous system including the brain, the 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: orbits, sinuses, skull base, aero-digestive tract, and salivary glands
Thoracic malignancies
Abdominal malignancies when dose constraints to small bowel or other normal abdominal tissue are exceeded and present administration of a therapeutic dose
Pelvic malignancies including: prostatic, gynecological and anal carcinoma
Other pelvic or retroperitoneal malignancies.

Other malignancies not delineated in the above can be supported with submission of documentation for medical necessity should a denial occur. The determination of appropriateness and medical necessity for IMRT for any site shall be found in the documentation from the radiation oncologist and must be available when requested or submitted in the appeals process.

Limitations:

IMRT is not considered reasonable and necessary when at least one of the criteria listed in the "Coverage Indications, Limitations, and/or Medical Necessity" section of this LCD are not present.

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

where IMRT does not offer an advantage over conventional or three-dimensional conformal radiation therapy techniques that deliver good clinical outcomes and low toxicity
clinical urgency, such as spinal cord compression, superior vena cave syndrome or airway obstruction
palliative treatment of metastatic disease where the prescribed dose does not approach normal tissue tolerances
inability to accommodate for organ motion, such as for a mobile lung tumor
inability of the patient to cooperate and tolerate immobilization to permit accurate and reproducible dose delivery

There must be documented rationale of the advantage of IMRT versus the use of other radiation therapy methods in the medical record of each patient for whom IMRT is provided.

The CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 13, section 13.5.4 outlines that reasonable and necessary services are ordered and/or furnished by qualified personnel; IMRT services will be considered reasonable and necessary only when performed by appropriately trained providers. Hence, a qualified physician for this service is defined as follows: Training and expertise must have been acquired within the framework of an accredited residency and/or fellowship program in the applicable specialty/ subspecialty, i.e., Radiation Oncology.

It is expected that all personnel involved in administering, supervising, and treating patients for the indications outlined in this LCD meet the regulations set forth by each state or district, as well as for Medicare and the Nuclear Regulatory Commission (NRC), as applicable. These personnel include the radiation oncologist or other qualified physician radiation/medical physicist, radiation technologist and radiation assistant. These compliances must be made available when requested.

Free standing facilities (office or clinic), hospital based practices, and mobile delivery units affiliated with a place of service (POS) must meet Federal and local (state) radiation protection guidelines in regard to patient safety and quality assurance as well as the physician supervision requirements.

As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.

Summary of Evidence

N/A

Analysis of Evidence (Rationale for Determination)

N/A

Proposed Process Information

Synopsis of Changes

Changes	Fields Changed
	N/A

Associated Information

Sources of Information

Bibliography

Open Meetings

Contractor Advisory Committee (CAC) Meetings

MAC Meeting Information URLs

Proposed LCD Posting Date

Comment Period Start Date

Comment Period End Date

Reason for Proposed LCD

Requestor Name	Requestor Letter
	View Letter

Requestor Information

Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code	Description
Please accept the License to see the codes.

Revenue Codes

Code	Description
Please accept the License to see the codes.

ICD-10-CM Codes that Support Medical Necessity

ICD-10-CM Codes that DO NOT Support Medical Necessity

Additional ICD-10 Information

General Information

Associated Information

Documentation Requirements

Please refer to the Local Coverage Article: Billing and Coding: Intensity Modulated Radiation Therapy (IMRT) (A56746) for documentation requirements that apply to the reasonable and necessary provisions outlined in this LCD.

Utilization Guidelines

Please refer to the Local Coverage Article: Billing and Coding: Intensity Modulated Radiation Therapy (IMRT) (A56746) for utilization guidelines that apply to the reasonable and necessary provisions outlined in this LCD.

Sources of Information

ACR-ASTRO Practice Parameter for Intensity Modulated Radiation Therapy (IMRT). Practice Guideline. Amended 2014 (Resolution 39); 1-11.

ASTRO Model Policies for Intensity Modulated Radiation Therapy (IMRT), 2015

ASTRO Radiation Oncology Coding Resource, Updated April 1, 2016 (E-Book)

Bibliography

N/A

Revision History Information

Revision History Date	Revision History Number	Revision History Explanation	Reasons for Change
07/31/2019	R4	12/06/2019: The content in the LCD was revised to be consistent with the new format supported by CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.1.	Other
07/31/2019	R3	Revision Number: 3 Publication: July 2019 Connection LCR A/B2019-040 Explanation of Revision: Based on CR 10901, the LCD was revised to remove all billing and coding and all language not related to reasonable and necessary provisions (“Bill Type Codes”, “Revenue Codes”, “CPT/HCPCS Codes”, “ICD-10 Codes that Support Medical Necessity”, “Documentation Requirements” and “Utilization Guidelines” sections of the LCD) and place them into a newly created billing and coding article. Also, the CMS IOM language has been removed from the LCD and instead, the IOM citation related to this language is referenced in the “CMS National Coverage Policy” section of the LCD. The effective date of this revision is for claims processed on or after January 8, 2019, for dates of service on or after October 3, 2018. In addition, during the process of moving the ICD-10-CM diagnosis codes to the billing and coding article, the ICD-10-CM diagnosis code ranges were broken out and listed individually and any ICD-10-CM diagnosis codes not meeting LCD medical necessity were removed. They are as follows: D49.511, D49.512, and D49.59. Also the following ICD-10-CM diagnosis codes were added: C09.9, C34.91, C34.92, C38.3, C4A.59, C43.59, C44.09, C49.A1, C7A.090, C7B.02, C7B.04, C7B.1, C76.0, C77.1, C77.2, C77.3, C77.4, C77.5, C77.8, C78.01, C78.02, C78.1, C78.2, C78.39, C78.4, C78.5, C78.6, C78.7, C78.89, C79.82, C83.09, C83.19, C83.39, C83.59, C83.79, C85.21, C85.22, C85.23, C85.24, C85.25, C85.26, C85.27, C85.28, C85.29, C85.81, C85.82, C85.83, C85.84, C85.85, C85.86, C85.87, C85.88, C85.89, C85.91, C85.92, C85.93, C85.94, C85.95, C85.96, C85.97, C85.98, C85.99, C88.4, C90.20, C90.22, C90.32, D33.0, D33.1, D33.4, D33.7, D35.5, D43.0, D43.1, D43.3, D43.4, D43.8, D44.3, D44.4, D44.5, D44.6, D44.7, and D48.1. The effective date of this revision is for dates of service on or after October 3, 2018. 07/31/2019: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination and therefore not all the fields included on the LCD are applicable as noted in this LCD.	Other (Revisions based on CR 10901)
10/01/2018	R2	Revision Number: 2 Publication: September 2018 Connection LCR A/B2018-074 Explanation of Revision: Based on CR 10847 (Annual 2019 ICD-10-CM Update) the LCD was revised. Deleted ICD-10-CM diagnosis code ranges C43.11 - C43.12, C4A.11 - C4A.12, C44.112 - C44.119, C44.122 - C44.129, and C44.192 - C44.199 and replaced them with ICD-10-CM diagnosis code ranges C43.111 - C43.122, C4A.111 - C4A.122, C44.1121 - C44.1192, C44.1221 - C44.1292 and C44.1921 - C44.1992, respectively. Also, added ICD-10-CM diagnosis code range C44.1321-C44.1392. The effective date of this revision is based on date of service. 10/01/2018: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination and therefore not all the fields included on the LCD are applicable as noted in this LCD.	Revisions Due To ICD-10-CM Code Changes
10/01/2017	R1	Revision Number: 1 Publication: September 2017 Connection LCR A/B2017-038 Explanation of Revision: Based on CR 10153 (Annual 2018 ICD-10-CM Update) the LCD was revised. Added ICD-10-CM diagnosis codes C96.20 – C96.29. Deleted ICD-10-CM diagnosis code C96.2. The effective date of this revision is based on date of service. 10/01/2017: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination and therefore not all the fields included on the LCD are applicable as noted in this policy.	Revisions Due To ICD-10-CM Code Changes

Associated Documents

Attachments
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Updated On	Effective Dates	Status
12/06/2019	07/31/2019 - N/A	Currently in Effect	You are here
07/18/2019	07/31/2019 - N/A	Superseded	View
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Intensity Modulated Radiation Therapy (IMRT)

Document Note

Note History

Contractor Information

LCD Information

Document Information

Issue

CMS National Coverage Policy

Coverage Guidance

Proposed Process Information

Coding Information

Bill Type Codes

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Revenue Codes

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CPT/HCPCS Codes

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ICD-10-CM Codes that Support Medical Necessity

Group 1

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Additional ICD-10 Information

General Information

Revision History Information

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