Local Coverage Determination (LCD)

Chemotherapy Drugs and their Adjuncts

L37205

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L37205
Original ICD-9 LCD ID
Not Applicable
LCD Title
Chemotherapy Drugs and their Adjuncts
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL37205
Original Effective Date
For services performed on or after 09/16/2017
Revision Effective Date
For services performed on or after 11/30/2023
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
08/01/2017
Notice Period End Date
09/15/2017
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

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.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

Copyright © 2024, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (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.

Issue

Issue Description

Biannual review was completed with no change in coverage.

Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Italicized font -represents CMS national NCD language/wording copied directly from CMS Manuals or CMS Transmittals.  Contractors are prohibited from changing national NCD language/wording.

CMS Pub. 100-02 Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health Services, Section 50, Drugs and Biologicals

CMS Pub. 100-04 Medicare Claims Processing Manual, Chapter 12, Physician/Nonphysician Practitioners, Section 30.5, Payment for Codes for Chemotherapy Administration and Nonchemotherapy Injections and Infusions

CMS Pub. 100-04 Medicare Claims Processing Manual, Chapter 14, Ambulatory Surgical Centers, Section 10, General

CMS Pub. 100-04 Medicare Claims Processing Manual, Chapter 17, Drugs and Biologicals, Section 90.2, Drugs, Biologicals, and Radiopharmaceuticals

CR 9749: August 24, 2016, CPT G0498: Chemo extend IV infusion with pump

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

This LCD addresses the coverage for chemotherapy agents based on the patient’s condition, the appropriateness of the dose and route of administration, based on the clinical condition, medical necessity and the standard of medical practice regarding the effectiveness of the drug for the diagnosis and condition.

  1. Per this LCD, chemotherapy agents may be covered if reasonable and medical necessity is met

    AND

    • the drug is FDA approved

    AND

    • listed in the NCCN Clinical Practice Guidelines in Oncology (NCCN) with the specific ICD-10 diagnosis (that is being treated) for the drug/agent.
      • the chemotherapy agent must be listed Category 1 or 2A in NCCN,
      • the chemotherapy agent must be utilized per the NCCN Recommended Use (order or combination).
  2. If the medically accepted indications are listed in one of the other Medicare approved compendia (Micromedex DrugDex as Class I, Class IIa, or Class IIb; American Hospital Formulary Service -Drug Information (AHFS) narrative text is “supportive”; Clinical Pharmacology narrative text is “supportive”; or Lexi-Drugs is listed as “Use Off-Label” and rated as “evidence level A”). A use is not medically accepted if the indication appears in the Medicare approved compendia as: NCCN as Category 3; Micromedex DrugDex as Class III; AHFS narrative text is “not supportive”; Clinical Pharmacology narrative text “not supportive”; or Lexi-Drugs is listed as “use: Unsupported”.
Summary of Evidence

A compendium is a listing of U.S. Food and Drug Administration (FDA) approved drugs and biologics. In some cases, compendia specialize in a particular subset of drugs, such as those used for anti-cancer treatment. Compendia include a summary of how each drug works in the body, as well as information for health care practitioners about proper dosing and whether the drug is recommended or endorsed for use in treating a specific disease. The compendia employ various rating and recommendation systems that may not be readily cross-walked from compendium to compendium.   

As a practical matter, WPS GHA is aware of the broad availability and use of the NCCN guidelines and compendia in oncology clinical practice. While the CMS Pub. 100-02 Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health Services, Section 50, Drugs and Biologicals instructions regarding compendia do not give exclusive status to any one of the named compendia, WPS GHA finds that NCCN is more commonly cited by oncology practitioners and providers who seek coverage for chemotherapy. With that in mind, unlabeled uses of chemotherapy are covered, as noted above in Coverage Guidance. This is to assist the provider in real-time coverage that is in accordance with a compendium.  

The contractor may also consider individual cases with provided published peer reviewed literature if the claim denies and the provider feels the treatment is medically necessary. 

The development and coverage guidelines in this policy were based on a review of pertinent medical literature, Medicare regulations, policies from other Medicare contractors, the Medicare approved compendia, and discussions with appropriate specialists. 

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) is a fundamental activity of the National Comprehensive Cancer Network. The NCCN Guidelines are updated in an evidence-based process integrated with the expert judgment of multidisciplinary panels of expert physicians from NCCN Member Institutions.

Analysis of Evidence (Rationale for Determination)

Level of evidence
Quality-Strong
Strength-Strong
Weight-Strong

Chemotherapy is an ever-expanding area. New agents are frequently receiving FDA approval for cancer treatment, and the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) is a guiding source for appropriate off-label uses of these chemotherapy agents.

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
N/A
Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
View Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description
N/A

Revenue Codes

Code Description
N/A

CPT/HCPCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

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

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information

Documentation Requirements
The medical record should include the disease being treated with the name and dosage of the drug being administered. The patient's medical record must contain documentation that fully supports the medical necessity for services included within this LCD. This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.

Utilization Guidelines
Coverage for medication is based on the patient’s condition, the appropriateness of the dose and route of administration, based on the clinical condition and the standard of medical practice regarding the effectiveness of the drug for the diagnosis and condition. The drug must be used according to the indication and protocol listed in the accepted compendia ratings listed in this LCD.

Sources of Information

N/A

Bibliography

American Hospital Formulary Service Drug Information.

Compendia for Coverage of Off-Label Uses of Drugs and Biologics in an Anticancer Chemotherapeutic Regimen: Final Report. US Department of Health & Human Services - Centers for Medicare and Medicaid Services. 2007. Available at https://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id46TA.pdf

National Comprehensive Cancer Network (NCCN). https://www.nccn.org/

United States Pharmacopeia Drug Information (USP-DI).

United States Pharmacopeia Drug Information: Drug Information for the Health Care Professional. Vol 1.27th ed. Greenwood Village, CO: Thomson Micromedex 2007:1733-1739.

United States Pharmacopeia National Formulary (USP-NF).

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
11/30/2023 R6

Posted 11/30/2023 Hyperlinks were removed from CMS National Coverage Policy regulations. Spelling errors were corrected under Bibliography to the word Pharmacopeia. Review was completed 10/26/2023.

  • Other (Review)
05/26/2022 R5

Posted 05/26/2022-Under CMS National Coverage Policy where referencing CMS Pub 100-04, Medicare Benefit Policy Manual was changed to Medicare Claims Processing Manual.

  • Other (Review)
12/30/2021 R4

12/30/2021 Review completed 10/22/2021. Under summary of evidence, removed paragraph containing duplicate information. Moved information from Summary of Evidence to Coverage Guidance 2.If the medically accepted indications are listed in one of the other Medicare approved compendia (Micromedex DrugDex as Class I, Class IIa, or Class IIb; American Hospital Formulary Service -Drug Information (AHFS) narrative text is “supportive”; Clinical Pharmacology narrative text is “supportive”; or Lexi-Drugs is listed as “Use Off-Label” and rated as “evidence level A”). A use is not medically accepted if the indication appears in the Medicare approved compendia as: NCCN as Category 3; Micromedex DrugDex as Class III; AHFS narrative text is “not supportive”; Clinical Pharmacology narrative text “not supportive”; or Lexi-Drugs is listed as “use: Unsupported”.

  • Other (Review)
11/28/2019 R3

11/28/2019 Associated A55640: Not Otherwise Classified Chemotherapy Agents (NOC) retired effective 11/28/2019 and link removed. Content has been moved to the new template. Review completed 11/01/2019.

  • Other (Formatting change)
11/01/2019 R2

Change Request 10901 Local Coverage Determinations (LCDs): it will no longer be appropriate to include Current Procedure Terminology (CPT)/Health Care Procedure Coding System (HCPCS) codes or International Classification of Diseases Tenth Revision-Clinical Modification (ICD-10-CM) codes in the LCDs. All CPT/HCPCS, ICD-10 codes, and Billing and Coding Guidelines have been removed from this LCD and placed in the Billing and Coding Article related to this LCD. Consistent with Change Request 10901, if any language from IOMs and/or regulations was present in the LCD, it has been removed and the applicable manual/regulation has been referenced.

  • Revisions Due To Code Removal
08/01/2018 R1

08/01/2018 Annual review completed 06/29/2018. Grammatical corrections made. No change in coverage.

  • Other (Annual review)
N/A

Associated Documents

Attachments
N/A
Related National Coverage Documents
N/A
Public Versions
Updated On Effective Dates Status
11/20/2023 11/30/2023 - N/A Currently in Effect You are here
05/17/2022 05/26/2022 - 11/29/2023 Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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