RETIRED LCD Reference Article Billing and Coding Article

Billing and Coding: Treatment with Yttrium-90 Microspheres

A54072

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Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.
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Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A54072
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: Treatment with Yttrium-90 Microspheres
Article Type
Billing and Coding
Original Effective Date
10/01/2015
Revision Effective Date
04/12/2018
Revision Ending Date
11/01/2023
Retirement Date
11/01/2023
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.

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CMS National Coverage Policy

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Article Guidance

Article Text

Noridian receives requests for coverage of the treatment of various conditions with yttrium-90 microspheres. If all requirements of the Federal Drug Administration’s (FDA) Premarket Approval (PMA) approved indications (full approval based on safety and efficacy), use of yttrium microspheres will be covered. If the treatment indication is under study with an Investigation Device Exemption (IDE), submit an application for (IDE) study coverage.

JF Part A: https://www.noridianmedicare.com/parta/forms/mr_forms/fda_approved_ide_mac.pdf.
JF Part B: https://www.noridianmedicare.com/partb/forms/mr_forms/fda_approved_ide_mac.pdf.

If the product has FDA Humanitarian Device Exemption (HDE) approval (reasonable safety but efficacy not demonstrated), submit the claim for payment, noting the HDE number in Item 19 of the 1500 Claim Form or the electronic equivalent for Part B billings. If the claim is denied, appeal and request a Contractor Medical Director (CMD) review. For additional information, see the Noridian article titled “Humanitarian Use Devices and Humanitarian Device Exemptions.”

Background: At the current time there are two companies that manufacture and sell yttrium-90 microspheres in the USA: Sirtex and MDS Nordion.
Sirtex
o Sirtex manufactures resin microspheres called SIR-Spheres&reg. This product is FDA-approved for the treatment of colorectal metastases (mCRC) to the liver when the liver tumors are unresectable.
o There is a RCT study in the USA called SIRFLOX, involving SIR-Spheres&reg (under an IDE) in combination with FOLFOX6 +/- Avastin as a first line treatment for patients with metastatic colorectal cancer (mCRC).

MDS Nordion
o MDS Nordion manufactures glass microspheres called TheraSphere&reg. TheraSphere&reg has HDE approval from the FDA for the treatment of hepatocellular cancer (HCC) for use in “radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma (HCC) who can have placement of appropriately positioned hepatic arterial catheters.
o The device is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion, when clinical evaluation warrants the treatment.”
o Nordion has opened IDE studies for use of the product in the treatment of unresectable advanced HCC if the patient is not eligible for any curative procedures and for whom standard-of-care therapy with sorafenib is planned.


Response To Comments

Number Comment Response
1
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Coding Information

Bill Type Codes

Code Description
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Revenue Codes

Code Description
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CPT/HCPCS Codes

Group 1

(2 Codes)
Group 1 Paragraph

Coding Information:
Providers are instructed to bill Q3001 when using either SIR-Spheres or TheraSpheres in a non-OPPS facility setting. Providers must place the name of the device and invoice price in Item 19 of the CMS 1500 Claim Form or the electronic equivalent or the claim will be denied for Part B billings.

Group 1 Codes
Code Description
C2616 BRACHYTHERAPY SOURCE, NON-STRANDED, YTTRIUM-90, PER SOURCE
Q3001 RADIOELEMENTS FOR BRACHYTHERAPY, ANY TYPE, EACH
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CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

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Group 1 Codes

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ICD-10-CM Codes that Support Medical Necessity

Group 1

(10 Codes)
Group 1 Paragraph

Manufacturer: Sirtex Medical
Brachytherapy device name: SIR-Spheres®
FDA status:
Full PMA approval for mCRC
IDE for mCRC (+FOLFOX6+Avastin)
Particle: Resin particle with Y-90
HCPCS Code: C2616

ICD-10 C78.7 and 1) either a diagnosis from Group 1 or Group 2 (or both).

Group 1

Group 1 Codes
Code Description
C18.0 Malignant neoplasm of cecum
C18.1 Malignant neoplasm of appendix
C18.2 Malignant neoplasm of ascending colon
C18.3 Malignant neoplasm of hepatic flexure
C18.4 Malignant neoplasm of transverse colon
C18.5 Malignant neoplasm of splenic flexure
C18.6 Malignant neoplasm of descending colon
C18.7 Malignant neoplasm of sigmoid colon
C18.8 Malignant neoplasm of overlapping sites of colon
C18.9 Malignant neoplasm of colon, unspecified

Group 2

(6 Codes)
Group 2 Paragraph

Group 2

Group 2 Codes
Code Description
C19 Malignant neoplasm of rectosigmoid junction
C20 Malignant neoplasm of rectum
C21.0 Malignant neoplasm of anus, unspecified
C21.1 Malignant neoplasm of anal canal
C21.2 Malignant neoplasm of cloacogenic zone
C21.8 Malignant neoplasm of overlapping sites of rectum, anus and anal canal

Group 3

(1 Code)
Group 3 Paragraph

OR 2) ICD-10 C78.7 and

Group 3 Codes
Code Description
Z85.038 Personal history of other malignant neoplasm of large intestine

Group 4

(1 Code)
Group 4 Paragraph

Manufacturer: MDS Nordion
Brachytherapy device name: TheraSphere®
FDA status:
HDE for HCC
IDE for HCC (+ Sorafenib)
Particle: Glass matrix with Y-90
HCPCS Code: C2616

Group 4 Codes
Code Description
C22.0 Liver cell carcinoma
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ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

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Group 1 Codes

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ICD-10-PCS Codes

Group 1

Group 1 Paragraph

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Group 1 Codes

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Additional ICD-10 Information

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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 article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

Code Description
N/A

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 article, 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 article should be assumed to apply equally to all Revenue Codes.

Code Description
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Other Coding Information

Group 1

Group 1 Paragraph

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Group 1 Codes

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Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Revision History Information

Revision History Date Revision History Number Revision History Explanation
11/01/2023 R4

Coverage articles may be retired due to lack of evidence of current problems or CMS may have issued guidance regarding national coverage. The Noridian guidance in the retired article may still be helpful in assessing medical necessity. Where providers have adjusted their billing and coding practices to correspond to the guidance in a coverage article, they will want to be very careful in departing from these practices just because the article is retired. Provider offices remain responsible for correct performance, coding, billing, and medical necessity under Medicare. This responsibility for correct claims submission is unchanged whether or not there is a coverage article in place.

04/12/2018 R3

As required by CR 10901, article is converted to a formal billing and coding type article. There is no change in coverage.

04/12/2018 R2

This article effective 4/12/2018, combines JEA A54071 in JEB A54072 so that both JEA and JEB Contract numbers will have the same final MCD Article number A54072.

09/15/2014 R1 Dual diagnostic criteria is added when billing for SIR-Spheres®.
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
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Related National Coverage Documents
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SAD Process URL 1
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SAD Process URL 2
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Statutory Requirements URLs
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Rules and Regulations URLs
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CMS Manual Explanations URLs
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Other URLs
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Public Versions
Updated On Effective Dates Status
11/01/2023 04/12/2018 - 11/01/2023 Retired You are here
05/07/2020 04/12/2018 - N/A Superseded View
04/02/2018 04/12/2018 - N/A Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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