Superseded Local Coverage Article

Treatment with Yttrium-90 Microspheres

A54072

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Superseded
To see the currently-in-effect version of this document, go to the section.

Contractor Information

Article Information

General Information

Article ID
A54072
Original ICD-9 Article ID
A52207
Article Title
Treatment with Yttrium-90 Microspheres
Article Type
Article
Original Effective Date
10/01/2015
Revision Effective Date
04/12/2018
Revision Ending Date
N/A
Retirement Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

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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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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®. 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® (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®. TheraSphere® 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.


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 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.

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.

N/A

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
CodeDescription
C2616 BRACHYTHERAPY SOURCE, NON-STRANDED, YTTRIUM-90, PER SOURCE
Q3001 RADIOELEMENTS FOR BRACHYTHERAPY, ANY TYPE, EACH

ICD-10-CM Codes that are Covered

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
CodeDescription
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
CodeDescription
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
CodeDescription
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
CodeDescription
C22.0 Liver cell carcinoma

ICD-10-CM Codes that are Not Covered

N/A

Revision History Information

Revision History DateRevision History NumberRevision History Explanation
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®.

Associated Documents

Related Local Coverage Documents
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Related National Coverage Documents
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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
05/07/2020 04/12/2018 - N/A Currently in Effect View
04/02/2018 04/12/2018 - N/A Superseded You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

  • Sirtex
  • Nordion
  • TheraSphere
  • SIR-Spheres
  • HDE
  • Humanitarian Device Exemption
  • brachytherapy