Local Coverage Article Billing and Coding

Billing and Coding: Voretigene Neparvovec-rzyl (Luxturna®)

A56419

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Contractor Information

Article Information

General Information

Article ID
A56419
Article Title
Billing and Coding: Voretigene Neparvovec-rzyl (Luxturna®)
Article Type
Billing and Coding
Original Effective Date
05/06/2019
Revision Effective Date
01/01/2023
Revision Ending Date
N/A
Retirement Date
N/A
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CMS National Coverage Policy

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

Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

CMS Internet-Only Manual, Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, §50 Drugs and Biologicals

CMS Internet-Only Manual, Pub 100-04, Medicare Claims Processing Manual, Chapter 23, §30 Services Paid Under the Medicare Physician's Fee Schedule

CMS Internet-Only Manual, Pub 100-04, Medicare Claims Processing Manual, Chapter 30 Financial Liability Protections

Article Guidance

Article Text

The information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) for voretigene neparvovec-rzyl (Luxturna®) L37863.

Coding Guidelines:

General Guidelines for Claims submitted to Part A or Part B MAC:

Procedure codes may be subject to National Correct Coding Initiative (NCCI) edits or Outpatient Prospective Payment System (OPPS) packaging edits. Refer to NCCI and OPPS requirements prior to billing Medicare.

For services requiring a referring/ordering physician, the name and national provider identifier (NPI) of the referring/ordering physician must be reported on the claim.

A claim submitted without a valid ICD-10-CM diagnosis code will be returned to the provider as an incomplete claim under Section 1833(e) of the Social Security Act.

The diagnosis code(s) must best describe the patient's condition for which the service was performed. For diagnostic tests, report the result of the test if known; otherwise, the symptoms prompting the performance of the test should be reported.

Advance Beneficiary Notice of Noncoverage (ABN) Modifier Guidelines

An ABN may be used for services which are likely to be non-covered, whether for medical necessity or for other reasons. Refer to CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 30 Financial Liability Protections, for complete instructions.

Effective from April 1, 2010, non-covered services should be billed with modifier –GA, -GX, -GY, or –GZ, as appropriate. 

The –GA modifier (“Waiver of Liability Statement Issued as Required by Payer Policy”) should be used when physicians, practitioners, or suppliers want to indicate that they anticipate that Medicare will deny a specific service as not reasonable and necessary, and they do have an ABN signed by the beneficiary on file. Modifier GA applies only when services are expected to be denied because they do not meet the Medicare program requirements for reasonable and necessary care. Effective April 1, 2010, Part A Medicare Administrative Contractors (MAC) systems will automatically deny services billed with modifier GA. An ABN, Form CMS-R-131, should be signed by the beneficiary to indicate that ‎he/she accepts responsibility for payment.‎ The -GA modifier may also be used on assigned claims when a patient refuses to sign the ABN and the latter is properly witnessed. For claims submitted to the Part A MAC, occurrence code 32 and the date of the ABN is required.

Modifier GX (“Notice of Liability Issued, Voluntary Under Payer Policy”) should be used when the beneficiary has signed an ABN, and a denial is anticipated based on provisions other than medical necessity, such as statutory exclusions of coverage or technical issues. An ABN is not required for these denials, but if non-covered services are reported with modifier GX, Part A MAC systems will automatically deny the services.

The –GZ modifier should be used when physicians, practitioners, or suppliers want to indicate that they expect that Medicare will deny an item or service as not reasonable and necessary and they have not had an ABN signed by the beneficiary. ‎

If the service is statutorily non-covered, or without a benefit category, submit the ‎appropriate CPT/HCPCS code with the -GY modifier. An ABN is not required for these denials, and the limitation of liability does not apply for beneficiaries. Services with modifier GY will automatically deny. 

Specific coding guidelines for this policy:

Voretigene neparvovec-rzyl (Luxturna®) is a gene therapy product approved by the United States (U.S.) Food and Drug Administration (FDA) for treatment of vision loss due to certain heritable retinal dystrophies with confirmed biallelic RPE65 mutation-associated retinal dystrophies. Specifically, this represents approximately 2% of cases of autosomal recessive retinitis pigmentosa (RP) and 8-16% of cases of Leber congenital amaurosis (LCA).

A single treatment with 1.5x1011 vector genomes of voretigene neparvovec-rzyl (Luxturna®) administered by subretinal injection per eye per lifetime has been found to clinically improve functional vision in patients with RP and LCA with biallelic mutations of the RPE65 gene with sufficient viable photoreceptors.

Treatment of the contralateral eye must occur no sooner than 6 days and no later than 18 days after treatment of the first eye.

The safety and effectiveness of more than 1 treatment per eye per lifetime has not been established.

For Part A and B Services:

For dates of service 07/01/18 through 12/31/18, to report Luxturna® on a claim, use the HCPCS code C9032 and the appropriate modifier (-RT or –LT) designating the recipient eye. Effective for dates of service on and after 01/01/19, the HCPCS code J3398 should be used to report Luxturna® on a claim along with the appropriate modifier (-RT or –LT) designating the recipient eye.

For all dates of service, the number of HCPCS units administered must be reported on the claim (service units (field locator 46) of the UB-04 (CMS 1450 form)); Box 24g of the CMS 1500 form or electronic equivalent). Additionally, the 11-digit National Drug Code (NDC) must be reported in the revenue description field (Form Locator 43) without delimiters, such as commas or hyphens on the UB-04 (CMS 1450 form) or the equivalent 5010 electronic claims field; or in the shaded area of Box 24.A. of the CMS 1500 form or its electronic equivalent.

In addition to the HCPCS and NDC codes for Luxturna®, the requisite pars plana vitrectomy (PPV) and subretinal injection surgical procedures should be reported as CPT® code 67036 and CPT® code 67299. The appropriate site modifier (-RT or –LT) must be appended to each of the surgical CPT® codes.

Manufacturer-designated Centers of Excellence certification must be noted in Box 19 of CMS 1500 form or equivalent electronic claim field.

Submission of all of the required elements outlined in the Documentation Requirements section of the companion LCD is also required for payment of claims for Luxturna®.

Coding Information

CPT/HCPCS Codes

Group 1

(3 Codes)
Group 1 Paragraph

Note: Providers are reminded to refer to the long descriptors of the CPT/HCPCS codes in their CPT® book.

The following CPT/HCPCS codes are used for reporting the procedures associated with the subretinal injection of voretigene neparvovec-rzyl (Luxturna®).

Group 1 Codes
CodeDescription
67036 VITRECTOMY, MECHANICAL, PARS PLANA APPROACH;
67299 UNLISTED PROCEDURE, POSTERIOR SEGMENT
J3398 INJECTION, VORETIGENE NEPARVOVEC-RZYL, 1 BILLION VECTOR GENOMES

CPT/HCPCS Modifiers

Group 1

(4 Codes)
Group 1 Paragraph

N/A

Group 1 Codes
CodeDescription
GA WAIVER OF LIABILITY STATEMENT ISSUED AS REQUIRED BY PAYER POLICY, INDIVIDUAL CASE
GX NOTICE OF LIABILITY ISSUED, VOLUNTARY UNDER PAYER POLICY
GY ITEM OR SERVICE STATUTORILY EXCLUDED, DOES NOT MEET THE DEFINITION OF ANY MEDICARE BENEFIT OR, FOR NON-MEDICARE INSURERS, IS NOT A CONTRACT BENEFIT
GZ ITEM OR SERVICE EXPECTED TO BE DENIED AS NOT REASONABLE AND NECESSARY

ICD-10-CM Codes that Support Medical Necessity

Group 1

(2 Codes)
Group 1 Paragraph

Note: It is the provider’s responsibility to select codes carried out to the highest level of specificity and selected from the ICD-10-CM code book appropriate to the year in which the service is rendered for the claim(s) submitted.

 

Group 1 Codes
CodeDescription
H35.50 Unspecified hereditary retinal dystrophy
H35.52 Pigmentary retinal dystrophy

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

N/A

ICD-10-PCS Codes

N/A

Additional ICD-10 Information

N/A

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

Other Coding Information

N/A

Revision History Information

Revision History DateRevision History NumberRevision History Explanation
01/01/2023 R7

Under CPT/HCPCS Codes Group 1: Codes the description was revised for 67299. This revision is due to the 2023 Annual/Q1 CPT/HCPCS Code Update and is retroactive effective for dates of service on or after 1/1/23.

04/08/2021 R6

Under CMS National Coverage Policy added regulation Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Under Article Text subsection Coding Guidelines: General Guidelines for Claims submitted to Part A or Part B MAC revised verbiage in seventh paragraph, second sentence to read “Modifier GA applies only when services are expected to be denied because they do not meet the Medicare program requirements for reasonable and necessary care”. Formatting errors were corrected throughout the article. Acronyms were inserted where appropriate throughout the article.

05/28/2020 R5

Under Article Title changes were made to remove trademark and add registered mark. Under CMS National Coverage Policy added “prohibits Medicare payment for any claim which lacks the necessary information to process the claim” to Title XVIII of the Social Security Act, §1833(e) and added CMS Internet-Only Manual, Pub 100-04, Medicare Claims Processing Manual, Chapter 30 Financial Liability Protections. Under CPT/HCPCS Modifiers Group 1: Codes added GZ. Formatting, punctuation and typographical errors were corrected throughout the Article. Acronyms were inserted where appropriate throughout the Article. Luxturna® was added where applicable throughout the Article.

10/24/2019 R4

This article is being revised in order to adhere to CMS requirements per chapter 13, section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs and incorporate into related Billing and Coding Articles. Regulations regarding billing and coding were removed from the CMS National Coverage Policy section of the related Voretigene Neparvovec-rzyl (Luxturna™) L37863 LCD and placed in this article. Under CPT/HCPCS Modifiers Group 1: Codes added GA, GX, GY. The registered trademark symbol was added throughout article where applicable. Acronyms were defined throughout the article. Formatting, punctuation and typographical errors were corrected throughout the article.

 

09/05/2019 R3

Under Contract Number removed contract 11004 as it was inadvertently added with Revision 1.

06/17/2019 R2

Under Article Text the verbiage “All coding located in the Coding Information section has been removed from the related Voretigene Neparvovec-rzyl L37863 Local Coverage Determination (LCD) and added to this article” has been deleted. Under CPT/HCPCS Codes Group 1: Paragraph the word “Injections” has been deleted and the verbiage “Note: Providers are reminded to refer to the long descriptors of the CPT/HCPCS codes in their CPT book. The following CPT/HCPCS codes are used for reporting the procedures associated with the subretinal injection of voretigene neparvovec (LuxturnaTM)” has been added. Under CPT/HCPCS Codes Group 1: Codes the following CPT codes have been added: 67036, 67299. Under CPT/HCPCS Codes Group 1: Codes C9032 has been deleted. CPT/HCPCS Codes Group 2: Paragraph and Group 2: Codes have been deleted. Under Covered ICD-10 Codes Group 1: Paragraph the verbiage “Note: It is the provider’s responsibility to select codes carried out to the highest level of specificity and selected from the ICD-10-CM code book appropriate to the year in which the service is rendered for the claim(s) submitted” has been added.

 

05/06/2019 R1

The information in this article contains billing, coding or other guidelines that complement the Voretigene Neparvovec-rzyl L37863 Local Coverage Determination (LCD).

 

Associated Documents

Related Local Coverage Documents
LCDs
L37863 - Voretigene Neparvovec-rzyl (Luxturna®)
Related National Coverage Documents
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Statutory Requirements URLs
N/A
Rules and Regulations URLs
N/A
CMS Manual Explanations URLs
N/A
Other URLs
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Public Versions
Updated On Effective Dates Status
01/10/2023 01/01/2023 - N/A Currently in Effect You are here
03/30/2021 04/08/2021 - 12/31/2022 Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

  • Luxturna
  • Vorteigene neparvovec-rzyl