Billing and Coding: Voretigene Neparvovec-rzyl (Luxturna)

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 under the **Documentation
Requirements** section of the related LCD is also required for payment of
claims for Luxturna.