According to the American Academy of Ophthalmology EyeWiki, “Geographic atrophy is a chronic progressive degeneration of the macula, as part of late-stage age-related macular degeneration (AMD). The disease is characterized by localized sharply demarcated atrophy of outer retinal tissue, retinal pigment epithelium and choriocapillaris. It starts typically in the perifoveal region and expands to involve the fovea with time, leading to central scotomas and permanent loss of visual acuity. It is bilateral in most cases. Over 8 million people are affected worldwide with GA, approximately 20% of all individuals with AMD. The incidence of GA is expected to rise as the age-burden of developed countries is increasing.”¹

Q. How is geographic atrophy (GA) identified?

A. During an eye exam, indirect ophthalmoscopy is used to examine the fundus. When the examiner identifies an abnormal appearance in the macula, additional diagnostic tests may be ordered. Fundus autofluorescence (FAF), a type of fundus photography, is a noninvasive imaging modality for mapping naturally and pathologically occurring fluorophores in the posterior pole.²

Hypoautofluorescence is associated with GA. Clinically, the ophthalmologist will see a macula decorated with drusen and a sharply demarcated area in the macular region with atrophic retina, lacking pigmentation and visible underlying choroidal vessels.¹

Optical coherence tomography (OCT) also provides important information about intraretinal fluid and development of concurrent choroidal neovascularization. To evaluate visual function, microperimetry is useful. Finally, multifocal electroretinography is useful for differentiating GA from intermediate AMD.

From a billing perspective, the ophthalmologist may perform fundus photography (92250) and OCT of the macula (92134) on the same day, but bill just one of them due to explicit bundles within the National Correct Coding Initiative (NCCI). Select the diagnostic test with the greatest clinical utility to bill.

Q. How is GA treated?

A. Historically, there has been no treatment. Two new drugs are in development: avacincaptad pegol (Iveric Bio) and pegcetacoplan (Apellis) with approvals anticipated in early 2023. Both are complement inhibitors that slow the growth of GA. Pegcetacoplan inhibits complement factor C3 and avacinacaptad pegol inhibits complement factor C5. The results of clinical trials have been mostly encouraging due to the potential to preserve vision, but there are concerns about adverse events and side effects.^3-5 Ophthalmologists will need to carefully weigh the risks and benefits during the patient selection process. Higher risk patients with foveal encroachment will likely be prioritized over lower risk patients.

Q. How are avacincaptad pegol and pegcetacoplan administered?

A. These medications are administered by the ophthalmologist by intravitreal injection (CPT 67028). This procedure is already common for the treatment of another form of macular degeneration — exudative AMD.

Q. Are there any HCPCS J-codes for intravitreal complement inhibitors to treat GA?

A. Not yet. Complement inhibitors are classified as drugs,⁶ so J3490 (unclassified drugs) is a temporary identifier on a claim for reimbursement until permanent HCPCS codes are assigned. Importantly, don’t confuse intravitreal pegcetacoplan with Empaveli subcutaneous infusion (Apellis) that is reported with J7799 (“not otherwise classified” drugs, other than inhalation drugs, administered through home medical equipment). The distinction between them is the route of administration.

Q. What chart documentation is important for intravitreal injections?

A. Intravitreal injections are common and associated with frequent requests for additional documentation after a claim for reimbursement. Reviewers can be very critical when information is missing. Key elements include indication for the intravitreal injection, eye(s) injected, procedure description, drug description, dose, discard of any leftover drug, and discharge instructions.

Q. What are the reimbursement implications if the ophthalmologist injects a complement inhibitor and an anti-VEGF agent in the same eye on the same day?

A. CMS has developed Medically Unlikely Edits (MUEs) within the NCCI to reduce improper payments for Part B claims.⁷ An MUE identifies the maximum units of service that a provider could report under most circumstances for a single beneficiary on a single date of service. CPT 67028 has an MUE of 1. Consequently, only 1 injection will be reimbursed for this situation. Reimbursements for the pharmaceuticals are not affected by MUEs.

Q. What is the CMS policy on billing for free samples of drugs?

A. When a company provides free samples for physician evaluation, only the procedure is billed on a claim for reimbursement and not the supply. CMS has a longstanding policy that free samples are ineligible for reimbursement.⁸ RP

Editor’s note: Listen to discussion of this article on the Retina Podcast at www.retinapodcast.com .

REFERENCES

1. American Academy of Ophthalmology. Geographic atrophy. Accessed November 18, 2022. https://eyewiki.aao.org/Geographic_Atrophy
2. American Academy of Ophthalmology. Fundus autofluorescence. Accessed November 18, 2022. https://eyewiki.aao.org/Fundus_Autofluorescence
3. Apellis. Apellis announces pegcetacoplan showed continuous and clinically meaningful effects at month 18 in phase 3 DERBY and OAKS studies for geographic atrophy (GA). News release. Accessed November 18, 2022. https://investors.apellis.com/news-releases/news-release-details/apellis-announces-pegcetacoplan-showed-continuous-and-clinically
4. Liao DS, Metapally R, Joshi P. Pegcetacoplan treatment for geographic atrophy due to age-related macular degeneration: a plain language summary of the FILLY study. Immunotherapy. 2022;14(13):995-1006. doi:10.2217/imt-2022-0078
5. Iveric Bio. Iveric bio, Inc. announced positive topline results from GATHER2, the company’s second phase 3 clinical trial of Zimura® (avacincaptad pegol), a novel investigational complement C5 inhibitor, for the treatment of geographic atrophy (GA). News release. Accessed December 6, 2022. https://investors.ivericbio.com/news-releases/news-release-details/iveric-bio-announces-positive-topline-data-zimurar-gather2-phase
6. Ricklin D, Lambris JD. Complement-targeted therapeutics. Nat Biotechnol. 2007;25(11):1265-1275. doi:10.1038/nbt1342
7. Centers for Medicare & Medicaid Services. Medicare NCCI medically unlikely edits (MUEs). Accessed November 18, 2022. https://www.cms.gov/medicare-medicaid-coordination/national-correct-coding-initiative-ncci/ncci-medicare/medicare-ncci-medically-unlikely-edits
8. MBPM chapter 16 §40 no legal obligation to pay. Accessed November 18, 2022. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c16.pdf