LCD/NCD Portal

L28939

 

OCULAR PHOTODYNAMIC THERAPY (OPT) WITH VERTEPORFIN

 

04/23/2012

 

Indications and Limitations of Coverage and/or Medical Necessity

 

Medicare will consider OPT with verteporfin medically reasonable and necessary when performed for the following indication:

• For the treatment of age-related macular degeneration in patients with predominantly classic subfoveal CNV lesions. (where the area of classic CNV occupies > 50% of the area of the entire lesion) at the initial visit as determined by a fluorescein angiogram. (CNV lesions are comprised of classic and/or occult components.).

• Prior to verteporfin OPT retreatment:

o Documentation of the patient’s condition must include fluorescein angiographic evidence of current leakage from CNV.

o There are NO requirements regarding:

 Visual acuity.

 Lesion size.

 Number of retreatments when treating predominantly classic lesions.

• Effective 04/01/2004, Medicare will consider OPT with verteporfin medically reasonable and necessary when performed for treating:

o Subfoveal occult with no classic CNV associated with AMD.

o Subfoveal minimally classic CNV (where the area of classic CNV occupies < 50% of the area of the entire lesion) associated with AMD.

o The above 2 indications are considered reasonable and necessary only when:

 The lesions are small (4 disk areas or less in size) at the time of initial treatment or within the 3 months prior to initial treatment.

And

 The lesions have shown evidence of progression within the 3 months prior to initial treatment.

• Evidence of progression must be documented by

o Deterioration of visual acuity (at least 5 letters on a standard eye examination chart).

o Lesion growth (an increase in at least 1 disk area).

o The appearance of blood associated with the lesion.

• Effective 06/07/2004, Medicare will consider OPT with verteporfin medically reasonable and necessary when performed for treating:

o Patients with predominantly classic subfoveal CNV associated with macular degeneration, secondary to presumed ocular histoplasmosis or pathologic myopia.

• Medicare will NOT consider the performance of OPT with verteporfin medically reasonable and necessary when ANY of the following circumstances exist:

o Inability to obtain photographs and an adequate, legible fluorescein angiogram to document CNV (including difficulty with venous access) unless there is a documented history of fluorescein allergy.

o There is no evidence of CNV leakage (as determined by fluorescein angiography).

• The use of OPT with verteporfin for other types of AMD (e.g. patients with juxtafoveal or extrafoveal CNV lesions (lesions outside the fovea), atrophic, or dry AMD) is NONCOVERED.

 

Limitations

• Central serous retinopathy (CSR) is a rare condition characterized by macular serous detachment which allows choroidal fluid to leak into the subretinal space.

o The build-up of fluid seems to occur because of small breaks in the retinal pigment epithelium.

• ICD-9-CM code 362.41 (Central serous retinopathy) is NOT a covered diagnosis given its use has not been demonstrated to be a standard of care and claims can be denied as not medically reasonable and necessary.

o MAC J9 will address individual consideration for claims with this diagnosis and records may be requested for prepayment review.

o The documentation must clearly support that the patient was refractory to standard treatments and that no reasonable alternative treatments were available.

o The record should clearly outline the indication (diagnostic criteria) and medical need (episode of care) for persistent CSR that does not resolve spontaneously after 3 months with the following indications present:

 The patient is having visual symptoms such as visual disturbance, distortion, or metamorphopsia.

And

 Optical coherence tomography (OCT) shows the presence of subretinal fluid involving the fovea.

And

 There is active angiographic leakage at the level of the retinal pigment epithelium (RPE) on fluorescein angiography (FA) caused by central serous retinopathy but no other diseases noted.

AND

 There is no complete resolution of the central serous retinopathy after 3 months

 

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 policy does not apply to that Bill Type.

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

 

13x Hospital Outpatient

85x Critical Access Hospital

 

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 policy 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 policy should be assumed to apply equally to all Revenue Codes.

 

0360 Operating Room Services - General Classification

0636 Pharmacy - Drugs Requiring Detailed Coding

 

CPT/HCPCS Codes

 

67221 DESTRUCTION OF LOCALIZED LESION OF CHOROID (EG, CHOROIDAL NEOVASCULARIZATION); PHOTODYNAMIC THERAPY (INCLUDES INTRAVENOUS INFUSION)

67225 DESTRUCTION OF LOCALIZED LESION OF CHOROID (EG, CHOROIDAL NEOVASCULARIZATION); PHOTODYNAMIC THERAPY, SECOND EYE, AT SINGLE SESSION (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY EYE TREATMENT)

J3396 INJECTION, VERTEPORFIN, 0.1 MG

 

 

ICD-9 Codes that Support Medical Necessity

 

115.02 HISTOPLASMA CAPSULATUM RETINITIS

115.92 HISTOPLASMOSIS RETINITIS UNSPECIFIED

360.21 PROGRESSIVE HIGH (DEGENERATIVE) MYOPIA

362.52 EXUDATIVE SENILE MACULAR DEGENERATION OF RETINA

 

ICD-9 Codes that DO NOT Support Medical Necessity

 

 

362.50 MACULAR DEGENERATION (SENILE) OF RETINA UNSPECIFIED

362.51 NONEXUDATIVE SENILE MACULAR DEGENERATION OF RETINA

 

 

Documentation Requirements

• Medical record documentation maintained by the performing physician must clearly indicate the medical necessity of the service being billed.

o In addition, documentation that the service was performed must be included in the patient's medical record.

o This information is normally found in the office/progress notes, hospital notes, and/or procedure/operative report.

• The documentation maintained by the performing physician should include the following:

o Evaluation and management exam including the name and total calculated drug dose (mg) of the photodynamic therapy drug administered and the patient's body surface area on which the dose of the drug is based.

o Fluorescein angiography report, which should include the description of the lesion (e.g., predominantly classic, unless there is a documented history of fluorescein allergy.

• Documentation should support the criteria for coverage as set forth in the “Indications and Limitations of Coverage and/or Medical Necessity” section of this policy.

 

Utilization Guidelines

• It is expected that these services would be performed as indicated by current medical literature and/or standards of practice.

o When services are performed in excess of established parameters, they may be subject to review for medical necessity.

• If it is determined on an individual case basis that CSR was medically reasonable and necessary, only one treatment of OPT with verteporfin would be expected.

 

Treatment Logic

• Ocular photodynamic therapy (OPT) is a form of treatment for the “wet” or exudative form of age-related macular degeneration (AMD).

o The wet form of macular degeneration involves the growth of abnormal blood vessels called choroidal neovascularization (CNV) beneath the retina resulting in leakage and bleeding.

o Without treatment, a majority of patients eventually develop scar tissue beneath the macula, which results in loss of central vision.

o The concept of OPT is to selectively close the abnormal blood vessels, eliminate the bleeding and leakage, and stabilize or improve the vision.

• OPT is similar to traditional laser ablation in that abnormal blood vessels are destroyed.

o However, it is unique in that the low intensity laser activation of the drug verteporfin (VISUDYNE) preserves the surrounding structures from destruction that is an unfortunate side effect of traditional thermal laser.

o This feature allows use of this treatment for preservation of vision when the CNV occurs close to the center of the macula.

• OPT is a two-step process.

o In the first step, the patient receives an intravenous injection of verteporfin.

o The verteporfin circulates through the body and adheres to the walls of the abnormal blood vessels beneath the macula.

o A laser is then used to shine light into the back of the eye.

o When this light beam activates the verteporfin, there is closure of the blood vessel.

o Over time, the body is able to absorb the blood and fluid, which results in stabilization or improvement of visual function.

• Over the course of 1-3 months, the blood vessels that have been treated with OPT typically open again and leakage may recur.

o Treatment is performed at three-month intervals if there is evidence of continued leakage from the blood vessels.

 

Sources of Information and Basis for Decision

 

Blinder, K., Blumenkranz, M., Bressler, N., Bressler, S., & Donato, G. (2003). Verteporfin therapy of subfoveal choroidal neovascularization in pathologic myopia. Ophthalmology, 110(4), 667-673.

 

FCSO LCD 29239, Ocular Photodynamic Therapy (OPT) with Verteporfin. 04/23/2012. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

Keam, S., Scott, L., & Curran, M. (2003). Verteporfin: A view of its use in the management of subfoveal choroidal neovascularization. Drugs 2003, 63(22), 2521-2554.

 

Miller, J.W., Schmidt-Erfurth, U., Sickenberg, M., et al. (1999). Photodynamic therapy with verteporfin for choroidal neovascularization caused by age-related macular degeneration: Results of a single treatment in a phase I and II study. Archives of Ophthalmology, 117 (10), 1177-1187.

 

Moon, J., Gon Yu, H., Wan Kim, T., Chan Kim, H., & Chung, Hum. (2009). Prognostic factors related to photodynamic therapy for central serous chorioretinopathy. Graefe's Archive for Clinical and Experimental Ophthalmology,247: 1315-1323.

 

Schmidt-Erfurth, U., Miller, J.W., Sickenberg, M., et al. (1999). Photodynamic therapy with verteporfin for choroidal neovascularization caused by age-related macular degeneration: Results of retreatments in a phase I and II study. Archives of Ophthalmology, 17 (10), 1161-1173.

 

Slakter, J.S. (2000). Photodynamic therapy. Available on-line: http://www.vrmny.com/PDT.htm.

 

TAP Study Group. (1999). Photodynamic therapy of subfoveal choroidal neovascularization in age-related macular degeneration with verteporfin. Archives of Ophthalmology, 117(10), 1329-1345.

 

VISUDYNE TM (verteporfin for injection) package insert.

 

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2012 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

 

CMS LCD L28939 Ocular Photodynamic Therapy (OPT) with Verteporfin