L29239-LCD

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Local Coverage Determination (LCD) for Ocular Photodynamic Therapy (OPT) with Verteporfin (L29239)

Contractor Information

Contractor Name

First Coast Service Options, Inc. opens in new window

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L29239

LCD Title

Ocular Photodynamic Therapy (OPT) with Verteporfin

Contractor's Determination Number 67221

Primary Geographic Jurisdiction opens in new window Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

Applicable FARS/DFARS Apply to Government Use. 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. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 02/02/2009 Original Determination Ending Date

Revision Effective Date

For services performed on or after 04/23/2012 Revision Ending Date

CMS National Coverage Policy

Coverage Issues Manual, Sections 35-100 and 45-30 Medicare Carriers Manual, Section 2049

National Coverage Determinations Manual, sections 80.2 and 80.3 Program Memorandum 9 (Change Request 3191, dated 04/01/2004)

Indications and Limitations of Coverage and/or Medical Necessity

Ocular photodynamic therapy (OPT) is a form of treatment for the “wet” or exudative form of age-related macular degeneration (AMD). 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. Without treatment, a majority of patients eventually develop scar tissue beneath the macula, which results in loss of central vision. 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; 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. 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. In the first step, the patient receives an intravenous injection of verteporfin. The verteporfin circulates through the body and adheres to the walls of the abnormal blood vessels beneath the macula. A laser is then used to shine light into the back of the eye. When this light beam activates the verteporfin, there is closure of the blood vessel. 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. Treatment is performed at three-month intervals if there is evidence of continued leakage from the blood vessels.

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, documentation of the patient’s condition must include fluorescein angiographic evidence of current leakage from CNV. There are no requirements regarding visual acuity, lesion size, and 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:

• Subfoveal occult with no classic CNV associated with AMD; and

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

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 deterioration of visual acuity (at least 5 letters on a standard eye examination chart), lesion growth (an increase in at least 1 disk area), or 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:

• 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:

• 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; and

• 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. 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. MAC J9 will address individual consideration for claims with this diagnosis and records may be requested for prepayment review. The documentation must clearly support that the patient was refractory to standard treatments and that no reasonable alternative treatments were available. 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.

999x Not Applicable

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.

99999 Not Applicable

CPT/HCPCS Codes

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

DESTRUCTION OF LOCALIZED LESION OF CHOROID (EG, CHOROIDAL NEOVASCULARIZATION);

67225 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

Diagnoses that Support Medical Necessity N/A

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

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

Medical record documentation maintained by the performing physician must clearly indicate the medical necessity of the service being billed. In addition, documentation that the service was performed must be included in the patient's medical record. 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:

• 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.

• 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.

Appendices

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

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.

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. Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was developed in cooperation with advisory groups, which

includes representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 12/04/2008

Revision History Number 1

Revision History Explanation Revision Number:1 Start Date of Comment Period: N/A

Start Date of Notice Period:05/01/2012 Revised Effective Date: 04/23/2012

LCR B2012-037

April 2012 Connection

Explanation of Revision: Under the ‘Indications and Limitations of Coverage and/or Medical Necessity’ section of the LCD, a subheading for ‘Limitations’ was added with verbiage to include the off-labeled indication of central serous retinopathy (CSR) (ICD-9-CM code 362.41) to be reviewed on an Individual Consideration basis with specified criteria. In addition, the ‘Utilization Guidelines’ section was updated regarding CSR, and the ‘Sources of Information and Basis for Decision’ section was updated. The effective date of this revision is based on date of service.

Revision Number:Original

Start Date of Comment Period:N/A Start Date of Notice Period:12/04/2008 Revised Effective Date:02/02/2009

LCR B2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the carrier predecessors of First Coast Service Options, Inc. (Triple S and FCSO).

For Florida (00590) this LCD (L29239) replaces LCD L6006 as the policy in notice. This document (L29239) is effective on 02/02/2009.

Reason for Change Typographical Correction