(Medicare National Coverage Determinations Manual)

80.3.1 - Verteporfin - Effective April 3, 2013  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  A. General   Verteporfin, a benzoporphyrin derivative, is an intravenous lipophilic photos ensitive drug with an absorption peak of 690 nm. Verteporfin was first approved by the Food and Drug Administration on April 12, 2000, and subsequently approved for inclusion in the United States Pharmacopoeia on July 18, 2000, meeting Medicares definition of a drug as defined under 1861(t)(1) of the Social Security Act. Verteporfin is only covered when used in conjunction with ocular photodynamic therapy (OPT) when furnished intravenously incident to a physicians service.   B. Nationally Covered Indicat ions  Effective April 1, 2004, OPT with verteporfin is covered for patients with a diagnosis of neovascular age -related macular degeneration (AMD) with:    Predominately classic subfoveal  choroidal neovascularization (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 (FA). (CNV lesions are comprised of classic and/or occult components.) Subsequent follow -up visits require either an optical coherence tomography (effective April 3, 2013) or an FA (effective April 1, 2004) to access treatment response.   There are no requirements regarding visual acuity, lesion size, and number of retreatmen ts when treating predominantly classic lesions.    Subfoveal occult with no classic CNV associated with AMD.    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:   1. 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,   2.  The lesions have shown evidence of progres sion 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 appearan ce of blood associated with the lesion.   C. Nationally Non -Covered Indications   Other uses of OPT with verteporfin to treat AMD not already addressed by the Centers for Medicare & Medicaid Services will continue to be non- covered. These include, but are n ot limited to, the following AMD indications: juxtafoveal or extrafoveal CNV lesions (lesions outside the fovea), inability to obtain an FA, or atrophic or dry AMD.   D. Other  The OPT with verteporfin for other ocular indications, such as pathologic myopia or presumed ocular histoplasmosis syndrome, continue to be eligible for local coverage determinations through individual A/B MAC discretion.  80.4 - Hydrophilic Contact Lenses  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: o f ICD -10, Implementation: Upon Implementation of ICD -10)  Hydrophilic contact lenses are eyeglasses within the meaning of the exclusion in 1862(a)(7)  of the Social Security Act and are not covered when used in the treatment of non-diseased eyes with spherical ametrophia, refractive astigmatism, and/or corneal astigmatism.  Payment may be made under the prosthetic device benefit, however, for hydrophili c contact lenses when prescribed for an aphakic patient.   A/B MACs are authorized to accept a Food and Drug Administration (FDA ) letter of approval or other FDA -published material as evidence of FDA approval.  (See 80.1 for coverage of a hydrophilic lens as a corneal bandage.)   Cross -references:   The Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health Services, 100 and 120.  The Medicare Benefit Policy Man ual, Chapter 16, General Exclusions from Coverage, 20 and 90.  80.5 - Scleral Shell  (Rev. 1, 10- 03-03) CIM 65.3   Scleral shell (or shield) is a catchall term for different types of hard scleral contact lenses.  A scleral shell fits over the entire expo sed surface of the eye as opposed to a corneal contact lens which covers only the central non- white area encompassing the pupil and iris.  Where an eye has been rendered sightless and shrunken by inflammatory disease, a scleral shell may, among other things, obviate the need for surgical enucleation and prosthetic implant and act to support the surrounding orbital tissue.  In such a case, the device serves essentially as an artificial eye.  In this situation, payment may be made for a scleral shell under 1861(s)(8)  of the Act.   Scleral shells are occasionally used in combination with artificial tears in the treatment of dry eye of diverse etiology.  Tears ordinarily dry at a rapid rate, and are continually replaced by the lacrimal gland.  When the lacrimal gland fails, the half -life of artificial tears may be greatly prolonged by the use of the scleral contact lens as a protective barrier against the drying action of the atmosphere.  Thus, the difficult and sometimes hazardous process of frequent installation of artificial tears may be avoided.  The lens acts in this instance to substitute, in part, for the functioning of the diseased lacrimal gland and would be covered as  a prosthetic device in the rare case when it is used in the treatment of dry eye.   Cross -references:   The Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health Services, 120 and 130  The Medicare Benefit Policy Manual, Chapter 1, Inpatient Hospital Services, 40 and 120.1.  80.6 - Intraocular Photography  (Rev. 1, 10- 03-03) CIM 35 -39  Intraocular photography is covered when used for the diagnosis of such conditions as macular degeneration, retinal neoplasms, choroid di sturbances and diabetic retinopathy, or to identify glaucoma, multiple sclerosis and other central nervous system abnormalities.  Make Medicare payment for the use of this procedure by an opthalmologist in these situations when it is reasonable and necessa ry for the individual patient to receive these services.   80.7 - Refractive Keratoplasty  (Rev. 1, 10- 03-03) CIM 35 -54  Not Covered   Refractive keratoplasty is surgery to reshape the cornea of the eye to correct vision problems such as myopia (nearsightedness) and hyperopia (farsightedness).  Refractive keratoplasty procedures include keratomileusis, in which the front of the cornea is removed, frozen, reshaped, and stitched back on the eye to correct either near or farsightedness; keratophakia, in which a reshaped donor cornea is inserted in the eye to correct farsightedness; and radial keratotomy, in which spoke -like slits are cut in the cornea to weaken and flatten the normally curved central portion to correct nearsightedness.   The correction of common refractive errors by eyeglasses, contact lenses or other prosthetic devices is specifically excluded from coverage.  The use of radial  keratotomy and/or keratoplasty for the purpose of refractive error compensation is considered a substitute or alternative to eye glasses or contact lenses which are specifically excluded by 1862 (a)(7)  of the Act (except in certain cases in connection with cataract surgery).  In addition, many in the medical community consider such procedures cosmetic surgery which is excluded by 1862 (a)(10) of the Act.  Therefore, ra dial keratotomy and keratoplasty to treat refractive defects are not covered.   80.7.1 - Keratoplasty  (Rev. 1, 10- 03-03)  Keratoplasty that treats specific lesions of the cornea, such as phototherapeutic keratectomy that removes scar tissue from the visual field, deals with an abnormality of the eye and is not cosmetic surgery.  Such cases may be covered under 1862(a)(1)(A) of the Act.   The use of lasers to treat ophthalmic  disease constitutes opthalmalogic surgery.  Coverage is restricted to practitioners who have completed an approved training program in ophthalmologic surgery.  80.8 - Endothelial Cell Photography  (Rev. 1, 10- 03-03) CIM 50 -38  Endothelial cell photography involves the use of a specular microscope to determine the endothelial cell count.  It is used by ophthalmologists as a predictor of success of ocular surgery or certain other ocular procedures.  Endothelial cell photography is a covered procedure under Medicare when reasonable and necessary for patients who meet one or more of the following criteria:   Have slit lamp evidence of endothelial dystrophy (cornea guttata),   Have slit lamp evidence of corneal edema (unilateral or bilateral),   Are about to undergo a secondary intraocular lens implantation,  Have had previous intraocular surgery and require cataract surgery,   Are about to undergo a surgical procedure associated with a higher risk to corneal endothelium; i.e., phacoemulsification, or refractive surgery (see 80.7 for excluded refractive procedures),   With evidence of posterior polymorphous dystrophy of the cornea or irido-corneal -endothelium syndrome, or   Are about to be fitted with extended wear contact lenses after intraocular surgery.   When a presurgical examination for cataract surgery is performed and the conditions of this section are met, if the only visual problem is cataracts, endothelia l cell photography is covered as part of the presurgical comprehensive eye examination or combination brief/intermediate examination provided prior to cataract surgery, and not in addition to it.  (See 10.1)   80.9 - Computer Enhanced Perimetry  (Rev. 1, 10- 03-03) CIM 50 -49  Computer enhanced perimetry involves the use of a micro- computer to measure visual sensitivity at preselected locations in the visual field.   It is a covered service when us ed in assessing visual fields in patients with glaucoma or other neuropathologic defects.   80.10 - Phaco -Emulsification Procedure - Cataract Extraction  (Rev. 1, 10- 03-03) CIM 35 -9  In view of recommendations of authoritative sources in the field of ophthal mology, the subject technique is viewed as an accepted procedure for removal of cataracts.  Accordingly, program reimbursement may be made for necessary services furnished in connection with cataract extraction utilizing the phaco- emulsification procedure.   80.11 - Vitrectomy  (Rev. 48, Issued:  03- 17-06; Effective/Implementation Dates:  06 -19-06) CIM -  35-16  Vitrectomy may be considered reasonable and necessary for the following conditions:  vitreous loss incident to cataract surgery, vitreous opacities due to vitreous hemorrhage or other causes, retinal detachments secondary to vitreous strands, proliferative  retinopathy, and vitreous retraction.  See chapter 23 of the Medicare Claims Processing Manual for how to determine payment for physician vitrectomy services and the Medicare Claims Processing Manual, Chapter 14, Ambulatory Surgical Centers, 40, for how to determine payment for ASC facility vitrectomy services.  Also, see the Medicare Claims Processing Manual, Chapter 23, Fee Schedule Administration and Coding Requirements, 20.9, to identify when, for Medicare payment purposes, certain vitrectomy c odes are included in other codes or when codes for other services include vitrectomy codes.   80.12 - Intraocular Lenses (IOLs)  (Rev. 1, 10- 03-03) CIM 65 -7  An intraocular lens, or pseudophakos, is an artificial lens which may be implanted to replace the natural lens after cataract surgery.  Intraocular lens implantation services, as well as the lens itself, may be covered if reasonable and necessary for the individual. Implantation services may include hospital, surgical, and other medical services, includi ng preimplantation ultrasound (A -scan) eye measurement of one or both eyes.   Cross -reference:   The Medicare Benefit Policy Manual, Chapter 6,Hospital Services Covered Under Part B, 10.  The Medicare Benefit Policy Manual, Chapter 15, Covered Medical an d Other Health Services, 120.