National Coverage Determinations
Table of Contents
- Hydrophilic Contact Lens for Corneal Bandage
- Photodynamic Therapy
- Ocular Photodynamic Therapy
- Photosensitive Drugs
- Verteporfin
- Hydrophilic Contact Lenses
- Scleral Shell
- Intraocular Photography
- Refractive Keratoplasty
- Keratoplasty
- Endothelial Cell Photography
- Computer Enhanced Perimetry
- Phaco-Emulsification Procedure - Cataract Extraction
- Vitrectomy
- Intraocular Lenses
Hydrophilic Contact Lens for Corneal Bandage
Some hydrophilic contact lenses are used as moist corneal bandages for the treatment of acute or chronic corneal pathology, such as bulbous keratopathy, dry eyes, corneal ulcers and erosion, keratitis, corneal edema, descemetocele, corneal ectasis, Mooren’s ulcer, anterior corneal dystrophy, neurotrophic keratoconjunctivitis and for other therapeutic reasons.
Please refer to the following CMS IOMs for further information:
- Publication 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 1, Section 80.1
- See hydrophilic contact lens as a prosthetic device in the CMS IOM references below:
Photodynamic Therapy
Photodynamic therapy is a medical procedure which involves the infusion of a photosensitive (light-activated) drug with a very specific absorption peak. This drug is chemically designed to have a unique affinity for the diseased tissue intended for treatment. Once introduced to the body, the drug accumulates and is retained in diseased tissue to a greater degree than in normal tissue. Infusion is followed by the targeted irradiation of this tissue with a non-thermal laser, calibrated to emit light at a wavelength that corresponds to the drug’s absorption peak. The drug then becomes active and locally treats the diseased tissue.
Ocular Photodynamic Therapy
OPT is used in the treatment of ophthalmologic diseases; specifically, for AMD, a common eye disease among the elderly. OPT involves the infusion of an intravenous photosensitizing drug called verteporfin followed by exposure to a laser. OPT is only covered when used in conjunction with verteporfin.
Photosensitive Drugs
Photosensitive drugs are the light-sensitive agents used in photodynamic therapy. Once introduced into the body, these drugs selectively identify and adhere to diseased tissue. The drugs remain inactive until they are exposed to a specific wavelength of light, by means of a laser, that corresponds to their absorption peak. The activation of a photosensitive drug results in a photochemical reaction which treats the diseased tissue without affecting surrounding normal tissue.
Verteporfin
Verteporfin, a benzoporphyrin derivative, is an intravenous lipophilic photosensitive drug with an absorption peak of 690 nm. Verteporfin was first approved by the FDA on 4/12/2000 and subsequently approved for inclusion in the United States Pharmacopoeia on 7/18/2000, meeting Medicare’s definition of a drug as defined under Section 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 physician’s service.
Hydrophilic Contact Lenses
Hydrophilic contact lenses are eyeglasses within the meaning of the exclusion in Section 1862(a)(7) of the Social Security Act and are not covered when used in the treatment of nondiseased eyes with spherical ametrophia, refractive astigmatism, and/or corneal astigmatism. Payment may be made under the prosthetic device benefit, however, for hydrophilic contact lenses when prescribed for an aphakic patient.
- CMS IOM Publication 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 1, Section 80.4
- CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, “Covered Medical and Other Health Services,” Section 100 and Section 120
- CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 16, “General Exclusions from Coverage,” Section 20 and Section 90
Scleral Shell
Scleral shell (or shield) is a catch-all term for different types of hard scleral contact lenses. A scleral shell fits over the entire exposed 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 Section 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.”
- CMS IOM Publication 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 1, Section 80.5
- CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, “Covered Medical and Other Health Services,” Section 120 and Section 130
- CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 1, “Inpatient Hospital Services,” Section 40 and Section 120.1
Intraocular Photography
Intraocular photography is covered when used for the diagnosis of such conditions as macular degeneration, retinal neoplasms, choroid disturbances 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 ophthalmologist in these situations when it is reasonable and necessary for the individual patient to receive these services.
Refractive Keratoplasty
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.
Keratoplasty
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 Section 1862(a)(1)(A) of the Act.
Endothelial Cell Photography
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 criteria.
Computer Enhanced Perimetry
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 used in assessing visual fields in patients with glaucoma or other neuropathologic defects.
Phaco-Emulsification Procedure - Cataract Extraction
In view of recommendations of authoritative sources in the field of ophthalmology, 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.
Vitrectomy
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.
- CMS IOM Publication 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 1, Section 80.11
- See CMS IOM Publication 100-04, Medicare Claims Processing Manual, Chapter 23 for determining payment for physician vitrectomy services
- CMS IOM Publication 100-04, Medicare Claims Processing Manual, Chapter 14, “Ambulatory Surgical Centers,” Section 40
- See CMS IOM Publication 100-04, Medicare Claims Processing Manual, Chapter 23, “Fee Schedule Administration and Coding Requirements,” Section 20.9, to identify when, for Medicare payment purposes, certain vitrectomy codes are included in other codes or when codes for other services include vitrectomy codes.
Intraocular Lenses
An IOL, 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, including preimplantation ultrasound (A-scan) eye measurement of one or both eyes.
- CMS IOM Publication 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 1, Section 80.12
- CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 6, Section 10, "Hospital Services Covered Under Part B"
- CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 120, “Covered Medical and Other Health Services”
- CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 16, Section 20 and Section 90, “General Exclusions from Coverage”
Reviewed 9/11/2024