(Medicare National Coverage Determinations Manual)

Establishment of an office within an institution would not modify rules otherwise applicable for determining coverage of the physicians personal professional services within the institution.  However, in view of the opportunity afforded to a physician who maintains such an office for rendering services to a sizable number of patients in a short period of time or for performing frequent services for the same patient, claims f or physicians services rendered under such circumstances would require careful evaluation by the A/B MAC to assure that payment is made only for services that are reasonable and necessary.   Cross -reference:   The Medicare Benefit Policy Manual, Chapter 15,  Covered Medical and Other Health Services.   The Medicare Benefit Policy Manual, Chapter 6, Hospital Services Covered Under Part B, 20.4.1.  70.4 - Pronouncement of Death  (Rev. 1, 10- 03-03) CIM 50 -19  According to established legal principles, an individual is not considered deceased until there has been official pronouncement of death.  An individual is therefore considered to have expired as of the time he/she is pronounced dead by a person who is legally authorized to make such a pronouncement, usually a physician.  Reasonable and necessary medical services rendered up to and including pronouncement of death by a physician are covered diagnostic or therapeutic services.  70.5 - Hospital and Skilled Nursing Facility Admission Diagnostic Procedures  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  These instructions describe the application of the reasonable and necessary payment exclusion to diagnostic procedures, such as chest x -rays, urinalysis, etc. provided to patients upon admission to a hospital or skilled nursing facility.  The major factors which support a determination that a diagnostic procedure performed as part of the admitting procedure to a hospital or  skilled nursing facility is reasonable and necessary, are:   A.  The test is specifically ordered by the admitting physician (or a hospital or skilled nursing facility staff physician having responsibility for the patient where there is no admitting physician):  i.e., it is not furnished under the standing orders of  a physician for his patients;  B.  The test is medically necessary for the diagnosis or treatment of the individual patients condition; and  C.  The test does not unnecessarily duplicate the same test performed on an outpatient basis prior to admission or performed in connection with a recent hospital or skilled nursing facility admission.  Where the A/B MAC has not already done so, consult with the Quality Improvement Organizations (QIOs) to obtain information gathered by the QIOs on a sample basis as to whether x -rays and diagnostic tests are being specifically ordered as described under subsection (A).   80 - Eye (Rev. 1, 10- 03-03)  80.1 - Hydrophilic Contact Lens for Corneal Bandage  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  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, corne al edema, descemetocele, corneal ectasis, Moorens ulcer, anterior corneal dystrophy, neurotrophic keratoconjunctivitis, and for other therapeutic reasons.   Payment may be made under 1861(s)(2)  of the Social Security Act for a hydrophilic contact lens approved by the Food and Drug Administration (FDA) and used as a supply incident to a physicians service.  Payment for the lens is included in the payment for the physician s service to which the lens is incident.  A/B MACs are authorized to accept an FDA letter of approval or other FDA published material as evidence of FDA approval.  (See 80.4 for coverage of a hydrophilic contact lens as a prosthetic device.)  See the Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health Services, and the Medicare Benefit Policy Manual, Chapter 6, Hospital Services Covered Under Part B, 20.4.  80.2 - Photodynamic Therapy  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  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 treatme nt. 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 wave length that corresponds to the drugs absorption peak. The drug then becomes active and locally treats the diseased tissue.   Ocular Photodynamic Therapy (OPT)   Ocular Photodynamic Therapy (OPT) is used in the treatment of ophthalmologic diseases. OPT is only covered when used in conjunction with verteporfin (see section 80.3, Photosensitive Drugs).    Classic Subfoveal Choroidal Neovascular (CNV) Lesions -  OPT is covered with a diagnosis of neovascular age -related macular degeneration (AMD) with predominately classic subfoveal choroidal neovascular (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). Subsequent follow -up visits will require either a n optical coherence tomography or an FA to access treatment response. There are no requirements regarding visual acuity, lesion size, and number of re -treatments.    Occult Subfoveal CNV Lesions -  OPT is non- covered for patients with a diagnosis of AMD with occult and no classic CNV lesions.   Other Conditions -  Use of OPT with verteporfin for other types of AMD (e.g., patients with minimally classic CNV lesions, atrophic, or dry AMD) is non- covered. OPT with verteporfin for other ocular indications such as pathologic myopia or presumed ocular histoplasmosis syndrome, is eligible for coverage through individual A/B MAC discretion.  80.2.1 - Ocular Photodynamic Therapy (OPT) - Effective April 3, 2013  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation:  of ICD -10, Implementation: Upon Implementation of ICD -10)  A. General   Ocular Photodynamic Therapy (OPT) is used in the treatment of ophthalmologic diseases; specifically, for age- related macular degeneration (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.   Effective July 1, 2001, OPT with verteporfin was approved for a diagnos is of neovascular 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).   On Oct ober 17, 2001, the Centers for Medicare & Medicaid Services (CMS) announced its intent to cover OPT with verteporfin for AMD patients with occult and no classic subfoveal CNV as determined by an FA. The October 17, 2001, decision was never implemented.   On March 28, 2002, after thorough review and reconsideration of the October 17, 2001, intent to cover policy, CMS determined that the current non- coverage policy for OPT for verteporfin for AMD patients with occult and no classic subfoveal CNV as determine d by an FA should remain in effect.   Effective August 20, 2002, CMS issued a non- coverage instruction for OPT with verteporfin for AMD patients with occult and no classic subfoveal CNV as determined by an FA.   B. Nationally Covered Indications   Effective April 1, 2004, OPT with verteporfin c ontinues to be approved for a diagnosis of neovascular AMD with predominately 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 an FA. (CNV lesions are compris ed of classic and/or occult components.) Subsequent follow -up visits require either an optical coherence tomography (OCT) (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 re -treatments when treating predominantly classic lesions.   In addition, after thorough review and reconsideration of the August 20, 2002, non-coverage policy, CMS determines that the evidence is adequate to conclude that  OPT with verteporfin is reasonable and necessary for treating:   1.  Subfoveal occult with no classic CNV associated with AMD; and,   2.  Subfoveal minimally classic CNV (where the area of classic CNV occupies <50% of the area of the entire lesion) associ ated 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 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.  C. Nationally Non -Covered Indications   Other uses of OPT with verteporfin to treat AMD not already addressed by CMS will continue to be non- covered. These include, but are not limited to, the following AMD indications:    Juxtafoveal or extrafoveal CNV lesions (lesions outside the fovea),   Inability to obtain a fluorescein angiogram,   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.  80.3 - Photosensitive Drugs  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  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 u ntil 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. This drug was first approved by the Food and Drug Administration on April 12, 2000, and subseque ntly, approved for inclusion in the United States Pharmacopoeia on July 18, 2000, meeting Medicares definition of a drug when used in conjunction with ocular photodynamic therapy (OPT) (see section 80.2, Photodynamic Therapy) when furnished intravenousl y incident to a physicians service. For patients with age- related macular degeneration (AMD), verteporfin is only covered with a diagnosis of neovascular AMD with predominately classic subfoveal choroidal neovascular (CNV) lesions (where the area of class ic CNV occupies 50% of the area of the entire lesion) at the initial visit as determined by a fluorescein angiogram (FA). Subsequent follow -up visits will require either an optical coherence tomography or an FA to access treatment response. OPT with verteporfin is covered for the above indication and will remain non- covered for all other indications related to AMD (see section 80.2). OPT with verteporfin for use in non -AMD conditions is eligible for coverage through individual A/B MAC discretion.  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