L36962: Medicare Part A/B local coverage determination (LCD) comment
`summary
`
`LCD Number
`
`L36962
`
`Contractor Name
`
`First Coast Service Options, Inc.
`
`Contractor Numbers
`
`Florida
`09101 -
`09201 - Puerto RicoNirgin Islands
`09102— Florida
`09202— Puerto Rico
`09302 — Virgin Islands
`
`Contractor Type
`
`MAC Part A/B
`
`LCD Title
`
`Vascular Endothelial Growth Factor Inhibitors for the Treatment of Ophthalmological Diseases
`
`AMA CPT Copyright Statement
`CPT& only copyright 2002-2017 American Medical Association. All rights reserved. CPT® is a registered trademark of the American
`Medical Association, 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-201 0 are trademarks of the American Dental
`Association.
`Start Date of Comment Period:
`
`09/29/2016
`
`End Date of Comment Period:
`
`11/14/2016
`
`Comments received:
`Comment #1: Comment was received suggesting First Coast eliminate the language in the local coverage determination (LCD) that
`uses the labeling information from the manufacturer, as it is only a suggestion and is not meant to be a formal guideline. Long term
`results often suffer in some patients if the treatment interval is stretched out too far, and it sometimes is necessary to treat every four
`weeks. Allow it to be based on clinical evidence supported by optical coherence tomography (OCT) or angiogram.
`
`Contractor response: Thank you for your comment and recommendation. The LCD will be revised to include additional US Food and
`Drug Administration (FDA) "Dosing and Administration" guidelines for Lucentis (ranibizumab injection) and Eylea (aflibercept)
`injection. In addition, as stated in the "Limitations" section of the LCD, frequency is considered excessive when services are performed
`more frequently than listed in the package insert or generally accepted by peers and the reason for additional services is not justified by
`documentation. Dose and frequency should be in accordance with the FDA label or recognized compendia (for off-label uses). Medical
`evidence that can be considered includes in order of preference, published authoritative evidence derived from definitive randomized
`clinical trials or other definitive studies, clinical guidelines, and general acceptance by the medical community (standard of practice), as
`supported by sound medical evidence based on: scientific data or research studies published in peer-reviewed medical journals;
`consensus of expert medical opinion (i.e., recognized authorities in the field); or medical opinion derived from consultations with
`medical associations or other health care experts. When services are performed in excess of established parameters, they may be
`subject to review for medical necessity.
`
`Comment #2: A comment was received suggesting the potential for undertreating patients due to fear of non-reimbursement for Eylea.
`The recent American Society of Retina Specialists (ASRS) meeting and many journal articles show that real life patient vision
`gain/maintenance two to five years after diagnosis does NOT mirror clinical trials and the single consistent reason is under-treatment.
`Treat and-extend with close monitoring has the best success rate in maintaining vision.
`
`-
`
`Form Date: 05/02/2014
`1-3.2.41 NO Part A/B LCD Comment Summary Sheet
`
`Page 1 of 4
`
`"1
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`EXHIBIT
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`11
`I BROWN
`_±tiL' 2022.
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`Mylan Exhibit 1140
`Mylan v. Regeneron, IPR2021-00881
`Page 1
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`The following language is concerning: "Frequency is considered excessive when services are performed more frequently than listed in
`the package insert or generally accepted by peers and the reason for additional services is not justified by documentation. Dose and
`frequency should be in accordance with the FDA label or recognized compendia (for off-label uses). When services are performed in
`excess of established parameters, they may be subject to review for medical necessity."
`
`The printed recommendation for Eylea does not work for every patient. There may be an upsurge in either unnecessary testing to justify
`more frequent dosing or a rise in denied claims with delay in payment to justify regimen. Regeneron has stated quite clearly that the
`labeling indications are a suggestion and NOT a treatment guideline.
`
`A recommendation was received to amend the 41n and 5th indications for Eylea to include language explaining that these are only
`suggested dosing and individual patient dosing must be determined by outcome.
`
`Contractor response: Thank you for your comment. See comment response #1.
`
`Comment #3: Given the results of all studies to date that show no difference between Avastin and the others, Avastin should be the
`first line treatment and only allow the use of Lucentis or Eylea if Avastin fails or if there is evidence that Avastin did not work in the
`fellow eye. This is true for all diagnoses except diabetic macular edema with best corrected visual acuity worse than 20/50. In that case,
`Eylea has been found superior.
`
`Contractor response: Thank you for your comment. The LCD addresses reasonable and necessary (R&N) criteria for the use of
`Vascular Endothelial Growth Factor (VEGF) inhibitors. As published in CMS IOM 100-08, Chapter 13, Section 13.5.1, in order to be
`covered under Medicare, a service shall be reasonable and necessary. One definition a contractor considers for a service to be
`reasonable and necessary is if the service is at least as beneficial as an existing and available medically appropriate alternative. Cost is
`not taken into account during the development of an LCD.
`
`Comment #4: Once stability is reached and therapy is done for maintenance with wet macular degeneration, there is no need to bill for
`fundus photography, OCT and angiogram at every four week injection visit. Quarterly testing would be more appropriate in those cases.
`In the diabetic macular edema and vein occlusion patients, an end point is often reached and treatment should be discontinued. There
`is no proof that "prophylactic" treatment for these conditions has any benefit. In cases where macular degeneration has either
`geographic atrophy in addition to the wet form of the disease or the wet form did not respond or treatment was ineffective and the vision
`is poor (20/200 or worse, e.g.), there is no reason to continue the treatment so there should be cessation of treatment at that point.
`
`Contractor response: Thank you for your comment. The contractor agrees that in cases where macular degeneration has either
`geographic atrophy in addition to the wet form of the disease or the wet form did not respond or treatment was ineffective and the vision
`is poor (20/200 or worse, e.g.), there is no reason to continue the treatment, so there should be cessation of treatment Continuing
`treatment in the aforementioned circumstances would not be reasonable and necessary since it would be exceeding the medical need.
`
`The LCD addresses the limited indications of vascular endothelial growth factor inhibitors for the treatment of ophthalmological
`diseases. The treatment frequency should be consistent with the clinical assessment (symptoms, exam, testing when indicated (OCT,
`fluorescein angiogram, etc.) as documented in the medical record. The LCD does not address frequency limitations for fundus
`photography, OCT and angiogram. It is expected testing, when indicated, will be performed with accepted standards of practice and
`clearly supported in the medical record. First Coast has the following LCDs addressing these services: Scanning Computerized
`Ophthalmic Diagnostic Imaging (L33751), Fluorescein Angiography (L33997), and Fundus Photography (L33670).
`
`Comment #5: Comment received requesting that the list of indications for Avastin (bevacizumab) in the new LCD include the
`conditions already listed in the existing Avastin (bevacizumab) LCD dated June 30, 2009, which are supported by the ASRS position
`paper on Avastin (bevacizumab) and are widely accepted within the retina community. Specifically, the new policy has not included
`retinal neovascularization, retinal edema, rubeosis iridis, branch retinal vein occlusion (BRVO) and central retinal vein occlusion
`(CRVO) with retinal neovascularization, or cystoid macular edema. Additionally, there are no restrictions on the use for proliferative
`diabetic retinopathy to only a single dose. A request was made to remove this limitation. Below is a list of revised/added indications.
`
`Proliferative diabetic retinopathy requiring troatrnont with retinal locor photocoagulation or vitroctomy as a 6 H91 prooporative
`4e&e
`
`Stage 3 retinopathy of prematurity (ROP)
`
`Cystoid Macular Degeneration of Retina
`
`Retina Edema
`
`Rubeosis Iridis
`
`Retinal Neovascularization
`
`Glaucoma associated with vascular disorders of the eye
`
`BRVO with retinal neovascularization
`
`CRVO with retinal neovascularization
`
`In addition, under "lCD-10 codes that support medical necessity" section on Avastin, a request was made to add the following codes to
`the current LCD.
`
`H21.1 Vascular disorders of the iris and ciliary body
`
`Form Date: 05/02/2014
`1-3.2.41 MP Part A/B LCD Comment Summary Sheet
`
`Page 2 of 4
`
`Mylan Exhibit 1140
`Mylan v. Regeneron, IPR2021-00881
`Page 2
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`

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`H34.81 11 Central retinal vascular occlusion, right eye with retinal neovascularization
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`H34.8121 Central retinal vascular occlusion, left eye with retinal neovascularization
`
`H34.8131 Central retinal vascular occlusion, bilateral with retinal neovascularization
`
`H34.8311 Tributary (branch) retinal vein occlusion (BRVO), right eye with retinal neovascularization
`
`H34.8321 Tributary (branch) retinal vein occlusion(BRVO), left eye, with retinal neovascularization,
`
`H34.8331 Tributary (branch) retinal vein occlusion (BRVO). Bilateral, with retinal neovascularization
`
`H35.351 Cystoid macular degeneration, right eye
`
`H35.352 Cystoid macular degeneration, left eye
`
`H35.353 Cystoid macular degeneration, bilateral
`
`H35.81 Retina edema
`
`H40.51 Glaucoma secondary to other eye disorders, right eye
`
`H40.52 Glaucoma secondary to other eye disorders, left eye
`
`1-140.53 Glaucoma secondary to other eye disorders, bilateral
`
`H35.059 Retina Neovascularization, unspecified, unspecified eye
`
`Contractor response: Thank you for your comment and suggestions. The LCD will be revised to add some of the suggested
`indications and diagnosis codes. Diagnosis code H35.05g (Retina Neovascularization, unspecified, unspecified eye) and glaucoma
`associated with vascular disorders of the eye will not be added because the LCD already contains more specific coding and language
`related to these indications.
`
`Comment #6: I would suggest the LCD be corrected to match the current FDA guidelines for Eylea® (aflibercept). The current FDA
`language for Eylea (aflibercept) is as follows:
`
`Eylea® (aflibercept) injection is indicated for the treatment of patients with:
`
`Neovascular (Wet) Age-related Macular Degeneration (AMD): The recommended dose for Eylea is 2 mg administered by
`intravitreal injection every 4 weeks (monthly) for the 12 weeks (3 months), followed by 2 m once every 8 weeks (2 months).
`Although Eylea may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated in
`most patients when Eylea was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week
`(monthly) dosing after the first 12 weeks (3 months).
`
`Macular Edema following Retinal Vein Occlusion (RVO): The recommended dose for Eylea is 2 mg administered by intravitreal
`injection every 4 weeks (monthly).
`
`Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR) in Patients with DME: The recommended dose is 2 m
`administered by intravitreal injection every 4 weeks (monthly) for the first 5 injections, followed by 2 mg once every 8 weeks (2
`months). Although Eylea may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not
`demonstrated in most patients when Eylea was dosed every 4 weeks compared to every 8 weeks. Some patients may need
`every 4 week (monthly) dosing after the first 20 weeks (5 months).
`
`Contractor response: Thank you for your comment and recommendation. The LCD will be revised to add the current FDA language
`for Neovascular (Wet) Age-related Macular Degeneration (AMD) and Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR) in
`patients with DME,
`
`Comment #7: A comment was received suggesting eliminating the following contraindication in the "Limitations" section of the LCD:
`patients with active intraocular inflammation. There is not a contraindication to using anti-VEGF therapy in eyes with active
`inflammation, as it can be helpful in uveitis patients that develops rubeosis, neovascularization of the disc (NVD)/ neovascularization
`elsewhere (NVE), choroidal neovascularization (CNV) and in some cases cystoid macular edema (CME). This limitation (inflammation)
`should be eliminated, and if not for all the medications, at least for Avastin.
`
`Contractor response: Thank you for your comment and suggestion. The LCD will be revised to remove this contraindication from the
`"Limitations" section of the LCD.
`
`Comment #8: A comment was received requesting the following limitation be moved to indicate the acceptance of bilateral treatment,
`with different medication on the same date of service, as appropriate physician care.
`
`It is not typical to inject one anti-VEGF medication in one eye and another in the other eye. If different medications are injected
`into each eye during the same date of service, the rationale for this therapy must be documented in the medical record and the
`billing modifier (RT/LT) must be appended to the correct drug.
`
`This guideline "allows" injecting two different medications on the same date of service. However, stating this "is not typical" is incorrect.
`This scenario is common in practice. Each eye is evaluated as a separate, independent organ. The diseases being treated with anti-
`VEGF mediations affect each eye differently, depending on the stage of the disease. Anti-VEGF medications have varying mechanisms
`of action. These differences can affect the eye differently. It is unusual to treat diabetic patients with different medication, but wet
`
`Form Date: 05/02/2014
`1-3.2.41 Ml' Part A/B LCD Comment Summary Sheet
`
`Page 3 of 4
`
`Mylan Exhibit 1140
`Mylan v. Regeneron, IPR2021-00881
`Page 3
`
`

`

`macular degeneration is an entirely different disease. Treatment regiments last longer, and require adjustment of medications in many
`patients to produce the best therapeutic result.
`
`Contractor response: Thank you for your comment and suggestion. The language in the LCD will be changed to: It is not expected to
`inject one anti-VEGF medication in one eye and another in the other eye.
`
`Form Date: 05/02/2014
`1-3.2.41 MP Part A/B LCD Comment Summary Sheet
`
`Page 4 of 4
`
`Mylan Exhibit 1140
`Mylan v. Regeneron, IPR2021-00881
`Page 4
`
`