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Response to Comments: MolDX: VitaRisk ™ Pharmacogenetic Test for Dry Age-related Macular Degeneration (AMD)

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A55564
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Response to Comments: MolDX: VitaRisk ™ Pharmacogenetic Test for Dry Age-related Macular Degeneration (AMD)
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Response to Comments
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07/10/2017
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The comment period for the MolDX: Vita Risk™ Pharmacogenetic Test for Dry Age-related Macular Degeneration (AMD) (LCD) DL37140 began on 02/16/2017 and ended on 04/03/2017. Comments were received from the provider community. The notice period begins on 05/25/2017 and ends 07/09/2017. The LCD becomes final on 07/10/2017.

Response To Comments

Number Comment Response
1 Commenter would like the decision to non-cover Vita Risk test for AMD to be reversed. Patients are all unique and do not respond uniformly to any of our interventions. Genetic typing will explain much of this stratification of results. Patients with AMD purchase the over-the-counter AREDS vitamins with the expectation that they will provide a treatment benefit. Although the AREDS trial demonstrated an overall benefit, more recent genetic analyses of AREDS data has convincingly shown that this average benefit is the product of widely differing individual treatment responses. The evidence indicates that these differences in response to AREDS vitamins are due in large part to genetic risk markers (CFH and ARMS2 ). I have scanned the literature cited in the draft LCD which seems to omit or overlook key elements of the scientific evidence about the potentially harmful effects within subpopulations. It is my understanding that multiple independent researchers have demonstrated the pharmacogenetic effect in separate, well-designed analyses. However, the denial of coverage seems to rely heavily on a single analysis, AREDS Report 38, which presents data that run counter to its conclusion that the AREDS formulation had benefits across all genotypes. The other papers cited as evidence against of the pharmacogenetic effect are simply opinion pieces -none of the other articles present data or statistics. I remain concerned that some of my Medicare patients with this genetic profile would not benefit from AREDS. In fact, these patients are actually significantly more likely to suffer vision loss while taking AREDS vitamins. The Vita Risk test can identify which patients benefit maximally from the AREDS vitamins and which may be harmed. This is important to me and my practice for clinical decision-making and the test is medically necessary for the optimal care of patients with AMO. See Summary Response to Comments.
2 I am contacting you to provide my support for the Medicare approval of Vita Risk genetic sub-group testing for patients with dry ARMD. I am and have been a practicing retinal physician for the past 30 years and am actively involved in the management of patients with macular degeneration. Additionally, I continue to be involved in clinical research and have been and investigator for many trials including the Age Related Eye Disease Study. I am also a member of the AAO and ASRS and am an attending physician in a highly regarded fellowship training program for vitreo-retinal diseases. I have reviewed the literature on this current controversy regarding the benefits of genetic sub-typing for patients with dry AMD and have concluded that the arguments presented by Awh and colleagues are compelling. I believe that their science is sound given the inherent restrictions in a retrospective review and that the finding of potential patient harm from standard of care treatment with AREDS 2 multivitamin supplementation is alarming. From my reading of AREDS report 38, I disagree with their conclusion that genetic sub typing is unnecessary as this does not follow from the data they have presented. I would strongly urge you to consider approval for Vita Risk testing for Medicare patients with ARMD. As a clinician I believe this information is medically necessary in the proper treatment of my patients. All doctors should strive to “first do no harm”, and I am concerned that by treating some patients with specific genetic sub types I may indeed by doing them more harm than good. See Summary Response to Comments.
3 I am writing to you in support of Medicare coverage for Vita Risk genetic sub-group testing in patients with dry macular degeneration. I am a retinal specialist with over 20 years experience and actively care for many Medicare patients with AMD on a daily basis. Our practice is involved in numerous clinical research trials, including the Age Related Eye Disease Study, and is a well respected training program for vitreoretinal surgery and diseases. I am a member of the American Academy of Ophthalmology and the American Society of Retina Specialists Patients with AMD purchase the over-the counter AREDS vitamins with the expectation that they will provide a treatment benefit. Although the AREDS trial demonstrated an overall benefit, more recent genetic analyses of AREDS data have convincingly shown that this average benefit is the product of widely differing individual treatment responses. The evidence indicates that these differences in response to AREDS vitamins are due in large part to genetic risk markers (CFH and ARMS2). I have reviewed the literature cited in the draft LCD, and the arguments made by Awh and colleagues are justified in the potential patient harm of standard multivitamin therapy for all genetic subtypes. However, the denial of coverage seems to rely heavily on a single analysis, AREDS Report 38, which presents data that run counter to its conclusion that the AREDS formulation had benefits across all genotypes. The other articles cited as evidence against of the pharmacogenetic effect are simply opinion pieces – none of the other articles present data or statistics. Furthermore, I do not agree with the recently released report by the ASRS Genetic Task Force regarding genetic testing and nutritional supplements for AMD. The report fails to critique or verify any of the claims made by the AREDS Study Group publications – it merely repeats the criticisms made by the AREDS Study Group criticisms of the Awh, et al, publications. I am concerned that taking AREDS vitamins will result in harm to some of my Medicare patients with AMD. The Vita Risk test can identify these patients and is medically necessary for the optimal care of those patients with intermediate AMD. I urge you to consider approval for Vita Risk testing for improved patient care. See Summary Response to Comments.
4 One hundred forty seven (147) form letters or emails in support of AMD testing were received from Macular Degeneration Association (MDA) members and optometrists, sponsored in large part by MDA, located in Sarasota, FL. See Summary Response to Comments.
5 As a patient-focused organization, the MDA has been following with close interest the scientific development related to personalized medicine using genetic testing in the treatment of dry AMD. Given the prevalence of AMD in the over 65 population, this has a significant impact on Medicare. Our staff and membership has been closely following these developments and the growing body of evidence that a not insignificant portion of the dry AMD population does not benefit from the AREDS supplements due to a particular genetic phenotype. There is also concern that these vitamins if taken by this specific group may actually cause irreparable harm. As we understand it, these findings indicate that two variants of the CFH gene and one ARMS2 variant makes these AMD patients sensitive to zinc and, as a result, more likely to experience vision loss as a result of taking the popular supplements. The findings in the 2014 study “Treatment response to antioxidants and zinc based on CFH and ARMS2 genetic risk allele number in the age-related eye disease study” suggest that between 13 and 19 percent of patients with intermediate dry AMD may be afflicted. Although researchers at the National Eye Institute (NEI) have not reached the same stated conclusion, the data presented in their own published analyses belie their conclusions. We were perplexed by this disconnect between the data and the NEI recommendations related to AREDS supplements and genetic testing, and were deeply troubled to discovered from government documents that individual officials at NEI are earning millions of dollars in royalty payments based on the private marketing of non-prescription AREDS supplements. While we do not know whether such significant financial interest in the sale of vitamins are impacting the clinical judgment and ultimate policies of the institution, we remain troubled that the NEI consistently fails to disclose these conflicts of interest and frequently maintains in papers and presentations that no conflicts exist. The NEI continues to promote the value of taking AREDS to all patients despite the lack of regulatory review regarding their safety or effectiveness. The MDA has filed a complaint with the Director of the NIH regarding the lack of disclosure. Regardless of the NEI’s position regarding the appropriate use of these supplements, it does not and should not impact or impede Medicare coverage of genetic testing. The MDA has spoken to countless patients about these issues, including many who have been genetically tested. Once educated about the potential risks of AREDS, most patients want the opportunity to learn about their relevant genetic profile. Those patients who have the affected gene variants are extremely upset when they understand that their vision loss may be because of taking the AREDS formula. Others are happy to have this information so they do not waste money on supplements that will not improve their eye health. Those that have not been tested are gravely concerned for their vision. This is a significant public health concern. I have also communicated with numerous experts in this field including eye care professionals, geneticists and professional institutions including members and senior leadership of the American Society of Retina Specialists (ASRS) and the American Academy of Ophthalmology (AAO). It is evident that there is no scientific data to support the effectiveness or the safety of AREDS in these patients. The vast majority of clinicians I have spoken with want to apprise their patients of the full range of clinical options, and recommend genetic testing for patients when medically appropriate. The MDA has carefully reviewed your draft LCD for Vita Risk, which, at first, seems to grasp the scientific merit of testing patients to insure optimal treatment with these high-dose compounds. We are quite disappointed, however, with the paradoxical decision to deny patient access to this medically necessary test. It is plain to us that the rationale offered in the draft LCD is not derived from the most credible scientific evidence. Based on ongoing communications with medical experts, we find the Awh et al. findings to be the most compelling evidence of the serious risks posed to some dry AMD patients. Most of the other articles cited are derived from the same biased NEI conclusions, and are opinion pieces rather than contain any independent primary data. We have also had the opportunity to speak with Dr. Johanna Seddon of the New England Eye Center at Tufts University regarding some exciting new findings that cast further doubt on the NEI orthodoxy. AMD is a disease that affects almost one in five Caucasian families as well as all other racial and ethnic groups to various extents. When it progresses to cause vision loss, AMD has a significant negative impact on the independence and the quality of life for both the individual as well as the family. It also has a significant impact on the cost of healthcare. I am sure I don’t need to tell you that wet AMD is expensive to treat. Although AREDS is the only treatment used to prevent the progression to wet AMD for some patients it indisputably does not prevent or slow that progress and appears actually to hasten it. Patients pay for vitamins themselves, out of pocket, which is another reason that it is irresponsible to deny patients’ access to a once-ina- lifetime test that the draft LCD acknowledges improves the safety of taking the only treatment for dry AMD. Based on thorough review of the draft LCD, referenced and external literature on the subject, and discussion with many patients, caregivers, clinicians, and other experts, the MDA sees no valid clinical reason to deny Medicare beneficiaries access to this vital genetic information. For all of these reasons, we implore you to reconsider your draft LCD on Vita Risk. On behalf of the MDA and our whole community, we appreciate the opportunity to provide the patient perspective and hope you will seriously consider our position. If you have any questions or require additional information, I encourage you to reach out to us! See Summary Response to Comments.
6 I am the President of Lunovus LLC (www.lunovus.com ). We provid e AREDS eye supplements to eye care professionals including an exclusive contract with US Retina LLC, an organization consisting of some 750 Retina Specialists across the country. Lunovus provides these doctors (and their patients) with the AREDS2 formulation and a similar non-AREDS formulation without Zinc to serve their patients following the Vita Risk gene test. We have provided this tailored product line for the last few years. I am writing in response to the proposed draft coverage determination of the Vita Risk Pharmacogenetic Test for Dry AMD. The Vita Risk test should be covered by CMS. Patients with AMD purchase the AREDS vitamins expecting that they will benefit from the use of the AREDS vitamins. Although the AREDS formulation provides a benefit to many patients to delay the progression of AMD, some patients should be taking the AREDS without Zinc to receive the proper benefits of the vitamins due to their genetic profile. These differences in response to AREDS supplements are due in large part to genetic risk (CFH and ARMS2 ).We rely on the doctor to provide the Vita Risk test and recommend the appropriate formulation. With the Vita Risk test, doctors can identify and recommend the appropriate form of the AREDS vitamins. This is important and medically necessary information for doctors and their patients with AMD. The Vita Risk test should be covered by CMS so patients can access the best formulation that could help preserve their vision. See Summary Response to Comments.
7 (multiple form letters with same or slightly different comments): As a retina specialist who routinely treats patients with Age-related Macular Degeneration (AMD), I am writing in response to the proposed draft coverage decision of the Vita Risk Pharmacogenetic Test for Dry AMD. The Vita Risk test should be covered by CMS. Patients with AMD purchase the AREDS vitamins with the expectation that they will delay or prevent progression of their AM D. Although the AREDS trial demonstrated an overall benefit, more recent genetic analyses of AREDS data has shown that this average benefit is the product of widely differing individual responses. These differences in response to AREDS vitamins are due in large part to genetic risk (CFH and ARMS2 ). I have reviewed the literature related to this issue and I will not recommend AREDS supplements to patients who are diagnosed with a genetic profile contraindicating the ARED·s supplement. The Vita Risk test can identify which patients benefit maximally from the AREDS vitamins and which may be harmed. This is important and medically necessary for the optimal care of patients with AMO. The Vita Risk test should be covered by CMS. See Summary Response to Comments.
8 (multiple form letters): As a practicing optometrist who uses Vita Risk genetic testing to determine the appropriate eye nutritional therapy for my patients, I would like to strongly urge CMS to reimburse this test. This is the only tool available to eye care professionals to identify patients who may be harmed by the zinc component of AREDS supplements. These people must be identified and protected from extra zinc exposure as part of the management of dry age related macular degeneration. Early detection and treatment of wet disease is the key to vision preservation. Optometrists and patients must have access to this test to realize the most benefit from early treatment while at the same time, lightening the financial burden on our healthcare system by improving outcomes of AREDS treatment. See Summary Response to Comments.
9 (multiple similar letters): I am writing as a retina specialist and also the former CAC Ophthalmology representative in TN to CAHABA. I routinely treat patients with age-related macular degeneration (AMD). I am writing in response to the proposed draft coverage decision of the Vita Risk Pharmacogenetic Test for Dry AMD. The Vita Risk test should be covered by CMS. Patients with AMD purchase the over-the-counter AREDS vitamins with the expectation that they will benefit. Although the AREDS trial demonstrated an overall benefit, more recent genetic analyses of AREDS data has convincingly shown that this average benefit is the product of widely differing individual treatment responses. These differences in response to AREDS vitamins are due in large part to genetic risk (CFH and ARMS2). I have reviewed the literature cited in the draft LCD. It seems that multiple independent researchers have demonstrated the pharmacogenetic effect in separate, well-designed analyses. However, the opposition is based on a single analysis (AREDS Report 38). The other papers that you cite as evidence against of the pharmacogenetic effect are simply opinion pieces – none of the other articles present data or statistics and one paper (Hampton, et al) is just a literature review. The Vita Risk test can identify which patients benefit maximally from the AREDS vitamins and which may be harmed. This is important and medically necessary for the optimal care of patients with AMD. The Vita Risk test should be covered by CMS. See Summary Response to Comments.
10 In my attempt to help prevent loss of vision from agerelated macular degeneration (ARMD), I have taken a keen interest in the role of diet, vitamins, and genetics in the progression of this disease. The AREDS Report No. 8 (2) was encouraging, but I had reservations because the investigators’ conclusions could only be supported statistically through considerable retrospective data manipulation. Benefits from the AREDS formula for eyes with category 3 ARMD was only found among patients with monocular AREDS category 4 or bilateral category 3 after excluding those with geographic atrophy. Not only is the benefit of rather expensive AREDS supplements for all patients questionable, but there might be serious side-effects from taking vitamins in quantities that far exceed natural exposures. Vitamin E in the dosage used in the AREDS formula increases mortality (3). Also, zinc frequently causes constipation and abdominal discomfort in seniors, who are naturally predisposed to these problems and might not recognize the iatrogenic source. Zinc might be linked to dementia (4). I was encouraged by the reports of Awh et al. (5), which showed that guidance by specific genetic markers could greatly enhance the utility of zinc plus antioxidant supplementation. Other investigators have confirmed the utility of genetic testing (6). I am sure your committee is aware of these reports. I have studied these articles carefully and discussed the results with my colleagues, and I am impressed with the quality of the analyses and the remarkably strong associations between certain genotypes and the responses to antioxidant supplementation. In contrast, the NEI’s emphatic opposition to genetic testing has struck me as biased and grounded on dubious scientific analyses. In a report that claimed to disprove Awh et al.’s 2015 findings, Chew et al. (7) declared that the AREDS formula “was found to be beneficial and the treatment of choice” in all 4 genotype subgroups. Based on the information Chew et al. presented, antioxidants alone had nearly the effectiveness as the AREDS formula for the patients they designated genotype group 2, and there was no difference between antioxidants alone, zinc alone, or the AREDS formula for genotype group 3 patients. Chew et al. used a data set that was considerably smaller than that of Awh et al., (526 vs. 989), and they did not report any basic information such as the number of patients in each subgroup, the numbers of patients with AMD progression versus nonprogression, or the p values for any of the data. Evidently, this report (published as a letter) was not peer reviewed. Initially, I attributed the NEI’s apparent bias to its sharing the AREDS formula patent with Bausch and Lomb. I was surprised to learn from a Medscape article that Dr. Chew’s supervisor, Frederick Ferris III, MD, the clinical director of the NEI and chairman of the AREDS study, has been receiving royalties on the AREDS formula. (8) It is my understanding that these royalties have totaled more than $2 million. The evidence for Vita Risk testing relies on retrospective/prospective data, as do the AREDS investigators who recommend use of supplements for certain Group 3 patients described above. Based on a wide range of epidemiological studies and the AREDS itself, I think there is good reason to believe that vitamin supplements can help prevent the progression of ARMD. Without genetic testing, the value of taking the AREDS formula is very limited, largely because the data indicate that zinc is not helpful for many patients and likely promotes ARMD for some patients. I think there is already overwhelming evidence of Vita Risk’s value. Still, a prospective study to confirm Vita Risk’s utility would be desirable, and I would be glad to participate in such a study. An ethical challenge of doing such a study would be justifying the denial of genetic testing to the control group, since I think there is compelling evidence that this control group would be much more likely to have an inferior outcome. In conclusion, I strongly recommend that CMS cover Vita Risk genetic testing. Loss of vision is one of the greatest fears among seniors, and CMS coverage would make testing much more available to people who otherwise could not afford it. Further, I would expect coverage to be cost-effective for CMS. Treatment of wet AMD has become extremely expensive due to the widespread use of Lucentis and Eylea, and prevention of AMD progression with the correct vitamin supplements would likely save CMS a huge amount of money. See Summary Response to Comments.
11 I am a member of a large retinal subspecialty group and participate in numerous randomized clinical trials. I actively participate in the training of residents as a Clinical Professor at UT-Southwestern Medical Center. I am a member of the American Academy, American Society of Retinal Specialists, and Association for Research in Vision and Ophthalmology; as well as several invitation-onl y select groups such as the Macula Society and Club Jules Gonin. I treat patients with AMD every day in my clinic. The current recommendation from the American Academy of Ophthalmology and the National Eye Institute is for patient s with high risk AMD to use the over-thecounter AREDS vitamins. Patients with AMD are desperate to avoid vision loss and take all kinds of supplements; even ones with no scientific validation. I previously recommended the AREDS 2 supplements as the only scientifically valid treatment to reduce the risk of vision loss in my patients. I now know that several prominent statisticians question the validity of the original AREDS trial. The statistical test used is not the appropriate one for the data. The NEI has an economic incentive to continue to push the current formulation. Further genetic analysis of the AREDS data shows that although there was an overall benefit, this average benefit is the product of widely differing individual treatment responses. As you know, the CFH and ARMS2 genes appear to have a significant impact on the response to AREDS vitamins. I do not agree with the recently released report by the ASRS Genetic Task Force regarding genetic testing and nutritional supplements for AMD. The draft LCD states in the Clinical Validation section that the papers from Klein and Awh have "been challenged". The challenge however comes in the form of papers with no new scientific data. I have not seen any scientific data that actually challenges the belief that differing genetic background s alter the response to the AREDS vitamins. And there is convincing evidence that this actually is true. How can I in good conscience recommend the AREDS vitamins to my patients when their genetic constitution is unknown? Shouldn't these desperate patients have the opportunity to decide for themselves what they should take to decrease their risk of serious vision loss? You are denying these patients access to a simple test that gives them incredibly powerful information. Many of my patients are smart enough to review the current data and decide for themselves which vitamin supplement they should take. The possibility that the current AREDS 2 supplement may actually increase the risk of vision loss is something of immense importance to my patients! I consider the test medically necessary for appropriate care. CMS coverage of the Vita Risk test is necessary to ensure access to this important test for my Medicare patients. For these reasons, I strongly encourage you to reverse this draft recommendation of non coverage and to issue a positive decision for coverage of the Vita Risk test. See Summary Response to Comments.
12 I am an optometrist in Sun City Arizona, a retirement community. I see many patients with AMD, and know first hand how devastating this disease can be. In addition, I have written and lectured to colleagues on nutritional protection for the macula for patients with and without AMD. Specifically, my area of study has been the macular carotenoids lutein, zeaxanthin, and meso-zeaxanthin. I have read and understand all of the pertinent studies regarding CFH and ARMS2 risk alleles and the effect zinc has on them in terms of retarding or accelerating progression of disease. Quite frankly, with knowledge of these studies, I can’t fathom why the AREDS or AREDS2 formula is still available for use without a doctor’s prescription. And the only way to determine if the AREDS formula is right for a patient is through genetic testing. I have used the Macula Risk genetic test (which includes VitaRisk analysis) on over 200 patients. I have taken many patients off of AREDS and AREDS2 due to safety concerns, i.e. they had high CFH and low ARMS2 risk alleles. I feel it is ethical and necessary for me to inform patients with AMD who are candidates for AREDS supplements about the option of genetic testing. Without Medicare coverage, many of my patients will not have access to this medically necessary test. I have reviewed the literature cited in the draft LCD, which seems to omit or overlook key elements of the scientific evidence about the potentially harmful effects within certain subpopulations. It is my understanding that a number of independent researchers have demonstrated the pharmacogenetic effect in separate, well-designed analyses. However, the denial of coverage seems to rely heavily on a single analysis, AREDS Report 38, which presents data that run counter to its conclusion that the AREDS formulation had benefits across all genotypes. The other articles cited as evidence against of the pharmacogenetic effect are simply opinion pieces – none of the other articles present data or statistics. I am concerned that taking AREDS vitamins will result in harm to some of my Medicare patients with AMD. The Vita Risk test can identify these patients. This knowledge is critical for appropriate clinical decision making. The Vita Risk test is medically necessary for the optimal care of those patients with intermediate AMD for whom I am considering treatment with AREDS vitamins. CMS coverage of the Vita Risk test is necessary to ensure access to this important test for my Medicare patients. For these reasons, I strongly encourage you to reverse this draft recommendation of non-coverage and to issue a positive decision for coverage of the Vita Risk test. See Summary Response to Comments.
13 As a retina specialist actively engaged in the management of patients diagnosed with dry age-related macular degeneration (AMD), I advocate the use genetic testing to enhance patient care. I have been implementing AMD genetic testing for at least 5 years. The testing allows me to identify patients who are high risk for progressing to neovascular AMD. Once identified, the patients are monitored closely. Early detection is critical so timely treatment can be started with anti-VEGF intraocular injections when they convert and vision can be improved or stabilized. After reviewing the clinical data on AMD genetic testing, I support its utilization to optimize the choice of supplements as determined by the Vita Risk genetic test. Given the availability of such essential technology for appropriate supplement recommendation, I strongly endorse CMS/ Medicare reimbursement of the test. My responsibility is to diagnose and manage patients with dry AMO and treat when they convert to neovascular AMO. I recognize the importance of an early diagnosis of wet AMO and the application of appropriate nutritional support as a treatment to prevent disease progression. The Vita Risk technology insures patients receive the correct AREDS supplement. See Summary Response to Comments.
14 I am a retinal specialist who treats many patients with age-related macular degeneration (AMD) and many of these patients are Medicare patients. I have reviewed and read the pertinent literature, and I am convinced that it would be in the patients’ best interest to have access to and coverage of a Medicare approved genetic test for selecting the appropriate nutritional supplement for patients with AMD. The evidence supports the use of Vita Risk genetic testing for patients with intermediate AMD, and I feel strongly that the Vita Risk test is medically necessary. As things presently stand, I don’t know what is best to tell patients because they may have increased risk of advanced AMD by taking the AREDS formulation if they have a certain genetic subtype. Others (the majority) will benefit from the AREDS vitamins. The problem is that without genetic testing I don’t know who may benefit and who may be harmed. Therefore, I am urging you to approve coverage for this test so that I can firmly recommend or not recommend the AREDS vitamins to the proper patients and protect the ones who may be harmed by the vitamins. This test will help me make a better informed clinical management decision for my patients. Patients with AMD purchase the over-the-counter AREDS vitamins with the expectation that they will achieve a treatment benefit. Although the AREDS trial demonstrated an overall benefit, more recent genetic analyses of AREDS data have convincingly shown that this average benefit is the product of widely differing individual treatment responses. The evidence indicates that these differences in response to AREDS vitamins are due in large part to genetic risk markers (CFH and ARMS2). I have reviewed the literature cited in the draft LCD, which seems to omit or overlook key elements of the scientific evidence about the potentially harmful effects within certain subpopulations. It is my understanding that a number of independent researchers have demonstrated the pharmacogenetic effect in separate, well-designed analyses. However, the denial of coverage seems to rely heavily on the conclusions of AREDS Report 38, which presents data that run counter to its conclusion that the AREDS formulation had benefits across all genotypes. The other articles cited as evidence against of the pharmacogenetic effect are simply opinion pieces or editorials without supporting data or statistics. I do not agree with the recently released report by the ASRS Genetic Task Force regarding genetic testing and nutritional supplements for AMD. The report fails to critique or verify any of the claims made by the AREDS Study Group publications – it merely repeats the criticisms made by the AREDS Study Group criticisms of the Awh, et al. publications. I do not agree with the American Academy of Ophthalmology opinion, as well. I think that both of these committees were politically motivated and their conclusions were faulty and pressured. I am concerned that taking AREDS vitamins will result in harm to some of my Medicare patients with AMD. The Vita Risk test can identify these patients. This knowledge is critical for appropriate clinical decision making. The Vita Risk test is medically necessary for the optimal care of those patients with intermediate AMD for whom I am considering treatment with AREDS vitamins. CMS coverage of the Vita Risk test is necessary to ensure access to this important test for my Medicare patients. It is ethical and necessary for me to inform patients with AMD who are candidates for AREDS supplements about the option of genetic testing. Without Medicare coverage, many of my patients will not have access to this medically necessary test. See Summary Response to Comments.
15 I am a retired R.N. and have seen the devastating results of Age-Related Macular Degeneration in 2 dear family members. To deny Medicare coverage of a simple test that could help prevent blindness in certain genetic populations is unconscionable. Many elderly have no spare change and are at the mercy of the system as to what care they can receive. I know as I worked with the poor as a public health nurse for over thirty years. Vitamins to help prevent AMD are advertised nightly on TV. Many will take them inadvertently not realizing the harm that can be caused by the zinc in them if they belong to the genetic population so affected. Education for the need of the test should be required with the ads and Medicare should not deny coverage. See Summary Response to Comments.
16 I have reviewed Dr. Awh's report from 2013 and 2015. Even though it is a post hoc analysis of the AREDS study population the combination of high risk alleles does make sense from a statistical standpoint and does create numbers that have significance. Having 2 risk alleles for CFH(complement factor H) showed increase risk of progression with the standard AREDS II formula. In fact, it appears that there is a 43% greater risk of progression vs placebo. The other combinations that were analyzed had different risk ratios. Some of these confirmed the benefit of the vitamin formula and others showed benefits of some of the components or at least neutrality. These numbers were verified and duplicated by Dr. Kustra and Dr. Rosner. Additionally, the larger analysis by Dr. Seddon using two eyes from individuals showed that there may not be a benefit to the use of the vitamins, antioxidants, zinc or combination, across all subsets of patients. This fact alone brings into question the need for this therapy across all levels of macular degeneration patients. The vitamin formula is approximately $30 per month. I certainly understand that these types of analyses are not as strong as a prospective, randomized, blinded study, but they are very compelling. I know that we already have many ridiculously expensive pharmaceuticals that we use every day to treat the exudative form of macular degeneration. I clearly do not want to see more money exhausted on costly testing, but the impact on society and individuals would be much greater in the 19% of patients that show a 43% greater progression to advanced macular degeneration. Regardless of how one looks at this information, you cannot use AREDS report number 38 to refute Dr. Awh's analysis. The data presented in that study and the additional editorials does not have enough statistical significance to be of any value. They are based on small subgroups and opinion not scientifically reproducible numbers. To choose not to cover the genetic testing on this would be based on a subjective process and not objective data. Additionally, the statement from the ASRS in January 2017 was also simply a subjective opinion from a small group of retinal specialists that in no way was representative of all members of our organization. See Summary Response to Comments.
17 I would like to list a few bullet points in regards to the AREDS vitamins and genetics. 1. Though recommending the AREDS vitamins since the initial publication of the original AREDS1 trial, there have been lingering concerns of its overall modest benefit. Also, it has been recommended, in many instances, where there is no benefit. Many practitioners and almost all patients do not understand that the vitamin only benefits individuals with more advanced stages of AMD. 2. Only after the original trial was published, was there is increasing evidence of that beta-carotene being was harmful to smokers. Most practitioners felt that this affect would wane with cessation of smoking. The AREDS2 trial indicated that the even a prior history of smoking was a permanent affect associated with an increased risk of lung cancer in persons treated with beta carotene. Clearly, the AREDS1 formula was harmful to some patients. 3. American Academy of Ophthalmology’s EyeNet January 2017 lead article was titled “Precisions Medicine: How Genetics and Genomics Are Transforming Ophthalmology”. 4. Just in print was the summary of a presentation at the Angiogenesis meeting for macular degeneration at Bascom Palmer titled “Patients with certain Genetic Variants are at Greater Risk for AMD Progression”. 5. In medicine in general, particularly and for cancer related therapy in particular, the current emphasis is to tailor drug therapy in accordance with individual’s genetics. Dr. Awh’s work published in Ophthalmology, as well as Dr. Johanna Seddon’s independent review of data published in the British Journal of Ophthalmology provide scientific support to the role of an individual’s genetic makeup determining the clinical response to the use of the AREDS vitamin. See Summary Response to Comments.
18 I am well versed in the literature regarding issues of genetic testing for patients with AMD. The evidence that those with 2 CFH and 0 ARMS2 risk alleles have increased risk of AMD progression if treated with the AREDS formulation is powerful and compelling. DNA collected at the start of the AREDS for the express purpose of post-hoc analysis made this research possible, and it is difficult to imagine it could have provided a more clinically valuable discovery given that it strongly suggests that significant numbers of patients have elevated their risk of developing blindness simply by taking a vitamin formulation that is ubiquitously provided to all AMD patients. I find the efforts of certain AREDS and NEI investigators to discredit and obscure the work of Awh, et al, both disappointing and largely astonishing. I must comment on the recently published ASRS Genetics Task Force report regarding genetic testing for patients with AMD and explain why it should not be considered to be representative of the unified opinion of the ASRS Executive Committee or the membership of the ASRS as a whole. The Task Force was a well-intended effort launched to respond to member concerns of bias and incomplete analysis found in an earlier AAO Genetics Task Force statement. Unfortunately, the ASRS Task Force was crippled for over two years by internal discord, in part due to the influence of the NEI over certain members. The result was not the critical analysis hoped for, but basically an editorial that accepts without criticism the findings of AREDS Report 38, a publication that many consider flawed in design and incorrect in conclusion. For reasons that were largely political more than scientific, the ASRS Executive Committee allowed the Genetics Task Force to publish its report without peer review and without approval of much of the ASRS Executive Committee or membership. Unfortunately, I and many others disagree with the Task Force Report and feel that its publication does a disservice to retina specialists and to patients with AMD. It is ironic that individuals who treat the AREDS recommendations as sacrosanct choose to criticize the recommendations of Awh, et al., as lacking due to “insufficient data”. The AREDS findings were never validated with a second trial, so a separate data set will probably never be available. However, multiple independent analyses of the AREDS data set itself show that the response to the AREDS formulation varies greatly based on individual genetic risk. As a physician who regularly examines, treats, and advises patients with AMD, I think that patients, and their families, deserve to know whether the over the counter supplements they purchase provide no benefit, or most importantly, may cause harm. Not every patient with intermediate AMD takes AREDS supplements - some are intolerant to vitamins and others cannot afford them. Thus, I would not use the Vita Risk test unless I was prepared to start select patients with intermediate AMD on vitamin therapy, to feel comfortable that I was not increasing their risk of progression to more blinding forms of AMD. See Summary Response to Comments.
19 I have reviewed the literature cited in the draft LCD, which seems to omit or overlook key elements of the scientific evidence about the potentially harmful effects within certain subpopulations. It is my understanding that a number of independent researchers have demonstrated the pharmaco-genetic effect in separate, well-designed analyses. However, the denial of coverage seems to rely heavily on a single analysis, AREDS Report 38, which presents data that run counter to its conclusion that the AREDS formulation had benefits across all genotypes. The other articles cited as evidence against of the pharmacogenetic effect are simply opinion pieces – none of the other articles present data or statistics. As a member of the American Society of Retina Specialists, I do not agree with the recently released report by the ASRS Genetic Task Force regarding genetic testing and nutritional supplements for AMD. The report fails to critique or verify any of the claims made by the AREDS Study Group publications – it merely repeats the criticisms made by the AREDS Study Group criticisms of the Awh, et al, publications. See Summary Response to Comments.
20 I am familiar with the scientific literature and discussion regarding the use of genetic testing in the management of AMD. As each year passes, there is more proof that AMD, the leading cause of blindness in older Americans, is profoundly influenced by genetics. All agree that the risk of developing intermediate and advanced AMD is strongly influenced by certain genetic risk alleles. There are multiple papers that show that the most impactful of these risk alleles, CFH and ARMS2, also influence the response to the AREDS formulation. The work of Awh, et al, demonstrates that the interactions of AREDS treatment with CFH and ARMS2 move in opposite directions, with increased CFH risk associated with a negative response to the AREDS formulation and increased ARMS2 risk associated with a positive response. It is logical that patients at the extremes of genetic risk, those with 2 CFH and with 0 ARMS2 risk alleles, would have the least favorable response to the AREDS formulation. The data in the Awh paper and in the AREDS Report 38 paper (as shown by Awh in a correspondence published in Ophthalmology), clearly show that this subgroup of patients had worse outcomes if treated with the AREDS formulation than if treated with placebo. These findings were generated from analysis of AREDS data, which is the only dataset available with long-term outcomes of patients treated with placebo or with the AREDS formulation. Given evidence that taking the AREDS formulation may harm some patients with AMD, it is essential that patients with intermediate AMD have access to the Vita Risk test to allow them, with their doctors, to make informed decisions about the risks and benefits of taking nutritional supplements. In my opinion, genetic testing should lead to better compliance among patients who benefit from the AREDS formulation, elimination of harm among those with 2 CFH and 0 ARMS2 risk alleles, and overall improved outcomes for patients with intermediate AMD. CMS coverage is necessary to make this testing accessible to Medicare age patients with intermediate AMD. See Summary Response to Comments.
21 The following is offered in support of coverage for genotype testing: 1. The Seddon et al paper shows that CFH interacts statistically with the AREDS treatment, as does the ARMS2 gene. This interaction is independent of gene grouping or subgroup analysis. AREDS formulation treatment provides no benefit for those with either high CFH risk alleles or with low ARMS2 risk alleles. This is consistent with the conclusions of Awh el al. In the Seddon paper, 1/3 of patients derive no benefit from the AREDS supplement, and patients with the combination of high CFH and low ARMS2 risk appear to have done worse. The Seddon paper is the most recent, largest and independent analysis of AREDS patients. Seddon's data clearly show and state in the abstract that "The effectiveness of antioxidant and zinc supplementation appears to differ by genotype." This alone should be sufficient to make genotyping patients for CFH and ARMS2 a clinically useful test. 2. The major finding of Awh, et al, was that patients with 2 CFH risk alleles and no ARMS2 risk alleles had an increased risk of AMD progression if treated with high dose zinc or with the AREDS formulation. Actually the essence of his data show that zinc supplementation may be deleterious for anyone who has no risk alleles for ARMS2. 3. Post-hoc analysis is traditionally used to generate a working hypothesis but requires subsequent analysis using more stringent methods and additional data sets before any conclusions can be made". The Awh, et al, analysis is based on all publically available DNA from the single data set used as the basis for AREDS treatment recommendations. AREDS results were never validated and never will be validated in a new second independent trial because of the cost and time and effort. While there are no placebo-controlled "additional data sets", Chew later reported on a cohort of the AREDS group which had not been previously studied. This is the subject of a letter after the AREDS report 38. The Awh, el al, subgroup analysis strongly suggests harm to a readily identifiable group of patients (those with no ARMS2 risk alleles). From discussions with an independent statistician, the real issue is that Awh et al used a "step wise regression analysis" NOT a "retrospective regression analysis" as mentioned in the ASRS report. None the less, a “step wise regression analysis" is a good and acceptable method when initially exploring data for possible significant interactions. It is a good "exploratory method" when beginning to formulate a hypothesis. 4. The ASRS Report reiterates the criticism of Wittes and Musch (both members of the AREDS Study Group), who published an editorial, not a peer-reviewed analysis, on this subject. Their argument that Awh, el al, did not correct adequately for multiple statistical testing, is correct but not significant (and these statisticians, Witts and Musch, knew that but still argued this point suggesting some sort of other agenda). However, for the sake of argument, the Awh, et al, p value of 0.00420 could have been corrected for over 10 independent variables and still reached a level of statistical significance. 5. AREDS Report 38 is accepted at face value. This analysis utilized a statistical design looking for "interactions". The subsequent 44 residual cohort analysis was the proper procedure and analysis to perform as a follow up to the exploratory step wise analysis. If one looks carefully at AREDS 38, ALL of the genotypes with no ARMS2 risk alleles who received zinc had a finding trending toward zinc being deleterious. Also in Chew's "residual cohort analysis" the subjects with low ARMS2 risk alleles have a definite trend for zinc being harmful with a Hazard ration of 1.5 It just did not reach statistical significance because the "residual cohort" was also under powered with only 526 subjects. None of these were statistically significant because the study was likely under powered. AREDS Report 38 and the subsequent "residual cohort" directly conflicts with Seddon's more recent report. The biggest problem is that "finding no significance" does not mean there IS no significance, only that the study did not find a difference possibly because was underpowered. 6. There are several independent reports demonstrating that genotyping data does add prognostic information that goes beyond what can be obtained from clinical phenotype alone (per ARDS study). There are many reports showing that CFH and ARMS2 genotyping is predictive of progression of the disease beyond that of the clinical progression of AREDS report. For me and my patients, there is significant value in this alone irrespective of the potential for zinc to be detrimental. There is new information regarding Vita Risk. In the Journal of VitreoRetinal Diseases, fresh evidence describing the hazards of AREDS antioxidants for individuals with normal eyes who do not have genetic risk factors for AMD has appeared.(http://joumals.sagepub.com/doi/pdf/10 .1177/2474126416680931) Individuals with adverse genetics have a decreased risk of developing the earliest signs of the disease if they take vitamins. This underscores the interaction of vitamins and genetics in AMD and shows a gene-environment interaction at each stage of this disease. See Summary Response to Comments.
22 I have followed the debate regarding the impact of genetic risk on the response to the AREDS formulation with both interest and concern. I have read all the relevant publications that deal with the issue of an identifiable group of patients with AMD, those with 2 CFH and 0 ARMS2 risk alleles, that have an increased risk of AMD progression on AREDS formulation. This finding has been contested and viewed by some as a challenge to AREDS recommendations published over 15 years ago. However, that is not the case. This is not a challenge to the NEI findings of 15 years ago, but is an expansion of our understanding and fine-tuning of the observed effects. In many fields of medicine, we have seen original findings of an intervention in a group of people to be improved upon, after information on genetic background was applied. The controversy raised by some (but not the majority) should not detract from efforts to uniformly obtain and cover for genetic testing for patients with AMD. The influence of genetics on AMD progression is unquestioned. Now, there is real potential for personalized medicine to improve the lives of patients with AMD. A recent publication in a high impact journal showed that a subset of patients with dry AMD can experience a reversal of their disease with improvement in visual acuity after high dose statin administration. My own preliminary research has revealed a pharmacogenetic response associated with the CFH risk allele in patients with dry AMD treated with high dose statins. In our unpublished genetic analysis of these patients we observed that responders vs nonresponders had different genetic signature of the CFH risk allele. Patients with intermediate AMD live with the continual fear of developing advanced disease. To deny these patients access to a genetic test that can improve their chances of maintaining useful vision is not ethical. In my opinion, the Vita Risk genetic test is medically necessary for the appropriate management of select patients with intermediate AMD. See Summary Response to Comments.
23 I would agree that our understanding of genotypephenotype relationships in AMO is incomplete. However, that is true of the entire field of medical genetics in which our understanding of all genotype-phenotype relationships is changing at warp speed. From my own practice experience in evaluating and testing of patients with all types of hereditary eye disease it seems clear that our understanding may never be complete or certainly won 't be any time soon. Do we wait on that and at whose expense? I do not agree with the American Academy of Ophthalmology that one or more prospectively designed clinical trials will need to demonstrate the value of genetic testing in AMO. While that might seem superficially reasonable there are valid reasons not to wait on that or even to expect it could happen. First, we already have it. The AREDS study was prospective and the DNA available for analysis was simply analyzed subsequently with respect to specific subgroups determined by supplementation and risk alleles for AMD. Second, who would be subjects for a study to confirm that certain of them will lose vision, a likely outcome given the existing data, and what IRB would ever approve it? See Summary Response to Comments.
24 CMS has a PQRS quality indicator that reports the rate of physician counseling on the value of AREDS supplements to patients with age related macular degeneration who are over 50 years of age (Measure #140 (NQF 0566)). Through this measure, physicians are encouraged to recommend this intervention to their patients with the expectation that fewer will progress to choroidal neovascular disease that is costly to treat and devastating personally. The scientific basis for this quality indicator is one study, the Age Related Eye Disease Study (2001),1 which was conducted before our modern understanding of the genetics of AMD2 and the biological effects of zinc on the activity of a key determinant of AMD, the complement factor H gene3. Since then, convincing reports of the interaction of the AREDS supplements with specific genotypes have been published with the most recent suggesting that 1/3 of all AMD patients will not benefit from these vitamins and other reports showing that a portion of these patients are actually at risk of being made worse4,5. This quality indicator needs to be modified to reflect this new information. The NEI AREDS promoters have been given the credibility of tax payer support but are tainted by significant royalty payments by Bausch and Lomb to the Institute and to the Clinical Director personally. This unfortunate conflict prevents them from usefully contributing to the modernization of AREDS use. This just can’t be overlooked. The NEI has also been identified with a decades-long public health message around the use of vitamin supplements: its entire research program would be called into question by a public reconsideration of the AREDS supplements universal merit. The indicator should be modified to reflect counseling about both the supplements and the availability of a reimbursed genetic test. See Summary Response to Comments.
25 I have followed the use of zinc therapy in AMD from the beginning. I followed the subsequent AREDS study with interest. More recently I have reviewed all the literature on genetic testing for CHF and ARMS2 alleles in relation to zinc efficacy in AMD. It is very clear that genetic variation in these two genes has a profound effect on the results of zinc therapy in AMD. There is substantial benefit to some patients with AMD from zinc therapy, but it is also clear that there is a group of AMD patients who are harmed by zinc therapy. Further research is important, but when potential harm is identified, the burden of proof of safety is on those that propose the therapeutic use of zinc and the AREDS formulation in AMD patients. To me, it is clearly important to do this genetic testing now that we know that the genotypes identify who will be helped and who will be harmed by zinc therapy. Thus, I strongly favor coverage of these tests because I think such testing will be an important benefit to patients. I state this opinion not only as a major developer of zinc therapy for other diseases, but as a human geneticist. Human geneticists are now being bombarded by calls to assist in the movement of medical therapy from "one size fits all" to "personalized", or as it is sometimes called, "precision" medicine. This means for example, genetic testing to identify patients who will benefit from therapy A vs therapy B. This genetic approach to "personalized" or "precision" medicine is becoming the new norm. Genetic testing of AMD patients to optimize their therapy is such an obvious application of this widely accepted concept that it is surprising that there is any controversy about the value of this testing for AMD patients. See Summary Response to Comments.
26 This policy is in line with our current guidelines on genetic testing for AMD. The burden of proof is on the manufacturers to show that this test is effective and that the definitive studies have still not been done. There is no specimen bank available to repeat this study. See Summary Response to Comments.
27 See Summary Response To Comments. Summary Response to Comments: A very large number of identical comments (form letters) were received from members of the MDA membership and optometrists (some members provided copies of the cover letter from the MDA). To a lesser extent, form letters were also received from clinicians, particularly optometrists. One ophthalmologist provided the following email that was submitted to info@macularhope.org and ethics@aao.org: “I disapprove of your scare tactics, i.e., latest letter to my patient stating as fact that supplements may be harmful, and encouraging a letter to the Medicare intermediary to approve of coverage for your genetic screen. I am aware of the "controversy" and what you state to my patient in your letters is presented as incontrovertible fact. It is not.” No new scientific data was provided by any commenter. The draft noncoverage policy for Vita Risk has been changed to a coverage policy for patients with intermediate to severe macular degeneration. Although the American Academy of Ophthalmology supports one or more prospectively designed clinical trials to demonstrate the value of genetic testing in AMD, some commenters noted that there is no specimen bank available to confirm the role of genetics in AMD. Additionally, commenters expressed concern that an IRB would never approve a clinical study to confirm that patients will lose vision, a likely outcome given the existing data. One commenter (comment not included above to protect the commenter) indicated that he used Vita Risk to “screen” patients for AMD. Screening for AMD is NOT a Medicare benefit. To be eligible for any Medicare benefit, except when screening is statutorily provided by Congress, a patient must have signs or symptoms of a disease.
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