Medicare is still researching the use of the genetic test. We are expecting their decision to cover it this year. – MDA
Medicare to reimburse genetic testing for AMD
Her genetic profile (two high-risk CFH alleles and low-risk ARMS 2 alleles) was precisely the one that predicts a more rapid progression of her dry AMD to wet if zinc is ingested. The lab results of her genetic test stated: “Vitamin recommendation based upon CFH and ARMS2 genotyping: AREDS without zinc.”
The patient was furious that she was never offered the noninvasive cheek swab genetic test initially and that her doctors told her to continue the AREDS formulation even after her right eye converted from dry AMD to wet. She subjectively complains of blurred and distorted vision. Her most recent best-corrected visual acuity was 20/100 and 20/50.
As recommended most recently, she takes a product containing lutein, zeaxanthin and mesozeaxanthin with no additional zinc.
Patient files lawsuit
A lawsuit ensued. Questions related to prevailing standard of care were raised. Without doubt, there are more eye clinicians who do not obtain genetic analysis than those who do in patients with AMD. Hence, one could argue that the doctors met the existing standard of care at the time the care was rendered.
The case was settled for an undisclosed amount even before depositions were taken. The physicians did not want the publicity, and the patient realized that the doctors did meet the standard of care. If the case went to trial, it is possible that a culpable verdict would have resulted in a change in the standard of care.
Of interest, the ruling of CMS to cover genetic testing will most likely result in large numbers of clinicians using the genetic test, and this could result in a new standard of care.
- References:
- American Academy of Ophthalmology Retina/Vitreous Preferred Practice Pattern Panel. Age-Related Macular Degeneration. 2015. Posted January 2015. Accessed Aug. 17, 2017.
- AREDS Research Group. Arch Ophthalmol. 2001;119(10):1417-1436.
- AREDS2 Research Group. JAMA. 2013;309(19):2005-2015;doi:10.1001/jama.2013.4997.
- AREDS2 Research Group. JAMA Ophthalmol. 2013;131(7):843-850;doi:10.1001/jamaophthalmol.2013.4412.
- Awh CC, et al. Ophthalmology. 2013;120(11):2317-2323;doi:10.1016/j.ophtha.2013.07.039.
- Awh CC, et al. Ophthalmology. 2015;122(1):162-169;doi:10.1016/j.ophtha.2014.07.049.
- Chew EY, et al. Ophthalmology. 2014;121(11):2173-2180;doi:10.1016/j.ophtha.2014.05.008.
- Chew EY, et al. Ophthalmology. 2015;122(1):212–215;doi: 10.1016/j.ophtha.2014.10.012
- Fritsche LG, et al. Nat Genet. 2016;48(2):134-143;doi:10.1038/ng.3448.
- Hampton BM, et al. Clin Ophthalmol. 2015;9:873-876;doi:10.2147/OPTH.S84155.
- Jager RD, et al. N Engl J Med. 2008;358(24):2606-2617;doi:10.1056/NEJMra0801537.
- Klein ML, et al. Ophthalmology. 2008;115(6):1019-1025;doi:10.1016/j.ophtha.2008.01.036.
- Kvansakul J, et al. Ophthalmic Physiol Opt. 2006;26(4):362-371.
- Schwartz SG, et al. J Ophthalmol. 2011;Article ID 25249;doi.org/10.1155/2011/252549.
- Seddon JM, et al. Br J Ophthalmol. 2016;100:1731-1737;doi:10.1136/bjophthalmol-2016-308624.
- Seitsonen SP, et al. PLOS One. 2008;3:e3833;doi:org/10.1371/journal.pone.0003833.
- Wittes J, et al. Ophthalmology. 2015;122(1):3–5; doi:http://dx.doi.org/10.1016/j.ophtha.2014.10.023.
- For more information:
- Jerome Sherman, OD, FAAO, a member of the Primary Care Optometry NewsEditorial Board, is a Distinguished Teaching Professor at the SUNY College of Optometry and in private practice at Omni Eye Surgery in New York. He can be reached at j.sherman@sunyopt.edu.
Disclosures: Sherman has lectured for, received honorarium from or consulted with ArcticDx, Annidis, Carl Zeiss Meditec, DGH, Diopsys, Eye Solutions, Heidelberg, MacuHealth, Optos, Optovue, PHP, Quantel and Topcon.
Source: Healio & Jerome Sherman, OD, FAAO
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