Michigan has prohibited an online "vision test" company from further violating the state's Eye Care Consumer Protection Law with a cease and desist order, reflecting doctors' concerns over unlawful prescriptions.
Issued to Opternative on Feb. 12, 2016, (obtained via Freedom of Information Act request on March 11), the cease and desist order from the Michigan Department of Licensing and Regulatory Affairs (LARA) directs Opternative to immediately halt actions violating the state's public health code, including:
- Issuing prescriptions for contacts and/or spectacles to patients without a Michigan-licensed doctor first performing a complete ocular health assessment—one that goes beyond simply an objective refractive test.
- Issuing prescriptions for contacts and/or spectacles to patients based solely upon a test that relies on objective refractive data generated by an autorefractor or other automated testing device.
Per a formal complaint filed to LARA in August 2015, the Michigan Optometric Association (MOA) contested the "prescriptions" issued through Opternative's app-based service as invalid under state law. Under Opternative's model, ophthalmologists write prescriptions using measurements from a rudimentary "vision test" administered by consumers themselves on their smartphones—with varying degrees of accuracy.
Michigan's Eye Care Consumer Protection Law declares prescriptions valid only after a state licensee performs an "examination and evaluation," defined as an assessment of ocular health and visual status that does not consist solely of objective refractive data generated from an automated device.
Therefore, the MOA contended in its August appeal: "It appears that the exam is 'performed' by a computer and the ophthalmologist simply signs off on a computer-generated prescription without ever actually examining the patient ... as a result, any prescription issued via Opternative will have no value to the patient."
Roger Seelye, O.D., MOA Legislative Committee chair, says prior to the Eye Care Consumer Protection Law, Michigan had no legal definition of a contact lens or eyeglasses prescription. This void of proper patient protection prompted MOA to move forward legislatively to address this health care concern, making sure to involve all vision care professionals by reaching out to ophthalmology for collaborative legislation.
"Both professions agreed that for the protection of an unsuspecting and unassuming public, a legal prescription for either spectacles or contact lenses should only be derived as a result of a comprehensive eye examination, which includes both an ocular health assessment and determination of the refractive status," Dr. Seelye says. "Thus, measurement of refractive error by means of any automated device, either in person or electronically, does not fit the legal definition of a comprehensive eye examination and any prescription produced in that manner is not a legal or valid prescription in the state of Michigan."
Elizabeth M. Becker, O.D., MOA president, adds that when Opternative launched their program within the state, MOA initiated a campaign with complaints directed to both LARA and the state's Attorney General: "The MOA will continue to monitor any new programs for the health and benefit of our patients in Michigan. I am both impressed and grateful to all who have worked on this with us."
Steven A. Loomis, O.D., AOA president, says the cease and desist order against Opternative is an important step in safeguarding the health of Michigan residents.
"Online vision tests like Opternative are, at best, estimates of consumers' refractive errors; they are not eye examinations in which a patient can be assured that their prescription has been accurately validated in person, and more importantly, that their eye health has been evaluated by their doctor." Dr. Loomis says. "The Michigan Department of Licensing and Regulatory Affairs' sole responsibility is protection of the public, and that is what this order accomplishes because the public is being misled by online claims."
'Advocacy force' continues challenging online 'vision tests'
Concerned for consumers' health and safety, the AOA and state associations continue to call out online "vision tests" and the profit-centric companies that tout convenience through ambiguous and sometimes inaccurate claims. The AOA contends that there are severe pitfalls in separating refractive tests from routine comprehensive eye examinations performed in person by an eye care professional, and this message is circulating among government authorities, the media and public.
This past October, Dr. Loomis reaffirmed AOA's request for a full U.S. Food and Drug Administration investigation (member login required) of Opternative's misleading claims connected to the unproven use of a medical device, and reported its website's questionable doctor locator function that listed optometrists without their knowledge.
"Wherever we find violations of federal or state law, our AOA and state associations will be pressing for full enforcement," Dr. Loomis said at the time. "Where laws may need to be updated to better protect the public, we will be an advocacy force."
Online contact lens retailer, Vision Direct UK, to halt sales without required prescriptions after AOA complaints
After years of the AOA alerting the company of regulatory and legal requirements regarding contact lens sales, Vision Direct recently announced on its website that it was halting its no-prescription service.
The advocacy collaborative fighting for patient safety and the doctor-patient relationship reports on a productive 2020, despite COVID-19 challenges, and recently welcomed Alcon as its newest member.
At Nov. 17 FDA workshop, doctors of optometry warn of a lack of communication regarding the safety of online vision tests. The AOA, which continues to educate the public on these mobile apps and to hold them accountable, offers its expertise.