The underlying concern of online refractions

February 1, 2016
Pamela J. Miller, OD, FAAO, JD, FNAP

There is no question that our profession is undergoing rapid change as well as significant challenges. As a profession, we are faced with the dual responsibility of protecting our patient and maintaining our proficiency. Both of these also fall under the legal jurisdiction of the State Board of Optometry in the states in which we are licensed. Some state boards have already acted, but most have not. One that has not is California.

There is no question that our profession is undergoing rapid change as well as significant challenges. As a profession, we are faced with the dual responsibility of protecting our patient and maintaining our proficiency. Both of these also fall under the legal jurisdiction of the State Board of Optometry in the states in which we are licensed. Some state boards have already acted, but most have not. One that has not is California.

For over two years, optometry has faced distinctive challenges that have been overlooked or pushed aside by those very same state boards. The California State Board has thus far neglected to act on the topic of online refraction, in spite of being made aware of the potential harm and receiving both written and oral testimony about it.

One wonders if the CA State Board is afraid to act, believes it has no jurisdiction to act, feels there is no violation of the optometry rules and regulations, is just ignorant, feels that because no consumer has been directly harmed it cannot act, or outright thinks that there is no instance of the consumer being misled or harmed.

Related: Eyecare community raises red flags over Opternative

Multiple apps and websites are available or being developed to conduct refractions. There is no direct or actual supervision by a licensed optometrist or ophthalmologist. At least one site (Opternative) posts a disclaimer, yet still uses the term “eye exam” when describing its product.

Opternative cofounder Aaron Dallek described the service as a “convenient and very affordable way” for getting a prescription ($40 for a refraction/$60 for a contact lens Rx; taking less than 25 minutes), costing less than a “traditional refractive eye exam.” Cofounder Steven Lee, OD, who is not licensed in CA, said it was “statistically equivalent” to the traditional eye exam. The website goes on to say that the “Opternative eye exam was as accurate as a traditional refractive exam performed by an optometrist or ophthalmologist using a phoropter.”

The California Brokers listed as a new product in its Insurance Insider newsletter (July 29, 2015) a paragraph promoting Opternative under the heading “Covered California Releases Rates for 2016.” The result is that California’s Life and Health Professionals is now promoting a product that is misleading to the public, to professionals in the insurance arena, and is not compliant with CA state law.

Next: Industry taking action

 

Industry taking action

In June 2014, the Association of Regulatory Boards of Optometry (ARBO) passed a resolution regarding online dispensing. The resolution created a committee to study online dispensing.1

WHEREAS, the public safety and welfare may be adversely affected by the online dispensing of contact lenses, glasses, and other optical devices in certain settings; and

WHEREAS, it appears that the online dispensing of contact lenses, glasses, and other optical devices is unregulated in certain settings; now therefore be it

RESOLVED, at this 95th Annual Meeting of the Association of Regulatory Boards of Optometry (ARBO) House of Delegates that the ARBO Board of Directors establish a committee to gather data on both the regulation and non-regulation of online dispensing of contact lenses, glasses, and other optical devices; and to have that committee report to the ARBO Board of Directors and appropriate governmental agencies, and report back at the next Annual Meeting on the current regulatory structures as well as recommendations to enhance the protection of the public.

Submitted by the Ontario College of Optometrists

Editorial: Why Blink and Opternative are a disaster waiting to happen

In January 2015, The Optometric Society released a consumer brochure, “Eye Before See,” designed to educate the public about the pitfalls and dangers of online refractions. The Optometric Society has personally appeared before the CA State Board with both written and oral testimony regarding the potential dangers of online refractions.

In August 2015 in an interview, American Optometric Association (AOA) Steve Loomis formally opposed online refractions.2

The AOA expressed concerns about possible “abuses of technology’s promise and false claims that can leave patients misled, misinformed or confused.” Dr. Loomis said Opternative may be problematic because clients miss some important benefits they’d receive during an eye exam.

“The consumer believes they’ve had an exam when they really haven’t,” Loomis said. “It misses the diagnostic parts for cataracts, or for glaucoma or for diabetes.” And a more thorough eye exam is usually quick and painless for patients.

“Rather than expanding care,” he said, “patients think that they’ve had care that they don’t have, and so they don’t get the care that they need.” 

Ultimately, even the CA Optometric Association came out with a statement warning about the dangers of online refractions and the potential harm that can result to the consumer, who in good faith believes that he has no ocular health or undiagnosed medical conditions and relies on the online results as a substitute for a complete visual examination.3

Next: California laws and regulations

 

California laws and regulations

California law is very specific under Chapter 5.4, Section 2540 (Business & Professions Code of California):4

“No person other than a physician and surgeon or optometrist may measure the powers or range of human vision or determine the accommodative and refractive status of the human eye or the scope of its function in general or prescribe ophthalmic devices.”

Section 3041 addresses the acts constituting the practice of optometry, and Section 2290.5 addresses telehealth. Current laws (including Sections 3110 and 651) address unlicensed practice.

Doctors are required to be licensed in the state, and patients must have the ability to reach the doctor actually signing the prescription as well as a location to return to for further care or remediation of a problem.

Online refractions do not constitute a substitute for a visual examination; it is not equivalent to utilizing an auto-refractor in a professional office. Auto-refractors are utilized merely as a tool in a field of diagnostic and information gathering equipment prior to developing a patient’s prescription.

More from Dr. Miller: Top 5 ways you break the law in your practice

There is potential for serious and even life-threatening harm to the patient. The perception on the part of the patient is that an online refraction or an auto-refraction performed by a non-doctor constitutes a complete examination. The fact that a physician who may be licensed in the patient’s state actually signs the script does not constitute the direct supervision and oversight that is needed to ensure the health and safety of the patient.

Patient self-reporting, with no follow-up or in-person questioning, is misleading at best and potentially criminal at worst.

Should state board members wait to act until a consumer is actually harmed or should state board members do the job they were appointed to do-enforce the laws of the state and more importantly, protect the consumer? They are the only advocate for the consumer that exists.

It can be argued that failing to do so is an abdication of the board’s duties and that any unlicensed, untrained individual can practice optometry (or ophthalmology) in California.

Next: Arguments favoring action in CA

 

Arguments favoring action in CA

Some of the arguments favoring the CA State Board taking action include:

• Online refractions are a violation of the existing CA law and fail to meet the current standard of care for an eye exam.

• Significant concerns of public welfare, eye health, and public safety are involved.

• Opternative is currently operating in CA and sending Rxs into the state.

• There is no direct communication between the patient/consumer and the doctor signing the script.

• Opternative is currently advertising for optometrists and ophthalmologists on its website.

• The state board has a duty and an obligation to protect the consumer.

• The consumer may ultimately be harmed and is being misled into believing that an online “eye exam” is equivalent to an eye exam performed by a licensed optometrist or physician and surgeon.

• The standard of care is not being met-an online refraction is not a substitute for a comprehensive eye examination.

• An auto-refractor is merely a diagnostic tool and not a substitute for an eye exam.

• The fact that Medicare requires billing separately for a refraction does not constitute any acknowledgement that a refraction is not part of a full examination.

• The consumer has no way to contact a doctor if questions or concerns arise.

• Many consumers are unaware of existing (or potential) health or ocular problems that a doctor may discover during an examination.

• Contact lenses are medical devices which have serious potential for harm and require updating as well as regular assessment for eye health, comfort, and optimum visual performance.

Related: Blink in-home vision test worries ODs

Next: Arguments against CA taking action

 

Arguments against CA taking action

Some of the arguments against the CA State Board taking action include:

• Possible violation of the Sherman Anti-Trust Act.

• Telemedicine is here to stay and online refractions are simply an aspect of telemedicine.

• Online refractions are inevitable, regardless of whether the state board acts or refrains from acting.

• Precedent in North Carolina where the court found that the North Carolina State Board of Dental Examiners acted to protect the dental profession instead of the consumer and was anti-competitive regarding teeth whitening.5

• The state board will be setting a precedent if it comes out against online refractions or where there is no direct supervision by a licensee.

Related: NYSOA says Blink in-home vision test is illegal

Where do we go from here?

At the CA State Board of Optometry’s November 20, 2015, meeting, members spoke to the sense of urgency, the fact that the board needs to be as aggressive as it can and as quickly as it can, and the possibility of false advertising. In late January 2016, the California Optometric Association has asked its members to document 15 cases in which an online refraction would have completely missed a serious eye disease. In addition, it has produced several short animated videos about online eye tests for members to share on the practice social media pages.

Only rarely does a State Board of Optometry have a golden opportunity to truly make a difference and set itself out as a leader while pursuing its mission.

 

 

References

1. Association of Regulatory Boards in Optometry. “Resolution 2. Create Committee to Study On-Line Dispensing.” Available at: https://www.arbo.org/Documents/resolution_dispensing.pdf. Accessed 2/1/16.

2. Gaitan D. Online Eye Exams: Misleading or the Future of Care? Available at: http://ww2.kqed.org/futureofyou/2015/10/08/online-eye-exams-misleading-or-the-future-of-care/. Accessed 2/1/16.

3. California Optometric Association. Online eye refractions illegal in California. Available at: http://www.coavision.org/i4a/pages/index.cfm?pageID=4127. Accessed 2/1/16.

4. California Legislative Information. Available at: https://leginfo.legislature.ca.gov/faces/codes_displayText.xhtml?lawCode=BPC&division=2.&title=&part=&chapter=5.4.&article=. Accessed 2/1/16

5. North Carolina State Board of Dental Examiners v. Federal Trade commission. U.S. Supreme Court, 2015. Available at: http://www.supremecourt.gov/opinions/14pdf/13-534_19m2.pdf. Accessed 2/1/16.

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