Vision Health Safety Advocates Call FTC Ruling Dangerous; Congressmen Bobby Rush and Michael C. Burgess, M.D. vow to continue working to protect patients

The Health Care Alliance for Patient Safety (APS) today raised concerns about the final Federal Trade Commission Contact (FTC) Lens Rule that fails to adequately address the dangerous practice of utilizing computer-generated voice calls to verify contact lens prescriptions and places significant burdens on doctors.

In response, APS, together with Congressman Bobby Rush (D-IL) and Congressman Michael C. Burgess, M.D. (R-Texas), vowed to continue their work to pass the Contact Lens Prescription Verification Modernization Act to protect patients. The bill, H.R. 3975, which is co-sponsored by Congressmen Rush and Burgess, has support from Members of both parties.

“I am admittedly disappointed that the final rule still allows automated recordings for prescription verification,” Congressman Bobby Rush (D-IL) said. “Our bill, the Contact Lens Prescription Verification Modernization Act, would correct this outrageous loophole by prohibiting automated verification calls, a practice that has no place in verifying sensitive medical information.”

“I appreciate the FTC updating its Contact Lens Rule to provide increased flexibility for prescription contact lenses. It is critical for patients to receive the correct prescription when ordering contact lenses. The rule requires prescribers to automatically provide a copy of a patient’s prescription and to verify it when provided to third-party sellers. I am disappointed the rule still allows automated recordings for prescription verification, a practice which has led to patient harm when prescriptions have been misunderstood,” Congressman Michael C. Burgess, M.D. said. “A bill I introduced with Representative Bobby Rush, the Contact Lens Prescription Verification Modernization Act, would fix this and protect consumers. I will continue working to ensure that patients and their doctors continue to be at the center of prescribing and safe use of regulated medical devices”

Unless patients have provided them with a copy of the prescription, online contact lens sellers are required to verify a contact lens prescription with the prescribing doctor before completing the sale of these medical devices. Many sellers use computer-generated voices and calls, like robocalls, to attempt verification.

However, robocalls – which will be allowed to continue under this FTC ruling – are undependable and require significant follow-up by doctors and their staff, as the information these robocalls provide is often incomplete, impossible to understand or related to a person who has never been a patient of the eye doctor receiving the call. If an optometrist’s office is unable to verify the validity of a prescription within eight business hours, a contact lens prescription is automatically considered “verified” and sold, even if it was not the prescribed lens.

APS has long maintained that a safer, more responsible and efficient verification method would be email, a technology that is cost effective and could provide clear, written communication to ensure patients receive their correct prescription for contact lenses—Class II and III medical devices. It is inconceivable why the FTC chose to adopt a rule that favors this type of verbal communication over a more modern and accepted method like email.

The proposed Contact Lens Prescription Verification Modernization Act increases patient safety by prohibiting prescription verification made via robocall and establishing a paper trail by instead requiring that online sellers use direct communication – a live phone call, fax, or e-mail – to confirm prescriptions.

“The Federal Trade Commission’s final Contact Lens Rule regarding automated calls is seen as dangerous by eye doctors and patients who know that the continued use of antiquated prescription verification technology means incorrect prescriptions will continue to be sent to patients, which could lead to adverse vision health outcomes,” said Dr. Deanna Alexander, O.D., Chairwoman of the Health Care Alliance for Patient Safety. “APS has been working with Congress to pass legislation to remedy this ill-advised ruling on robocalls from the Federal Trade Commission.

The final rule from the FTC also places significant burdens on vision doctors by requiring them to collect, maintain and store signed paperwork from a patient acknowledging receipt of their contact lenses. Throughout the FTC’s consideration of the proposed rule, APS suggested modern, informative and less intrusive means of communicating with patients. Unfortunately, the FTC failed to heed this guidance, instead choosing an outdated, burdensome technology.

Dr. Alexander, speaking on the additional burdens placed on doctors through signed acknowledgement forms, said, “Requiring doctors to maintain and store signed acknowledgement forms for years means adding more costly, administrative burdens that don’t improve patient care and health outcomes. APS will continue to advocate for more effective means of communications with patients that don’t shift physician offices’ focus away from patient care.”

Background

APS has been active advocates for patient safety throughout the comment period for the Contact Lens Rule. In 2018, the organization submitted its formal written comment, which included the following:

Out-of-Date Methods for Passive-Verification

In the proposed rule in December 2016, the FTC took the position that updates to the methods used in the verification process were not needed “because the current regulatory framework sufficiently prohibits the use of expired prescriptions.” APS believes the current advancements in technology allow for the FTC to issue guidance on new acceptable forms of verification, (e.g. emails) and disallow outdated forms of verification, like robocalls. Many of the outdated methods currently used do not constitute “direct communication” as intended by Congress.

APS supports the passive-verification process. However, advancements in technology now allow both sellers and prescribers to keep electronic health records. FTC action to modernize its guidance around passive-verification communication while excluding antiquated technology (e.g. robocalls) would provide greater documentation and the possibility of greater oversight in the verification process. Greater oversight, understanding and documentation will ultimately create a safer and more efficient environment for contact lens wearers and the verification of their prescriptions through clearer, concise and accurate communication between the prescriber and the seller.

Signed Acknowledgment

In the FTC’s proposed rule, the Commission proposed to require a signed acknowledgment form of prescription release that would allow the patient to acknowledge receipt of their contact lens prescription. In addition, the prescriber would be required to maintain this acknowledgement form for not less than three (3) years so they may be available for inspection by the FTC.

APS understands that the proposed requirement was in response to a small number of claims that suggest that prescribers were not freely giving patients their contact lens prescription as required under the law. In fact, the FTC itself conceded that “many reports of compliance and noncompliance are anecdotal and robust empirical data is sparse.” It is our belief that the Commission’s purpose for the signed acknowledgment form was to educate consumers of their rights while also subjecting doctors to spot investigations regarding the adherence to the law. APS believes that less intrusive means can be used to educate consumers of their rights to freely receive their prescriptions while also ensuring doctors follow the law.

Signage can inform patients of their rights under the law while at the same time providing a form of communication (e.g. phone number) to report any bad actors. This form of education is less intrusive and less burdensome while arguable more informative than a signed paper acknowledgment. APS urges the Commission to consider signage or other forms of educating consumers of their rights that are less intrusive and less burdensome than a signed acknowledgment form.

###

About the Health Care Alliance for Patient Safety

The Health Care Alliance for Patient Safety, founded in 2018, advocates for eye health and safety and elevates the doctor-patient relationship – the essential foundation of personal health care decision making. Members of the Alliance for Patient Safety work together to raise awareness and protect public health. Advancing policy and collaboration between leading eye health advocates, vision innovators and trusted voices is essential to elevate patient care.

The Alliance is made up of patient safety advocates, eye doctors, contact lens manufacturers and insurers.

To become a local advocate or to get involved in protecting patient safety, visit www.patientsafetytoday.com.

Read the full press release. 

Advocates Urge Georgia Governor Brian Kemp to Continue Protecting Patients’ Vision Health Amid Pandemic

Call comes as some groups seek to weaken safety regulations, jeopardizing patients’ vision safety

(Alexandria, Va.) – The Health Care Alliance for Patient Safety (APS) today sent a letter to Georgia Gov. Brian Kemp urging him to protect his constituents’ vision safety by maintaining Georgia’s strong safeguards that ensure vision exams are conducted by doctors and that vision care decisions are made in close consultation between the patient and eyecare provider. 

The call from APS comes as certain online contact lens retailers are attempting to use the coronavirus pandemic to loosen essential patient safeguards that are critical to dispensing accurate and safe contact lens prescriptions. Poor-fitting contact lenses or substitutions provided to patients by some online retailers can result in a wide range of visual or ocular harm, including eye pain, vision impairment, corneal neovascularization, keratitis and corneal ulcers.

“Telehealth, which APS supports, is a critical part of our health care system, especially in rural areas. We are proud of optometrists across the country, and in Georgia, for deploying robust telehealth services amid difficult circumstances presented by the pandemic in order to care for their patients and strengthen the doctor-patient relationship,” said Dr. Deanna Alexander, O.D., Chairwoman of the Health Care Alliance for Patient Safety. “Unilaterally removing the doctor from being able to care for their patient, assess potential vision risks and advise on proper corrective vision treatment, as some have suggested to Governor Kemp, would be misguided. We appreciate Georgia’s strong record on protecting patients’ vision safety and respectfully ask Governor Kemp to remain steadfast in his commitment to protecting Georgians vision safety.”

In place of an in-person exam by licensed and trained optometrists, certain online contact lens retailers are actively marketing digital vision assessment applications. Often, these groups use the “results” from these inadequate applications to move patients into contact lenses that they were not prescribed, jeopardizing patient safety. These online retailers also falsely claim that their own brand of lenses are a “generic” version of the patient’s prescribed lens.

What most patients don’t know is that the Food and Drug Administration (FDA) has specifically said that there is “no regulatory pathway for marketing of generic contact lenses. The current clinical care paradigm does not support substitution of contact lens brands without a clinical evaluation.”

The Alliance was founded in 2018 to advocate for patient safety and to protect and defend the doctor-patient relationship – the essential foundation of personalized health care decision making. For more information, please visit www.PatientSafetyToday.com.

Read the full press release

May 20, 2020

Healio News - The Health Care Alliance for Patient Safety is calling on the Federal Trade Commission to increase its enforcement of the federal patient safeguards related to contact lens sales in light of the fact that many optometry practices are not fully operational during the COVID-19 pandemic.

Additionally, the American Optometric Association warns the public to be cautious of “at-home eye exam” or “vision test” product claims.

Read more. 

With many doctors of optometry caring for patients via telehealth or working with reduced staff, Alliance for Patient Safety calls for the FTC to require online retailers to seek written electronic prescription verification, enforce federal patient health safeguards related to contact lens sales

(Alexandria, Va.) –  On May 11, the Health Care Alliance for Patient Safety (APS) sent a formal letter to the Federal Trade Commission (FTC) asking for immediate action to protect the eye health and safety of contact lens patients across the country amid the coronavirus (COVID-19) pandemic.

While doctors of optometry across the country are continuing to provide essential care for emergency issues, their hours and staff have been significantly reduced to comply with CDC guidance. Recent Jobson Optical Research data shows that over 90 percent of respondents’ practices are in a locality under a stay-at-home order, which means doctors are not in their offices unless there is an emergency issue. The report also shows that up to 60 percent of optometrists have had to let go of staff as a result of the pandemic, and that 44.5 percent of those doctors have had to lay off their entire staff. Combined, these two factors mean that optometry practices are facing challenges in responding to contact lens prescription verification telephone calls, meaning patients could end up receiving contact lenses other than those they were prescribed. 

Given the data, APS is calling on the FTC to increase its enforcement of the federal patient health safeguards related to contact lens sales during this time. While APS wants to ensure patients can safely maintain access to contact lenses during this time, APS members are deeply concerned that online contact lens sellers that continue to violate the patient safety standards as written in the Contact Lens Rule and the Fairness to Contact Lens Consumers Act (FCLCA) pose an increased risk to patient safety during the pandemic.  

In the letter to the FTC, APS Chair Dr. Deanna Alexander, O.D., said:

“Certain online retailers’ continuing use of antiquated robocall prescription verification is deeply disturbing during this pandemic when doctors are not physically in the office and/or do not have the staff capacity to answer the calls. Even during normal times, these robocalls require significant follow-up by doctors and their staff, as the information they provide is often incomplete, difficult/impossible to understand, or related to a person who has never been a patient of the eye doctor receiving the call. Additionally, they too frequently provide no option to replay the call to confirm the information or a valid call-back number to contact if the information about the prescription is incorrect. If we are to properly ensure patient safety and effectively expand available hospital capacity during the COVID-19 pandemic, we must close regulatory loopholes that allow for the sale of nonprescribed lenses that result in patient harm.”

APS members agree that substituting contact lenses can result in significant injury, including corneal ulcers and impaired or full loss of vision. One common adverse health event related to improper contact lens wear/the use of lenses is keratitis, a painful eye infection that leads to 1 million doctor and hospital visits annually, at a cost of $175 million to the U.S. healthcare system. The APS supports the modernization of the contact lens prescription verification process, which would help ensure patients receive the contact lenses prescribed by their eye care professional, keeping them safer from threats to eye health. APS and will continue to advocate for the use of written verification methods to ensure compliance on all sides. 

Read the full press release.

The Health Care Alliance for Patient Safety (APS) sent a formal letter to the Federal Trade Commission (FTC) asking for immediate action to protect the vision safety of patients across the country amid the coronavirus (COVID-19) pandemic. Read the letter here.

January 08, 2019

Healio News - The Health Care Alliance for Patient Safety sponsored a briefing for U.S. Senate Policy Staff on the medical dangers and safety threats posed by counterfeit contact lenses in Washington.

A 2017 study conducted by the FDA found that 60% of counterfeit lenses tested were positive for microbial contamination, according to a press release from the alliance.

Read more. 

United States House Staff Learn of Dangers of Counterfeit Contact Lenses at Policy Briefing

Organized by the Health Care Alliance for Patient Safety - bringing together Congressional Staffers, FDA, industry partners, and Optometrists

(WASHINGTON) – The Healthcare Alliance for Patient Safety (APS) convened a panel of experts today on Capitol Hill to brief congressional staff in the House of Representatives on the medical dangers and safety threats posed by counterfeit contact lenses. Following a similar APS presentation for Senate staff in 2018, this panel was a critical step to ensure that Congressional staff at-large are briefed on the dangers of counterfeit lenses—especially since counterfeiting is sometimes overlooked as a major health and safety issue. 

The briefing included remarks about the current statistics and dangers of counterfeit lenses in the U.S., FDA and efforts to track and mitigate counterfeit lenses, and policy solutions to prevent counterfeiting from impacting patients. Panelists represented FDA and industry, including:  

• Dr. Deanna Alexander, O.D., F.A.A.O., Chairwoman, Health Care Alliance for Patient Safety
• Dr. Malvina Eydelman, Center for Device and Radiological Health, Food & Drug Administration
• Thomas Swinnen, President North America, Johnson & Johnson Vision Care, Inc
• Dr. Gary Orsborn, Vice President Global Professional & Clinical Affairs, CooperVision
• Dr. Bob Theaker, American Optometric Association representative

Staff learned that while a significant number of these dangerous, counterfeit contact lenses are sold online from suspect retailers or seized upon being imported, some make it into local novelty stores—as was reported by Popular Science Magazine.

A 2017 study conducted by the FDA which was published in the Journal of Forensic Sciences, found that 60 percent of counterfeit lenses tested came back positive for microbial contamination, which can cause medical aliments leading to vision loss.

“Ensuring patients are always using a FDA cleared or approved medical device that is authentic and prescribed by their eye care professional is critical when it comes to their eye health and safety and should be taken seriously,” said Dr. Deanna Alexander, Chairwoman of the Health Care Alliance for Patient Safety. “Contact lenses are categorized by the FDA as Class II and Class III medical devices that can pose significant harm to consumers including vision impairment when proper protocols are not followed.”

APS will continue to advocate for efforts to prevent the dangerous sale of counterfeit lenses because they have serious consequences for patient health.

Senate Subcommittee Urges FTC to Modernize the Contact Lens Verification Process

Latest action from the U.S. Senate means both Chambers have called on the FTC to act in the interest of patient health & safety

(WASHINGTON) – The Health Care Alliance for Patient Safety (Alliance) yesterday applauded the Senate Committee on Appropriations’ urging the Federal Trade Commission (FTC) to update the process by which contact lens prescriptions are verified. 

The Committee report, which accompanies the Senate Financial Services and General Government (FSGG) funding bill, comes as the FTC reviews additional public comments on the proposed Contact Lens Rule. Patient safety advocates have repeatedly called attention to flaws in current rules related to prescription verification.

The Senate FSGG report, which can be read here, states:

Contact Lenses.—The Committee is encouraged by the FTC’s acknowledgement of certain patient safety concerns in its most recent draft Contact Lens Rule. While the Committee is pleased the FTC has proposed some improvements to previous drafts related to prescription release, electronic delivery, and illegal substitution, the Committee remains concerned that the FTC has not sufficiently addressed the need for the prescription verification process to be modernized to provide for adequate enforcement of the law. Therefore, the Committee urges the FTC to reevaluate its definition of direct communication and consider eliminating the use of automated telephone verification messages, to ensure an effective prescription verification process exists to allow the FTC to properly enforce the rule.

For several years, Alliance members and patient safety advocates have called for updated verification methods that would ensure patients receive the proper medical devices they were prescribed by their eye care professional. 

In July, the Alliance submitted comments to the FTC that highlighted the problems with the current prescription verification system. The comments read, in part, “APS is very concerned with several patient-safety issues regarding automated telephone verification and invalid verification requests that may lead to the alteration of a patient’s contact lens prescription and excessive-quantity sales. Individually, each of these issues pose significant threats to patient eye health. Together, they create an environment where eye health problems have a strong correlation to the disregard for appropriate contact lens care and the implicit de-valuation of a regular eye health exam, which is critical to ensure the safety of contact lens interaction with patients’ eyes.” 

Recent action by both the U.S. House FSGG and Senate FSGG demonstrate Congress shares the Alliance’s concerns on how the current contact lens verification process can jeopardize patient safety.

In response to the action taken by Senate FSGG, Deanna Alexander, OD, Chairwoman of the Alliance stated, “Yesterday’s action by the U.S. Senate Appropriations Committee shows that the Alliance’s patient safety advocates are being heard by Members of Congress. We thank the Committee for their work and attention to this important issue. Now, as the FTC continues to review comments on their revised Contact Lens Rule, it’s time for regulators to recognize the need to modernize the way in which prescriptions are verified to ensure patients’ vision health is protected.”

The House Committee on Appropriations FSGG Subcommittee passed similar language in June 2019.

August 20, 2019

Healio News - CooperVision asked the Federal Trade Commission to consider patient safety, the eye care provider’s expertise, stronger enforcement and the use of technology for prescription verification as it evaluates proposed changes to the Contact Lens Rule.

In a letter the company submitted to the Federal Trade Commission (FTC) July 29, CooperVision said, “Fostering competition should not come at the expense of patient safety and excellent lens wearing experiences.”

Read more. 

August 9, 2019

The Ripon Advance - U.S. Rep. Michael Burgess (R-TX) recently introduced bipartisan legislation to protect the nation’s contact lens consumers from unsafe online sales practices.

“In the 21st century marketplace, American patients have more options for buying contact lenses than ever before,” Rep. Burgess said. “It is critical for patients to receive the correct prescription when ordering contact lenses — regardless of where they place the order.”

Read more.