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.

Health Care Alliance for Patient Safety Applauds Introduction of the Contact Lens Prescription Verification Modernization Act

Bipartisan Legislation Introduced in the House by Representatives Rush (IL-1) and Burgess (TX-26)

(WASHINGTON) – The Health Care Alliance for Patient Safety (Alliance) released the following statement in response to today’s introduction of the Contact Lens Prescription Verification Modernization Act (H.R. 3975). The bipartisan legislation introduced by Representative Bobby Rush (D-IL-1) and Representative Michael Burgess (R-TX-26) will help modernize the contact lens prescription verification process and make it simpler and safer for millions of contact lens wearers.

Millions of Americans are able to purchase their contact lenses online thanks to the Fairness to Contact Lens Consumers Act (FCLCA). However, as a patient health safeguard, the law requires online sellers to verify the validity of contact lens prescriptions with the patient’s doctor before fulfilling an order. While the FCLCA clearly allows the use of telephone, fax, or e-mail for verifying prescriptions, the Federal Trade Commission (FTC) has interpreted the law to allow robocall verification, as well. 

The use of robocalls to confirm the accuracy of a prescription, which includes several specifications, is far too complicated for an automated phone system. Information relayed in these robocalls is oftentimes garbled or does not align with a patient’s chart—making it difficult, or even impossible, to correctly identify the patient and proper prescription.

“Robocalls should never be used to communicate with a physician’s office regarding patient health and safety matters,” said Barbara L . Horn, OD, President of the American Optometric Association.  “With Internet-based mass retailers failing to fix the problem, AOA doctors of optometry are pleased to see Reps. Bobby Rush (D-IL), Michael Burgess, MD (R-TX) and other health policy leaders in Congress joining together on a bi-partisan basis with the Health Care Alliance for Patient Safety to close an outrageous robocall loophole that’s undermining quality care and putting the public at risk.”

 H.R. 3975 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 bill also requires online sellers to develop HIPAA-compliant methods for patients to electronically transmit contact lens prescriptions. 

Dr. Deanna Alexander, Chairwoman of the Health Care Alliance for Patient Safety, said, “Increasing patients’ choice in the contact lens marketplace should never jeopardize patient safety. The Alliance thanks Congressman Rush and Congressman Burgess for the introduction of this thoughtful legislation that strengthens patient safety and addresses a loophole in the current passive verification system, which often leaves patients at risk of being provided incorrect prescriptions that can lead to adverse health conditions and even vision loss. We will continue to work with Congress to be a strong voice and advocate for patient health and safety.”

On May 2, 2019, the FTC proposed supplemental rulemaking on the 2016 proposed Contact Lens Rule acknowledging some of the key problems associated with prescription verification via robocalls and the misuse of the prescription verification process, which can contribute to substitution of a non-prescribed brand or manufacturer of lenses. However, the proposed supplemental rulemaking does not close the contact lens prescription verification loophole. The Alliance believes congressional action is necessary to ensure that patients receive the exact lenses prescribed by their doctor and increase patient safety. A fact sheet on the Contact Lens Prescription Verification Modernization Act can be found here. 

“H.R. 3975 will help ensure prescription validation for millions of contact lens wearers is completed in the most responsible way possible,” said Mary Anne Murphy, OD, and VSP Global board member. “We commend the Health Care Alliance for Patient Safety for its strong leadership on this important legislation which protects patients, while also preserving choice and convenience for them.”

More than 45 million Americans rely on contact lenses – U.S. Food and Drug Administration Class II and Class III regulated medical devices – for safe and effective vision correction. Contact lenses are more complex than they appear, having differing shapes, strengths, and water contents. There are no generics. Improper lens usage, which can result from the substitution of lenses not as prescribed by the patient’s doctor, can lead to serious health complications, including infections and other sight-threatening conditions, such as corneal edema, ulcers, and neovascularization. 

“Addressing shortcomings in outmoded verification techniques is central to ensuring what’s prescribed is actually dispensed. This is essential for optimal vision and ocular health, since doctors select specific contact lenses for individual patient needs,” said Michele Andrews, OD, Senior Director, North American Professional & Academic Affairs, CooperVision. “The Contact Lens Prescription Verification Modernization Act does just that, with the potential to advance healthy contact lens wear for millions of Americans.”

The Health Care Alliance for Patient Safety has made it a priority to close loopholes within the existing verification process and prevent the substitution of lenses to reduce the risk of preventable vision loss.

As the FTC seeks additional public comments on the proposed Contact Lens Rule, Congressional intent to protect patient safety remains clear

The Health Care Alliance for Patient Safety (Alliance) this week expressed its support of the House Committee on Appropriations for urging the Federal Trade Commission (FTC) to update the process by which contact lens prescriptions are verified.
 
The Committee report, which accompanies the Financial Services and General Government (FSGG) funding bill, comes as the FTC is accepting 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 FSGG report, which can be read here, states:
 

Health Care Alliance for Patient Safety: FTC Proposed Contact Lens Rule Recognizes Health and Safety, but Opportunities Remain to Address Prescription Verification Loophole and Illegal Sale of Contact Lenses

The Healthcare Alliance for Patient Safety (Alliance) released the following statement in response to last week’s Federal Trade Commission (FTC) proposed supplemental rulemaking on the 2016 proposed Contact Lens Rule.

Congress charged the FTC with enforcing contact lens prescription verification requirements with the passage of the 2004 Fairness to Contact Lens Consumers Act (FCLCA). However, a lack of enforcement of some patient safety protections and the allowance of robocalls as a permissible form of communication for prescription verification has contributed to a growth in illegal sales, including through the filling of expired or non-existent prescriptions and the filling of prescriptions with devices other than what was prescribed by the doctor which put patients eye health and safety at risk.

The FTC’s proposed rule acknowledges some of the key problems associated with prescription verification via robocalls but does not close the verification loophole. Instead, the proposed rule only requires that automated verification telephone messages are “delivered in a slow and deliberate manner and at a reasonably understandable volume,” and “that prescribers be able to repeat the message.”

The FTC shared its concern about the misuse of the prescription verification process to substitute a different brand or manufacturer of lenses. The Alliance agrees with the FTC that contact lens brands are not interchangeable and that substitution is a growing problem in the market, but the Alliance believes that greater enforcement is necessary to ensure that patients receive the exact lenses prescribed by their doctor.

Dr. Deanna Alexander, Chairwoman of the Health Care Alliance for Patient Safety, said, “The FTC’s proposed rule does recognize important issues with the contact lens market, but it does not fully address patient safety concerns around robocall verification of contact lens prescriptions or the ongoing enforcement of illegal substitution for what the patient’s doctor has prescribed. Re-playable, slow and deliberate messages are not the same thing as accurate and secured verification. We believe there is more work to be done to close the verification loophole and protect patients throughout the verification process.”

More than 45 million Americans rely on contact lenses – U.S. Food and Drug Administration Class II and Class III regulated medical devices – for safe and effective vision correction. Contact lenses are more complex than they appear, having differing shapes, strengths, and water contents. There are no generics. Improper lens usage, which can result from the substitution of lenses not as prescribed by the patient’s doctor, can lead to serious health complications, including infections and other sight-threatening conditions, such as corneal edema, ulcers, and neovascularization.

The Health Care Alliance for Patient Safety has made it a priority to close loopholes within the existing verification process and prevent the substitution of lenses to reduce the risk of preventable vision loss. We will continue to work with the FTC, the Food and Drug Administration, the Centers for Disease Control and Prevention, and Congress to be a strong voice and advocate for patient health and safety.

Read the full press release.

Health Care Alliance for Patient Safety Members Brief Congressional Offices on Concerns Regarding Robocalls and Substitution of Contact Lenses

Advocates in Washington for AOA Fly-In

(WASHINGTON) – Today, members of the Health Care Alliance for Patient Safety (APS) visited nearly a dozen congressional offices. During these meetings, APS advocates briefed Members of Congress and their staffs on problems that vision care patients face including online sellers’ problematic use of robocalls and the medical dangers and safety threats posed by the substitution of lenses that have not been prescribed to a patient.

From left to right: Dr. Jim DeVleming (AOA), Dr. Dorothy Hitchmoth (AOA), Dr. Deanna Alexander (Chair, Health Care Alliance for Patient Safety), Clay Arnold (CooperVision), Dr. Mike Mayers (Johnson & Johnson Vision)

The 2004 Fairness to Contact Lens Consumers Act requires that all third-party sellers must verify prescriptions with an eye doctor and fill the prescription as written. However, the Federal Trade Commission’s (FTC) Contact Lens Rule allows verification to be done via robocalls. Oftentimes, information relayed in these robocalls is garbled or do not align with a patient’s chart—making it difficult, or even impossible, to correctly identify the patient and proper prescription.

More than 45 million Americans rely on contact lenses – U.S. Food and Drug Administration Class II and Class III regulated medical devices – for safe and effective vision correction. Contact lenses are more complex than they appear, having differing shapes, strengths, and water contents. There are no generics. Substitution of lenses not as prescribed by the patient’s doctor can lead to serious health complications, including infections and other sight-threatening conditions, such as corneal edema, ulcers, and neovascularization.

Dr. Deanna Alexander, Chairwoman of the Health Care Alliance for Patient Safety, said, “Access to contact lenses should be fair and safe for patients while preserving the doctor-patient relationship, just as Congress intended. The Health Care Alliance for Patient Safety is committed to working with lawmakers and regulators to address the FTC Contact Lens Rule verification loophole that puts patients’ eye health and safety at risk.”

From left to right: Dr. Deanna Alexander (Chair, Health Care Alliance for Patient Safety), Dr. Mary Anne Murphy (VSP), Dr. Jeff Sonsino (AOA), Dr. Mike Mayers (Johnson & Johnson Vision), Travis Rush (Sightbox), Dr. Gary Orsborn (CooperVision) & Dr. Dorothy Hitchmoth (AOA)

The Health Care Alliance for Patient Safety has made it a priority to close loopholes within the existing verification process and prevent the dangerous sale of counterfeit lenses and the substitution of lenses to reduce the risk of preventable vision loss.

Read the full press release here. 

(WASHINGTON) – The Healthcare Alliance for Patient Safety today held a briefing in Washington, DC, for U.S. Senate policy staff on the medical dangers and safety threats posed by counterfeit contact lenses, which can cause medical conditions that lead to blindness.

A 2017 study conducted by the US Food and Drug Administration, 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 ailments leading to vision loss.

Policy leaders also learned at the briefing 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.

The Health Care Alliance for Patient Safety has made it a priority to prevent the dangerous sale of counterfeit lenses, which can cause vision loss.

Dr. Mike Mayers, director of advocacy at Johnson & Johnson Vision, who sat on the panel to brief policy leaders, commented, “In today’s global marketplace, we are likely to continue to see counterfeit contact lenses become prevalent and sophisticated. We must partner with others, including our government, as a greater force to deter the growing threat of counterfeit. Today’s briefing was a step forward in growing that partnership.”

In addition to Mayers, the panel also included:

• Dr. Malvina Edyelman, Center for Device and Radiological Health, Food & Drug Administration
• Dr. Deanna Alexander, O.D., F.A.A.O., Chairwoman, Health Care Alliance for Patient Safety
• Dr. Chris Wroten, Optometrist, Bond Wroten Eye Clinic

“Counterfeit contact lenses, which can be marketed as a costume accessory or be packaged as a traditional medical device, put health and vision safety in significant danger,” said Dr. Alexander. “The Health Care Alliance for Patient Safety recognizes that the sale of counterfeit medical devices to trusting patients is dangerous, and our coalition is committed to seeking action from lawmakers and regulators to end this practice.”

Read the full press release here.

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(ARLINGTON, Va.) – The Healthcare Alliance for Patient Safety (Alliance) today released a statement following yesterday’s announcement from the Federal Trade Commission (FTC) that online retailers were in violation of the FTC’s Contact Lens Rule (Rule), resulting in a $60,000 fine and barring the sites from selling contact lenses in the future.

HollywoodColorContacts.com, WorldColorContacts.com and TopModelContacts.com, and their seller, Lawrence L. Duskin, were charged with providing contact lenses to consumers without obtaining the required prescription, failing to verify the prescription information, and failing to keep the records required by the Rule.

The full statement from the FTC, which was released yesterday, December 6, 2018, can be found here.

In response, Dr. Deanna Alexander, O.D., F.A.A.O., chairwoman of the Alliance, issued the following statement:

“The Alliance commends the Federal Trade Commission for taking action to ban these online retailers who were in clear violation of the Contact Lens Rule and putting patients in serious danger. The Alliance, its members, patients and patient advocates have continually communicated that violations of the Rule occur and steps need to be taken to better protect patients. Today, we applaud the FTC for their attention and action to keep patients safe.”

Read the full document here. 

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(WASHINGTON) – The Health Care Alliance for Patient Safety (Alliance) today held an event titled “Evolution of Telehealth: Patient Awareness and Education” in Washington, DC, in conjunction with The Hill. Speakers and panelists continually advocated for synchronizing modern telehealth practices with a strong doctor-patient relationship – a win-win for patients who would see an
increase in health care access while also fostering better health outcomes.

“A bipartisan group of federal lawmakers, telehealth experts, and vision and health care professionals today made clear that even as technology makes us more connected, a strong doctor-patient relationship remains fundamental to treating existing medial ailments and improve health outcomes,” said Alliance Chairwoman Dr. Deanna Alexander, O.D. “The Alliance believes that increased usage of telemedicine can help increase access to healthcare, but technology must be used prudently and can’t be seen as a replacement for all in-person examinations and care.”

Panelists shared how regular consultation with a doctor is critically important to promoting patient health. In the vision health field, a staggering ninety-four percent of patients reported a change in their prescription since their last visit – meaning without a regular eye exam, the patient would have an incorrect prescription. Eye doctors can also determine over 270 underlying health conditions during an exam – like macular degeneration, diabetes, hypertension and glaucoma – making regular examinations crucial to preventative care.

Meanwhile, ill-advised online vision screenings increase the likelihood of poor-fitting lenses. A wrongly-fitted contact lens can cause blurred vision leading to blindness, open sores on the patient’s eyes, and bacterial and viral infections that could lead to vision loss.

Further, in-person consultations can assist with educating patients on proper vision health practices. The Centers for Disease Prevention and Prevention (CDC) has reported the troubling frequency of dangerous practices related to improper contact lens care, all of which can lead negative health conditions:

• Fifty percent of patients wear contact lenses while sleeping
• Fifty-five percent of patients improperly add contact solution to their cases, instead of emptying the case and using new, clean solution
• Eighty-two percent of patients keep their contact lens cases longer than recommended

Event speakers included Congressman Buddy Carter (R-GA), Senator Bill Cassidy, M.D. (R-LA), Congresswoman Doris Matsui (D-CA), Mr. Peter Menziuso, President of North America for Johnson & Johnson Vision, and Co-Chair of the Health Care Alliance for Patient Safety, Dr. David Cockrell, Owner of Cockrell Eyecare Center in Stillwater, Okla., Susan Polan, Associate Executive Director, Public Affairs & Advocacy, American Public Health Association, Natasa Sokolovich, Executive Director, Telehealth, University of Pittsburgh and Samantha Zenlea, Senior Regulatory Policy Specialist, National Council on Aging.

Read the press release here. 

(ARLINGTON, Va.) -  The Health Care Alliance for Patient Safety (Alliance) today announced an additional speaker at their event titled “Evolution of Telehealth: Patient Awareness and Education” on Thursday, September 27, 2018 at 7:30 a.m. at the Washington Court Hotel in Washington, D.C.  Mr. Peter Menziuso, President of North America Vision Care for Johnson & Johnson Vision, and Co-Chair of the Alliance, will provide the sponsor’s perspective at the event.

The event is part of The Hill’s event series and is open to the public and members of the press. Those interested in attending can RSVP here. The event is free to attend.

Other event speakers will include a bipartisan group of lawmakers, industry professionals, and vision and telehealth experts. The event will explore how telemedicine is making healthcare more efficient and effective, when in-person services might be more reliable and how to maintain a strong doctor-patient relationship as technology evolves.

A full list of speakers is as follows:

• Congressman Buddy Carter (R-GA)
• Senator Bill Cassidy, M.D. (R-LA)
• Congresswoman Doris Matsui (D-CA)
• Peter Menziuso, President of North America Vision Care for Johnson & Johnson Vision, and Co-Chair of the Health Care Alliance for Patient Safety
• David Cockrell, Owner of Cockrell Eyecare Center in Stillwater, Okla.
• Susan Polan, Associate Executive Director, Public Affairs & Advocacy, American Public Health Association
• Natasa Sokolovich, Executive Director, Telehealth, University of Pittsburgh
• Samantha Zenlea, Senior Regulatory Policy Specialist, National Council on Aging

Event details are as follows:

“Evolution of Telehealth: Patient Awareness and Education”

Thursday, September 27, 2018

7:30-9:30 a.m.

Washington Court Hotel Grand Ballroom

525 New Jersey Ave.

Washington, D.C. 20001

For more information on the event, please click here. Members of the press or the general public can RSVP for the event by clicking here.

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 http://www.patientsafetytoday.com/.

Read the press release here. 

Free event will be held in Washington, D.C. on September 27th; Event is open to the public, press

(ARLINGTON, Va.) - The Health Care Alliance for Patient Safety today announced that it will sponsor an event titled “Evolution of Telehealth: Patient Awareness and Education” on Thursday, September 27, 2018 at 7:30 a.m. at the Washington Court Hotel in Washington, D.C. The event is part of The Hill’s event series and is open to the public and members of the press. Those interested in attending can RSVP here. The event is free to attend.

Speakers, which will include a bipartisan group of lawmakers, industry professionals and vision and telehealth experts, will explore how telemedicine is making healthcare more efficient and effective, when in-person services might be more reliable and how to maintain a strong doctor-patient relationship as technology evolves.

Speakers will include:

• Congressman Buddy Carter (R-GA)
• Senator Bill Cassidy, M.D. (R-LA)
• Congresswoman Doris Matsui (D-CA)
• Dr. David Cockrell, Owner of Cockrell Eyecare Center in Stillwater, Okla.
• Susan Polan, Associate Executive Director, Public Affairs & Advocacy, American Public Health Association
• Natasa Sokolovich, Executive Director, Telehealth, University of Pittsburgh
• Samantha Zenlea, Senior Regulatory Policy Specialist, National Council on Aging

Event details are as follows:

“Evolution of Telehealth: Patient Awareness and Education”
Thursday, September 27, 2018
7:30-9:30 a.m.
Washington Court Hotel Grand Ballroom
525 New Jersey Ave.
Washington, D.C. 20001

For more information on the event, please click here. Members or the general public can RSVP for the event by clicking here.

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.

Full Document