I write to you today as Chairman of the Health Care Alliance for Patient Safety (HCAPS), a patient-centric group representing health care providers and manufacturers within the eye care industry. HCAPS is dedicated to ensuring patient health and safety, as well as upholding the doctor-patient relationship, which is the essential foundation of personalized health care decision making.
We write to you today with significant concerns with House Bill 342, a bill that could have a detrimental impact on patient eye health and safety for the approximately 992,000 patients wearing contact lenses in the state of Utah.
HB 342 would impose additional unnecessary administrative burdens on physicians. The bill would require physicians to document aspects of their discussions with patients that already occur as part of standard practice. The bill mandates that doctors document and patients confirm that the patient understands that there are a range of contact lens choices available. Discussing patient options is the standard of care in the eye examination and contact lens assessment and fitting process. Further, it’s well known that patient involvement in health care decision making is recognized as key to treatment plan adherence. In addition to the requirement to document the obvious information regarding contact lens options, HB 342 would also require doctors to provide a prescription for any contact lens a patient requests if the doctor finds the lens to be “medically appropriate” for the patient. We are concerned that the bill as written may create an antagonistic relationship between doctors and their patients - essentially undermining the clinical decision-making process of physicians.
If passed, this legislation would stand in strong contrast to the efforts this legislature has made in recent years to make Utah lauded as an example of a state that recognizes the value of reducing regulatory burden to increase economic prosperity and opportunity. In the state of Utah, the majority of contact lenses are typically prescribed by optometrists whose practices are best described as small businesses. While small businesses in Utah fared better during the pandemic than many other states, to push additional regulatory burdens on them now is unwise and unnecessary.
This proposed legislation would weaken the foundation of current patient safety standards and represents a significant overreach likely to disrupt doctor-patient conversations through unnecessary regulation.
If implemented, this bill could also lead to more cases of improper use of contact lenses, which already cause nearly 1 million additional health care visits and $175 million in added healthcare costs each year.
To be clear, contact lenses are classified by the FDA as Class II and Class III medical devices. While the manufacturers, some of which are our members, produce numerous variations of these devices to meet the various clinical needs of patients, the Food and Drug Administration’s (FDA) definition of these distinct classifications clearly demonstrates the need for involvement of the health care provider. This defined classification and tiering process supports patient-driven health care solutions when appropriate and provider-driven prescribing when warranted. It is precisely this process that contributes to successful contact lens wear for the millions of consumers who elect to wear contact lenses.
The FDA, who is tasked with overseeing the safety, effectiveness and manufacturing of contact lenses has stated that a patient should beware of attempts to substitute brands of their contact lens prescription. They even go on to say that “The correct choice of which lens is right for you should be based only on an examination by your eye care professional…” Circumventing this process is bad policy and risks patient safety.
In addition, we are concerned that there are known problems with how certain contact lens retailers have marketed themselves to patients. In January 2022, the Department of Justice (DOJ) and Federal Trade Commission (FTC) fined Hubble Contacts 3.5 million dollars for violations of federal rules and regulations and for potentially misleading the public. FTC and DOJ alleged that Hubble altered prescriptions by substituting its own Hubble brand when that wasn’t what the consumer was prescribed. The company also failed to disclose that many reviews of Hubble contact lenses “were not by unbiased consumers but were written by reviewers who were compensated for their reviews, and, in at least one instance, by one of its own executives.” As the CDC has recognized, one of the best ways for patients to get the maximum benefit of contact lenses is to talk with their doctor. To attempt to legislate those conversations is unnecessary.
We appreciate freedom of choice within the healthcare marketplace, as this freedom drives competition and innovation, which ultimately leads to better patient care. Unfortunately, the changes suggested in HB 342 fall short of any innovative competition because they simply require doctors to document conversations that are part of the examination process and part of the patient’s record. These suggested changes simply provide a false sense of greater choice, as choice already exists when doctors and patients discuss the patient’s unique needs, and the physician prescribes the lens best suited based on clinical expertise.
In light of our concerns, The Health Care Alliance for Patient Safety would object to HB 342.
As Chairman of HCAPS, representing the collective interests of businesses and providers within the eye health industry, we respectfully request that you reconsider moving HB 342 forward and table this legislation for the sake of patient safety.
Thank you very much for your leadership during these incredibly trying times; I can only imagine the difficulty you have faced in your position on issues such as these and many others. If you have any questions or comments, please contact Alison Teitelbaum, Executive Director of APS, at [email protected], as we would enjoy the opportunity to discuss this issue with you further.
David Cockrell, O.D.
Chair, Health Care Alliance for Patient Safety