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«October 26, 2015 Donald S. Clark Federal Trade Commission Office of the Secretary 600 Pennsylvania Avenue NW. Suite CC–5610 (Annex C) Washington, ...»

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• A doctor of optometry reported a patient presented with central corneal keratitis as a result of purchasing colored contact lenses at a market in Columbus, Ohio. The patient purchased the lenses without a prescription, received no physician guidance on appropriate wear of the lenses, and slept in the lenses for two months.

• A patient indicated to a doctor of optometry he had purchased contact lenses from 1-800 CONTACTS with a prescription from three years ago. The patient had severe corneal disruption, swelling, infiltrates and haze with reduced best-corrected vision. In addition to being treated with anti-inflammatories and antibiotics, the patient had to miss two days of work due to pain. Loss of work productivity, in addition to medical costs, must be considered when evaluating the overall costs.

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6345a3.htm 9 • A doctor of optometry reported two patients had purchased contact lenses from a local dollar store. One patient suffered acute red eye with a small peripheral corneal infiltrate acute and the other experienced keratoconjunctivitis.

• A doctor of optometry reported treating a patient who experienced a corneal ulcer after wearing lenses purchased at a beauty supply store.

All of these incidents threaten patients with permanent vision loss and require treatment that leads to increased health care costs and loss of productivity, which are a significant cost for consumers.

6. What modifications, if any, should be made to the Rule to reduce any costs imposed on consumers? What evidence supports the proposed modifications? How would these modifications affect the benefits provided by the Rule?

At a minimum, the basic patient safeguards outlined in the FCLCA must be enforced to protect patients and reduce unnecessary costs. Retailers should be punished for selling contact lenses without a valid prescription. Individuals who attempt to sell products via social media and the companies that host the social media sites must be informed of the legal requirements surrounding the sale of contact lenses and violators must be punished. As was noted above, steps must be taken to ensure retailers do not sell large quantities of contact lenses when that sale could compromise a patient’s eye health. Additionally, more needs to be done so patients are aware regular eye examinations are essential to prevent harm and ensure optimal vision.

7. What benefits, if any, has the Rule provided to businesses, including small businesses?

What evidence supports the asserted benefits?

The Internet facilitates an increasing number of contact lens retailers, which presumably is beneficial for those businesses, both large and small. However, while the Rule was intended to increase competition, the online contact lens market is dominated by one retailer. On July 30, 2014, during a hearing before the Senate Judiciary Committee's antitrust panel, R. Joe Zeidner, General Counsel for 1-800 CONTACTS, indicated his company controlled approximately three quarters of the online contact lens retail market.16 So, while the FCLCA was intended to increase competition, an unintended anti-competitive consequence has been the emergence of one dominating online retailer.

8. What modifications, if any, should be made to the Rule to increase its benefits to businesses, including small businesses? What evidence supports the proposed modifications? How would these modifications affect the costs the Rule imposes on businesses, including small businesses? How would these modifications affect the benefits to consumers?

http://www.judiciary.senate.gov/hearings/watch?hearingid=12e98234-5056-a032-52ea-90f98e940d9b (minute 111) 10 To improve the Rule for small business, including the practices of doctors of optometry, the

AOA requests the following:

1) FTC must no longer allow the use of robocalls for verifying patient prescriptions.

2) FTC should ban marketing reorders to consumers after prescriptions have expired, unless or until the seller has actual knowledge that the prescription has not expired, or an identical new prescription has been issued.

3) FTC should develop a distinct complaint submission process for contact lens-related concerns.

4) FTC should require the contact lens seller to respond to prescriber verification questions within eight business hours, or cancel the sale without verification.

5) FTC should state a preference for the use of an improved verification process by sellers instead of sellers requesting copies of actual prescriptions from customer’s physicians as a way to verify a customer’s order.

The FCLCA clearly allows sellers to use telephone, facsimile, or electronic mail for verifying prescriptions. However, in the development of the Contact Lens Rule, it was the FTC who interpreted this language to mean "automated telephone systems" or "robocalls" were acceptable forms of communication. The FTC did note the Commission would "monitor whether full, valid requests for verification of a prescription are being made through the use of automated telephone systems." The FTC went on to say, "If evidence demonstrates that sellers are not making valid verification requests but are providing consumers with contact lenses despite deficient requests, the Commission may revisit this issue.” Over the past ten years, AOA has often received complaints from doctors of optometry that robocalls from 1-800 CONTACTS were difficult to understand or did not include all of the necessary information to confirm a prescription.





The use of robocalls to confirm the accuracy of a prescription, which includes specific numbers for strength, base curve and quantity, is far too complicated for an automated phone system. The FTC must revisit this issue and consider the Congressional and federal agency action that has been taken in the past ten years to better limit robocalls. Ideally, the AOA would like to see all prescription requests from retailers come in writing, either via fax or email. However, because the use of phone calls is allowable under the FCLCA, the AOA urges the FTC to, at a minimum, prohibit the use of robocalls and to ensure physicians who are confirming the accuracy of prescriptions for regulated medical devices are able to speak with a live person working for the seller. This would clearly benefit consumers because there would be a greater likelihood that prescription information was properly communicated. While 1-800 CONTACTS claims the phone verification provides “an absolutely consistent approach that conveys all of the required information, we use a system that works exactly the same–every time,”17 we understand from doctors of optometry that, in practice, this is simply not true. Verification by robocall does not work.

The FCLCA allows telephone calls for prescription verification, but the law does not specify telephone communication must include automatic dialers. The AOA takes exception with the FTC's interpretation that telephone communication, "is commonly understood to include automated telephone systems." It’s also more commonly understood automated telephone http://www.1800contacts.com/connect/articles/rx-verification-info 11 systems are an abuse of telephone communication. The FTC previously indicated that disallowing robocalls would be against Congressional intent. However, as technology has evolved over the past ten years, so has the view of automated phone systems. The FTC has reported receiving as many as 200,000 complaints about robocalls every month, and as recently as August confirmed that it’s the number one consumer complaint received by the FTC.

Companies have been fined millions of dollars for inappropriate robocalls. In June, the Federal Communications Commission (FCC) cracked down on the use of robocalls and the FTC has specifically noted that robocalls are only acceptable in limited circumstances, such as for informational purposes.18 The FCC had held contests and workshops to come up with ways to block robocalls. Why would the FTC want to allow them under the Contact Lens Rule? In testimony to Congress in June, Lois Greisman, FTC associate director of the Division of Marketing Practices, described robocalls as an epidemic, and acknowledged that telephone companies could legally use call-blocking technology to provide relief from such calls.

Widespread use of such technology impedes the contact lens prescription verification process.

It’s time to specifically end the use of robocalls for verifying contact lens prescriptions.

The Rule indicates it is a requirement for the prescription verification request to include the name of a contact person at the seller’s company. The AOA often hears from doctors of optometry who have difficulty reaching an individual at 1-800 CONTACTS to discuss prescription concerns. While the Rule notes the person whose name is provided on the verification form need not personally handle the verification, it is clear a contact person must be reasonably available for physicians. The company has trademarked its tagline boasting the company is “The World’s Largest Contact Lens Store,” with 350 customer service representatives, but they seem unable to provide one reliable contact who physicians can reasonably access.19 This unfair practice places a burden on eye care professionals who seek crucial clarification or other information to facilitate the sale of contact lenses by a competitor.

Ensuring that physicians have an individual to discuss concerns with would ultimately benefit patients and ensure the patient received the appropriate lenses. The AOA recommends the FTC require sellers to respond to prescriber concerns in the verification process within the same eight business hour expectation for prescribers to verify prescriptions. That is, when a seller contacts a prescriber to verify a prescription and the prescriber responds on a timely basis with a legitimate concern to discuss with the seller to enable verification, the seller may not assume the prescription is verified but instead must personally contact the prescriber and discuss the concerns within eight business hours, or cancel the sale.

Given the widespread non-compliance with the FCLCA noted throughout these comments, the AOA requests the FTC set up a specific complaint system for FCLCA-related concerns. The online complaint assistant service currently operated by the FTC is not appropriately set up to receive these types of complaints and doctors who take time out of their practices to report issues of concern often feel their reports go unnoticed by the FTC. Setting up a distinct FCLCA complaint system would be a benefit to patients as well, providing them with a simple process to follow in case they have contact lens sale-related concerns.

http://www.consumer.ftc.gov/articles/0259-robocalls#Prerecorded_Calls http://www.1800contacts.com/the-company.html 12 Requests by sellers directly to physicians for copies of patient prescriptions should be disfavored.

In virtually all instances in which a seller might request a copy of a customer’s actual prescription, the seller could also use the established verification process. Verifications, while in need of improvement as described elsewhere in these comments, consume less physician and staff time than retrieving, copying, and transmitting a copy of the patient’s actual prescription to sellers. The verification process also contains safeguards that requests for copies of prescriptions do not. Sellers would only need to request a copy of a prescription directly from the customer’s physician when (i) the patient does not submit the prescription; and (ii) the patient is unable to provide any information about the prescription to the seller (e.g. from a copy of the prescription, personal notes, documentation from previous purchases, or a box of lenses currently being used) in order to permit use of the verification process. This combination of circumstances would reasonably be expected to be uncommon, and likely only occur at the time of the first purchase of contact lenses after a recent visit to the doctor when the prescription has been lost and the information on the prescription forgotten.

9. What significant costs, if any, including costs of compliance, has the Rule imposed on businesses, including small businesses? What evidence supports the asserted costs?

Physician small-business owners spend significant time responding to prescription verifications that are inaccurate or incomplete. Robocalls, which automatically redial until a message is broadcast to someone at a physician’s practice, are a cost to businesses as this outreach often interferes with treating patients and can tie up phone lines needed for urgent patient matters. An inability to reach a contact person at a retailer is another cost to physician small businesses who may spend significant time on hold or attempting to use various phone numbers to reach a live person. The costs that physician small business owners expend related to the Rule are actually most often related to non-compliance on the part of retailers. If physician small business owners only received accurate prescription verification requests for lenses that were appropriately prescribed then there would be much fewer added costs such as those related to robocalls or an inability to appropriately reach contacts at retailers.

10. What modifications, if any, should be made to the Rule to reduce the costs imposed on businesses, including small businesses? What evidence supports the proposed modifications? How would these modifications affect the benefits provided by the Rule?

As noted in questions 8 and 9, eliminating robocalls, providing verifications in writing, prohibiting reorders of expired prescriptions, and requiring the prescription verification contact person at a retailer to discuss prescription concerns within eight hours would reduce the burden on the small business doctors of optometry.

As stated in response to Question 8, requests from sellers to physicians for copies of actual prescriptions consume more physician and staff time than responding to verifications, thereby adding to the cost of compliance with the Rule. Modifying the Rule to favor use of an improved verification process, whenever feasible, would save optometrist and staff time and not undermine any of the stated purposes and benefits of the Rule – in fact, it would enhance the patient safety purposes of the Rule by encouraging appropriate use of the verification process, which includes safeguards that enhance patient safety.

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