What is the new contact lens rule?

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  • Furthermore, in 2013, 57% of prescriptions nationally were sent electronically from physicians to pharmacies, with the rate in a few states over 80%.
  • Although the Rule does not require that prescribers retain the notations, the Commission expects prescribers would make and retain such notations in the normal course of their business and thus believes the proposal wouldn’t normally create much, if any, additional burden.
  • Reviewing the relevant statutes and applicable case law, the Commission does not believe sellers risk conducting illegal calls by recording them.
  • Jobson Research, ECP Digital Solutions Study (also finding that of these surveyed, approximately 74.4% contacted their patients by email, which 45.5% used it to respond to personal questions concerning the patient’s eye health).

To file a complaint online, click “Report Now” and choose “Health” in the set of complaint topics. While the FTC doesn’t resolve individual issues, your report helps the agency investigate rule violations and may lead to enforcement action. Provide a prescription that is valid for a minumum of one year , unless the prescriber has a medical reason for setting a shorter expiration date.
portal would be sufficient to fulfill the Rule’s obligation for prescribers to provide a copy of the prescription after completing the contact lens fitting, the Commission sought comments on its proposed Rule modification. The Commission also asked for comments on whether prescribers ought to be necessary to maintain any records documenting a patient’s verifiable consent to get a prescription electronically. Commenter reaction to the Commission’s proposal in the SNPRM was varied.
In the NPRM, the Commission pointed out that the Act will not permit prescribers to limit the communication mechanism sellers could use to submit requests for verifying prescriptions, and that sellers can easily use any or every one of the three delineated methods, telephone, facsimile, or e-mail. In addition to the suggestions—discussed previously—that the Commission increase its enforcement of the existing Rule, or impose new requirements only as a penalty for specific providers within non-compliance, some commenters proposed alternative method of making certain consumers receive their prescriptions.

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As a result, the Commission is unable to estimate what part of the 49% who stated they did not automatically receive their prescription—in the most recent survey—gave that response because they misunderstood when they were eligible for receive their prescription. “Business hour” also can include, at the seller’s option, a prescriber’s regular business hours on Saturdays, so long as the seller has actual understanding of these hours.
However, the Commission does not have any reason to trust that such notation should take any more than for the individual to read and sign the document, therefore the Commission will maintain steadily its calculation as though all confirmations requested under , , or require exactly the same amount of time. The Rule anticipates prescription presentation by prescribers to sellers. Section 315.5 indicates that one way sellers can sell contact lenses is if they get a prescription from the prescriber directly or by facsimile. The Commission also notes that nothing in the Rule prevents active verification by way of a seller. If it prefers, a seller can elect to actively verify a prescription. CLR Panel IV Tr., supra note 121, at 5 (stating that

You don’t have beneath the Rule for sellers to keep recordings of unsuccessful verification attempts. The Commission can be instituting a forty-business-hour requirement for prescribers to supply additional copies of prescriptions upon request from the patient’s agent to make certain patients or their agents can receive additional copies of these prescription in a timely manner. Additionally, prescribers would be required to note in the patient’s file the name of the requester and the date and time the prescription was provided so that the Commission can determine, if necessary, whether a prescriber has complied with the Rule.

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In other words, to avail themselves of the exception, sellers must ask consumers to provide the maker or brand listed on the prescription. The SNPRM further provided that a seller would not have the ability to avail itself of the exception by relying on a prepopulated or preselected box, or on consumers’ online searches for a particular manufacturer or brand, as an indication that they were prescribed that manufacturer or brand.

  • Respond to a obtain yet another copy of the prescription, by you or your contact lens or eyeglass seller, within 40 business hours.
  • As a result, the burden from obtaining and retaining prescriptions likely offsets the burden from making verification requests and storing records of such requests.
  • Other commenters recommended that the Commission require prescribers to react to such requests inside a shorter time frame.
  • As previously noted, the Commission currently faces challenges in enforcing the Rule.
  • “It takes time for software development and to push out new builds.

The Rule already indicates what information must be contained in the message, and the excess requirements the Commission is implementing should ensure it is easier for prescribers to get the information. Should seller verification messages be deficient in providing all of the required information, prescribers should notify the seller.
No alteration of prescription.A seller may not alter a lens prescription. Notwithstanding the preceding sentence, a seller may substitute for private label contacts specified on a prescription identical contacts that the same company manufactures and sells under different labels. Require the patient to sign a waiver or release as a condition of releasing or verifying a prescription under paragraph or of the section.

See also National Association of Optometrists and Opticians (SNPRM Comment #129) (stating that with more practitioners moving to practice management systems and electronic health records, digital delivery of lens prescriptions is a “very feasible” option for many prescribers, which will further reduce the burden of the confirmation requirement). Johnson & Johnson Vision Care recognized that the exception could serve as guidance for sellers to find out whether they are responsible for an illegal prescription alteration.

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