AAO 2020
TEST 2
Observers of ophthalmic procedures
Ophthalmologists or ophthalmic surgery/laser centers at times require or desire the presence of observers during an ophthalmic procedure. Such observers include sales representatives from medical device or medical equipment manufacturing companies, visiting colleagues, or family members. The surgeon and the facility have the right to refuse such requests. If they agree to allow the observer, certain steps must be taken in order to honor the patient’s right to privacy and the physician’s and facility’s duty to protect the confidentiality of medical information, and to ensure the safety of patients, staff, and visitors. Observers of ophthalmic procedures will provide an overview of the issues associated with observers, and provide a sample consent form.
Research or the practice of medicine?
OMIC policyholders regularly contact our confidential Risk Management Hotline for help deciding if what they are doing is research or the practice of medicine. They may want to use a drug or device outside of clinical trials before it has been approved by the FDA, or off-label after approval. Some want to offer their patient a novel surgical technique. Research or Practice of Medicine provides useful guidance.
October Alert: FTC Contact Lens Rule Effective October 16
October 9, 2020
Dear OMIC Insureds:
The following information is shared with you to ensure you are aware of the Federal Trade Commission’s New Contact Lens (prescription) Rule and you understand how you can meet those requirements.
The FTC rule requires contact lens prescription prescribers do the following:
- Provide patients with a copy of their contact lens prescription.
- Confirm patients have received their contact lens prescription.
- Keep a record of the patient’s confirmation for at least three years.
- Contact lens prescribers must note if a patient refuses to sign a confirmation and save that refusal in their medical record.
In changing the rule, the FTC exempted prescribers who lack a financial interest in the sale of contact lenses.
There are four ways prescribers can comply:
- Request that the patient sign a form, confirming they received their contact lens prescription.
- Request that the patient sign a copy of a contact lens prescription that was provided. You must retain a copy in your records and provide the patient with a copy of the signed document.
- Request that the patient sign a prescriber-retained copy of the sales
receipt for the examination that contains a statement confirming - If a digital copy of the prescription was provided to the patient (via
your online portal, electronic mail or text message), retain evidence
that such prescription was sent, received or made accessible,
downloadable and printable.
In addition to the above requirements, OMIC has developed patient information forms to help you respond to patient requests for their contact lens prescription as well as a Contact Lens Agreement template for your practice.
Click on the following link to the OMIC website to download these documents. https://www.omic.com/contact-lens-prescriptions-patient-forms/
Contact OMIC’s Risk Management department if you have questions by calling 1-800-562-6642 and enter ‘4’ for Risk Management, or email us at riskmanagement@omic.com.
Contact Lens Prescriptions- Patient Forms
To assist your practice with patient requests for contact lens prescriptions, the following sample-patient forms are offered below. We include a template for a Contact Lens Agreement that would reflect your practice’s policy regarding contact lens prescriptions. See the FTC Contact Lens Rule, effective 10/16/2020, for compliance requirements for contact lens prescribers: FTC CL Rule
If you have questions, please contact OMIC’s Risk Management group. Email us at riskmanagement@omic.com or call us at 1-800-652-6642, enter 4 for Risk Management.
Contact Lens Request – Denied Follow Up Care Needed
Contact-Lens-Prescription COPY Requested
Sample CL Prescription Received-Patient Signature
Sample CL Agreement- New FTC CL Rule effective 10-16-2020
Medical Record Request Includes Expired Contact Lens Prescription
