Practice Management, Standards, and Regulations
Regulatory framework
In the United States, contact lenses are Class II medical devices under 21 CFR 886, and both the lens and the fitting constitute a prescription. The FTC Contact Lens Rule (2004, amended 2020) requires the prescriber to give the patient a copy of the contact lens prescription at no charge when the fitting is complete, whether or not the patient asks, and to obtain a signed acknowledgment of receipt. The patient may designate anyone to receive the prescription. Prescribers must respond to a seller's verification request within eight business hours. A prescription may not be conditioned on purchase, and a prescriber may not require a waiver. Expiration is typically one year unless a documented medical reason justifies a shorter period.
Records and standards. ANSI Z80.20 and the ISO 18369 series define lens parameters, tolerances, and labeling. Keep fitting records, keratometry, and follow-up notes consistent with state law and payer requirements; document medical necessity for specialty designs (sclerals, ortho-k) and any deviation from the manufacturer's replacement schedule.
Practice operations. Staff may perform delegated tasks - history, visual acuity, insertion and removal training, inventory - within state scope-of-practice rules, but clinical judgment (final lens parameters, diagnosis) stays with the licensed practitioner. Bill evaluation and management codes for problem-focused visits and vision/refraction codes for routine care.
Rule of thumb: if a question asks who may withhold a contact lens prescription, the answer is no one - the release obligation is unconditional once the fitting is complete.