CMS Pub. 100-02, ch. 15, § 30.4

B3-2020.25

Effective April 1, 1987, a doctor of optometry is considered a physician with respect to all services the

optometrist is authorized to perform under State law or regulation. To be covered under Medicare, the

services must be medically reasonable and necessary for the diagnosis or treatment of illness or injury, and

must meet all applicable coverage requirements. See the Medicare Benefit Policy Manual, Chapter 16,

“General Exclusions from Coverage,” for exclusions from coverage that apply to vision care services, and

the Medicare Claims Processing Manual, Chapter 12, “Physician/Practitioner Billing,” for information

dealing with payment for items and services furnished by optometrists.

A. FDA Monitored Studies of Intraocular Lenses

Special coverage rules apply to situations in which an ophthalmologist is involved in a Food and Drug

Administration (FDA) monitored study of the safety and efficacy of an investigational Intraocular Lens

(IOL). The investigation process for IOLs is unique in that there is a core period and an adjunct period. The

core study is a traditional, well-controlled clinical investigation with full record keeping and reporting

requirements. The adjunct study is essentially an extended distribution phase for lenses in which only

limited safety data are compiled. Depending on the lens being evaluated, the adjunct study may be an

extension of the core study or may be the only type of investigation to which the lens may be subject.

All eye care services related to the investigation of the IOL must be provided by the investigator (i.e., the

implanting ophthalmologist) or another practitioner (including a doctor of optometry) who provides services

at the direction or under the supervision of the investigator and who has an agreement with the investigator

that information on the patient is given to the investigator so that he or she may report on the patient to the

IOL manufacturer.

Eye care services furnished by anyone other than the investigator (or a practitioner who assists the

investigator, as described in the preceding paragraph) are not covered during the period the IOL is being

investigated, unless the services are not related to the investigation.

B. Concurrent Care

Where more than one practitioner furnishes concurrent care, services furnished to a beneficiary by both an

ophthalmologist and another physician (including an optometrist) may be recognized for payment if it is

determined that each practitioner’s services were reasonable and necessary. (See §30.E.)