OIG Weighs in on Proposed Care for “Premium” IOL Implants

Would an arrangement for co-management that involves additional payment for items and services that are not covered under Medicare involve prohibited remuneration under the anti-kickback statute? In an advisory opinion, posted October 7, 2011, the Office of Inspector General (OIG) concluded that a proposed arrangement between ophthalmologists in a group practice to co-manage cataract surgery patients, including Medicare beneficiaries, with optometrists external to that group practice who would separately charge the beneficiaries for services related to premium refractive intraocular lenses (IOLs) that are not covered by the Medicare program, would not generate prohibited remuneration under the anti-kickback statute. Therefore, the OIG would not impose administrative sanctions, including civil money penalties on the ophthalmology group practice in connection with the proposed arrangement.

Medicare Coverage of Conventional Lens v. Premium Lens

Cataract surgery involves removing a clouded crystalline lens and replacing it with a permanent prosthetic intraocular lens (Conventional IOL), which provides patients with clear distance vision but does not correct any pre-existing refractive problems. Patients receiving a Conventional IOL would require glasses or contact lenses to correct other vision problems. Newer types of IOLs, however, can correct vision at multiple ranges or correct astigmatism (Premium IOLs). Premium IOLs cost significantly more than Conventional IOLs. In addition to the implant itself being more costly, the facility and physician may require additional resources for fitting and inserting and additional visual acuity testing.

The Medicare program covers Conventional IOLs when reasonable and necessary for a patient as well as one pair of glasses or contact lenses following cataract surgery. If a Medicare beneficiary elects to receive a Premium IOL, Medicare pays for the medically necessary cataract surgery as well as the covered aspect of the IOL. The beneficiary is responsible for the professional and facility fees associated with increased testing and other services related to the correction of refractive errors and the difference in cost between the Premium IOL and the Conventional IOL. Cataract surgery is a global surgical procedure. The group practice certified that it follows all applicable Medicare billing and coding requirements for co-managed patients.

When a patient elects to receive a Premium IOL, the group practice charges a flat fee of per eye for the additional testing and related physician services. The group practice does not reduce this fee if a patient elects to return to his or her referring optometrist for post-operative services because the group practice performs all noncovered services associated with a Premium IOL during the timeframe in which the patient is under its care, whether or not that patient is co-managed.

 The Proposed Arrangement

 The group practice would not have any written or unwritten agreements with optometrists for the co-management of patients receiving Premium IOLs. In addition, the group practice certified that it would notify all patients, whether they are receiving a Conventional IOL or a Premium IOL, of their option to return to their optometrists for post­operative care if such a transfer would be clinically appropriate.

The group practice requires all patients who choose to return to their optometrists sign an informed consent to memorialize the decision. The group practice certified that it would notify patients receiving a Premium IOL that their optometrists may charge additional fees for the post­operative services that the patients would not incur if the group practice furnished the care. The group practice would incorporate this notification into the informed consent process.

OIG Analysis

OIG concluded that the opportunity for the optometrist to earn a fee for services not covered by the Medicare program in connection with post-operative management of Premium IOL patients would not constitute prohibited remuneration under the anti-kickback statute based on the following facts present in the proposed arrangement:

  • The group practice would have no written or unwritten agreements to co-manage patients with optometrists. The group practice would explain to all patients that they may receive their post-surgical care from the group practice or from their referring optometrist, following a determination of clinical appropriateness.
  • The group practice would inform patients receiving Premium IOLs that, if they choose to return to their optometrist for post-operative care, the optometrist may charge them for any services related to the Premium IOL. Informing the patient of potential additional charges that the patient would not incur by receiving follow-up care with the group practice, reduces the likelihood that the patient will choose to return to the referring optometrist.
  • The increased costs associated with a Premium IOL are not covered by the Medicare program. Although the group practice would co-manage a beneficiary receiving a Premium IOL with an optometrist who may charge the beneficiary for additional noncovered services provided, there would be no increase costs to the Medicare program.
  • The group practice certified that it would transfer a patient back to his or her optometrist only upon the patient’s request after explaining the patient’s options for post-surgical treatment providers, including the potential for incurring additional fees by returning to the optometrist.