Look before you leap! The US Centers for Medicare and Medicaid Services maintains strict regulations for payment for surgery and devices that use implants, and it depends on each specialty to provide honest supervision and notification of problems that would affect beneficiaries’ (ie, patients’) welfare and well-being. One of the ways it does this involves only paying for services that are deemed medically reasonable and necessary. In glaucoma surgery, this is tied to US Food and Drug Administration (FDA) premarket approval for the devices or implants used.¹

Food and Drug Administration Premarketing Approval

FDA Approval

FDA approval is a mandatory contingency for usage. FDA approvals for supraciliary or suprachoroidal MIGS devices are pretty much on hold due to the absence of clinical trials demonstrating no long-term damaging of the corneal endothelial cells. If a given device has not received FDA premarket approval to be marketed and sold in the United States, it cannot be used in surgical procedures performed here. Surgery related to insertion cannot be billed to Medicare or other insurers. A medical device that has not been approved, cleared, nor licensed by the FDA to be marketed neither will be reimbursed nor is legal to use. Wittingly submitting this for payment could be considered insurance fraud.

Case in Point

As an illustrative example, a device is approved by a local hospital’s Institutional Review Board (IRB) and is also approved and used for treatment outside the United States. It does not have FDA approval. This is a totally noncovered service for both the ASC and the surgeon. It is illegal to bill Medicare for the surgery or the device. One example of this would be insertion of a MINIject device (iSTAR Medical), because the manufacturer is European and the device is not available in the United States.

FDA Recall of a Device

The CyPass implant was recalled by both Alcon and the FDA when long-term studies revealed marked decrease of corneal endothelial cells, thus essentially commencing mandatory corneal endothelial studies for future FDA approval of suprachoroidal/supraciliary MIGS devices that potentially could produce the same adverse effect.

Here is a listing of some of the limitations that should be followed when performing MIGS surgeries that are not medically reasonable and necessary:

• Glaucoma drainage devices that do not have FDA premarketing approval/clearance and/or devices that have been recalled;
• Glaucoma drainage devices used outside of the FDA premarketing approval/clearance parameters (off label);
• Insertion of an anterior-segment aqueous drainage device without extraocular reservoir, via internal approach into the suprachoroidal/supraciliary space; and
• Additional insertions of anterior-segment aqueous drainage device(s) without extraocular reservoir, via internal approach into the trabecular meshwork or subconjunctival space.

Conclusion

Compliance should always be considered first when considering using new implants or performing off-label procedures. Webinars and other recorded, written, and virtual communications, which are overly abundant at the present time, are replete with colleague-to-colleague advice on the use of new non-FDA approved implants, off-label use, and noncompliant coding. Please remember that these usages are illegal in ordinary practice. GP

Riva Lee Asbell is principal of Riva Lee Asbell Associates, an ophthalmic reimbursement firm specializing in Medicare reimbursement and compliance. Reach her at rivalee@rivaleeasbell.com.

Reference

1. Asbell RL. MIGS 2020. Ophthalmology Management. 2020(February; The Ophthalmic ASC). https://www.ophthalmologymanagement.com/supplements/2020/february-2020/february-2020-the-ophthalmic-asc/coding-amp;-compliance .