Pertinent reimbursement issues with billing/coding regulations and adherence to strict Medicare compliance rules when surgically implanting MIGS (Minimally or Micro-Invasive Glaucoma Surgery) devices continue to present in 2021. All information here is based on Medicare regulations.

Both terms—Minimally Invasive Glaucoma Surgery and then Micro-Invasive Glaucoma Surgery—were coined by Iqbal (Ike) K. Ahmed, MD, FRCSC, and, as described by him, are generally circumscribed by the following characteristics:

“MIGS procedures share five distinct qualities: (1) ab interno, microincisional, conjunctiva-sparing approach; (2) minimal trauma to and disruption of normal anatomy and physiology, with devices that exhibit a high level of biocompatibility; (3) moderate to high IOP-lowering efficacy; (4) an extremely positive safety profile; and (5) rapid recovery by the patient. Although other procedures may share some of these traits, they do not necessarily fit the true definition of MIGS.”¹

This year’s grid of implantable MIGS devices remains the same as that of 2020 (see February 2020 issue of Ophthalmic ASC).²

THE CPT BOOK‘S BIG BOO-BOO

Because the Current Procedural Terminology (CPT) manual of codes is second nature to me, I have quite a few memorized and, thus, it was quite by chance when I recently looked in the CPT 2020 and noticed the following:

“Minimally Invasive Glaucoma Surgery (External Approach) 66150, 66155, 66160, 66170, 66172, 66183”

For those of you who do not have these codes memorized, the descriptors are as follows:

Having kept an old copy of Coding Illustrated from 1997 as archival material, I researched and found all the above codes in the book, thus precluding any claims for them to be considered MIGS codes—a nomenclature that surfaced approximately in 2014 or so from Dr. Ahmed.

I recommend to all my readers that the CPT information simply be ignored.

It has been brought to the attention of the CPT Editorial Panel and, hopefully will be fixed. However, it does appear in the 2021 CPT book, so please don’t be confused or misinformed.

CATEGORY I vs CATEGORY III CODES

A Peek At 2022. Two new Category I codes for cataract extraction with insertion of MIGS device, and perhaps a Category III code for a stand alone code, are currently scheduled for 2022. The compliance and coding regulations that have been delineated by Medicare are likely to be applied to these codes with perhaps additional modifications.

ASCs may want to monitor the surgeons’ coding to make sure it is correct and corresponds to their own.

There are different parameters that must be met in order for a CPT code to be issued. Category I codes are the permanent codes, whereas Category III codes—often referred to as new technology codes—are temporary.

Here are some of the comparisons:

MANDATORY COMPLIANCE REGULATIONS/FDA APPROVALS

When a surgical procedure or instrument receives FDA approval, its usage parameters are mandated in the information distributed with the purchase. The following categories and information apply.

FDA Approved Usage. An approved usage of a device occurs when the product is used in accordance with the diagnostic parameters specified on the product label and using surgical techniques that are in compliance with the corresponding restrictions as specified by the FDA.

Example: iStent, iStent inject, and iStent inject W (Glaukos) as well as Hydrus mirostent (Ivantis) are approved for use only in conjunction with cataract surgery and not as stand-alone procedures.

FDA Approved Device/Not Approved Usage. This occurs when a given device is used for treatment for a condition or usage not specifically approved by the FDA on the label, although the device is FDA-approved for another indication. An off-label use of an FDA-approved device may be awarded a Category III CPT code; however, this is not synonymous with obtaining Medicare payment. Where Medicare goes, most of the other insurers follow. Category III codes do not require FDA approval whereas Category I codes do.

Example: iStent is approved for the treatment of mild to moderate glaucoma. It is not approved for treatment of refractory glaucoma. The latter use would be considered an off-label usage; currently, as would stand-alone usage without concurrent cataract surgery.

Example: Xen 45 Gel Stent (Allergan) inserted via an ab externo approach.

FDA Not Approved Device/Not Approved Usage. If a given device has not received FDA premarket approval to be marketed it cannot either be used or sold in the USA. Use of the device cannot be billed to Medicare or other insurers.

Further clarification regarding these issues is best provided by a healthcare attorney.

Example: A device is approved by a local hospital’s Institutional Review Board (IRB) and also is approved and used for treatment outside the USA. It does not have FDA approval. This is a totally non-covered service for both the ASC and the surgeon. It is illegal to bill Medicare or the patient for the surgery or the device.

Example: Insertion of a MINInject device from Europe.

Off-Label Use Of MIGS Devices. Off-label uses of MIGS implants continues to proliferate, and a checklist should be followed when using them. In medicine, the term “Off-Label” is well known, but there is not a great deal of attention paid to the attendant compliance regulations that should be followed if a product is used off-label. It is imperative that ASC personnel and surgeons understand the responsibilities inherent in an off-label use.

Informed Consent. When a device is used off-label, it is mandatory a separate informed consent be issued that specifies it is being used as such. This may be one of the most overlooked compliance issues in ophthalmology and is extremely important. OMIC has a sample informed consent form for off-label use on its website: omic.com/informed-consent-for-off-label-use-of-a-drug-or-device/ .

Furthermore, if a risk management event does occur, the physician may not be able to present a sufficient defense. The ASC may be co-joined. It is best to consult with a healthcare attorney on this issue.

MEDICARE’S REVISED LOCAL COVERAGE DETERMINATIONS (LCDs) FOR MIGS SURGERY

LCDs have been issued or revised by the end of 2020. This has been addressed in-depth in last year’s The Ophthalmic ASC article.² Here are some of the major highlights:

Billing/Coding for More Than One Surgery and/or Device. For ASCs the use of any additional devices used in MIGS surgery is regulated by the N1 modifier signifying that additional devices are packaged and may only be billed once by the ASC. This applies to iStent as well as iStent inject products and other devices such as Hydrus. The use of the add-on code +0376T is prohibited by Medicare and most other insurers.

Billing/Coding for Supraciliary or Suprachoroidal Devices. It is unlikely that the FDA will approve future supraciliary or suprachoroidal devices without long-term studies of corneal endothelial loss and there have not been any devices approved in 2020.

Usage Clarification for Coding/Billing for Multiple Devices in the Same Procedure

The following usages apply:

• A single insertion per eye of an anterior segment aqueous drainage device(s)performed in conjunction with cataract surgery for treatment of mild to moderate open angle glaucoma, (Hydrus, iStent, iStent inject products).
• A single insertion per eye of an aqueous drainage device(s) without extraocular reservoir, via internal approach into the subconjunctival space is considered medically reasonable and necessary as a stand-alone treatment for refractory glaucoma only (Xen 45 gel stent).
• Stand-alone procedures for implantable devices without concurrent cataract surgery are not approved.
• Additional inserter use for device insertions on one eye is considered not medically reasonable and necessary.
• Add-on code +0376T (Insertion of anterior segment aqueous drainage device, without extraocular reservoir; internal approach, into the trabecular meshwork; each additional device). MACs neither cover nor pay for the second device and it is considered medically unnecessary. The insertion of a second stent never did receive FDA premarket approval.

CODING FOR COMPLICATIONS OF MIGS PROCEDURES

Complications occurring with MIGS implanted devices need to be coded properly in order to obtain reimbursement. A complication that occurs after the surgery is often coded differently from complications that occur intraoperatively and may only require use of a modifier. Guidance for coding subsequent procedures related to handling of complications related to the initial insertion, regardless of time frame, is discussed in depth in the 2020 article and includes instruction in the following issues that may be difficult to obtain elsewhere:

• Removal of the Device
• Inability to Complete the Insertion of the Device
• Repositioning/Trimming of the Device

SOURCES FOR ADVICE

Chart Documentation and Medical Necessity. In the February 2018 issue of The Ophthalmic ASC, I wrote an article titled ”ASC & Physician Medicare Audits: Cataracts & MIGS Surgery” that is replete with checklists and forms that both ASCs and practices can use to properly and completely document their procedures.³ I suggest you look it up and consider using these forms. ■

CPT codes copyrighted by the American Medical Association 2020

REFERENCES & RESOURCES

1. Ahmed IK. Defining MIGS. Cataract and Refractive Surgery Today. October 2014.
2. Asbell RL. MIGS: Medicare’s New 2020 Compliance and Reimbursement Regulations. Ophthalmic ASC. Feb 2020. Accessible at RivaLeeAsbell.com
3. Asbell RL. ASC & Physician Medicare Audits for Cataract & MIGS Surgery. Ophthalmic ASC. Feb 2018.
   Asbell RL. A MIGS Compliance Compendium. Ophthalmic ASC. October 2018.
   Asbell RL. CyPass Device Removal/Revision: Coding & Reimbursement Challenges. RivaLeeAsbell.com : Featured Article, October 2018.