In 2023, 5 Medicare Administrative Contractors (MACs) — WPS, CGS, NGS, Noridian, and Palmetto — developed new, controversial and restrictive local coverage determination (LCD) policies for minimally invasive glaucoma surgery (MIGS). In December, they announced they “… will not become final and therefore have been removed from the Medicare Coverage Database. Accordingly, at this time there will be no change in the current status of coverage for MIGS.” Many ophthalmologists, ambulatory surgery centers (ASCs), and manufacturers are relieved but express concern about what’s next. 

Medicare’s Reasonable and Necessary Criteria

The Medicare law only covers items and services that are “reasonable and necessary.”¹ But what does that mean? The Medicare manual provides the following definition:²

1. Safe and effective
2. Not experimental or investigational
3. Appropriate for Medicare patients, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it meets the following criteria:

• • Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member;
  • Furnished in a setting appropriate to the patient’s medical needs and condition;
  • Ordered and furnished by qualified personnel;
  • Meets, but does not exceed, the patient’s medical need; and
  • Is at least as beneficial as an existing and available medically appropriate alternative. 

In the absence of an LCD for MIGS, we apply these general criteria starting with the formal directions for use for the relevant products. The manufacturer’s package label and the FDA’s approval letter for their product describing indications are authoritative sources. Excluded from coverage are off-label uses and any overt contraindications (Table 1). 

Table 1: Selection of Glaucoma Products and Their Indications

For example, we can readily see that “adult” is a common indication, while pediatrics is often off-label. Furthermore, where “mild-to-moderate” is indicated, “severe” glaucoma is not. In cases where “combined with cataract surgery” is indicated, standalone MIGS is not. 

Essential Chart Documentation 

In support of medically necessary MIGS, essential chart documentation in the medical record will include antiglaucoma medication(s) success or failure, compliance with medications, filtration/cilioablation procedure(s) if performed, gonioscopy, laser trabeculoplasty if performed, longitudinal IOP, operative report with patient-specific indication(s), optic nerve imaging showing abnormalities, perimetry that establishes glaucoma stage, and target IOP. If the surgeon is forced to discontinue the MIGS procedure due to extenuating circumstances, CMS requires that the operative report specify the reason for termination of surgery; services actually performed; supplies actually provided; services not performed that would have been performed if surgery had not been terminated; supplies not provided that would have been provided if the surgery had not been terminated; time actually spent in each stage, eg, preoperative, operative, and postoperative; time that would have been spent in each of these stages if the surgery had not been terminated; and the HCPCS or CPT code for the procedure had it been performed.³ CPT includes specific modifiers for the surgeon (-53) and the ASC (-73, -74) in this unfortunate situation.

Financial Waivers

MIGS is covered for some reasons but not universally. Where it is doubtful that the payor will cover the procedure, then good practice management technique will use an appropriate financial waiver form or process prior to performing the MIGS procedure. In most situations, there are separate forms for the surgeon and the ASC. The beneficiary is financially responsible for noncovered services provided they were appropriately informed and consented. GP

Kevin J. Corcoran, COE, CPC, CPMA, FNAO, is principal of Corcoran & Corcoran in Las Vegas, Nevada.

References

1. Social Security Act 1862(a)

2. MPIM Chapter 13 §13.5.4

3. MCPM, Chapter 14 §40.4C