Presbyopia correction: Handling the new patient charges

Legal, billing and clinical experts join in updating key guidelines.

William F. Maloney

A note from the editors:
This article is the result of many hours of collaboration among the authors: attorneys Alan E. Reider, JD, and Allison Shuren, MSN, JD, together with billing compliance consultant Kevin J. Corcoran, COE, CPC, and OSN Cataract Surgery Section Editor William F. Maloney, MD.

We believe that it is an important contribution that will help to provide surgeons with the guidelines they need to move forward with pseudophakic presbyopia correction. We would like to thank the authors for the considerable time they have given to this effort. We hope that they will agree to continue their collaboration with regular updates on this important topic.

Contributors
Alan E. Reider	Allison Weber-Shuren	Kevin J. Corcoran

In recent months, interest in presbyopia correction has increased considerably, and the trickle of inquiries on the noncovered charges related to presbyopia correction at cataract surgery has become a torrent. It is clear that some important issues need clarification. This article — an update to the original legal treatment of this issue by Mr. Reider and Ms. Shuren (See “Refractive ‘bracket creep’ makes billing for presbyopia services complex,” March 15, 2005) — will include consideration of the ruling by the Centers for Medicare and Medicaid Services that was published thereafter in May 2005.

Lens-based presbyopia correction

Previously in this column, Dr. Maloney has described the different techniques for correcting presbyopia using lens implants. We broadly refer to this lens-based approach as “pseudophakic presbyopia correction” (PPC).

Currently, surgeons have several distinct alternatives within the PPC category. The first employs a uniform pair of one or another of the three designated presbyopia-correcting IOLs.

In a more recent variation of this approach known as “mix and match,” two different presbyopia-correcting IOLs are combined in a complementary binocular pairing to optimize the benefit and reduce the compromise of each.

Finally, a customized binocular pairing of conventional IOLs is created to provide a specific range of spherical myopic anisometropia calculated to deliver a patient’s designated reading vision goals in accordance with his or her predetermined defocus tolerances and suppression capacity. We refer to this PPC approach as “pseudophakic monovision.”

Each of these iterations of PPC has demonstrated the capacity to deliver uncorrected reading vision to a variety of candidates. None, however, works automatically, and none constitutes the best choice for every patient. In other words, currently there is no across-the-board, off-the-shelf solution to presbyopia correction.

Properly performed, each approach requires additional effort on the part of the surgeon, particularly during the preoperative process. Our primary focus in this article is the proper handling of noncovered charges related to this new category of services, designated “additional effort on the part of the surgeon.” We use the phrase “noncovered” to delineate charges for medically appropriate services that are not covered by Medicare or most third party payers and that are separately chargeable to the patient.

Not for every patient

First, we want to remind surgeons that some patients are not candidates for PPC. In addition to medical contraindications, there are patients who simply prefer wearing glasses. Others, while initially intrigued by the prospect, will decide against PPC for financial reasons. Because the surgeon cannot know each patient’s level of interest, suitable candidates should at least be advised of the PPC options prior to cataract surgery.

Cataract vs. refractive lens exchange

PPC is an optional component of two different surgical procedures: refractive lens exchange (RLE) and cataract extraction. When PPC is performed in conjunction with RLE, both services fall outside of the covered benefits for Medicare and most third-party payers. This generally makes the charges a fairly straightforward matter between the patient and the surgeon.

Establishing an appropriate charge structure for PPC when performed in conjunction with cataract extraction is more complicated because the two procedures are performed in tandem and the charges related to each require different treatment. Procedures related to cataract extraction are treatment of a medical disorder and are therefore covered services. However, procedures tied to the PPC portion of this hybrid surgery are elements of a refractive surgery procedure and not covered.

The critical covered-noncovered connection

This does not mean, however, that the noncovered charge for the PPC component of this hybrid surgery is treated exactly the same as if it were a procedure that is entirely noncovered, such as LASIK or RLE.

Although the fees assigned to the refractive and cataract components are treated differently, they are not completely autonomous. And while Medicare and other third-party payers maintain no oversight with respect to noncovered services, they are concerned about the potential that charges for noncovered services could be inflated to subsidize the reimbursement for covered services, thereby constituting impermissible balance billing. This ongoing connection to Medicare requires that all charges for noncovered services in a hybrid procedure be judged as reasonable by the CMS.

LASIK and RLE are not subject to this same oversight, although ethical considerations and consumer protection laws impose some degree of limitation on these charges as well.

Zeroing in on ‘reasonable’

It is vital that the surgeon have a working understanding of “reasonable” when setting fees for these noncovered services. In this context, one appropriate description is a usual and customary charge that the surgeon has assigned for the selected group of services at issue, as distinguished from the Medicare reimbursement level. At present there are some noncovered services performed in conjunction with PPC that do not yet have established usual and customary charges. Surgeons should use their best efforts to create “comparables” in this situation and document the rationale employed in the process.

What qualifies for consideration as noncovered?

Noncovered charges for PPC are divided into two distinct categories: devices and services.

Noncovered devices
The first is a facility charge related to a noncovered aspect of a device, in this case the presbyopia-correcting IOL, that applies only if and when a designated presbyopia-correcting IOL is utilized. This part seems to be clear enough to most surgeons.

Noncovered services
The second type of noncovered charge is related to noncovered services provided by either the facility or the surgeon. They are generally treated separately.

Facility noncovered services. This category relates to additional facility fees for refractive procedures such as LASIK correction of astigmatism. These facility charges, if any, also seem to be fairly clear.

Surgeon noncovered services. It is this category — noncovered charges for services provided by the surgeon — that needs clarification. This is especially true for those cases in which the correction of presbyopia employs the pseudophakic monovision approach, which does not use one of the three designated premium presbyopia-correcting IOLs.

In the section below we outline some of these noncovered surgeon services. We start more generally with several guiding principles and include specific examples where they may be helpful.

Which surgeon services qualify as noncovered?

Noncovered services provided by the surgeon include additional surgery and those specific tests related to the additional surgery that are required to best achieve PPC. Surgery performed to correct astigmatism is the most notable example in this category. Alteration of the location of the cataract incision alone does not qualify as noncovered surgical correction of astigmatism because this incision is part of standard cataract surgery and is covered, regardless of location.

Surgical correction of astigmatism may not always be necessary because some patients have little or no astigmatism. Because a residual refractive error with a spherical equivalent of 0.5 D or greater can noticeably alter the intended outcome of PPC, astigmatism of 0.75 D is generally the accepted threshold for surgical correction when PPC is part of the surgical plan.

Both the tests employed to determine the necessity of astigmatism correction and the astigmatic surgery itself are noncovered. Naturally, only patients who actually undergo astigmatism correction should incur the charge for the surgery as a noncovered service.

Noncovered services provided by the surgeon also include specific refractive tests, measurements and assessments that are not performed for a standard cataract patient but that are required to best achieve the intended PPC results. The preoperative testing for pseudophakic monovision, in particular, entails a variety of measurements for ametropias, ocular dominance, suppression capacity and interocular defocus tolerance. All of these tests are refractive in nature and go beyond the typical noncovered refraction. They may be considered as a group, categorized as a noncovered “refraction plus.”

The noncovered services provided by the surgeon can vary among patients and also by the PPC approach employed. Some surgeons may decide to charge each patient based on the specific services provided, while other surgeons may decide to charge a fixed fee for a bundle of services, recognizing that not all patients may require all of the services in the bundle. Regardless of which approach is taken, the key to compliance is to ensure that the patient is fully informed about the services offered, the charge for the services offered and that the charge for the services is reasonable. In the case of a bundled fee, pricing must reflect the fact that not all patients will receive all services in the bundle. Notice of Exclusion from Medicare Benefits (NEMB) or Notice of Exclusion from Health Plan Benefits (NEHB) should be part of the permanent medical record.

Noncovered services provided by the surgeon are limited to those specific tasks that constitute appropriate “additional work” employed to optimize the PPC outcome. If a physician does not perform any additional work, then there are no legitimate noncovered services. This is true regardless of how well the procedure might happen to accomplish the correction of presbyopia in a particular case.

Two examples illustrate this important principle:

1. Insertion of an IOL is part of routine cataract surgery and is covered. Solely changing from a conventional IOL to a premium presbyopia-correcting IOL without performing any additional tests or assessments to optimize outcomes does not qualify as a noncovered service no matter how effectively this may happen to correct presbyopia in a given case. No additional work took place over and above that required by routine cataract surgery. Therefore, while the noncovered presbyopia-correcting IOL device charge applies, no additional noncovered surgeon charges apply in this case.
   
   
2. Biometry, which necessarily includes selection of a specific refractive target, is part of routine cataract surgery and is covered regardless of the refractive target selected. Solely shifting the target from emmetropia to myopia in one eye — thereby generating some arbitrary, generic form of monovision without performing the additional tests and assessments necessary to customize the outcome to the patient’s particular reading goals — does not qualify as a noncovered service, no matter how effectively this may happen to correct presbyopia in a given case. No additional work took place over and above that required by routine cataract surgery; therefore no additional noncovered surgeon charges apply in this case.

Where we did not reach absolute unanimity

One type of service remains sufficiently ambiguous that we could not reach an entirely unanimous determination: length of consultation. We are aware that some physicians have argued that patient consultation for PPC is longer (ie, additional “chair time”) and that this constitutes a noncovered service warranting an additional charge.

Mr. Corcoran felt strongly that “chair time” is always a covered service and never, under any circumstances, constitutes the basis for an additional charge to the patient. He applied similar analysis to the matter of additional postoperative visits performed during the 90-day global period.

Mr. Reider and Ms. Shuren take a different approach. They noted that there is no clear ruling of which they are aware relating to this issue. They pointed, however, to the CMS ruling last year that stated that “In determining the physician service charge, the physician may take into account the additional physician work and resources required for insertion, fitting and vision acuity testing of the presbyopia-correcting IOL ...” While they believe that this language suggests that appropriate additional charges may be made, they cautioned that Medicare may take the position that any additional services not related to the insertion, fitting and visual acuity testing constitutes part of the covered cataract surgery fee and is not a noncovered service that may be charged to the patient. They applied similar analysis to the matter of additional postoperative visits performed during the 90-day global period.

Dr. Maloney emphasized that these issues were judged here to be either absolutely prohibited or, at least, a matter of concern. Pointing to the long-term interest of the profession in general and PPC in particular, he advised that colleagues take the most conservative position possible with these and any other unresolved questions regarding these new patient charges. Increasing clarity, he felt, will come with time.

Disclaimer

The Medicare reimbursement rules are extraordinarily complex when dealing with covered services alone. The convergence of covered and noncovered services creates still further confusion. In this article we have attempted to present our best understanding of these issues and sensitize the reader to the issues he or she must address when offering these services to patients. Nothing in this article should be relied upon by the reader as definitive coding or legal advice.

If you have specific questions, you are urged to contact your coding expert or attorney.

Next column

William F. Maloney, MD, will discuss ethical issues that will determine the long term success of presbyopia correction.

For more information:

• Kevin J. Corcoran, COE, CPC, an OSN Practice Management Section Member, can be reached at Corcoran Consulting Group, 1845 Business Ctr Drive, Suite 108, San Bernardino, CA 92408; 800-399-6565; 909-890-1333; e-mail: kcorcoran@corcoranccg.com.
• William F. Maloney, MD, is head of Eye Surgery Associates of Vista, Calif., and a well-known teacher of cataract and lens-based refractive surgery techniques. He can be reached at 2023 West Vista Way, Suite A, Vista, CA 92083; e-mail: maloneyeye@yahoo.com. In the interest of objectivity, Dr. Maloney has no financial interest in any ophthalmic product and has no financial relationship with any ophthalmic company.
• Alan E. Reider, JD, OSN Regulatory/Legislative Section Editor, can be reached at Arent Fox PLLC, 1050 Connecticut Ave. NW, Washington, DC 20036; 202-857-6462; fax: 202-857-6395; e-mail: reider.alan@arentfox.com.
• Allison Weber Shuren, MSN, JD, an OSN Regulatory/Legislative Section Member, can be reached at Arent Fox PLLC, 1050 Connecticut Ave. NW, Washington, DC 20036-5339; 202-775-5712; fax: 202-857-6395; e-mail: shuren.allison@arentfox.com.