How Do New Technologies Fit Within the CMS Rulings for Advanced Technology IOLs?

The Centers for Medicare and Medicaid Services (CMS) rulings for presbyopia-correcting IOLs (PC-IOLs) and astigmatism-correcting IOLs (AC-IOLs), collectively referred to as advanced technology IOLs (ATIOLs), clarified that these special lenses function to correct two distinct patient needs:  (1) aphakia induced by the removal of a cataract, and (2) the refractive errors associated with presbyopia or astigmatism.  Correction of aphakia is covered and paid for by Medicare in conjunction with medically necessary cataract surgery, whereas correction of refractive errors is not covered.  The rulings cleared the way for physicians and facilities to receive standard Medicare reimbursement for cataract surgery that includes the implantation of a PC-IOL- or AC-IOL while also being permitted to bill patients for the additional, incremental costs associated with presbyopia-correction or astigmatism-correction. 

The Rulings allow facilities to charge patients for the additional charges associated with the higher price of an ATIOL as compared to a conventional IOL, and they permit surgeons to charge patients for any medically appropriate work or services furnished which are related solely to the refractive-corrective function of the ATIOLs.  Examples include diagnostic tests to determine if a patient is a candidate for an ATIOL and steps which are intended to achieve precise placement of the ATIOL to impact its refractive function.   

Since the release of the Rulings, new technologies, such as femtosecond laser system (FLS) and image-guided systems for use in both the office and the operating room have been introduced with features specifically designed to improve precision when implanting ATIOLs.  These technologies should, therefore, improve the refractive function of the ATIOLs.  Like ATIOLs, some of these technologies offer other functions that are used in cataract surgery with conventional IOLs.  In the case of the FLS, industry communicated extensively with CMS in 2012 regarding the various functions of the systems, and CMS ultimately clarified that utilizing the imaging function of an FLS is a step that can be included in the calculation of the additional charges passed on to patients who choose an ATIOL.  The rationale for this policy is that the imaging is not medically necessary to achieve the intended outcome with the implantation of conventional IOLs—namely, the correction of aphakia.  In contrast, FLS imaging is designed to assist the surgeon in achieving more precise positioning of the ATIOL in the capsular bag, which, in turn, is intended to help patients achieve the spectacle independence they sought when they chose an ATIOL.   

Similarly, the new image-guided systems which utilize office-based imaging combined with digital eye-recognition and guidance technology in the operating room enable cataract surgeons to achieve highly precise axial orientation and/or centration of ATIOLs, thereby increasing the likelihood that the refractive function of the ATIOLs will perform as intended.  As with the FLS imaging function, the extra degree of precision in centration and axial alignment that should be achievable with this feature of image-guided systems is not necessary with conventional IOLs.

What all of these technologies have in common (ATIOLs, femtosecond laser systems, and image-guided systems) is that they offer features or functionality for both a covered service (cataract surgery) and a noncovered service (presbyopia and/or astigmatism correction).  As a result, surgeons and facilities must take care to charge patients only for the aspects of these technologies that are related to the noncovered function of ATIOLs.  When determining how to factor these technologies into total charges for ATIOL procedures, providers should use a reasonable method for determining what portion of the cost of these technologies is attributable to the noncovered service versus the covered service of cataract surgery.  When determining how much to mark up the portion of cost attributable to the noncovered service, there is no specific limit on markup or profit margin dictated by state or federal law.  Competitive factors in the local community will for the most part drive pricing and how much the market will bear.  That being said, physicians should be mindful that most state medical practice acts include either explicit prohibitions against price gouging of patients or general, catchall “unethical behavior” provisions that could be used by a state Boards of Medicine to take action against a physician’s license.  Such action could occur in a case where the physician is viewed as taking advantage of patients. 

In addition to offering ATIOLs, many cataract surgeons offer to correct corneal astigmatism at the time of cataract surgery.  Regardless of the tool used for performing this procedure—knife or laser—it is a non-covered service, and patients are financially liable for this not-medically-necessary procedure.  It is important for patients to understand that the astigmatism correction is a distinct surgical procedure, and it is wise to obtain separate informed consent agreements for the cataract surgical procedure and the astigmatism correction procedure.  Some surgeons who plan to use a laser for such correction will put language in their informed consent agreements which serves as advance authorization from the patient that a knife may be used instead of the laser should the surgeon decide during the operative session that use of the laser is not practical. 

Finally, surgeons and facilities should take care in explaining to patients exactly how much they are being asked to pay and for what services the payment is required.  Patients have a right to know, and clear information should reduce or eliminate instances in which patients believe incorrectly that the fees for noncovered services are related to the basic, medically necessary cataract surgery.  

Allison Shuren, JD

Arnold & Porter

Washington, DC

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