Cataract Surgery Report

Keep the message real for FSL cataract surgery

Shape promotional claims with an eye on professional and regulatory guidelines.

By Kevin J. Corcoran, COE, CPC, FNAO

About the Author: Kevin Corcoran, COE, CPS, FNAO, is president of Corcoran Consulting Group in San Bernadino, Calif.

New technology in ophthalmology holds a similar attraction for surgeons that fast, sexy sports cars hold for college students. The appeal is great but there are also reasons for caution. History teaches us that some publicity attracts unwanted attention. In 1990, The Argus-Press of Owosso, Mich., published a story under the headline “Critics question number of operations for cataracts” that came to be known as the “Big Cutters” hullabaloo. It painted an unflattering picture of ophthalmic surgeons and led to years of questions about medical necessity for cataract surgery. Cataract surgeons are facing a similar issue today with the advent of ophthalmology’s latest equivalent of a sexy sports car, femtosecond laser-assisted cataract surgery.

CURB YOUR ENTHUSIASM

Last year, after years of growing publicity for the technology, CMS guidance addressed laser-assisted cataract surgery. Its message:

We are providing this guidance because of a recent press release from an ophthalmology practice that described use of bladeless, computer-controlled laser surgery for cataract removal. The press release may imply a different Medicare policy regarding non-covered services that may be charged to the beneficiary if the cataract surgery is performed using a bladeless, computer-controlled laser. The press release states:

“While traditional cataract surgery is fully covered by most private medical insurance and Medicare, bladeless cataract surgery requires patients to pay out-of-pocket for the portion of the procedure that insurance does not cover.

“Medicare coverage and payment for cataract surgery is the same irrespective of whether the surgery is performed using conventional surgical techniques or a bladeless, computer controlled laser.”

Subsequent advice from AAO and ASCRS further stressed:

Promotional claims must be consistent with the best available clinical evidence and should not be deceptive or misleading to patients. Caution should be exercised with advertising or public media statements that describe why patients must pay additional out-of-pocket fees.

Balance billing Medicare beneficiaries to use the FS laser for covered steps of cataract surgery is prohibited.

Both professional societies advocated that practices offer transparency to patients with respect to all financial arrangements.

AAO GUIDANCE ON AD CLAIMS

In a 2007 advisory opinion of the AAO on Advertising Claims Containing Certain Potentially Misleading Phrases, the Academy asks:

In what circumstances is it deceptive to claim that certain ophthalmic procedures are “safe,” “harmless,” or “painless”; that treatments will “cure’” patients; or that ophthalmologists are “pioneers,” “leaders,” or “world famous”?

Let’s look at how that question applies to laserassisted cataract surgery. At the annual meetings of ASCRS and AAO in 2012, we saw significant enthusiasm for femtosecond laser technology for refractive cataract surgery. In 2011, the main auditorium at the ESCRS convention in Vienna was standing room only for several presentations on this technology. Nevertheless, presenters were careful not to make strong claims for the technology; published scientific evidence concerning overall success is scant.

At the July 2011 Town Hall meeting of the ASCRS in Chicago, several presenters argued for a wait-and-see approach and cautioned attendees not to say laser-assisted cataract surgery is “better” than traditional techniques.

The upshot is that you need to be very careful in your advertising language. While the word “precise” applies to this technology, words such as “superior” or “safer” do not, at this point.

BEST PRACTICES

What should you do? To balance enthusiasm for this new technology with prudence in light of good reasons for caution, take the high road. There are a number of signs on that road that you should heed:
• Compliance. Follow the CMS guidance. Construct a protocol for refractive cataract surgery that clearly differentiates covered and noncovered items and services.
• Transparency. Communicate with patients using full disclosure, clear language and a degree of fairness that puts the patient’s interest first. Specifically, financial waivers and informed consent should be couched in neutral terms so patient choice is preserved.
• Reasonableness. Establish rational, moderate charges for noncovered services consistent with your other professional fees.
• Fiscal responsibility. Create a sensible business plan using reasonable goals and assumptions. Follow sound accounting principles that associate costs with revenues.

Maintain financial discipline about capital investments, and only make sensible investments — that is, investments that do not rely on very aggressive assumptions about patient out-of-pocket expenditures to justify purchase of an expensive laser. In this case, “reasonable” assumptions match the total cost of the laser to expected usage, which generally requires an ambulatory surgery center or hospital outpatient department with a large volume of cataract surgery (estimated at 5,000 cases/year).
• Keep an open mind. Pay attention to new information about femtosecond laser technology as it becomes available. Research will reveal previously unknown strengths and weaknesses. Remain objective and take the long view, Time will tell if this approach is “better”.

PROCEED WITH CAUTION

The history of ophthalmology is resplendent with new technologies, some successful and some forgettable. This early stage of femtosecond laser use warrants a little patience until science catches up with the enthusiasm of the early adopters of laser-assisted cataract surgery and educates us all about its merits.

To avoid giving regulators cause for skepticism or the press reason to doubt the professionalism of surgeons, take the high road — follow the best practices suggested here. OM