Presbyopia-correcting IOLs present opportunity, but legal caution needed

Attorney reviews potential legal pitfalls during a section of the OSN New York Symposium on how to incorporate presbyopia IOLs into your practice.

Issue: February 15, 2007

ByDaniele Cruz

$Spotlight on Lens-Based Refractive Surgery$

NEW YORK — Cataract and refractive surgeons now have the opportunity to add premium presbyopia-correcting IOLs to their practices, but they must use caution when billing for these devices and related services to avoid violating Medicare guidelines, according to an expert.

Several faculty members at the OSN New York Symposium spoke favorably about the possibilities for “improving the bottom line” by including premium presbyopia-correcting IOLs in the list of options that patients have when undergoing cataract or refractive surgery. But OSN Regulatory/Legislative Section Editor Alan E. Reider, JD, followed those presentations with words of caution. He and others spoke during a session titled “Incorporating Presbyopic IOLs into Your Practice: Keys to Success.”

“Many have spoken about the tremendous opportunity from a practice and financial perspective,” he said. “But I am the lawyer, the bad guy, and I have to tell you to slow down a little bit and make sure you are doing it right. If you don’t, there are some potential problems that can confront you.”

The legal issues surrounding presbyopia-correcting IOLs are many, Mr. Reider said, but in his presentation he focused on the most significant matters, which deal mainly with the Medicare program and patients with cataracts.

CMS ruling

“The good news with respect to Medicare is that Medicare has taken a position on this,” Mr. Reider said.

Alan E. Reider

The Centers for Medicare and Medicaid Services issued a “somewhat unprecedented” ruling in May 2005 that essentially bifurcated the cataract procedure and the refractive procedure when a presbyopia-correcting IOL is implanted, he said.

“The bad news is that no one knows what it means, and that creates a serious problem from a legal and an enforcement perspective because we try to give you advice to make sure you stay the course, but that advice can be difficult to ascertain,” Mr. Reider said.

The ruling stated that Medicare will pay ASCs or hospitals for a presbyopia-correcting IOL as if it were a traditional IOL, and it will pay physicians as if they performed traditional cataract surgery, he said. Any noncovered services involved in the diagnostic workup and the surgery to implant the IOL, as well as the additional cost of the IOL itself, are the patient’s responsibility and must be separately billed to the patient.

Mr. Reider said it is not always clear what services are considered noncovered services, and that is where potential problems arise. He cautioned that surgeons may not bill the patient for services that are covered by Medicare as part of the cataract surgery procedure.

“Physicians may take into account additional physician work and resources for inserting, fitting and visual acuity testing of presbyopia-correcting IOLs,” Mr. Reider said. “Physicians may not charge patients for those services already included as part of the bundle for covered cataract surgery. If it is part of the bundle for cataract surgery, it is already part of the payment that Medicare is making to you. You may not charge a patient for those services. If you do, it is a violation of the Medicare assignment rules.”

Monitoring the IOL

To provide more guidance for physicians on the subtleties of billing for presbyopia-correcting IOLs, CMS published an explanatory document 3 months after its initial ruling on the subject. Mr. Reider quoted from that document, Medicare Learning Network Matters No. 3927:

“In determining the beneficiary’s liability, the facility and physician may take into account any additional work and resources required for insertion, fitting, vision acuity testing, and monitoring of the presbyopia-correcting IOL that exceeds the work and the resources attributable to insertion of a conventional IOL.”

One subtlety in this document’s language is the word “monitoring,” Mr. Reider noted.

He said he interprets “monitoring” to be part of examining and following up with the patient during the postoperative period, but Medicare is unclear whether the term applies to monitoring performed within the 90-day global fee period or only beyond that period.

Additional diagnostic testing and additional surgery time are billable to the patient, according to the ruling, Mr. Reider said.

“You can bill for additional time with respect to the insertion and fitting of the IOL. My question to you is, does it take more time? If it does, Medicare says, clearly, you may bill for it,” he said. “But if it does not take more time, you cannot bill for it.”

CMS allows partial Medicare coverage for toric IOLs

By Andy Moskowitz

The Centers for Medicare and Medicaid Services issued a ruling that allows Medicare beneficiaries undergoing cataract surgery to choose to receive astigmatism-correcting IOLs. As with the 2005 CMS ruling regarding presbyopia-correcting IOLs, Medicare will reimburse for the cost of a conventional IOL and conventional cataract surgery, and the beneficiary will be responsible for additional costs for the toric lenses and related services.

Conventional IOLs are covered under Medicare, but the treatment of pre-existing astigmatism is not, the CMS ruling points out. Medicare covers one pair of conventional eyeglasses or contact lenses after cataract surgery with insertion of an IOL.

“A single IOL that also corrects for pre-existing astigmatism may provide what is otherwise achieved by two separate items: an implantable conventional IOL, and surgical correction, eyeglasses or contact lenses,” the CMS ruling states. “Although astigmatism-correcting IOLs may serve the same function as eyeglasses or contact lenses furnished following cataract surgery, IOLs are neither eyeglasses nor contact lenses. Therefore, the astigmatism-correcting functionality of an IOL does not fall into the benefit category and is not covered. Any additional provider or physician services required to insert or monitor a patient receiving an astigmatism-correcting IOL are also not covered,” the ruling said.

The ruling, which took effect Jan. 22, follows a similar ruling in May 2005 that allowed partial Medicare coverage for presbyopia-correcting IOLs, according to a press release from the American Society of Cataract and Refractive Surgery.

As with that earlier ruling, the beneficiary is liable for charges that exceed those for a conventional IOL and for the physician services involved in the insertion of a conventional IOL, the ASCRS press release said.

“In determining the physician service charge, the physician may take into account the additional physician work and resources required for insertion, fitting and visual acuity testing of the astigmatism-correcting IOL compared to insertion of a conventional IOL,” the ruling said.

According to ASCRS, CMS officials said they will be issuing guidance to Medicare contractors in the coming weeks, including a list of which IOLs will be covered and proper coding procedures.

Comanagement billing

Another important issue that may contain pitfalls is billing for comanagement, Mr. Reider said.

He has been asked if a comanaging physician or optometrist can be paid more for comanaging a presbyopia-correcting IOL implant patient than for a traditional IOL implant patient.

“If the comanager performs no additional services than they do during the normal traditional IOL implant, then the answer is ‘no’ because there is no more work being performed,” Mr. Reider said. “On the other hand, if there are more intensive services otherwise provided or if the services are performed beyond the global period, then the answer is ‘yes,’ additional payment is warranted.”

If the physicians are using a percentage arrangement, Mr. Reider said to be sure the payment for comanagement is a reflection of the surgeon’s fee and not the fee for the diagnostic tests or the additional fee for the lens.

Off-label procedures

Presbyopia-correcting IOLs were approved by the U.S. Food and Drug Administration for use in cataract surgery, but it is “perfectly appropriate” to use them off-label for refractive lens exchange, he said.

However, if a physician performs lens exchange surgery on a patient without cataract as an off-label procedure, Mr. Reider said it is crucial to inform the patient that Medicare does not cover the procedure.

“If you do not and there is a bad result, you may wind up having your malpractice coverage denied, he said.

For more information:

Alan E. Reider, JD, can be reached at Arent Fox LLP, 1050 Connecticut Ave. NW, Washington, DC 20036; 202-857-6462; fax: 202-857-6395; e-mail: reider.alan@arentfox.com.

Reference:

Medicare Learning Network Matters No. 3927. Available at: www.cms.hhs.gov/MLNMattersArticles/downloads/MM3927.pdf.

Daniele Cruz is an OSN Staff Writer who covers all aspects of ophthalmology, focusing on optics, refraction and contact lenses.