A Medicare beneficiary learns a lesson

Outdated regulations prevent patient from choosing a premium high-tech IOL.

Issue: May 1, 2004

ByKevin J. Corcoran, COE, CPC, CPMA, FNAO

Telephone calls to my office usually come from doctors, lawyers, office managers and anyone connected with billing and filing claims. So I was surprised when my secretary announced that Dr. Abraham’s patient, Mr. Singh, wished to speak with me. Somehow, Mr. Singh had learned that I am the reimbursement consultant for eyeonics, the manufacturer of a new accommodative IOL, the Crystalens. He was seeking answers to his questions about possible Medicare coverage for his cataract surgery using this state-of-the-art IOL.

Patient background

During the first of many phone calls, Mr. Singh explained that he was a retired engineer, a Medicare beneficiary and had cataracts that were bothering him more and more over the past year or two.

Mr. Singh had just learned that the Food and Drug Administration had granted approval for the Crystalens in the United States. He wanted to know if Medicare would cover his cataract surgery with this IOL. Mr. Singh was exceptionally well informed. He knew that the Crystalens was different from other IOLs because it can provide the patient with distance, intermediate and near vision, thus freeing the patient from reliance on eyeglasses in most cases. He understood that clinical trials had been performed over many years, and he was familiar with the results. His ophthalmologist had not been allowed to enroll Mr. Singh in the clinical trials of the Crystalens because of some corneal dystrophy. Now that this IOL was approved, Mr. Singh wanted to proceed; he had waited patiently for this product and he felt it was the best choice for him.

In the mid 1970s, when I worked as an optician and contact lens technician, I grew fond of my elderly patients who relied on me for some of their eye care. Quickly, I dropped back into those old habits as I interviewed Mr. Singh about his history and vision requirements. I asked if his cataracts hindered him from performing the normal activities of daily living; he told me they did. I asked if new glasses helped; he said not very much. I asked if his ophthalmologist was willing to perform cataract surgery on him; he said yes, but that he was on a waiting list for the Crystalens. It seemed to me that Medicare would almost certainly cover his cataract surgery, but there was a problem.

The dilemma

The Crystalens is a premium IOL with a selling price of $800. Medicare regulations do not allow providers to balance bill beneficiaries for the extra cost associated with deluxe IOLs. In other Medicare regulations, Medicare does permit beneficiaries to select a deluxe frame, deluxe hearing aid or deluxe wheelchair and pay the difference between the purchase price and the Medicare allowable. Regrettably, that is not the case for IOLs. As I described these esoteric rules to Mr. Singh, he was a little disappointed but not deterred. He asked who he should contact at the Centers for Medicare and Medicaid Services to plead his case. I gave him CMS’s phone number at their headquarters in Baltimore. I told Mr. Singh that Andy Corley, CEO of eyeonics, and Stuart Cumming, MD, the inventor of the Crystalens, had visited CMS in the fourth quarter of 2003 to inform the agency about the Crystalens. They recommended that the old legacy rules about IOLs be updated to give Medicare beneficiaries the opportunity to choose this new IOL. The manufacturers did not ask CMS to pay for this deluxe IOL, merely permit beneficiaries to do so if they wished. After the meeting, we did not know how CMS would respond, but we hoped that they would appreciate why the old regulations no longer worked.

Stuck in limbo

A few weeks later, Mr. Singh called again. He gave me a list of CMS staffers he had spoken with about his case. Mr. Singh’s persistence was admirable, and he clearly understood what he was up against. The staffers had all been generous with their time but not particularly clear about how he might proceed. One staffer had suggested that he sign an Advance Beneficiary Notice (ABN).

At that point, I e-mailed Mr. Singh a copy of Corcoran Consulting Group’s Frequently Asked Questions about reimbursement for the Crystalens (Table). I explained that the purpose of an ABN is to inform a beneficiary when a service might not be covered by Medicare and give the beneficiary a chance to choose whether or not to proceed. In Mr. Singh’s case, there was little doubt that his cataract surgery would be covered. Mr. Singh volunteered that he was only too happy to pay an additional $650 for the Crystalens – he had calculated that Medicare would pay $150 of the cost of the lens, and he would cover the remainder for the IOL. Sadly, I told him Medicare’s current regulations would not permit his ophthalmologist to accept this commonsense offer. An ABN would not help – nothing less than a change of the regulations would fix the problem.

Technical challenges lie ahead for lens refilling

1.	How does Crystalens differ from other IOLs?	Crystalens is an accommodative IOL for adults with cataract who would benefit from near, intermediate and far vision without the use of spectacles. It moves in the eye to give a continuous full range of vision. This premium IOL is sold worldwide for the equivalent of about US $800.
2.	Does Medicare cover the Crystalens?	Sometimes. Like other IOLs, Medicare pays a hospital or ASC for an IOL as part of the facility fee. The procedure is covered by Medicare when medically necessary. The criteria for surgery include objective evidence of a cataract; reduced Snellen visual acuity; lifestyle complaints; good prognosis for improvement; and patient desires and can tolerate surgery. Your carrier’s local medical review policy (LMRP) will provide individual guidelines, and many include specific visual acuity or other requirements. Because of the cost of the Crystalens, hospitals and ASCs may be reluctant to purchase this lens for Medicare beneficiaries.
3.	How are hospitals paid for IOLs?	Hospitals are paid a facility fee that includes the IOL. The current national Medicare facility fee for cataract surgery with implantation of an IOL (66984) in a hospital outpatient department is $1,254. This amount varies according to local wage indices.
4.	How much does an ASC receive for an IOL?	An ASC is paid for the IOL as part of the facility fee. The national Medicare allowable facility fee for cataract surgery with implantation of an IOL (66984) is currently $973; this amount is adjusted by local wage indices. The Medicare allowable includes $150 as the calculated value of the IOL, but it is not separately identified in the payment or on the explanation of benefits.
5.	ASCs receive extra payment from Medicare for some IOLs. Does the Crystalens qualify?	No. The manufacturer of the Crystalens did not seek new technology IOL (NTIOL) status, so this lens is ineligible for an additional claim.
6.	Can a Medicare beneficiary pay the additional cost of this lens beyond what Medicare pays a hospital or ASC?	Not under the present Medicare program instructions to providers. Medicare regulations do not permit balance billing by the hospital or ASC. Patients may be held responsible only for the usual copayment and deductible amounts. Regulations also prohibit a beneficiary from purchasing the lens from the surgeon for later implantation. Some private insurers have indicated that the patient may pay for the “deluxe” portion of the Crystalens.
7.	How can a Medicare beneficiary obtain this lens?	A beneficiary may pay out-of-pocket for the Crystalens as part of a procedure not covered by Medicare. For example, if the beneficiary requests surgery for an incipient cataract that does not meet the medical necessity guidelines for Medicare payment, the cataract surgery would not be covered by Medicare. Both the surgeon and the facility should obtain an Advance Beneficiary Notice (ABN) documenting the beneficiary’s agreement to pay. Submit the claim with modifier GA appended to the CPT code for the procedure.
8.	Can I use 66982, complex cataract, to describe this procedure?	Not usually. Implantation of the Crystalens instead of another IOL does not require any special steps or unusual techniques, and does not qualify as complex surgery. Only if a procedure would otherwise be considered complex would it be appropriate to code 66982.
9.	Can I dissociate the covered and noncovered elements of this procedure by reporting two CPT codes?	No. MCM §5243.3 says “.… effective March 12, 1990, treat procedures 66983 and 66984 as a single procedure for payment purposes.” Do not unbundle the procedure into its component parts (e.g., 66850 + 66985).
10.	Does Medicare cover treatment of complications following a surgery that was not covered?	Yes. Medicare will cover visits, tests, and procedures that are medically necessary, even if the original procedure to which they are related was not covered.

Source: Corcoran Consulting Group

Not long after this call, I spoke with the billing office manager for Dr. Abraham. This competent individual instantly recognized our mutual acquaintance, Mr. Singh. She confirmed that this special patient was intelligent, persistent, and very well-informed. She also knew that Medicare’s regulations had boxed him into an untenable position. Mr. Singh could not have the Crystalens because no doctor, hospital or ASC could afford to absorb a financial loss on this premium IOL, and his generous offer to pay for the Crystalens was out of the question. Mr. Singh was stuck in limbo.

Time for change

What can we learn from this true story? Technology almost always advances faster than federal regulations. Certainly, that is the case for the Crystalens.

Interestingly, other third-party payers have no problem allowing their beneficiaries to select the Crystalens and pay for the IOL upgrade. So, Medicare beneficiaries remain on a waiting list for the Crystalens indefinitely, while other patients get the latest technology. So far, the agency has steadfastly refused to change their outdated regulations for IOLs to give Mr. Singh his choice.

Author’s note:

Other than the officials at eyeonics, all the names in this account have been changed to protect confidentiality; however, the people described in this article are real, and the story is genuine.

For Your Information:

Kevin J. Corcoran, COE, CPC, FNAO, is President, Corcoran Consulting Group. He can be reached at 1845 Business Center Dr., Ste. 108, San Bernardino, CA 92408; 800-399-6565; fax: 909-890-1333; e-mail: kcorcoran@corcoranccg.com; Web site: www.corcoranccg.com. Mr. Corcoran is the reimbursement consultant for eyeonics.

eyeonics, manufacturer of the Crystalens IOL, can be reached at 6 Journey, Ste. 125, Aliso Viejo, CA 92656; 866-393-6642; Web site: www.candcvision.com.