This article is more than 5 years old. Information may no longer be current.
Compliance issues relating to presbyopia-correcting IOLs
An expert in compliance issues answers frequently asked questions about billing for presbyopia-correcting IOLs. Part 1 in a series.
Click Here to Manage Email Alerts
![Compliance and the Law [logo]](/images/commonart/compliance_law.gif)
Over the past several months there has been significant activity in connection with Ruling 05-01 from the Centers for Medicare and Medicaid Services relating to Medicare coverage for presbyopia-correcting IOLs. While the ruling provides access to this new technology for ophthalmologists and their Medicare patients suffering from cataracts, it left unanswered many questions relating to its implementation. This is the first in a series of articles that will attempt to address some of the more frequently asked questions regarding presbyopia-correcting IOLs.
1. How are facilities and physicians reimbursed for implanting presbyopia-correcting IOLs in Medicare beneficiaries who suffer from cataracts?
Ruling 05-01 divides the implantation of a presbyopia-correcting IOL for a Medicare patient suffering from cataracts into two distinct procedures: a non-covered component and a covered component. Medicare will continue to reimburse both the physician and the facility for the covered component under the same standards as if a traditional IOL were implanted. To the extent that additional medically appropriate services are provided as a result of the implantation of a presbyopia-correcting IOL, the physician and the facility may charge the patient for those non-covered services.
2. What services may a physician bill to a patient?
|
Alan E. Reider |
Allison Weber-Shuren |
The ruling provides that a Medicare beneficiary is responsible for the facility and physician charges that relate exclusively to the correction of presbyopia. The ruling provides no specific guidance as to what services are encompassed by that directive, although it references the “additional physician work and resources for inserting, fitting, and visual acuity testing of presbyopia-correcting IOLs.” It appears that CMS anticipates that the physician community will be able to determine the appropriate services encompassed by this language.
3. How much may a physician charge a patient for the non-covered services provided?
Once again, the ruling provides no guidance other than the language cited above concerning the fact that physicians may take into account additional physician work and resources for inserting, fitting and visual acuity testing of presbyopia-correcting IOLs. Implicit in this statement is that the charges to the patient must reasonably reflect the value of the additional services performed. What is clear, however, is that physicians may not charge an amount for the non-covered services that is designed, in a way, to subsidize the reimbursement for Medicare covered services. Because the physician is billing Medicare for the covered cataract surgery procedure and because the Medicare program, either through the assignment provisions or the limiting charge rules, restricts physicians to reimbursement of certain predetermined amounts, physicians may not charge patients an amount in excess of the value of the non-covered services as a means to supplement the reimbursement for covered services.
4. What amount may a facility charge the patient in connection with the implantation of a presbyopia-correcting IOL?
The ruling provides language relating to facility charges, which is slightly different from that for physician charges. Specifically, the ruling states that a facility may charge the patient an additional facility charge “that exceeds the facility charge for insertion of a conventional IOL … [as well as] for resources required for fitting and vision acuity testing of a presbyopia-correcting IOL that exceeds the facility charges for resources furnished for a conventional IOL following cataract surgery.” In connection with this facility charge, it is anticipated that the facility charge will cover, at a minimum, an additional amount related to the higher cost of the presbyopia-correcting IOL as compared to the traditional IOL, as well as charges for additional services, as appropriate. Again, because hospitals and surgery centers accept assignment from Medicare for the covered facility fee, they may not charge the patient an amount for the non-covered service designed to subsidize reimbursement for the covered facility fee.
Next Column
In the January 1, 2006 issue, we will address the following 1) can a manufacturer sell a presbyopia-correcting IOL to a physician? 2)Who can the physician charge for the IOL and are there any limits? 3)If a physician purchases an IOL, are there any FDA or licensing laws that apply to the physician? 4) what are the marketing limitations which apply to promoting the IOL?
For Your Information:
- Alan E. Reider, JD, and Allison Weber-Shuren, JD, can be reached at Arent Fox PLLC, 1050 Connecticut Ave. NW, Washington, DC 20036; 202-857-6462; fax: 202-857-6395.