JAN 2013

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

Issue link: https://digital.eyeworld.org/i/104833

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January 2013 Updated ASCRS/AAO joint advisory on femtosecond laser billing guidelines by David F. Chang, M.D., chief medical editor O n Jan. 30, 2012, ASCRS and AAO jointly issued a member advisory document to provide current guidelines for billing Medicare beneficiaries when using the femtosecond (FS) laser at the time of cataract surgery. Prompted by questions and concerns about when it is permissible to bill Medicare cataract patients for using this technology, the two societies sought expert regulatory and legal advice to determine what the legal safe harbors are based on published CMS regulations. This informational document summarized this advice, but was not a "position" paper on the clinical merits of the technology or how it should be reimbursed. Along with ASCRS•ASOA Director of Government Relations Nancey McCann, I was the ASCRS physician representative to the work group that included AAO medical director of health policy William Rich, M.D., and AAO medical director for governmental affairs Michael Repka, M.D. As the document was being developed, we also met with the American Refractive Surgery Council (ARSC), a cooperative working group made up of industry executives and ASCRS representatives that supports the global interests of the refractive surgery industry. In January 2012, ARSC formally met with CMS staff to clarify whether patients receiving premium refractive IOLs could be billed for a FS laser capsulotomy, on the grounds that a refractive benefit was provided. CMS disagreed with ARSC's interpretation and made it Summary of CMS billing policy for FS laser at the time of cataract surgery (for consenting Medicare patients who have been informed of the additional cost): Can be billed to the patient: • Astigmatic keratotomy regardless of the type of IOL (including monofocal) • Imaging services used for patients receiving a toric or presbyopia-correcting IOL Cannot be billed to the patient: • Cataract surgical steps with the FS laser, including capsulotomy, nuclear fragmentation, and phaco incision (regardless of IOL used) • Imaging services used for patients receiving a monofocal IOL clear that the steps of the cataract procedure, including the capsulotomy, were covered regardless of the technology or instrumentation used. ASCRS and AAO finalized the guidelines shortly after CMS made this key determination and had the informational document reviewed by CMS prior to its release. Since then, ARSC and CMS have continued to discuss potential reimcontinued on page 9 Guidelines for billing Medicare beneficiaries when using the femtosecond laser T he allowable Medicare reimbursement for cataract surgery does not change according to the surgical methods used. For example, the reimbursement is the same whether a cystotome or femtosecond (FS) laser makes the capsulotomy. Providers may not "balance bill" a Medicare patient or his or her secondary insurer for any additional fees to perform covered components of cataract surgery with an FS laser. Medicare Part B permits patients to be billed for additional services used specifically to implant premium refractive IOLs (presbyopia-correcting and toric) for medically necessary cataract. The surgeon and facility may charge the patient for premium refractive IOLs (presbyopia-correcting and toric) and the associated incremental professional and technical services. The patient, however, must be informed about, and consent to, the additional out-of-pocket costs in advance. Refractive lens exchange A refractive lens exchange is not medically necessary and therefore is not covered under Medicare Part B. The surgeon and the facility may bill the patient. Tiered pricing is allowed (e.g., additional fee for premium refractive IOL; additional fee to use the FS laser for lens removal steps), subject to properly documented informed consent. Medically necessary cataract extraction with a conventional IOL (no astigmatic keratotomy) Medicare Part B covers the cataract surgery and the implantation of a conventional IOL without regard to the technology used. A surgeon may use the FS laser for the cataract surgery, but neither the surgeon nor the facility may obtain additional reimbursement from either Medicare or the patient over and above the Medicare-allowable amount. Medically necessary cataract extraction with a premium refractive IOL (no astigmatic keratotomy) Neither the surgeon nor the facility should use the differential charge allowed for implantation of a premium refractive IOL to recover all or a portion of the costs of using the FS laser for cataract surgical steps. As set forth above, Medicare Part B covers the cataract surgery and the implantation of a conventional lens without regard to the technology used. Imaging performed as part of the FS laser surgery, which is necessary to implant premium refractive IOLs, is considered a non-covered service as long as these services are not used routinely when implanting conventional IOLs. A separate charge for the imaging is allowed with that consideration. However, as set forth above, Medicare Part B covers the cataract surgery without regard to the technology used. The Medicare beneficiary receiving a premium refractive IOL may be charged for non-covered services (such as imaging), but not for using the FS laser to perform covered steps of cataract surgery, such as the phaco incision, capsulotomy, and lens fragmentation. Medically necessary cataract surgery plus astigmatic keratotomy performed for refractive indications Medicare will cover medically necessary cataract surgery, but not concurrent correction of astigmatism performed for refractive indications. Medicare patients may be charged a fee for performing astigmatic keratotomy, assuming that they were informed about, and consented to, the non-covered charges in advance. Because astigmatic keratotomy for refractive indications is a non-covered service, a higher fee can be charged for performing it using the FS laser, instead of with a metal or diamond blade. As with premium IOLs, however, the patient should not be charged an additional amount to concurrently perform the cataract surgical steps with the FS laser. While most astigmatism treatment is not covered, Medicare does cover the treatment of large degrees of astigmatism that were the result of previous ocular surgery. Local coverage determinations may apply. In this situation, neither the surgeon nor the facility may obtain additional reimbursement from either Medicare or the patient over and above the Medicare allowable amount. Additional considerations Advertising: 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. Extra charges to the beneficiary can only be billed when a premium refractive IOL is used, and when the same imaging services are not used by the surgeon when implanting conventional IOLs. Statements that imply otherwise should be avoided. CMS has provided an example of what it considers a misleading representation: "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." Transparency: Patient-shared pricing should be discussed openly with the patient. Increased charges should be explained and documented. Note: The guidelines presented in this advisory represent the best effort of AAO and ASCRS, as of November 2012, to determine when Medicare and its beneficiaries can be billed for using the FS laser during cataract surgery. They are subject to modification based on any new regulations issued by the Centers for Medicare and Medicaid Services or its contractors. The organizations suggest that ophthalmologists seek additional guidance directly from their Medicare carriers for coverage determinations under Medicare Part C or through commercial carriers. www.AcrySofReSTOR.com CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician. INDICATIONS: The AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lens (IOL) is intended for primary implantation for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag. WARNING/PRECAUTION: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Physicians should target emmetropia, and ensure that IOL centration is achieved. Care should be taken to remove viscoelastic from the eye at the close of surgery. Some patients may experience visual disturbances and/or discomfort due to multifocality, especially under dim light conditions. Clinical studies with the AcrySof® ReSTOR® lens indicated that posterior capsule opacification (PCO), when present, developed earlier into clinically significant PCO. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon for this product informing them of possible risks and benefits associated with the AcrySof® IQ ReSTOR® IOLs. Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof® Natural IOL and normal color vision. The effect on vision of the AcrySof® Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize; do not store over 45° C; use only sterile irrigating solutions such as BSS® or BSS PLUS® Sterile Intraocular Irrigating Solutions. ATTENTION: Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions. © 2013 Novartis 1/13 RES12192JAD

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