AMERICAN SOCIETY OF CATARACT AND REFRACTIVE SURGERY

OUTPATIENT OPHTHALMIC SURGERY SOCIETY

via Electronic Mail October 10, 2006

 

Mark McClellan, M.D., Administrator Centers for Medicare and Medicaid Services

Department of Health and Human Services

Attention: CMS-1506-P

Baltimore, MD 21244-8012

 

RE: CMS-1506-P; CMS-4125-P (Medicare Program; Hospital Outpatient Prospective Payment System and CY 2007 Payment Rates; Ambulatory Surgical Center List of Covered Procedures; Ambulatory Surgical Center Payments System and CY2008 Payment Rates; Medicare Administrative Contractors; and Reporting Hospital Quality Data for FY 2008 Inpatient PPS Annual Payment Update Program—HCAHPS Survey, SCIP, and Mortality)

 

Dear Dr. McClellan:

The Outpatient Ophthalmic Surgery Society (OOSS) is a professional medical association representing over 1000 ophthalmologists, nurses, and administrators who specialize in providing high-quality ophthalmic surgical services in cost-effective outpatient surgical environments, particularly ambulatory surgical centers (ASC).

The American Society of Cataract and Refractive Surgery (ASCRS) is a medical specialty society representing over 9,500 ophthalmologists in the United States and abroad who share a particular interest in cataract and refractive surgical care. ASCRS members perform the vast majority of cataract procedures performed annually in ASCs and hospitals.

On behalf of OOSS and ASCRS, we are taking this opportunity to comment on the 2007 proposed Ambulatory Surgical Center Covered Procedures List, the New Technology Intraocular Lens (NTIOL) proposal, and elements of the Hospital Outpatient Prospective Payment System (HOPPS) rule, all of which were published in the August 23, 2006 Federal Register. We will provide further extensive comments on the FY 2008 ASC payment proposal, with respect to which comments are due on November 6, 2006.

New Technology Intraocular Lenses (NTIOL)

OOSS and ASCRS, as representatives of surgeons who operate in high-quality, lower-cost, and patient-friendly operative environments, are dedicated to ensuring that ophthalmologists are able to offer to our patients state-of-the-art vision-restoring technology, including intraocular lenses (IOL). Our organizations were integrally involved in the enactment of legislation and the promulgation of regulations to implement the NTIOL benefit that provides ASCs with an additional payment enabling ophthalmic surgeons to implant IOLs with advanced and innovative characteristics that offer patients improved surgical outcomes and quality of life. Through the NTIOL program, our patients have been afforded access to the Allergan AMO Array Multifocal lens, the STAAR Surgical Elastic Ultraviolet-Absorbing Silicone Posterior Chamber IOL with Toric Optic, and the AMO Tecnis and Alcon Acrysof IQ lenses, both of which reduce spherical aberration. Generally speaking, we support the changes CMS is proposing to modify the processes through the agency notifies the public regarding NTIOL approvals and revises the content of applications requesting NTIOL status. We do offer the following recommendations:

• OOSS and ASCRS agree that requiring additional information within the application for NTIOL status should enable CMS to more comprehensively assess the clinical benefits of applicants’ NTIOL products, facilitating the adoption of appropriate designations and payment adjustments. However, application of these requirements by CMS should be guided by promoting, not inhibiting, access of patients to new technology.

• The enabling NTIOL regulation established a $50 additional payment for implantation of an NTIOL during cataract surgery. We believe that, in light of advances in cataract surgery technique and the availability of exceptional IOL products whose research, development and production costs exceed those of conventional lenses, the regulations should permit sponsors of new lens technologies to apply for payment adjustments that are greater than $50. Unless NTIOL payments adequately account for inflation in surgery centers’ IOL acquisition costs, our patients will be denied optimal potential surgical outcomes. The proposed modifications to the NTIOL application and payment adjustment process should enable the agency to complete the requisite evaluation of an NTIOL’s characteristics and costs. We would suggest that manufacturers of new lens products be afforded the opportunity of presenting to CMS dual submissions for agency review: (1) a request for approval of the applicant IOL to be approved for NTIOL status; and, (2) a request, based upon the submission of appropriate documentation, for the particular class of NTIOL to be eligible for a higher payment adjustment. In order to ensure maximum patient access to NTIOLs, the approval of a higher payment for a new NTIOL class, or a new lens within an existing class, should not affect the status of, or beneficiary access to, existing classes or lenses paid for at the standard $50 rate.

• We are not recommending herein that an NTIOL category be extended beyond the five-year period embodied within the original regulation. However, it is imperative that, consistent with the HOPPS pass-through process, the base ASC facility payments for cataract surgery be upwardly adjusted after the five-year period, to appropriately reflect the adoption rates of these more costly lenses within the ASC setting.

• We support the agency’s objective to codify the NTIOL review process to render it consistent with the annual notice and comment period that is proposed to be applied to the annual establishment of new payment rates for ASC services. We appreciate CMS’ need for ample time to review NTIOL applications and support, where absolutely necessary, the extension of the NTIOL review period from 30 to 90 days. However, as discussed below, we would expect that NTIOL sponsor/agency contact during the course of new product development and study should mitigate the need for CMS to avail itself of review time in excess of 30 days. Regardless of the review time, upon completion of application review, patients should have immediate access to NTIOL products in the ASC. It appears that the agency is proposing that NTIOL application approvals be “batched” into one annual payment rule and effective date. To ensure timely beneficiary access to approved NTIOLs, our organizations believe that the agency should implement a process similar to the new technology pass-through system applicable to hospital outpatient surgical services under which newly designated NTIOLs are available to patients upon CMS approval throughout the course of the year.

• As noted above, it is imperative that patients enjoy expeditious access to advances in IOL technology; this is contingent upon manufacturers of these products being afforded timely access to all NTIOL submission requirements and a meaningful agency review of their applications. CMS is proposing to post NTIOL requirements on its website. We are concerned that lags in website updates may compromise an NTIOL sponsor’s ability to design and implement requisite studies and generate data that will adequately support timely consideration and approval of an application. We would recommend that the proposed rule be reflective of CMS’ practice of meeting with manufacturers throughout the study design and application processes to ensure that the agency’s demands for documentation of an IOL’s benefits are fully understood by applicants and are met upon submission of the application. Alternatively, the agency should review an NTIOL application under the criteria published on the CMS website at the time of submission. We believe any changes to the rule or criteria should be made only under notice and comment rulemaking as announced in the Federal Register.

CY 2007 Update to List of Covered Procedures

In our comments submitted to CMS with respect to the 2005 procedures list update, we objected to CMS’ decision not to include CPT Code 66990 (use of ophthalmic endoscope) on the list of approved procedures. We reiterate our objection today with respect to the proposed rule. 66990 is an add-on code for a specific endoscopic surgical approach and does constitute surgery. It is reported on conjunction with many ophthalmic surgical services that are permitted and reimbursed in the ASC environment. Failure to include the code will result in these services being performed in the hospital inpatient or outpatient environments, at greater cost to the Medicare program and inconvenience to the beneficiary. We recommend that 66990 be added to the ASC list.

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Thank you for providing our organizations with the opportunity to present our comments on these important issues. We look forward to providing more extensive comments next month with respect to the proposed 2008 ASC payment system. Should you have any questions, contact our Washington representatives: Michael Romansky, Washington Counsel, OOSS at mromansky@ooss.org  or at 301.332.6474; or

Emily Graham, RHIT, CCS-P, CPC, ASCRS Manager of Regulatory Affairs at egraham@ascrs.org  or 703.591.2220.

 

Sincerely,

Samuel Masket, MD

President, ASCRS

 

William Fishkind, MD

President, OOSS