Centers for Medicare & Medicaid Services (CMS), HHS.
This notice solicits interested parties to submit requests for review of the appropriateness of the payment amount for a particular intraocular lens furnished by an ambulatory surgical center.
Requests for review must be received at the address provided no later than 5 pm E.S.T. on June 27, 2005.
Mail requests for review (one original and three copies) to the Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: Michael Lyman, Mailstop C1-09-06, 7500 Security Blvd., Baltimore, Maryland 21244-1850.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Michael Lyman, (410) 786-6938.End Further Info End Preamble Start Supplemental Information
On October 31, 1994, the Social Security Act Amendments of 1994 (SSAA 1994) (Pub. L. 103-432) were enacted. Section 141(b)(1) of SSAA 1994 required us to develop and implement a process under which interested parties may request a review of the appropriateness of the payment amount for intraocular lenses (IOLs) furnished by ambulatory surgical centers (ASCs) under section 1833(i)(2)(A)(iii) of the Social Security Act (the Act) on the basis that those lenses constitute a class of new technology intraocular lenses (NTIOLs).
On June 16, 1999, we published a final rule in the Federal Register entitled “Adjustment in Payment Amounts for New Technology Intraocular Lenses Furnished by Ambulatory Surgical Centers” (64 FR 32198) which added subpart F to 42 CFR part 416. The June 16, 1999 final rule established a process for adjusting payment amounts for NTIOLs furnished by ambulatory surgical centers (ASCs); defined the terms relevant to the process; and established an initial flat rate payment adjustment of $50 for IOLs that we determine are NTIOLs. The payment adjustment applies for a 5-year period that begins when we recognize a payment adjustment for the first IOL in a new class of technology, as explained below. Any subsequent IOLs with the same characteristics as the first IOL recognized for a payment adjustment will receive the adjustment for the remainder of the 5-year period established by the first recognized NTIOL. After July 16, 2002, we have the option of changing the $50 adjustment amount through proposed and final rulemaking in connection with ambulatory surgical center services. We have opted not to change the adjustment amount for calendar year 2005 (CY 05).
Review Process for Establishing Classes of New Technology Intraocular Lenses (NTIOLs)
We will classify an IOL as a NTIOL if the lens meets the definition of a “new Start Printed Page 30732technology IOL” in 42 CFR 416.180, which incorporates section 141(b)(2) of SSAA 1994. Under that section, a “new technology IOL” is defined as “an IOL that CMS determines has been approved by the Food and Drug Administration (FDA) for use in labeling and advertising the IOL's claims of specific clinical advantages and superiority over existing IOLs with regard to reduced risk of intraoperative or postoperative complication or trauma, accelerated postoperative recovery, reduced induced astigmatism, improved postoperative visual acuity, more stable postoperative vision, or other comparable clinical advantages.”
We evaluate requests for the designation of an IOL as an NTIOL by doing the following:
(1) Publishing a public notice in the Federal Register that identifies the requirements and deadline for submitting a request for a review of the appropriateness of the payment amount for an IOL.
(2) Processing requests to review the appropriateness of the payment amount for an IOL.
(3) Compiling a list of the requests we receive that identify the IOL manufacturer, IOL model number under review, name of the requester, and a summary of the request for review of the appropriateness of the IOL payment amount.
(4) Publishing an annual public notice in the Federal Register that lists the requests and provides the public with 30 days to submit comments on the IOLs for which a review was requested.
(5) Reviewing the information submitted with the applicant's request for review, and requesting confirmation from the FDA about labeling applications that have been approved on the IOL model under review. We also request FDA's recommendations as to whether or not the IOL model submitted represents a new class of technology that sets it apart from other IOLs.
(6) Determining which lenses meet the criteria to qualify for the payment adjustment based on clinical data and evidence submitted for review, the FDA's analysis, public comments on the lenses, and other available information. NTIOL applicants should provide good evidence-based studies supporting the claimed clinical benefits. We are interested in receiving data showing functional clinical improvements, as opposed to improvements that have statistical significance without functional clinical significance.
(7) Designating a type of material or a predominant characteristic of an NTIOL that sets it apart from other IOLs to establish a new class.
(8) Publishing a notice in the Federal Register (within 90 days after we publish the notice identified in paragraph (4) of this section) that announces the IOLs that we have determined are “new technology” IOLs. These NTIOLs qualify for a $50 (or other amount that we may adopt through notice and comment rulemaking) payment adjustment for a 5-year period.
(9) Adjusting payments effective 30 days after the publication of the final notice announcing our determinations described in paragraph (8) of this section.
Who May Request a Review
As specified in § 416.190, any party who is able to furnish the information required in § 416.195 may request that we review the appropriateness of the payment amount provided under § 1833(i)(2)(A)(iii) of the Act for an IOL that, as claimed by the party, meets the definition of a new technology IOL in § 416.180.
Requests To Review
As specified in § 416.195(a), a request to review must include all of the following information:
- The name of the manufacturer, the model number, and the trade name of the IOL.
- A copy of the FDA's summary of the IOL's safety and effectiveness.
- A copy of the labeling claims of specific clinical advantages approved by the FDA for the IOL.
- A copy of the IOL's original FDA approval notification.
- Reports of modifications made after the original FDA approval.
- Other information that supports the requestor's claim (including clinical trials, case studies, journal articles, etc.).
Privileged or Confidential Information
To the extent that information received from an IOL manufacturer can reasonably be characterized as a trade secret or as privileged or confidential commercial or financial information, § 416.195(b) requires that we maintain the confidentiality of the information and protect it from disclosure not otherwise authorized or required by Federal law as allowed under Exemption 4 of the Freedom of Information Act (5 U.S.C. 552(b)(4)) and, with respect to trade secrets, the Trade Secrets Act (18 U.S.C. 1905). We recommend that the requestor clearly identify all information that is to be characterized as confidential.
Application of the Payment Adjustment
As provided in § 416.200, we recognize all IOL(s) that meet the definition of a new technology IOL for purposes of subpart F of part 416 as belonging to a class of NTIOLs for a period of 5 years effective from the date that we recognize the first NTIOL in that subset. Any IOL that we subsequently recognize as belonging to a new technology subset receives the new technology payment adjustment for the remainder of the 5-year period established with our recognition of the first NTIOL in the subset. Beginning 5 years after the effective date of our initial recognition of a new technology subset, the payment adjustment ceases for all IOLs that we have designated as belonging to that subset.
I. Provisions of This Notice
Under our rules at 42 CFR part 416, subpart F, we are soliciting requests for review of the appropriateness of the payment amount for IOLs furnished by an ASC. Requests for review must comply with our regulations at § 416.195 and be received at the address provided by the date specified in the DATES section of this notice. We will announce timely requests for review in a subsequent notice that will allow for public comment. Currently, if we determine that an intraocular lens meets the definition of a new technology intraocular lens, the lens will be eligible for a payment adjustment of $50.
II. Collection of Information Requirements
Because the requirements referenced in this notice will not affect 10 or more persons on an annual basis, this notice does not impose any information collection and record keeping requirements that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
III. Regulatory Impact Statement
We have examined the impact of this notice as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for Start Printed Page 30733major rules with economically significant effects ($100 million or more annually). We have determined that this notice is not a major rule because it merely solicits interested parties to submit requests for review of the appropriateness of the payment amount with regard to a particular IOL furnished by an ASC.
The RFA requires agencies to analyze options for small business regulatory relief. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and government agencies. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $6 million to 29 million or less in any 1 year period. Approximately 83 percent of ASCs generate revenues of $18.5 million or less and are considered small business entities according to the Small Business Administration. Although a substantial number of ASCs may be affected, we do not believe there will be significant economic impact on small businesses for the reason stated above.
In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area and has fewer than 100 beds. We have determined that this notice, which affects only ASCs, will have no affect on small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule that may result in an expenditure in any one year by State, local, or tribal governments, in the aggregate, or by the private sector, of $110 million. Because this notice only affects ASCs, we have determined that it will not have a consequential effect on the governments mentioned or on the private sector.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State, local, or tribal governments, preempts State law, or otherwise has Federalism implications. Because this notice merely solicits interested parties to submit requests for review of the appropriateness of the payment amount with regard to a particular IOL furnished by an ASC, we have determined that it does not have an economic impact on State, local, or tribal governments.
In accordance with the provisions of Executive Order 12866, this notice was not reviewed by the Office of Management and Budget.
(Catalog of Federal Domestic Assistance Program No. 93.773 Medicare—Hospital Insurance Program; and No. 93.774, Medicare—Supplementary Medical Insurance Program)Start Signature
Dated: April 21, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 05-10760 Filed 5-26-05; 8:45 am]
BILLING CODE 4120-01-P