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###### Department of Health and Human Services

###### Centers for Medicare & Medicaid Services

          - [CMS-1347-N]

# AGENCY:

Centers for Medicare & Medicaid Services (CMS), HHS.

# ACTION:

Notice.

# SUMMARY:

This notice announces a public meeting to receive comments and recommendations (including accompanying data on which recommendations are based) from the public on the appropriate basis for establishing payment amounts for a specified list of new Clinical Procedural Terminology (CPT) codes for clinical laboratory tests in calendar year (CY) 2012. The meeting provides a forum for interested parties to make presentations and submit written comments on the new codes that will be included in Medicare's Clinical Laboratory Fee Schedule for CY 2012, which will be effective on January 1, 2012. The development of the codes for clinical laboratory tests is largely performed by the CPT Editorial Panel and will not be further discussed at the meeting.

# DATES:

*Meeting Date:*                         The public meeting is scheduled for Monday, July 18, 2011 from 9 a.m. to 2 p.m., Eastern Standard Time (E.S.T.).                    

*Deadline for Registration of Presenters:*                         All presenters for the public meeting must register by July 11, 2011.                    

*Deadline for Submitting Requests for Special Accommodations:*                         Requests for special accommodations must be received no later than 5 p.m., E.S.T. on July 11, 2011.                    

*Deadline for Submission of Written Comments:*                         Interested parties may submit written comments on the proposed payment determinations by September 23, 2011, to the address specified in the                         **ADDRESSES**                         section of this notice. We note that comments submitted should pertain to the payment basis for a specified list of new Clinical Procedural Terminology (CPT) codes.                    

# ADDRESSES:

The public meeting will be held in the main auditorium of the central building of the Centers for Medicare & Medicaid Services (CMS), 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

**FOR FURTHER INFORMATION CONTACT:**                         Glenn McGuirk, (410) 786-5723.                    

# SUPPLEMENTARY INFORMATION:

## I. Background

                    Section 531(b) of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554) requires the Secretary to establish procedures for coding and payment determinations for new clinical diagnostic laboratory tests under Part B of title XVIII of the Social Security Act (the Act) that permit public consultation in a manner consistent with the procedures established for implementing coding modifications for International Classification of Diseases (ICD-9-CM). The procedures and public meeting announced in this notice for new clinical laboratory tests are in accordance with the procedures published on November 23, 2001 in the                     **Federal Register**                     (66 FR 58743) to implement section 531(b) of BIPA.                 

                    Section 942(b) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub.                           ( print page 10601)                        L. 108-173) added section 1833(h)(8) of the Act. Section 1833(h)(8)(A) of the Act requires the Secretary to establish by regulation procedure for determining the basis for, and amount of, payment for any clinical diagnostic laboratory tests with respect to which a new or substantially revised Healthcare Common Procedures Coding System (HCPCS) code is assigned on or after January 1, 2005 (hereinafter referred to as, “new test” or “new clinical laboratory test”). Section 1833(h)(8)(B) of the Act sets forth the process for determining the basis for, and the amount of, payment for new tests. Pertinent to this notice, section 1833(h)(8)(B)(i) and section 1833(h)(8)(B)(ii) of the Act requires the Secretary to make available to the public a list that includes new tests for which establishment of a payment amount is being considered for a year and, on the same day that the list is made available, to publish in the                     **Federal Register**                     a notice of a meeting to receive comments and recommendations (including accompanying data on which recommendations are based) from the public on the appropriate basis for establishing payment amounts for new tests. Section 1833(h)(8)(B)(iii) of the Act requires that we convene a public meeting not less than 30 days after publication of the notice in the                     **Federal Register**                    . These requirements are codified at 42 CFR part 414, subpart G.                 

                    A newly created Current Procedural Terminology (CPT) code can represent either a refinement or modification of existing test methods, or a substantially new test method. The preliminary list of newly created CPT codes for calendar year (CY) 2012 will be published on our Web site as soon as possible at                     *http://www.cms.hhs.gov/​ClinicalLabFeeSched*.                

Two methods are used to establish payment amounts for new tests included in the CY 2012 Clinical Laboratory Fee Schedule. The first method called “cross-walking” is used when a new test is determined to be comparable to an existing test, multiple existing test codes, or a portion of an existing test code. The new test code is then assigned to the related existing local fee schedule amounts and the related existing national limitation amount. Payment for the new test is made at the lesser of the local fee schedule amount or the national limitation amount. We refer readers to § 414.508(a).

The second method called “gap-filling” is used when no comparable existing test is available. When using this method, instructions are provided to each Medicare carrier or Part A and Part B Medicare Administrative Contractor (MAC) to determine a payment amount for its geographic area(s) for use in the first year. These determinations are based on the following sources of information, if available: Charges for the test and routine discounts to charges; resources required to perform the test; payment amounts determined by other payers; and charges, payment amounts, and resources required for other tests that may be comparable or otherwise relevant. The carrier-specific amounts are used to establish a national limitation amount for the following years. We refer readers to § 414.508(b). For each new clinical laboratory test code, a determination must be made to either cross-walk or gap-fill.

## II. Format

This meeting to receive comments and recommendations (including accompanying data on which recommendations are based) on the appropriate payment basis for the specified list of new CPT codes is open to the public. The on-site check-in for visitors will be held from 8:30 a.m., E.S.T. to 9 a.m., E.S.T., followed by opening remarks. Registered persons from the public may discuss and recommend payment determinations for specific new test codes for the CY 2012 Clinical Laboratory Fee Schedule.

                    Presentations must be brief and accompanied by three written copies. CMS recommends that presenters make copies available for approximately 50 meeting participants, since CMS will not be providing additional copies. Presentations must also be electronically submitted to CMS on or before July 1, 2011. Presentations should be sent via e-mail to Glenn McGuirk, at                     *Glenn.McGuirk@cms.hhs.gov.*                     Once the presentations are collected, CMS will post them on the Clinical Laboratory Web site at                     *http://www.cms.hhs.gov/​ClinicalLabFeeSched.*                     Presenters should address the following items:                
    - New test code(s) and descriptor.
    - Test purpose and method.
    - Costs.
    - Charges.
    - Make a recommendation with rationale for one of two methods (cross-walking or gap-fill) for determining payment for new tests.

Additionally, the presenters should provide the data on which their recommendations are based. Presentations that do not address the above 5 items may be considered incomplete and may not be considered by CMS when making a payment determination. CMS may request missing information following the meeting in order to prevent a recommendation from being considered incomplete.

                    A summary of the proposed new test codes and the payment recommendations that are presented during the public meeting will be posted on the CMS Web site by early September 2011 and can be accessed at                     *http://www.cms.hhs.gov/​ClinicalLabFeeSched.*                     The summary on the CMS website will include a list of all comments received by August 8, 2011 (15 business days after the meeting). The summary will also include our proposed determinations with respect to the appropriate basis for establishing a payment amount for each code, an explanation of the reasons for each determination, the data on which the determinations are based, and a request for public written comments on the proposed determinations. Interested parties may submit written comments on the proposed payment determinations by September 23, 2011, to the address specified in the                     **ADDRESSES**                     section of this notice. Final payment determinations will be posted on our website in October 2011. Each determination will include a rationale, data on which the determination is based, and responses to comments and suggestions received from the public.                

After the final payment determinations have been posted on our Web site, the public may request reconsideration of the basis for and amount of payment for a new test as set forth in § 414.509. We also refer readers to the November 27, 2007 final rule (72 FR 66275 through 66280).

## III. Registration Instructions

                    The Division of Ambulatory Services in CMS is coordinating the public meeting registration. Beginning June 20, 2011, registration may be completed on-line at the following Web address:                     *http://www.cms.hhs.gov/​ClinicalLabFeeSched.*                     The following information must be submitted when registering:                
    - Name.
    - Company name.
    - Address.
    - Telephone number(s).
    - E-mail address(es).

                    When registering, individuals who want to make a presentation must also specify on which new clinical laboratory test code(s) they will be presenting comments. A confirmation will be sent upon receipt of the registration. Individuals must register by the date specified in the                     **DATES**                     section of this notice.                          ( print page 10602)    

## IV. Security, Building, and Parking Guidelines

The meeting will be held in a Federal government building; therefore, Federal security measures are applicable. In planning your arrival time, we recommend allowing additional time to clear security. It is suggested that you arrive at the CMS facility between 8:15 a.m and 8:30 a.m., E.S.T. so that you will be able to arrive promptly at the meeting by 9 a.m., E.S.T. Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. The public may not enter the building earlier than 8:15 a.m., E.S.T. (45 minutes before the convening of the meeting).

Security measures include the following:
    - Presentation of government-issued photographic identification to the Federal Protective Service or Guard Service personnel. Persons without proper identification may be denied access to the building.
    - Interior and exterior inspection of vehicles (this includes engine and trunk inspection) at the entrance to the grounds. Parking permits and instructions will be issued after the vehicle inspection.
    - Passing through a metal detector and inspection of items brought into the building.

We note that all items brought to CMS, whether personal or for the purpose of demonstration or to support a demonstration, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any personal belongings or items used for demonstration or to support a demonstration.

## V. Special Accommodations

                    Individuals attending the meeting who are hearing or visually impaired and have special requirements, or a condition that requires special assistance, should provide the information upon registering for the meeting. The deadline for such registrations is listed in the                     **DATES**                     section of this notice.                

## VI. Collection of Information Requirements

This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 35).

(Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program)

Dated: February 18, 2011.

Donald M. Berwick,

Administrator, Centers for Medicare & Medicaid Services.

[FR Doc. 2011-4295 Filed 2-24-11; 8:45 am]

BILLING CODE 4120-01-P