[Federal Register Volume 75, Number 103 (Friday, May 28, 2010)]
[Notices]
[Pages 30041-30043]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-12458]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1340-N]


Medicare Program; Public Meeting in Calendar Year 2010 for New 
Clinical Laboratory Tests Payment Determinations

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

ACTION: Notice.

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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) 2011. 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 2011, 
which will be effective on January 1, 2011. 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 Thursday, July 
22, 2010 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 16, 2010.
    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 16, 2010.
    Deadline for Submission of Written Comments: Interested parties may 
submit written comments on the proposed payment determinations by 
September 24, 2010, to the address specified in the ADDRESSES section 
of this notice.

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. L. 108-173) added section 
1833(h)(8) of the Act. Section 1833(h)(8)(A) of the Act states that 
such new tests are 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 
methods for determining payment bases for new tests. Pertinent to this 
notice, section 1833(h)(8)(B)(i) and (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

[[Page 30042]]

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) 2011 will be published on our 
Web site at http://www.cms.hhs.gov/ClinicalLabFeeSched upon publication 
of this notice in the Federal Register.
    Two methods are used to establish payment amounts for new tests 
included in the CY 2011 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.
    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. 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 2011 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. Before the annual meeting on July 22, 2010, 
presentations must also be electronically submitted to CMS on or before 
July 2, 2010. Presentations should be sent via e-mail to Glenn McGuirk, 
at <a href="/cdn-cgi/l/email-protection#41062d242f2f6f0c22063428332a01222c326f2929326f262e37"><span class="__cf_email__" data-cfemail="87c0ebe2e9e9a9cae4c0f2eef5ecc7e4eaf4a9efeff4a9e0e8f1">[email protected]</span></a>. 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:
    <bullet> New test code(s) and descriptor;
    <bullet> Test purpose and method;
    <bullet> Costs;
    <bullet> Charges; and
    <bullet> 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 
five 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 2010 and can be accessed 
at http://www.cms.hhs.gov/ClinicalLabFeeSched.
    In addition, the summary on the CMS Web site will also include a 
list of all comments received by August 6, 2010 (15 days after the 
meeting). The summary will also display our proposed payment 
determinations, an explanation of the reasons for each determination, 
and the data on which the determinations are based. Interested parties 
may submit written comments on the proposed payment determinations by 
September 24, 2010, to the address specified in the ADDRESSES section 
of this notice. Final payment determinations will be posted on our Web 
site in October 2010. 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 payment 
determinations as set forth in 42 CFR 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 22, 2010, 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:
    <bullet> Name;
    <bullet> Company name;
    <bullet> Address;
    <bullet> Telephone number(s); and
    <bullet> 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.

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:
    <bullet> 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.
    <bullet> Interior and exterior inspection of vehicles (this 
includes engine and trunk inspection) at the entrance to the

[[Page 30043]]

grounds. Parking permits and instructions will be issued after the 
vehicle inspection.
    <bullet> 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: May 7, 2010.
Marilyn Tavenner,
Acting Administrator and Chief Operating Officer, Centers for Medicare 
& Medicaid Services.
[FR Doc. 2010-12458 Filed 5-27-10; 8:45 am]
BILLING CODE 4120-01-P


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