[Federal Register Volume 74, Number 98 (Friday, May 22, 2009)]
[Notices]
[Pages 24017-24019]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-12030]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1407-N]


Medicare Program; Public Meeting in Calendar Year 2009 for New 
Clinical Laboratory Tests Payment Determinations

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

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice announces a public meeting to receive comments and 
recommendations (and 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) 2010. The meeting 
provides a forum for interested parties to make oral presentations and 
submit written comments on the new codes that will be included in 
Medicare's Clinical Laboratory Fee Schedule for CY 2010, which will be 
effective on January 1, 2010. 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 Centers for Medicare & Medicaid 
Services (CMS) meeting.

DATES: Meeting Date: The public meeting is scheduled for Tuesday, July 
14, 2009 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 9, 2009.
    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 9, 2009, the final day of registration.
    Deadline for Submission of Written Comments: Interested parties may 
submit written comments on the proposed payment determinations by 
September 18, 2009, 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) 
required 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)(B) of the Act, which sets forth the methods for determining 
payment bases for new tests. Section 1833(h)(8)(A) of the Act states 
that new tests are any clinical diagnostic laboratory tests with 
respect to which a new or substantially revised health care common 
procedures code (HCPCS) is assigned on or after January 1, 2005 
(hereinafter referred to as, ``new test'' or ``new clinical laboratory 
test''). 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 and recommendations (and 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 
either represent 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) 2010 will be published on our 
Web site at http://www.cms.hhs.gov/ClinicalLabFeeSched when this notice 
is published in the Federal Register.
    Two methods are used to establish payment amounts for new tests

[[Page 24018]]

included in the CY 2010 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 
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 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 2010 Clinical Laboratory Fee Schedule.
    Oral presentations must be brief and must be accompanied by three 
written copies. Presenters may also make copies available for 
approximately 50 meeting participants. Presenters should address the 
following:
     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 
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 our Web site by early September 2009 and can be accessed at 
http://www.cms.hhs.gov/ClinicalLabFeeSched.
    In addition, the summary will list other comments received by July 
29, 2009 (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 18, 2009, to the address specified in the 
ADDRESSES section of this notice. Final payment determinations will be 
posted on our Web site in October 2009. 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. See also (72 FR 66275 
through 66280).

III. Registration Instructions

    The Division of Ambulatory Services in CMS is coordinating the 
public meeting registration. Beginning June 15, 2009, 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.

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 registration 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)


[[Page 24019]]


    Dated: May 14, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare & Medicaid Services.
 [FR Doc. E9-12030 Filed 5-21-09; 8:45 am]
BILLING CODE 4120-01-P