[Federal Register Volume 76, Number 38 (Friday, February 25, 2011)]
[Pages 10600-10602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-4295]



Centers for Medicare & Medicaid Services


Medicare Program; Public Meeting in Calendar Year 2011 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 (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.


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.

[[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 
    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 Sec.  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 Sec.  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 [email protected]. 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.
     Make a recommendation with rationale for one of two 
methods (cross-walking or gap-fill) for determining payment for new 
    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 
    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 Sec.  414.509. We also 
refer readers to the November 27, 2007 final rule (72 FR 66275 through 

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:
     Company name.
     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.

[[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 
    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 
     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]