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[Federal Register Volume 78, Number 101 (Friday, May 24, 2013)]
[Notices]
[Pages 31560-31562]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-12225]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1451-N]

Medicare Program; Public Meeting in Calendar Year 2013 for New 
Clinical Laboratory Test 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 new or substantially revised Healthcare Common 
Procedure Coding System (HCPCS) codes being considered for Medicare 
payment under the clinical laboratory fee schedule (CLFS) for calendar 
year (CY) 2014.

DATES: Meeting Date: The public meeting is scheduled for Wednesday, 
July 10, 2013, from 9:00 a.m. to 3:00 p.m., Eastern Daylight Savings 
Time (EDST).
    Deadline for Registration of Presenters and Submission of 
Presentations: All presenters for the public meeting must register and 
submit their presentations electronically to Glenn McGuirk at 
Glenn.McGuirk@cms.hhs.gov by June 28, 2013 (EDST).
    Deadline for Submitting Requests for Special Accommodations: 
Requests for special accommodations must be received no later than 5:00 
p.m. on June 28, 2013 (EDST).
    Deadline for Submission of Written Comments: We intend to publish 
our proposed determinations for new and reconsidered codes for CY 2014 
by early September. Interested parties may submit written comments on 
these proposed determinations by September 27, 2013 (EDST), to the 
address specified in the ADDRESSES section of this notice or 
electronically to Glenn McGuirk at Glenn.McGuirk@cms.hhs.gov.

ADDRESSES: The public meeting will be held in the main auditorium of 
the Centers for Medicare & Medicaid Services (CMS), Central Building, 
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 tests are in accordance with 
the procedures published in the November 23, 2001 notice (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 requires the 
Secretary to establish by regulation procedures for determining the 
basis for, and amount of, payment for any clinical diagnostic 
laboratory test with respect to which a new or substantially revised 
Healthcare Common Procedure Coding System (HCPCS) code is assigned on 
or after January 1, 2005 (hereinafter referred to as ``new tests''). A 
code is considered to be substantially revised if ``there is a 
substantive change to the definition of the test or procedure to which 
the code applies (such as a new analyte or a new methodology for 
measuring an existing analyte-specific test).'' (See section 
1833(h)(8)(E)(ii) of the Act.)
    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. 
Section 1833(h)(8)(B)(i) and (ii) of the Act requires the Secretary to 
make available to the public a list that includes any such test for 
which establishment of a payment amount is being considered for a year 
and on the same day the list is made available, cause to have published 
in the Federal Register notice of a meeting to receive comments and 
recommendations (including accompanying data, which recommendations are 
based) from the public on the appropriate basis for establishing 
payment amounts for the tests on such list. This list of codes for 
which the establishment of a payment amount under the clinical 
laboratory fee schedule (CLFS) is being considered for calendar year 
(CY) 2014 is posted on the CMS Web site at http://www.cms.hhs.gov/ClinicalLabFeeSched.
    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.
    Two methods are used to establish payment amounts for new tests. 
The first method called ``crosswalking'' is used when a new test is 
determined to be comparable to an existing test code, multiple existing 
test codes, or a portion of an existing test code. The new test code is 
assigned the local fee schedule amounts and the national limitation 
amount of the existing test. Payment for the new test is made at the 
lesser of the local fee schedule amount or the national limitation 
amount (See 42 CFR 414.508(a)).
    The second method called ``gapfilling'' 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 
carrier geographic area for use in the

[[Page 31561]]

first year. The contractor-specific amounts are established for the new 
test code using 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. (See 42 CFR 
414.508(b) and 414.509 for more information regarding the gapfilling 
process.)

II. Format

    We are following our usual process, including an annual public 
meeting, to determine the appropriate basis and payment amounts for new 
test codes under the CLFS for CY 2014.
    This meeting to receive comments and recommendations (including 
accompanying data, which recommendations are based) on the appropriate 
payment basis for the new test codes contained on the preliminary list 
is open to the public. 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. The on-site check-in for 
visitors will be held from 8:30 a.m. to 9:00 a.m., followed by opening 
remarks. Registered persons from the public may discuss and recommend 
payment determinations for specific new test codes for the CY 2014 
CLFS.
    Because of time constraints, presentations must be brief, lasting 
no longer than 10 minutes, and must be accompanied by 3 written copies. 
In addition, CMS recommends that presenters make copies available for 
approximately 50 meeting participants, since CMS will not be providing 
additional copies. Written presentations must be electronically 
submitted to CMS on or before June 28, 2013. Presentation slots will be 
assigned on a first-come, first-served basis. In the event that there 
is not enough time for presentations by everyone who is interested in 
presenting, CMS will gladly accept written presentations from those who 
were unable to present due to time constraints. Presentations should be 
sent via email to Glenn McGuirk, at Glenn.McGuirk@cms.hhs.gov. 
Presenters should address all of the following items:
     New test code and descriptor.
     Test purpose and method.
     Costs.
     Charges.
     A recommendation, with rationale, for one of the two 
methods (crosswalking or gapfilling) for determining payment for new 
tests.
    Additionally, the presenters should provide the data on which their 
recommendations are based. Written presentations from the public 
meeting will be available upon request, via email, to Glenn McGuirk at 
Glenn.McGuirk@cms.hhs.gov. 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 to prevent a recommendation from 
being considered incomplete.
    Taking into account the comments and recommendations (and 
accompanying data) received at the public meeting, we will post our 
proposed determinations with respect to the appropriate basis for 
establishing a payment amount for each such 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 on the CMS Web site by early September 2013. This Web 
site can be accessed at http://www.cms.hhs.gov/ClinicalLabFeeSched. We 
also will include a summary of all comments received by July 31, 2013 
(15 business days after the meeting). Interested parties may submit 
written comments on the proposed determinations by September 27, 2013, 
to the address specified in the ADDRESSES section of this notice or 
electronically to Glenn McGuirk at Glenn.McGuirk@cms.hhs.gov. Final 
determinations of the payment amounts for new test codes to be included 
for payment on the CLFS for CY 2014 will be posted on our Web site in 
November 2013 along with the rationale for each determination, the data 
on which the determinations are based, and responses to comments and 
suggestions received from the public.
    After the final 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. (See the 
November 27, 2007 CY 2008 Physician Fee Schedule final rule with 
comment period (72 FR 66275 through 66280) for more information on 
these procedures.)

III. Registration Instructions

    The Division of Ambulatory Services in the CMS Center for Medicare 
is coordinating the public meeting registration. Beginning June 10, 
2013, 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.
     Email address.
    When registering, individuals who want to make a presentation must 
also specify which new test code 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., so that you will be able to arrive promptly at the 
meeting by 9:00 a.m. 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. 
(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 that information upon registering 
for the

[[Page 31562]]

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 3, 2013.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2013-12225 Filed 5-23-13; 8:45 am]
BILLING CODE 4120-01-P
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