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[Federal Register Volume 77, Number 103 (Tuesday, May 29, 2012)]
[Notices]
[Pages 31620-31622]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12982]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1441-N]

Medicare Program; Public Meeting in Calendar Year 2012 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 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) 2013.

DATES: Meeting Dates: The public meeting is scheduled for Monday, July 
16, 2012, from 9:00 a.m. to 5:00 p.m., and Tuesday, July 17, 2012, from 
9:00 a.m. to 12:00 p.m. All times are Eastern Daylight Savings Time.
    Deadline for Registration of Presenters: All presenters for the 
public meeting must register by July 6, 2012.
    Deadline for Written/Electronic Presentations: Written 
presentations must also be electronically submitted to on or before 
July 6, 2012.
    Deadline for Submitting Requests for Special Accommodations: 
Requests for special accommodations must be received no later than 5:00 
p.m., on July 6, 2012.
    Deadline for Submission of Written Comments: Interested parties may 
submit written comments on the proposed payment determinations by 
September 28, 2012, 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 tests are in accordance with 
the procedures published in the Federal Register on November 23, 2001 
(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 
HCPCS code is assigned on or after January 1, 2005'' (hereinafter 
referred to as, ``new test''). 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--(1) ``make available to the public (through an Internet Web site 
and other appropriate mechanisms)a list that includes any such test for 
which establishment of a payment amount is being considered for a 
year''; and (2) ``on the same day such list is made available, causes 
to have published in the Federal Register 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 the tests on such list.'' The list of 
codes for which the establishment of a payment amount under the CLFS is 
being considered for CY 2013 is posted on our 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, multiple existing test 
codes, or a portion of an existing test code. The new test code is 
assigned to 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 Sec.  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(s) for use in the first year. The carrier-
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. In the second year, the test code is paid at the 
national limitation amount, which is the median of the carrier-specific 
amounts. (See Sec.  414.508(b).)

II. Proposals in the CY 2013 Physician Fee Schedule Proposed Rule

    We are following our process to determine the appropriate basis and 
payment amount for new test codes under the CLFS for CY 2013. Some of 
these tests are molecular pathology tests. Stakeholders in the 
molecular pathology community continue to debate whether Medicare 
should pay for molecular pathology tests under the CLFS or the 
physician fee schedule (PFS). Medicare pays for clinical diagnostic 
laboratory tests through the CLFS and for services that ordinarily 
require physician work through the PFS. We believe that we would 
benefit from additional public comments on whether these tests are 
clinical diagnostic laboratory tests or whether they are services that 
should be paid under the PFS. Therefore, we intend to solicit public 
comments on this issue in the CY 2013 PFS proposed rule as well as

[[Page 31621]]

public comment on pricing policies for these tests under the PFS. We 
will make final decisions with respect to molecular pathology codes in 
the CY 2013 PFS final rule with comment period, and we will post on our 
Web site the final payment determinations for any codes paid under the 
CLFS in November.
    In addition, we intend to post our proposed determinations with 
respect to the appropriate basis for establishing a payment amount 
under the CLFS for each of these new test codes by September 28, 2012. 
If we later decide, based on comments received in response to the 
proposals set forth in the CY 2013 PFS proposed rule, that any of these 
codes are not clinical diagnostic laboratory test codes, we will post 
our final payment determinations only for the new test codes that we 
determine are clinical diagnostic laboratory test codes that will be 
paid under the CLFS. We intend to post these final payment 
determinations in November (at the same time as the CY 2013 PFS final 
rule with comment period is published).
    Comments and recommendations on whether these codes represent 
clinical diagnostic laboratory tests that should be paid under the CLFS 
or services that should be paid under the PFS should be provided in 
response to the proposals set forth in the CY 2013 PFS proposed rule. 
For purposes of this public meeting, comments and recommendations 
should be limited to the appropriate basis for establishing payment 
amounts for the new test codes under the CLFS for CY 2013.

III. Format

Meeting Overview

    This meeting to receive comments and recommendations (including 
accompanying data on 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 meeting provides a forum 
for interested parties to make presentations and submit written 
comments on new test codes. 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. Comments submitted should 
pertain to the payment basis for establishing a payment amount for the 
new test codes posted on the CMS Web site.

Meeting Agenda and Instructions for Presenters

    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 2013 CLFS.
    Because of time constraints, presentations must be brief, lasting 
no longer than 10 minutes, and must be accompanied by three written 
copies. In addition, CMS recommends that presenters make copies 
available for approximately 50 meeting participants, since additional 
copies will not be provided. Written presentations must also be 
electronically submitted to CMS on or before July 6, 2012. In the past, 
the meeting was held on a single day. This year's meeting will be held 
for an additional half day, extending the meeting to allow enough time 
for everyone who is interested in presenting information in person to 
be accommodated. However, 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, we 
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(s) and descriptor.
     Test purpose and method.
     Costs.
     Charges.
     A recommendation, with rationale, for one of the two 
methods (cross-walking or gap-filling) 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 
five items may be considered incomplete and may not be considered by 
CMS when making a payment determination. We may request missing 
information following the meeting in order 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 2012. This Web 
site can be accessed at http://www.cms.hhs.gov/ClinicalLabFeeSched. We 
also will include a summary of all comments received by August 6, 2012 
(15 business days after the meeting). Interested parties may submit 
written comments on the proposed payment determinations by September 
28, 2012, to the address specified in the ADDRESSES section of this 
notice. Final payment determinations on new test codes to be included 
for payment on the CLFS for CY 2013 will be posted on the CMS Web site 
in November 2012 along with the rationale for each such determination, 
the data on which the determinations are based, and responses to 
comments and suggestions received from the public.
    After the final payment determinations have been posted on the CMS 
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 final rule (72 FR 66275 through 66280).)

IV. Registration Instructions

    The Division of Ambulatory Services in CMS is coordinating the 
public meeting registration. Beginning June 18, 2012, registration may 
be completed on-line at the following web address: http://www.cms.hhs.gov/ClinicalLabFeeSched. All the following information must 
be submitted when registering:
     Name.
     Company name.
     Address.
     Telephone number(s).
     Email address(es).
    When registering, individuals who want to make a presentation must 
also specify on which new 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.

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. Security, Building, and Parking Guidelines

    The meeting will be held in a Federal government building; 
therefore, Federal

[[Page 31622]]

security measures are applicable. In planning your arrival to the CMS 
facility, we recommend allowing additional time to clear security. 
Attendees should arrive between 8:15 a.m. and 8:30 a.m., in order to be 
prompt for the 9:00 a.m. meeting. 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.

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

    Dated: May 22, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2012-12982 Filed 5-25-12; 8:45 am]
BILLING CODE 4120-01-P
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