[Federal Register Volume 81, Number 93 (Friday, May 13, 2016)]
[Notices]
[Pages 29863-29865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11269]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1646-N]


Medicare Program; Public Meeting on July 18, 2016 Regarding New 
and Reconsidered Clinical Diagnostic Laboratory Test Codes for the 
Clinical Laboratory Fee Schedule for Calendar Year 2017

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) 2017. This meeting also provides a forum for those who 
submitted certain reconsideration requests regarding final 
determinations made last year on new test codes and for the public to 
provide comment on the requests.

DATES: 
    Meeting Date: The public meeting is scheduled for Monday, July 18, 
2016 from 9:00 a.m. to 3:00 p.m., Eastern Daylight Savings Time 
(E.D.T.)
    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 
[email protected] by July 1, 2016 E.D.T.
    Deadline for Submitting Requests for Special Accommodations: 
Requests for special accommodations must be received no later than 5:00 
p.m. on July 1, 2016 E.D.T.
    Deadline for Submission of Written Comments: We intend to publish 
our proposed determinations for new test codes and our preliminary 
determinations for reconsidered codes (as described below in section 
II. Format) for CY 2017 by early September 2016. Interested parties may 
submit written comments on these determinations by early October, 2016, 
to the address specified in the ADDRESSES section of this notice or 
electronically to Glenn McGuirk at [email protected] (the 
specific date for the publication of these determinations on the CMS 
Web site, as well as the deadline for submitting comments regarding 
these determinations will be published on the CMS Web site).

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 of the Department of Health and Human Services 
(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 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 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. 
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 any such test for which

[[Page 29864]]

establishment of a payment amount is being considered for a year and, 
on the same day that the list is made available, causes to have 
published a notice in the Federal Register 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 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) 2017 is posted on the CMS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html?redirect=/ClinicalLabFeeSched/. Section 
1833(h)(8)(B)(iii) of the Act requires that we convene the 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 bases of payment are used to establish payment amounts for new 
tests. The first basis, called ``crosswalking,'' is used when a new 
test code 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 billed amount, the local fee schedule 
amount, or the national limitation amount. (See Sec.  414.508(a).)
    The second basis called ``gapfilling,'' is used when no comparable 
existing test is available. When using this method, instructions are 
provided to each Part A and Part B Medicare Administrative Contractor 
(MAC) to determine a payment amount for its Part B geographic area) for 
use in the first year. The contractor-specific amounts are established 
for the new test code using the following sources of information, if 
available: (1) Charges for the test and routine discounts to charges; 
(2) resources required to perform the test; (3) payment amounts 
determined by other payers; and (4) charges, payment amounts, and 
resources required for other tests that may be comparable or otherwise 
relevant. (See Sec.  414.508(b) and Sec.  414.509 for more information 
regarding the gapfilling process.)
    Under section 1833(h)(8)(B)(iv) of the Act, the Secretary, taking 
into account the comments and recommendations (and accompanying data) 
received at the public meeting, develops and makes available to the 
public a list of 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. Under section 1833(h)(8)(B)(v) of the 
Act, taking into account the comments received on the proposed 
determinations during the public comment period, the Secretary then 
develops and makes available to the public a list of final 
determinations of final payment amounts for new test codes 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 the CMS Web 
site, the public may request reconsideration of the basis and amount of 
payment for a new test as set forth in Sec.  414.509. Pertinent to this 
notice, those requesting that CMS reconsider the basis for payment or, 
for crosswalking, reconsider the payment amount as set forth in Sec.  
414.509(a) and (b)(1) may present their reconsideration requests at the 
following year's public meeting provided that the requestor made the 
request to present at the public meeting in the written reconsideration 
request. For purposes of this notice, we refer to these codes as the 
``reconsidered codes.'' The public may comment on the reconsideration 
requests. (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.)

II. Format

    We are following our usual process, including an annual public 
meeting to determine the appropriate basis and payment amount for new 
and reconsidered test codes under the CLFS for CY 2017.
    This meeting is open to the public. 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 make 
recommendations for specific new and reconsidered test codes for the CY 
2017 CLFS.
    We note that the July 2016 Clinical Diagnostic Laboratory Tests 
(CDLT) Advisory Panel meeting and the laboratory public meeting will be 
a joint meeting this year, on July 18, 2016. The announcement for the 
CDLT Advisory Panel meeting will be included in a separate Federal 
Register notice.
    Because of time constraints, presentations must be brief, lasting 
no longer than 10 minutes, and must be accompanied by three written 
copies. In addition, presenters should 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 July 1, 2016. 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 [email protected]. For 
reconsidered and new test codes, presenters should address all of the 
following 5 items:
    (1) Reconsidered or new test codes and descriptor.
    (2) Test purpose and method.
    (3) Costs.
    (4) Charges.
    (5) Recommendation with rationale for one of the two bases 
(crosswalking or gapfilling) for determining payment for reconsidered 
and 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 
[email protected]. Presentations regarding reconsidered and new 
test codes that do not address the above five items for presenters may 
be considered incomplete and may not be considered by CMS when making a 
determination. However, we 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 intend to post 
our proposed determinations with respect to the appropriate basis for 
establishing a payment amount for each new test code and our 
preliminary determinations with respect to the reconsidered codes along 
with an explanation of the reasons for each determination, the data on 
which the determinations are based, and a request for public written 
comments on these determinations on the CMS Web site by early September 
2016. This Web site can be accessed at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html?redirect=/ClinicalLabFeeSched/. We also will include a 
summary of all comments received by August 8, 2016 (15 business

[[Page 29865]]

days after the meeting). Interested parties may submit written comments 
on the proposed determinations for new test codes or the preliminary 
determinations for reconsidered codes by early October, 2016, to the 
address specified in the ADDRESSES section of this notice or 
electronically to Glenn McGuirk at [email protected] (the 
specific date for the publication of the determinations on the CMS Web 
site, as well as the deadline for submitting comments regarding the 
determinations, will be published on the CMS Web site). Final 
determinations for new test codes to be included for payment on the 
CLFS for CY 2017 and reconsidered codes will be posted on the CMS Web 
site in November 2016, 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. The final 
determinations with respect to reconsidered codes are not subject to 
further reconsideration. With respect to the final determinations for 
new test codes, the public may request reconsideration of the basis and 
amount of payment as set forth in Sec.  414.509.

III. Registration Instructions

    The Division of Ambulatory Services in the CMS Center for Medicare 
is coordinating the public meeting registration. Beginning June 6, 
2016, registration may be completed on-line at the following Web site: 
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html?redirect=/ClinicalLabFeeSched/. All the 
following information must be submitted when registering:
     Name.
     Company name.
     Address.
     Telephone numbers.
     Email addresses.
    When registering, individuals who want to make a presentation must 
also specify, which new test codes 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 meeting. The deadline for registration is listed in the DATES 
section of this notice.

    Dated: April 11, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2016-11269 Filed 5-12-16; 8:45 am]
 BILLING CODE 4120-01-P