[Federal Register Volume 82, Number 115 (Friday, June 16, 2017)]
[Notices]
[Pages 27708-27710]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12544]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1668-N]


Medicare Program; Public Meeting on July 31, 2017 Regarding New 
and Reconsidered Clinical Diagnostic Laboratory Test Codes for the 
Clinical Laboratory Fee Schedule for Calendar Year 2018

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) 2018. 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.
    The Clinical Diagnostic Laboratory Test (CDLT) Advisory Panel will 
participate in this meeting by gathering information and asking 
questions to presenters on July 31, 2017, and will hold a public 
meeting on August 1, 2017 to discuss matters of the Panel and make 
recommendations regarding the test codes presented at the CLFS public 
meeting. In the event the CLFS public meeting needs to extend to August 
1, 2017, the CDLT Advisory Panel will convene its public meeting 
immediately following the CLFS public meeting, rather than starting at 
9:00 a.m. Eastern Daylight Savings Time (E.D.T.) as currently planned.

DATES: Meeting Date: The CLFS public meeting is scheduled for Monday, 
July 31, 2017 from 9:00 a.m. to 5:00 p.m., E.D.T. If needed, the 
meeting will resume on Tuesday, August 1, 2017, beginning at 9:00 a.m. 
E.D.T.
    Deadline for Registration of Presenters and Submission of 
Presentations: All presenters for the CLFS public meeting must register 
and submit their presentations electronically to our CLFS dedicated 
email box, [email protected], by July 14, 2017 at 
5:00 p.m. E.D.T.
    Deadline for Submitting Requests for Special Accommodations: 
Requests for special accommodations must be received no later than 5:00 
p.m. E.D.T. on July 14, 2017.
    Deadline for Submission of Written Comments: Written comments 
regarding the presentations must be received by August 11, 2017 at 5:00 
p.m. E.D.T. (10 days after the meeting). We intend to publish our 
proposed determinations for new test codes and our preliminary 
determinations for reconsidered codes (as described later in this 
notice in section II. ``Format'') for CY 2018 by early September 2017. 
Comments in response to the preliminary determinations will be due by 
early October 2017. Interested parties should submit all written 
comments on presentations and preliminary determinations to the address 
specified in the ADDRESSES section of this notice or electronically to 
our CLFS dedicated email box, [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 CLFS 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) 
required 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) (now, ICD-10-CM). The procedures 
and clinical laboratory fee schedule (CLFS) 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 for 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 and 
42 CFR 414.502).
    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 
prior to Calendar Year (CY) 2018 (Beginning January 1, 2018, payments 
for tests will be set in accordance with the methodologies specified in 
section 1834A of the Act.). Pertinent to this notice, sections 
1833(h)(8)(B)(i) and (ii) of the Act require 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 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 CLFS is 
being considered for CY 2018 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

[[Page 27709]]

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. 
For a new CDLT that is assigned a new or significantly revised code 
before January 1, 2018, 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 amounts, or the national limitation 
amount. (See Sec.  414.508(a)(1)).
    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. In the first year, for a new CDLT that is 
assigned a new or substantially revised code before January 1, 2018, 
the contractor-specific amounts are established 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. In the second year, the test code is 
paid at the national limitation amount. (See Sec.  414.508(a)(2)).
    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 CLFS 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 
the payment amount as set forth in Sec.  414.509(a) and (b), may 
present their reconsideration requests at the following year's CLFS 
public meeting provided the requestor made the request to present at 
the CLFS 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 codes under the CLFS for CY 2018.
    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. E.D.T., followed by 
opening remarks. Registered persons from the public may discuss and 
make recommendations for specific new and reconsidered codes for the CY 
2018 CLFS.
    As stated in the SUMMARY section of this notice, the Clinical 
Diagnostic Laboratory Test (CDLT) Advisory Panel will participate in 
the CLFS public meeting by gathering information and asking questions 
to presenters on July 31, 2017, and will hold a public meeting on 
August 1, 2017 to discuss matters of the Panel and make recommendations 
regarding the test codes presented at the CLFS public meeting. The 
announcement for the CDLT Advisory Panel meeting is 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 14, 2017. Presentation slots will be 
assigned on a first-come, first-served basis. In the event there is not 
enough time for presentations by everyone who is interested in 
presenting, CMS will accept written presentations from those who were 
unable to present due to time constraints. Presentations should be sent 
via email to our CLFS dedicated email box, 
[email protected]. In addition, individuals may 
also submit requests after the CLFS public meeting to obtain electronic 
versions of the presentations. Requests for electronic copies of the 
presentations post public meeting should be sent via email to our CLFS 
dedicated email box, noted above.
    We are standardizing the presentation format for the CLFS public 
meeting. As a result, this year we are requiring presenters to submit 
all presentations using a standard PowerPoint template that is 
available on the CMS Web site, at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings.html, under the ``Meeting Notice and 
Agenda'' heading.
    For reconsidered and new codes, presenters should address all of 
the following five items:
    (1) Reconsidered or new 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. 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. We may, however, 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 CLFS 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 
2017. This Web site can be accessed at http://www.cms.gov/Medicare/
Medicare-Fee-for-Service-

[[Page 27710]]

Payment/ClinicalLabFeeSched/index.html?redirect=/ClinicalLabFeeSched/. 
Interested parties may submit written comments on the preliminary 
determinations for new and reconsidered codes by early October 2017, to 
the address specified in the ADDRESSES section of this notice or 
electronically to our CLFS dedicated email box, 
[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 2018 and reconsidered 
codes will be posted on the CMS Web site in November 2017, 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 CLFS public meeting registration. Beginning June 
19, 2017, and ending July 14, 2017, registration may be completed on-
line at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html?redirect=/ClinicalLabFeeSched/. On this 
Web page, under the heading ``Meeting Notice, Registration and 
Agenda,'' you will find a link entitled ``Register for CLFS Annual 
Meeting.'' Click this link and enter the required information. 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.
    If not attending the CLFS public meeting in person, the public may 
view the meeting via webcast or listen by teleconference. During the 
public meeting, webcasting is accessible online at http://cms.gov/live. 
Teleconference dial-in information will appear on the final Panel 
meeting agenda, which will be posted on the CMS Web site when available 
at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html?redirect=/ClinicalLabFeeSched/.

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. 
We suggest that you arrive at the CMS facility between 8:15 a.m. and 
8:30 a.m. E.D.T., so that you will be able to arrive promptly at the 
meeting by 9:00 a.m. E.D.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.D.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 that information upon registering 
for the meeting. The deadline for registration is listed in the DATES 
section of this notice.

    Dated: June 2, 2017.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2017-12544 Filed 6-15-17; 8:45 am]
 BILLING CODE 4120-01-P