[Federal Register Volume 84, Number 62 (Monday, April 1, 2019)]
[Notices]
[Pages 12257-12260]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06148]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1719-N]


Medicare Program; Public Meeting on June 24, 2019 Regarding New 
and Reconsidered Clinical Diagnostic Laboratory Test Codes for the 
Clinical Laboratory Fee Schedule for Calendar Year 2020

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

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recommendations (including 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) 
2020. 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 Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests 
(Advisory Panel on CDLTs) will participate in this CLFS Annual Public 
Meeting by gathering information and asking questions to presenters, 
and will hold its next public meeting on July 22 and 23, 2019. The 
public meeting for the Advisory Panel on CDLTs will focus on the 
discussion of and recommendations for test codes presented during the 
June 24, 2019 CLFS Annual Public Meeting. The Panel meeting also will 
address any other CY 2020 CLFS issues that are designated in the 
Panel's charter and specified on the meeting agenda.

DATES: 
    CLFS Annual Public Meeting Date: The meeting is scheduled for 
Monday, June 24, 2019 from 8:00 a.m. to 4:30 p.m., E.D.T.)
    Deadline for Registration of Presenters and Submission of 
Presentations: All presenters for the CLFS Annual Public Meeting must 
register and submit their presentations electronically to our CLFS 
dedicated email box at [email protected], by June 
10, 2019 at 5:00 p.m. E.D.T. Any presentations received after that date 
and time will not be included in the meeting.
    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 June 10, 2019.
    Deadline for Submission of Written Comments Related to the CLFS 
Annual Public Meeting: Written comments regarding the presentations 
must be received by July 8, 2019 at 5:00 p.m. E.D.T. (2 weeks after the 
meeting).
    Publication of Proposed Determinations: 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 2020 by early September 2019.
    Deadline for Submission of Written Comments Related to Proposed 
Determinations: Comments in response to the preliminary determinations 
will be due by early October 2019.
    Where to Submit Written Comments: 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 website, as well as the 
deadline for submitting comments regarding these determinations, will 
be published on the CMS website).

ADDRESSES: The CLFS Annual 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: Rasheeda Arthur, Ph.D., (410) 786-
3434. Submit all inquiries to the CLFS dedicated email box, 
[email protected] with the subject entitled ``CLFS 
Annual Public Meeting Inquiry.''

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. 
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, cause to have published in the Federal Register notice of a 
meeting to receive comments and recommendations (including 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 2020 will be posted on the Center for 
Medicare & Medicaid Services (CMS) website concurrent with the 
publication of this notice and may be updated prior to the CLFS Annual 
Public Meeting. The CLFS Annual Public Meeting list of codes can be 
found on the CMS website 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. The CLFS 
requirements regarding public consultation are codified at 42 CFR 
414.506.
    Two bases of payment are used to establish payment amounts for new 
clinical diagnostic laboratory tests (CDLTs). The first basis, called 
``crosswalking,'' is used when a new CDLT is determined to be 
comparable to an existing test, multiple existing test codes, or a 
portion of an existing test code. New CDLTs that were assigned new or 
substantially revised codes prior to January 1, 2018, are subject to 
provisions set forth under Sec.  414.508(a). For a new CDLT that is 
assigned a new or significantly revised code on or after January 1, 
2018, CMS assigns to the new CDLT code the payment amount established 
under Sec.  414.507 of the comparable existing CDLT. Payment for

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the new CDLT code is made at the payment amount established under Sec.  
414.507. (See Sec.  414.508(b)(1)).
    The second basis called ``gapfilling,'' is used when no comparable 
existing CDLT is available. When using this method, instructions are 
provided to each 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 on or after January 1, 2018, the MAC-
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; (4) charges, payment 
amounts, and resources required for other tests that may be comparable 
or otherwise relevant; and (5) other criteria that CMS determines 
appropriate. In the second year, the test code is paid at the median of 
the MAC-specific amounts. (See Sec.  414.508(b)(2)).
    Under section 1833(h)(8)(B)(iv) of the Act and Sec.  414.506(d)(1), 
CMS, taking into account the comments and recommendations (and 
accompanying data) received at the CLFS Annual 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 and Sec.  414.506(d)(2), taking into 
account the comments received on the proposed determinations during the 
public comment period, CMS then develops and makes available to the 
public a list of final determinations of payment amounts for tests 
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.
    Section 216(a) of the Protecting Access to Medicare Act of 2014 
(PAMA) (Pub. L. 113-93) added section 1834A to the Act. The statute 
requires extensive revisions to the Medicare payment, coding, and 
coverage requirements for CDLTs. Pertinent to this notice, section 
1834A(c)(3) of the Act requires the Secretary to consider 
recommendations from the expert outside advisory panel established 
under section 1834A(f)(1) of the Act when determining payment using 
crosswalking or gapfilling processes. In addition, section 1834A(c)(4) 
of the Act requires the Secretary to make available to the public an 
explanation of the payment rates for the new test codes, including an 
explanation of how the gapfilling criteria and panel recommendations 
are applied. These requirements are codified in Sec.  414.506(d) and 
(e).
    After the final determinations have been posted on the CMS website, 
the public may request reconsideration of the basis and amount of 
payment for a new CDLT 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 
Annual Public Meeting provided the requestor made the request to 
present at the CLFS Annual 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 CY 2008 Physician Fee Schedule final 
rule with comment period published in the Federal Register on November 
27, 2007 (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 2020.
    This meeting is open to the public. The on-site check-in for 
visitors will be held from 7:30 a.m. to 8:00 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 
2020 CLFS.
    As stated in the SUMMARY section of this notice, the Advisory Panel 
on CDLTs will participate in the CLFS Annual Public Meeting on June 24, 
2019 by gathering information and asking questions to presenters, and 
will hold its own public meeting on July 22 and 23, 2019, to discuss 
matters of the Panel and make recommendations regarding the test codes 
presented at the CLFS Annual Public Meeting. The announcement for the 
Advisory Panel on CDLTs meeting is included in a separate Federal 
Register notice.
    Due to 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 June 10, 2019. 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 Annual Public Meeting to obtain 
electronic versions of the presentations. Requests for electronic 
copies of the presentations after the public meeting should be sent via 
email to our CLFS dedicated email box, noted above.
    Presenters are required to submit all presentations using a 
standard PowerPoint template that is available on the CMS website, 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, 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. 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 CLFS Annual 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

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for public written comments on these determinations on the CMS website 
by early September 2019. This website can be accessed at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html?redirect=/ClinicalLabFeeSched/. 
Interested parties may submit written comments on the preliminary 
determinations for new and reconsidered codes by early October 2019, 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 website, as well as the 
deadline for submitting comments regarding the determinations, will be 
published on the CMS website). Final determinations for new test codes 
to be included for payment on the CLFS for CY 2020 and reconsidered 
codes will be posted on the CMS website in November 2019, 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 Annual Public Meeting registration. Beginning 
April 8, 2019, and ending June 10, 2019, 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 the new test codes on which 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. Registration is only required for individuals attending 
the meeting in person.
    If not attending the CLFS Annual 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 CLFS Annual Public Meeting agenda, which will be posted on the 
CMS website 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 campus and parking facilities 
between 7:00 a.m. and 8:00 a.m. E.D.T., so that you will be able to 
arrive promptly at the meeting by 8:00 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. We note that the public may 
not enter the CMS building earlier than 7:15 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.

VI. Collection of Information Requirements

    This document does not impose information collection requirements, 
that is, reporting, recordkeeping or third-party disclosure 
requirements. Consequently, there is no need for review by the Office 
of Management and Budget under the authority of the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501 et seq.).

    Dated: March 15, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-06148 Filed 3-29-19; 8:45 am]
 BILLING CODE 4120-01-P