16340 Federal Register / Vol. 79, No. 57 / Tuesday, March 25, 2014 / Notices 

—The procedures used to notify 

accredited MA organizations of 

deficiencies and to monitor the 

correction of those deficiencies; and 

—The procedures used to enforce 

compliance with accreditation 

requirements. 

• Detailed information about the 

individuals who perform surveys for the 

accreditation organization, including— 

++ The size and composition of 

accreditation survey teams for each type 

of plan reviewed as part of the 

accreditation process; 

++ The education and experience 

requirements surveyors must meet; 

++ The content and frequency of the 

in-service training provided to survey 

personnel; 

++ The evaluation systems used to 

monitor the performance of individual 

surveyors and survey teams; and 

++ The organization’s policies and 

practice with respect to the 

participation, in surveys or in the 

accreditation decision process by an 

individual who is professionally or 

financially affiliated with the entity 

being surveyed. 

• A description of the organization’s 

data management and analysis system 

with respect to its surveys and 

accreditation decisions, including the 

kinds of reports, tables, and other 

displays generated by that system. 

• A description of the organization’s 

procedures for responding to and 

investigating complaints against 

accredited organizations, including 

policies and procedures regarding 

coordination of these activities with 

appropriate licensing bodies and 

ombudsmen programs. 

• A description of the organization’s 

policies and procedures with respect to 

the withholding or removal of 

accreditation for failure to meet the 

accreditation organization’s standards or 

requirements, and other actions the 

organization takes in response to 

noncompliance with its standards and 

requirements. 

• A description of all types (for 

example, full, partial) and categories (for 

example, provisional, conditional, 

temporary) of accreditation offered by 

the organization, the duration of each 

type and category of accreditation and a 

statement identifying the types and 

categories that would serve as a basis for 

accreditation if CMS approves the 

accreditation organization. 

• A list of all currently accredited MA 

organizations and the type, category, 

and expiration date of the accreditation 

held by each of them. 

• A list of all full and partial 

accreditation surveys scheduled to be 

performed by the accreditation 

organization. 

• The name and address of each 

person with an ownership or control 

interest in the accreditation 

organization. 

• CMS will also consider NCQA’s 

past performance in the deeming 

program and results of recent deeming 

validation reviews, or look-behind 

audits conducted as part of continuing 

federal oversight of the deeming 

program under § 422.157(d). 

B. Notice Upon Completion of 

Evaluation 

Upon completion of our evaluation, 

including evaluation of comments 

received as a result of this notice, we 

will publish a notice in the Federal 

Register announcing the result of our 

evaluation. 

Section 1852(e)(4)(C) of the Act 

provides a statutory timetable to ensure 

that our review of deeming applications 

is conducted in a timely manner. The 

Act provides us with 210 calendar days 

after the date of receipt of an application 

to complete our survey activities and 

application review process. At the end 

of the 210 day period, we must publish 

an approval or denial of the application 

in the Federal Register. 

III. 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. 

IV. Response to Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

Dated: March 14, 2014. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2014–06520 Filed 3–24–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1610–N] 

Medicare Program; Public Meeting on 

July 14, 2014 Regarding New Clinical 

Diagnostic Laboratory Test Codes for 

the Clinical Laboratory Fee Schedule 

for Calendar Year 2015 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

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) 2015. 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 

14, 2014 from 9:00 a.m. to 3:00 p.m., 

Eastern Daylight Savings Time. 

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 July 3, 

2014. 

Deadline for Submitting Requests for 

Special Accommodations: Requests for 

special accommodations must be 

received no later than 5:00 p.m. on July 

3, 2014. 

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) for CY 2015 by 

early September. Interested parties may 

submit written comments on these 

determinations by early October, 2014 

to the address specified in the 

ADDRESSES section of this notice or 

electronically to Glenn McGuirk at 

Glenn.McGuirk@cms.hhs.gov (the 

specific date for the publication of these 

determinations on the CMS Web site, as 

well as the deadline for submitting 

comments regarding these 


emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 57 / Tuesday, March 25, 2014 / Notices 16341 

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 

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 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) 2015 is posted on the 

CMS Web site at http://www.cms.gov/

Medicare/Medicare-Fee-for-ServicePayment/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 

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 basis 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 areas) 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: 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.) 

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 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 during 

the public comment period, the 

Secretary 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 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 

and amount of payment for a new test 

as set forth in § 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 § 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 test codes 

under the CLFS for CY 2015. 

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 test codes for the CY 2015 

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 CMS will not be providing 

additional copies. Written presentations 

must be electronically submitted to 

CMS on or before July 3, 2014. 

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 


emcdonald on DSK67QTVN1PROD with NOTICES
16342 Federal Register / Vol. 79, No. 57 / Tuesday, March 25, 2014 / Notices 

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. For new test codes, 

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 bases (crosswalking 

or gapfilling) for determining payment 

for new tests. 

Additionally, the presenters should 

provide the data 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 regarding new test codes 

that do not address the above five items 

may be considered incomplete and may 

not be considered by CMS when making 

a 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 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 which 

the determinations are based, and a 

request for public written comments on 

these determinations on the CMS Web 

site by early September 2014. This Web 

site can be accessed at http://

www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/

ClinicalLabFeeSched/

index.html?redirect=/

ClinicalLabFeeSched/. We also will 

include a summary of all comments 

received by August 4, 2014 (15 business 

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, 2014, to the address 

specified in the ADDRESSES section of 

this notice or electronically to Glenn 

McGuirk at Glenn.McGuirk@

cms.hhs.gov (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 2015 and 

reconsidered codes will be posted on 

our Web site in November 2014, along 

with the rationale for each 

determination, the data 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 § 414.509. 

III. Registration Instructions 

The Division of Ambulatory Services 

in the CMS Center for Medicare is 

coordinating the public meeting 

registration. Beginning June 9, 2014, 

registration may be completed on-line at 

the following web address: http://

www.cms.gov/Medicare/Medicare-Feefor-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, setup, 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: March 14, 2014. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2014–06515 Filed 3–24–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3292–N] 

Medicare Program; Announcement of 

the Approval of the American 

Association for Laboratory 

Accreditation (A2LA) as an 

Accreditation Organization Under the 

Clinical Laboratory Improvement 

Amendments of 1988 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

application of the American Association 

for Laboratory Accreditation (A2LA) for 

approval as an accreditation 

organization for clinical laboratories 

under the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) program for all specialty and 

subspecialty areas under CLIA. We have 

determined that the A2LA meets or 


emcdonald on DSK67QTVN1PROD with NOTICES