31560 Federal Register / Vol. 78, No. 101 / Friday, May 24, 2013 / Notices 

VII. Special Accommodations 

Individuals attending the meeting 

who are hearing or visually impaired 

and have special requirements or other 

special accommodations must include 

the request for these services during 

registration. 

VIII. Panel Recommendations and 

Discussions 

The panel’s recommendations at any 

panel meeting generally are not final 

until they have been reviewed and 

approved by the panel on the last day 

of the meeting, before the final 

adjournment. These recommendations 

will be posted to our Web site after the 

meeting. 

IX. 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 (44 

U.S.C. 35). 

(Catalog of Federal Domestic Assistance 

Program; No. 93.773 Medicare—Hospital 

Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: May 17, 2013. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2013–12466 Filed 5–23–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1451–N] 

Medicare Program; Public Meeting in 

Calendar Year 2013 for New Clinical 

Laboratory Test Payment 

Determinations 

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) 2014. 

DATES: Meeting Date: The public 

meeting is scheduled for Wednesday, 

July 10, 2013, from 9:00 a.m. to 3:00 

p.m., Eastern Daylight Savings Time 

(EDST). 

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 June 

28, 2013 (EDST). 

Deadline for Submitting Requests for 

Special Accommodations: Requests for 

special accommodations must be 

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

28, 2013 (EDST). 

Deadline for Submission of Written 

Comments: We intend to publish our 

proposed determinations for new and 

reconsidered codes for CY 2014 by early 

September. Interested parties may 

submit written comments on these 

proposed determinations by September 

27, 2013 (EDST), to the address 

specified in the ADDRESSES section of 

this notice or electronically to Glenn 

McGuirk at 

Glenn.McGuirk@cms.hhs.gov. 

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 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 November 

23, 2001 notice (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. 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 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) 2014 is posted on the 

CMS 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 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 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 for use in the 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 78, No. 101 / Friday, May 24, 2013 / Notices 31561 

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.) 

II. Format 

We are following our usual process, 

including an annual public meeting, to 

determine the appropriate basis and 

payment amounts for new test codes 

under the CLFS for CY 2014. 

This meeting to receive comments 

and recommendations (including 

accompanying data, 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 

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. 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 2014 

CLFS. 

Because of time constraints, 

presentations must be brief, lasting no 

longer than 10 minutes, and must be 

accompanied by 3 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 June 28, 2013. 

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 

Glenn.McGuirk@cms.hhs.gov. Presenters 

should address all of the following 

items: 

• New test code and descriptor. 

• Test purpose and method. 

• Costs. 

• Charges. 

• A recommendation, with rationale, 

for one of the two methods 

(crosswalking or gapfilling) 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 5 items may be considered 

incomplete and may not be considered 

by CMS when making a payment 

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 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 2013. This 

Web site can be accessed at http:// 

www.cms.hhs.gov/ClinicalLabFeeSched. 

We also will include a summary of all 

comments received by July 31, 2013 (15 

business days after the meeting). 

Interested parties may submit written 

comments on the proposed 

determinations by September 27, 2013, 

to the address specified in the 

ADDRESSES section of this notice or 

electronically to Glenn McGuirk at 

Glenn.McGuirk@cms.hhs.gov. Final 

determinations of the payment amounts 

for new test codes to be included for 

payment on the CLFS for CY 2014 will 

be posted on our Web site in November 

2013 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 our Web site, the public 

may request reconsideration of the basis 

for, and amount of payment for, a new 

test as set forth in § 414.509. (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.) 

III. Registration Instructions 

The Division of Ambulatory Services 

in the CMS Center for Medicare is 

coordinating the public meeting 

registration. Beginning June 10, 2013, 

registration may be completed on-line at 

the following Web address: http:// 

www.cms.hhs.gov/ClinicalLabFeeSched. 

The following information must be 

submitted when registering: 

• Name. 

• Company name. 

• Address. 

• Telephone number. 

• Email address. 

When registering, individuals who 

want to make a presentation must also 

specify which new test code 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 

mstockstill on DSK4VPTVN1PROD with NOTICES

31562 Federal Register / Vol. 78, No. 101 / Friday, May 24, 2013 / Notices 

meeting. The deadline for such 

registrations is listed in the DATES

section of this notice. 

VI. 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 (44 

U.S.C. 35). 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: May 3, 2013. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2013–12225 Filed 5–23–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with Section 

3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the Health 

Resources and Services Administration 

(HRSA) has submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB). 

Comments submitted during the first 

public review of this ICR will be 

provided to OMB. OMB will accept 

further comments from the public 

during the review and approval period. 

Information Collection Request Title: 

Rural Health Information Technology 

Network Development Program (OMB 

No. 0915–0354)—REVISION 

The purpose of the Rural Health 

Information Technology Network 

Development (RHITND) Program, 

authorized under the Public Health 

Service Act, Section 330A(f) (42 U.S.C. 

254c(f)) as amended by the Health Care 

Safety Net Amendments of 2002 (Pub. L. 

107–251), is to improve health care and 

support the adoption of health 

information technology (HIT) in rural 

America by providing targeted HIT 

support to rural health networks. HIT 

plays a significant role in the 

advancement of the Department of 

Health and Human Services’ (HHS) 

priority policies to improve health care 

delivery. Some of these priorities 

include: improving health care quality, 

safety, and efficiency; reducing 

disparities; engaging patients and 

families in managing their health; 

enhancing care coordination; improving 

population and public health; and 

ensuring adequate privacy and security 

of health information. 

The intent of RHITND is to support 

the adoption and use of electronic 

health records (EHR) in coordination 

with the ongoing HHS activities related 

to the Health Information Technology 

for Economic and Clinical Health 

(HITECH) Act, enacted as part of the 

American Recovery and Reinvestment 

Act of 2009 (Pub. L. 111–5). The 

HITECH Act provides HHS with the 

authority to establish programs to 

improve health care quality, safety, and 

efficiency through the promotion of 

health information technology, 

including EHR. 

For this program, performance 

measures were drafted to provide data 

useful to the program and to enable 

HRSA to provide aggregate program data 

required by Congress under the 

Government Performance and Results 

Act of 1993 (Pub. L. 103–62). These 

measures cover the principal topic areas 

of interest to the Office of Rural Health 

Policy, including: (a) Access to care; (b) 

the underinsured and uninsured; (c) 

workforce recruitment and retention; (d) 

sustainability; (e) health information 

technology; (f) network development; 

and (g) health related clinical measures. 

Several measures will be used for this 

program. These measures will speak to 

the Office’s progress toward meeting the 

goals set. 

A 60-day Federal Register Notice 

regarding this collection request was 

published in the Federal Register on 

March 7, 2013, (Vol. 78, No. 45; page. 

14804). There were no public 

comments. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install and utilize 

technology and systems for the purpose 

of collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS

Instrument Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

Rural Health Information Technology Network Development Program ................................................................... 41 1 41 5.68 232.88 

Total .............................................................................. 41 1 41 5.68 232.88 

ADDRESSES: Submit your comments to 

the desk officer for HRSA, either by 

email to 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–5806. Please direct all 

correspondence to the ‘‘attention of the 

desk officer for HRSA.’’ 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email the 

HRSA Information Collection Clearance 

Officer at paperwork@hrsa.gov or call 

(301) 443–1984. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information request collection title for 

reference. 

Deadline: Comments on this ICR 

should be received within 30 days of 

this notice. 

mstockstill on DSK4VPTVN1PROD with NOTICES