Federal Register / Vol. 78, No. 230 / Friday, November 29, 2013 / Proposed Rules 71555 

Environmental Protection Agency, EPA 

New England Regional Office, 5 Post 

Office Square—Suite 100, (Mail code 

OEP05–2), Boston, MA 02109—3912. 

5. Hand Delivery or Courier. Deliver 

your comments to: Anne Arnold, 

Manager, Air Quality Planning Unit, 

Office of Ecosystem Protection, U.S. 

Environmental Protection Agency, EPA 

New England Regional Office, 5 Post 

Office Square—Suite 100, (Mail code 

OEP05–2), Boston, MA 02109—3912. 

Such deliveries are only accepted 

during the Regional Office’s normal 

hours of operation. The Regional 

Office’s official hours of business are 

Monday through Friday, 8:30 a.m. to 

4:30 p.m., excluding legal holidays. 

Please see the direct final rule which 

is located in the Rules Section of this 

Federal Register for detailed 

instructions on how to submit 

comments. 

FOR FURTHER INFORMATION CONTACT: 

Donald O. Cooke, Air Quality Unit, U.S. 

Environmental Protection Agency, EPA 

New England Regional Office, 5 Post 

Office Square—Suite 100, (Mail code 

OEP05–2), Boston, MA 02109–3912, 

telephone number (617) 918–1668, fax 

number (617) 918–0668, email 

cooke.donald@epa.gov. 

SUPPLEMENTARY INFORMATION: In the 

Final Rules Section of this Federal 

Register, EPA is approving the State’s 

SIP submittal as a direct final rule 

without prior proposal because the 

Agency views this as a noncontroversial 

submittal and anticipates no adverse 

comments. A detailed rationale for the 

approval is set forth in the direct final 

rule. If no adverse comments are 

received in response to this action rule, 

no further activity is contemplated. If 

EPA receives adverse comments, the 

direct final rule will be withdrawn and 

all public comments received will be 

addressed in a subsequent final rule 

based on this proposed rule. EPA will 

not institute a second comment period. 

Any parties interested in commenting 

on this action should do so at this time. 

Please note that if EPA receives adverse 

comment on an amendment, paragraph, 

or section of this rule and if that 

provision may be severed from the 

remainder of the rule, EPA may adopt 

as final those provisions of the rule that 

are not the subject of an adverse 

comment. 

For additional information, see the 

direct final rule which is located in the 

Rules Section of this Federal Register. 

Dated: November 8, 2013. 

Michael Kenyon, 

Acting Regional Administrator, EPA New 

England. 

[FR Doc. 2013–28530 Filed 11–27–13; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 412 

[CMS–1604–N] 

Medicare Program; Town Hall Meeting 

on FY 2015 Applications for New 

Medical Services and Technology AddOn Payments 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of meeting. 

SUMMARY: This notice announces a 

Town Hall meeting in accordance with 

the Social Security Act (the Act) to 

discuss fiscal year (FY) 2015 

applications for add-on payments for 

new medical services and technologies 

under the hospital inpatient prospective 

payment system (IPPS). Interested 

parties are invited to this meeting to 

present their comments, 

recommendations, and data regarding 

whether the FY 2015 new medical 

services and technologies applications 

meet the substantial clinical 

improvement criterion. 

DATES: Meeting Date: The Town Hall 

Meeting announced in this notice will 

be held on Wednesday, February 12, 

2014. The Town Hall Meeting will begin 

at 9:00 a.m. Eastern Standard Time 

(e.s.t.) and check-in will begin at 8:30 

a.m. e.s.t. Deadline for Registration for 

Participants (not Presenting) at the 

Town Hall Meeting and Submitting 

Requests for Special Accommodations: 

The deadline to register to attend the 

Town Hall Meeting and requests for 

special accommodations must be 

received no later than 5:00 p.m., e.s.t. on 

Tuesday, January 28, 2014. 

Deadline for Registration of Presenters 

of the Town Hall Meeting: The deadline 

to register to present at the Town Hall 

Meeting must be received no later than 

5:00 p.m., e.s.t. on Tuesday, January 21, 

2014. 

Deadline for Submission of Agenda 

Item(s) or Written Comments for the 

Town Hall Meeting: Written comments 

and agenda items for discussion at the 

Town Hall Meeting, including agenda 

items by presenters, must be received by 

Tuesday, January 21, 2014. In addition 

to materials submitted for discussion at 

the Town Hall Meeting, individuals may 

submit other written comments after the 

Town Hall Meeting, as specified in the 

ADDRESSES section of this notice, on 

whether the service or technology 

represents a substantial clinical 

improvement. These comments must be 

received by Wednesday, March 5, 2014, 

for consideration in the FY 2015 IPPS 

proposed rule. 

ADDRESSES: Meeting Location: The 

Town Hall Meeting will be held in the 

main Auditorium in the central building 

of the Centers for Medicare and 

Medicaid Services located at 7500 

Security Boulevard, Baltimore, MD 

21244–1850. 

In addition, we are providing two 

alternatives to attending the meeting in 

person—(1) there will be an open tollfree phone line to call into the Town 

Hall Meeting; or (2) participants may 

view and participate in the Town Hall 

Meeting via live stream technology and/ 

or webinar. Information on these 

options are discussed in section II.B. of 

this notice. 

Registration and Special 

Accommodations: Individuals wishing 

to participate in the meeting must 

register by following the on-line 

registration instructions located in 

section III. of this notice or by 

contacting staff listed in the FOR

FURTHER INFORMATION CONTACT section of 

this notice. Individuals who need 

special accommodations should contact 

staff listed in the FOR FURTHER

INFORMATION CONTACT section of this 

notice. 

Submission of Agenda Item(s) or 

Written Comments for the Town Hall 

Meeting: Each presenter must submit an 

agenda item(s) regarding whether a FY 

2015 application meets the substantial 

clinical improvement criterion. Agenda 

items, written comments, questions or 

other statements must not exceed three 

single-spaced typed pages and may be 

sent via email to newtech@cms.hhs.gov. 

FOR FURTHER INFORMATION CONTACT: 

Michael Treitel, (410) 786–4552, 

michael.treitel@cms.hhs.gov, or Celeste 

Beauregard, (410) 786–8102, 

celeste.beauregard@cms.hhs.gov or 

Carol Schwartz, (410) 786–0576, 

carol.schwartz@cms.hhs.gov. 

Alternatively, you may forward your 

requests via email to newtech@

cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 


sroberts on DSK5SPTVN1PROD with PROPOSALS
71556 Federal Register / Vol. 78, No. 230 / Friday, November 29, 2013 / Proposed Rules 

I. Background on the Add-On Payments 

for New Medical Services and 

Technologies under the IPPS 

Sections 1886(d)(5)(K) and (L) of the 

Social Security Act (the Act) require the 

Secretary to establish a process of 

identifying and ensuring adequate 

payments to acute care hospitals for 

new medical services and technologies 

under Medicare. Effective for discharges 

beginning on or after October 1, 2001, 

section 1886(d)(5)(K)(i) of the Act 

requires the Secretary to establish (after 

notice and opportunity for public 

comment) a mechanism to recognize the 

costs of new services and technologies 

under the hospital inpatient prospective 

payment system (IPPS). In addition, 

section 1886(d)(5)(K)(vi) of the Act 

specifies that a medical service or 

technology will be considered ‘‘new’’ if 

it meets criteria established by the 

Secretary (after notice and opportunity 

for public comment). (See the fiscal year 

(FY) 2002 IPPS proposed rule (66 FR 

22693, May 4, 2001) and final rule (66 

FR 46912, September 7, 2001) for a more 

detailed discussion.) 

In the September 7, 2001 final rule (66 

FR 46914), we noted that we evaluated 

a request for special payment for a new 

medical service or technology against 

the following criteria in order to 

determine if the new technology meets 

the substantial clinical improvement 

requirement: 

• The device offers a treatment option 

for a patient population unresponsive 

to, or ineligible for, currently available 

treatments. 

• The device offers the ability to 

diagnose a medical condition in a 

patient population where that medical 

condition is currently undetectable or 

offers the ability to diagnose a medical 

condition earlier in a patient population 

than allowed by currently available 

methods. There must also be evidence 

that use of the device to make a 

diagnosis affects the management of the 

patient. 

• Use of the device significantly 

improves clinical outcomes for a patient 

population as compared to currently 

available treatments. Some examples of 

outcomes that are frequently evaluated 

in studies of medical devices are the 

following: 

++ Reduced mortality rate with use of 

the device. 

++ Reduced rate of device-related 

complications. 

++ Decreased rate of subsequent 

diagnostic or therapeutic interventions 

(for example, due to reduced rate of 

recurrence of the disease process). 

++ Decreased number of future 

hospitalizations or physician visits. 

++ More rapid beneficial resolution 

of the disease process treatment because 

of the use of the device. 

++ Decreased pain, bleeding or other 

quantifiable symptoms. 

++ Reduced recovery time. 

In addition, we indicated that the 

requester is required to submit evidence 

that the technology meets one or more 

of these criteria. 

Section 503 of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA) 

amended section 1886(d)(5)(K)(viii) of 

the Act to revise the process for 

evaluating new medical services and 

technology applications by requiring the 

Secretary to do the following: 

• Provide for public input regarding 

whether a new service or technology 

represents an advance in medical 

technology that substantially improves 

the diagnosis or treatment of Medicare 

beneficiaries before publication of a 

proposed rule. 

• Make public and periodically 

update a list of all the services and 

technologies for which an application is 

pending. 

• Accept comments, 

recommendations, and data from the 

public regarding whether the service or 

technology represents a substantial 

improvement. 

• Provide for a meeting at which 

organizations representing hospitals, 

physicians, manufacturers and any 

other interested party may present 

comments, recommendations, and data 

to the clinical staff of CMS as to whether 

the service or technology represents a 

substantial improvement before 

publication of a proposed rule. 

The opinions and alternatives 

provided during this meeting will assist 

us as we evaluate the new medical 

services and technology applications for 

FY 2015. In addition, they will help us 

to evaluate our policy on the IPPS new 

technology add-on payment process 

before the publication of the FY 2015 

IPPS proposed rule. 

II. Town Hall Meeting and Conference 

Calling/Live Streaming Information 

A. Format of the Town Hall Meeting 

As noted in section I. of this notice, 

we are required to provide for a meeting 

at which organizations representing 

hospitals, physicians, manufacturers 

and any other interested party may 

present comments, recommendations, 

and data to the clinical staff of CMS 

concerning whether the service or 

technology represents a substantial 

clinical improvement. This meeting will 

allow for a discussion of the substantial 

clinical improvement criteria on each of 

the FY 2015 new medical services and 

technology add-on payment 

applications. Information regarding the 

applications can be found on our Web 

site at http://www.cms.gov/Medicare/

Medicare-Fee-for-Service-Payment/

AcuteInpatientPPS/newtech.html. 

The majority of the meeting will be 

reserved for presentations of comments, 

recommendations, and data from 

registered presenters. The time for each 

presenter’s comments will be 

approximately 10 to 15 minutes and 

will be based on the number of 

registered presenters. Presenters will be 

scheduled to speak in the order in 

which they register and grouped by new 

technology applicant. Therefore, 

individuals who would like to present 

must register and submit their agenda 

item(s) via email to newtech@

cms.hhs.gov by the date specified in the 

DATES section of this notice. 

In addition, written comments will 

also be accepted and presented at the 

meeting if they are received via email to 

newtech@cms.hhs.gov by the date 

specified in the DATES section of this 

notice. Written comments may also be 

submitted after the meeting for our 

consideration. If the comments are to be 

considered before the publication of the 

proposed rule, the comments must be 

received via email to newtech@

cms.hhs.gov by the date specified in the 

DATES section of this notice. 

B. Conference Call, Live Streaming, and 

Webinar Information 

For participants who cannot attend 

the Town Hall Meeting in person, an 

open toll-free phone line, (877) 267– 

1577, has been made available. The 

meeting number is ‘‘999 396 992.’’ 

Also, there will be an option to view 

and participate in the Town Hall 

Meeting via live streaming technology 

and/or a webinar. Information on the 

option to participate via live streaming 

technology and/or a webinar will be 

provided through an upcoming listserv 

notice and posted on the New 

Technology Web site at http://

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

AcuteInpatientPPS/newtech.html. 

Continue to check the Web site for 

updates. 

Disclaimer: We cannot guarantee 

reliability for live streaming technology 

and/or a webinar. 

III. Registration Instructions 

The Division of Acute Care in CMS is 

coordinating the meeting registration for 

the Town Hall Meeting on substantial 

clinical improvement. While there is no 

registration fee, individuals planning to 


sroberts on DSK5SPTVN1PROD with PROPOSALS
Federal Register / Vol. 78, No. 230 / Friday, November 29, 2013 / Proposed Rules 71557 

attend the Town Hall Meeting in person 

must register to attend. 

Registration may be completed online at the following web address: 

http://www.cms.gov/Medicare/

Medicare-Fee-for-Service-Payment/

AcuteInpatientPPS/newtech.html. 

Select the link at the bottom of the page 

‘‘Register to Attend the New Technology 

Town Hall Meeting’’. After completing 

the registration, on-line registrants 

should print the confirmation page(s) 

and bring it with them to the meeting(s). 

If you are unable to register on-line, 

you may register by sending an email to 

newtech@cms.hhs.gov. Please include 

your name, address, telephone number, 

email address and fax number. If seating 

capacity has been reached, you will be 

notified that the meeting has reached 

capacity. 

IV. Security, Building, and Parking 

Guidelines 

Because these meetings will be 

located on Federal property, for security 

reasons, any persons wishing to attend 

these meetings must register by the date 

specified in the DATES section of this 

notice. Please allow sufficient time to go 

through the security checkpoints. It is 

suggested that you arrive at 7500 

Security Boulevard no later than 8:30 

a.m. e.s.t. if you are attending the Town 

Hall Meeting in person so that you will 

be able to arrive promptly for the 

meeting. 

Security measures include the 

following: 

• Presentation of government-issued 

photographic identification to the 

Federal Protective Service or Guard 

Service personnel. 

• 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. 

Note: Individuals who are not registered in 

advance will not be permitted to enter the 

building and will be unable to attend the 

meeting in person. The public may not enter 

the building earlier than 45 minutes prior to 

the convening of the meeting(s). 

All visitors must be escorted in areas 

other than the lower and first floor 

levels in the Central Building. Seating 

capacity is limited to the first 250 

registrants. 

Authority: Section 503 of Pub. L. 108–173. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: November 5, 2013. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2013–28518 Filed 11–27–13; 8:45 am] 

BILLING CODE 4120–01–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 73 

[DA 13–2105; MB Docket No. 13–250; RM– 

11705] 

Radio Broadcasting Services; 

Tohatchi, New Mexico 

AGENCY: Federal Communications 

Commission. 

ACTION: Proposed rule. 

SUMMARY: This document requests 

comments on a petition for rulemaking 

filed by the Navajo Nation to amend the 

FM Table of Allotments, Section 

73.202(b) of the Commission’s Rules, by 

allotting FM Channel 268C2, Tohatchi, 

New Mexico, as a first local service 

under the Tribal Priority. A staff 

engineering analysis indicates that 

Channel 268C2 can be allotted to 

Tohatchi consistent with the minimum 

distance separation requirements of the 

Rules without the imposition of a site 

restriction. The reference coordinates 

are 35–54–37 NL and 108–46–26 WL. 

DATES: Comments must be filed on or 

before December 23, 2013, and reply 

comments on or before January 7, 2014. 

ADDRESSES: Secretary, Federal 

Communications Commission, 445 12th 

Street SW., Washington, DC 20554. In 

addition to filing comments with the 

FCC, interested parties should serve the 

petitioner as follows: Lauren Lynch 

Flick, Esq., Pillsbury, Winthrop, Shaw, 

& Pittman LLP, 2300 N Street NW., 

Washington, DC 20037. 

FOR FURTHER INFORMATION CONTACT: 

Rolanda F. Smith, Media Bureau, (202) 

418–2700. 

SUPPLEMENTARY INFORMATION: This is a 

synopsis of the Commission’s Notice of 

Proposed Rule Making, MB Docket No. 

13–250, adopted October 31, 2013, and 

released November 1, 2013. The full text 

of this Commission decision is available 

for inspection and copying during 

normal business hours in the FCC’s 

Reference Information Center at Portals 

II, CY–A257, 445 12th Street SW., 

Washington, DC 20554. This document 

may also be purchased from the 

Commission’s duplicating contractors, 

Best Copy and Printing, Inc., 445 12th 

Street SW., Room CY–B402, 

Washington, DC 20554, telephone 1– 

800–378–3160 or via email 

www.BCPIWEB.com. This document 

does not contain proposed information 

collection requirements subject to the 

Paperwork Reduction Act of 1995, 

Public Law 104–13. In addition, 

therefore, it does not contain any 

proposed information collection burden 

‘‘for small business concerns with fewer 

than 25 employees,’’ pursuant to the 

Small Business Paperwork Relief Act of 

2002, Public Law 107–198, see 44 U.S.C. 

3506(c)(4). 

Provisions of the Regulatory 

Flexibility Act of l980 do not apply to 

this proceeding. 

Members of the public should note 

that from the time a Notice of Proposed 

Rule Making is issued until the matter 

is no longer subject to Commission 

consideration or court review, all ex 

parte contacts are prohibited in 

Commission proceedings, such as this 

one, which involve channel allotments. 

See 47 CFR 1.1204(b) for rules 

governing permissible ex parte contacts. 

For information regarding proper 

filing procedures for comments, see 47 

CFR 1.415 and 1.420. 

List of Subjects in 47 CFR Part 73 

Radio, Radio broadcasting. 

Federal Communications Commission. 

Nazifa Sawez, 

Assistant Chief, Audio Division, Media 

Bureau. 

For the reasons discussed in the 

preamble, the Federal Communications 

Commission proposes to amend 47 CFR 

part 73 as follows: 

PART 73—RADIO BROADCAST 

SERVICES 

■ 1. The authority citation for part 73 

continues to read as follows: 

Authority: 47 U.S.C. 154, 303, 334, 336 and 

339. 

§ 73.202 [Amended] 

■ 2. Section 73.202(b), the Table of FM 

Allotments under New Mexico, is 

amended by adding Tohatchi, Channel 

268C2. 

[FR Doc. 2013–28549 Filed 11–27–13; 8:45 am] 

BILLING CODE 6712–01–P 


sroberts on DSK5SPTVN1PROD with PROPOSALS