Federal Register / Vol. 78, No. 235 / Friday, December 6, 2013 / Notices 73547 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Annual Early 

and Periodic Screening, Diagnostic and 

Treatment (EPSDT) Participation 

Report; Use: The baseline data collected 

is used to assess the effectiveness of 

state early and periodic screening, 

diagnostic and treatment (EPSDT) 

programs in reaching eligible children, 

by age group and basis of Medicaid 

eligibility, who are provided initial and 

periodic child health screening services, 

referred for corrective treatment, and 

receiving dental, hearing, and vision 

services. This assessment is coupled 

with the state’s results in attaining the 

participation goals set for the state. The 

information gathered from this report, 

permits federal and state managers to 

evaluate the effectiveness of the EPSDT 

law on the basic aspects of the program. 

The associated 30-day PRA package has 

been revised subsequent to the 

publication of the 60-day notice (78 FR 

48687). Form Number: CMS–416 (OCN: 

0938–0354); Frequency: Yearly; Affected 

Public: State, Local, or Tribal 

Governments; Number of Respondents: 

56; Total Annual Responses: 56; Total 

Annual Hours: 1,568. (For policy 

questions regarding this collection 

contact Marsha Lillie-Blanton at 410– 

786–8856.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Clinical 

Laboratory Improvement Amendments 

(CLIA) Regulations; Use: The 

information is necessary to determine 

an entity’s compliance with the 

Congressionally-mandated program 

with respect to the regulation of 

laboratory testing (CLIA). In addition, 

laboratories participating in the 

Medicare program must comply with 

CLIA requirements as required by 

section 6141 of OBRA 89. Medicaid, 

under the authority of section 

1902(a)(9)(C) of the Social Security Act, 

pays for services furnished only by 

laboratories that meet Medicare (CLIA) 

requirements. Form Number: CMS–R– 

26 (OCN: 0938–0612); Frequency: 

Monthly, occasionally; Affected Public: 

Private sector—Business or other forprofits and Not-for-profit institutions, 

State, Local or Tribal Governments, and 

the Federal government; Number of 

Respondents: 79,175; Total Annual 

Responses: 88,886,364; Total Annual 

Hours: 15,613,299. (For policy questions 

regarding this collection contact Raelene 

Perfetto at 410–786–6876). 

3. Type of Information Collection 

Request: New Collection (Request for a 

new OMB control number); Title of 

Information Collection: Medicaid 

Emergency Psychiatric Demonstration 

(MEPD) Evaluation; Use: Since the 

inception of Medicaid, inpatient care 

provided to adults ages 21 to 64 in 

institutions for mental disease (IMDs) 

has been excluded from federal 

matching funds. The Emergency 

Medical Treatment and Active Labor 

Act (EMTALA), however, requires IMDs 

that participate in Medicare to provide 

treatment for psychiatric emergency 

medical conditions (EMCs), even for 

Medicaid patients for whose services 

cannot be reimbursed. Section 2707 of 

the Affordable Care Act (ACA) directs 

the Secretary of Health and Human 

Services to conduct and evaluate a 

demonstration project to determine the 

impact of providing payment under 

Medicaid for inpatient services 

provided by private IMDs to individuals 

with emergency psychiatric conditions 

between the ages of 21 and 64. We will 

use the data to evaluate the Medicaid 

Emergency Psychiatric Demonstration 

(MEPD) in accordance with the ACA 

mandates. This evaluation in turn will 

be used by Congress to determine 

whether to continue or expand the 

demonstration. If the decision is made 

to expand the demonstration, the data 

collected will help to inform us as well 

as our stakeholders about possible 

effects of contextual factors and 

important procedural issues to consider 

in the expansion, as well as the 

likelihood of various outcomes. 

Subsequent to publication of the 60-day 

Federal Register notice (78 FR 45205), 

there was an increase in the burden due 

to an increase in time assessed for 

reviewing medical records and the need 

to obtain additional informed consents 

for beneficiary interviews. There have 

also been changes made to the ‘‘Key 

Informant Interview Questions’’ for 

clarification purposes. Form Number: 

CMS–10487 (OCN: 0938–NEW); 

Frequency: Annually; Affected Public: 

Individuals and households; State, 

Local and Tribal governments; Private 

sector—Business and other for-profits 

and Not-for-profits; Number of 

Respondents: 98; Total Annual 

Responses: 2,754; Total Annual Hours: 

2,613. (For policy questions regarding 

this collection contact Negussie Tilahun 

at 410–786–2058.) 

Dated: December 3, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–29143 Filed 12–5–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1463–N] 

Medicare Program; Semi-Annual 

Meeting of the Advisory Panel on 

Hospital Outpatient Payment (HOP 

Panel) March 10–11, 2014 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: This notice announces the 

first semi-annual meeting of the 

Advisory Panel on Hospital Outpatient 

Payment (the Panel) for 2014. The 

purpose of the Panel is to advise the 

Secretary of the Department of Health 

and Human Services (the Secretary) and 

the Administrator of the Centers for 

Medicare & Medicaid Services (the 

Administrator) on the clinical integrity 

of the Ambulatory Payment 

Classification (APC) groups and their 

associated weights, and hospital 

outpatient therapeutic services 

supervision issues. 

DATES: Meeting Dates: The first semiannual meeting in 2014 is scheduled for 

the following dates and times. The times 

listed in this notice are Eastern Standard 

Time (EST) and are approximate times; 

consequently, the meetings may last 

longer than the times listed in this 

notice, but will not begin before the 

posted times: 

• Monday, March 10, 2014, 1 p.m. to 5 

p.m. EST 

• Tuesday, March 11, 2014, 9 a.m. to 5 

p.m. EST 

Meeting Information Updates: 

The actual meeting hours and days 

will be posted in the agenda. As 

information and updates regarding the 

onsite and webcasted meeting and 

agenda become available, they will be 

posted to the CMS Web site at: http:// 

cms.gov/Regulations-and-Guidance/

Guidance/FACA/AdvisoryPanel

onAmbulatoryPaymentClassification

Groups.html. 


emcdonald on DSK67QTVN1PROD with NOTICES
73548 Federal Register / Vol. 78, No. 235 / Friday, December 6, 2013 / Notices 

Deadlines 

Deadline for Presentations and 

Comments: 

Presentations and Comments can be 

submitted by email or hard copy as 

follows: Presentations or comments and 

form CMS–20017 submitted by email, 

must be in the Designated Federal 

Official’s (DFO’s) email inbox 

(APCPanel@cms.hhs.gov) by 5 p.m. EST, 

Friday, January, 31, 2014. Presentations 

or comments and form CMS–20017 

submitted hardcopy, must be received 

by the DFO on or before Friday, 

February 7, 2014. Presentations and 

comments that are not received by the 

due dates will be considered late and 

will not be included on the agenda. (See 

below for submission instructions for 

both hardcopy and electronic 

submissions.) 

Meeting Registration Timeframe: 

Monday, January 20, 2014 through 

Friday, February 21, 2014 at 5 p.m. EST. 

Participants planning to attend this 

meeting in person must register online, 

during the above specified timeframe at: 

https://www.cms.gov/apps/events/

default.asp. On this Web page, double 

click the ‘‘Upcoming Events’’ hyperlink, 

and then double click the ‘‘HOP Panel’’ 

event title link and enter the required 

information. Include any requests for 

special accommodations. 

Note: Participants who do not plan to 

attend this meeting in person should not 

register. No registration is required for 

participants who plan to view the meeting 

via webcast. 

ADDRESSES: In commenting, please refer 

to file code CMS–1463–N. Because of 

staff and resource limitations, we cannot 

accept comments and presentations by 

facsimile (FAX) transmission. 

Meeting Location and Webcast: 

The meeting will be held in the 

Auditorium, CMS Central Office, 7500 

Security Boulevard, Woodlawn, 

Maryland 21244–1850. 

Alternately, the public may view this 

meeting via a webcast. During the 

scheduled meeting, webcasting is 

accessible online at: http://cms.gov/live 

or http://www.ustream.tv. Viewers 

interested in receiving the webcast from 

http://www.ustream.tv will need to type 

‘‘CMS Public Events’’ in the search bar 

to access the webcast. 

FOR FURTHER INFORMATION CONTACT: 

Chuck Braver, 7500 Security Boulevard, 

Mail Stop: C4–05–17, Woodlawn, MD 

21244–1850. Phone: (410) 786–3985. 

Email: APCPanel@cms.hhs.gov. 

Mail hardcopies and email copies to 

the following addresses: Chuck Braver, 

DFO, CMS, CM, HAPG, DOC—HOP 

Panel 7500 Security Blvd., Mail Stop: 

C4–05–17, Woodlawn, MD 21244–1850. 

Email: APCPanel@cms.hhs.gov. 

Note: We recommend that you advise 

couriers of the following information: When 

delivering hardcopies of presentations to 

CMS, call (410) 786–4532 or (410) 786–6719 

to ensure receipt of documents by 

appropriate staff. 

News Media: Representatives must 

contact our Public Affairs Office at (202) 

690–6145. 

Advisory Committees’ Information 

Lines: The phone number for the CMS 

Federal Advisory Committee Hotline is 

(410) 786–3985. 

Web sites: 

For additional information on the 

Panel and updates to the Panel’s 

activities, we refer readers to view our 

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

Regulations-and-Guidance/Guidance/ 

FACA/AdvisoryPanelonAmbulatory

PaymentClassificationGroups.html. 

Information about the Panel and its 

membership in the Federal Advisory 

Committee Act (FACA) database are also 

located at: http://facasms.fido.gov/. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Secretary is required by section 

1833(t)(9)(A) of the Social Security Act 

(the Act) and section 222 of the Public 

Health Service Act (PHS Act) to consult 

with an expert outside advisory panel 

regarding the clinical integrity of the 

Ambulatory Payment Classification 

(APC) groups and relative payment 

weights. The Panel (which was formerly 

known as the Advisory Panel on 

Ambulatory Payment Classification 

Groups) is governed by the provisions of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), as amended (5 U.S.C. 

Appendix 2), to set forth standards for 

the formation and use of advisory 

panels. 

The Charter provides that the Panel 

shall meet up to 3 times annually. We 

consider the technical advice provided 

by the Panel as we prepare the proposed 

and final rules to update the outpatient 

prospective payment system (OPPS). 

II. Agenda 

The agenda for the March 2014 

meeting will provide for discussion and 

comment on the following topics as 

designated in the Panel’s Charter: 

• Addressing whether procedures 

within an APC group are similar both 

clinically and in terms of resource use. 

• Evaluating APC group weights. 

• Reviewing the packaging of OPPS 

services and costs, including the 

methodology and the impact on APC 

groups and payment. 

• Removing procedures from the 

inpatient list for payment under the 

OPPS. 

• Using single and multiple 

procedure claims data for CMS’ 

determination of APC group weights. 

• Addressing other technical issues 

concerning APC group structure. 

• Recommending the appropriate 

supervision level (general, direct, or 

personal) for individual hospital 

outpatient therapeutic services. 

The Agenda will be posted on the 

CMS Web site before the meeting. 

III. Presentations 

The presentation subject matter must 

be within the scope of the Panel 

designated in the Charter. Any 

presentations outside of the scope of 

this Panel will be returned or requested 

for amendment. Unrelated topics 

include, but are not limited to, the 

conversion factor, charge compression, 

revisions to the cost report, passthrough payments, correct coding, new 

technology applications (including 

supporting information/documentation), 

provider payment adjustments, 

supervision of hospital outpatient 

diagnostic services and the types of 

practitioners that are permitted to 

supervise hospital outpatient services. 

The Panel may not recommend that 

services be designated as nonsurgical 

extended duration therapeutic services. 

The Panel may use data collected or 

developed by entities and organizations, 

other than DHHS and CMS in 

conducting its review. We recommend 

organizations submit data for CMS staff 

and the Panel’s review. 

All presentations are limited to 5 

minutes, regardless of the number of 

individuals or organizations represented 

by a single presentation. Presenters may 

use their 5 minutes to represent either 

one or more agenda items. 

All presentations will be shared with 

the public. Presentations may not 

contain any pictures, illustrations, or 

personally identifiable information. 

In order to consider presentations 

and/or comments, we will need to 

receive the following information: 

1. A hardcopy of the presentation; 

only hardcopy comments and 

presentations can be reproduced for 

public dissemination. 

2. An email copy of the presentation 

sent to the DFO mailbox, 

APCPanel@cms.hhs.gov. 

3. Form CMS–20017 with complete 

contact information that includes name, 

address, phone, and email addresses for 

all presenters and a contact person that 

can answer any questions and or 

provide revisions that are requested for 

the presentation. 


emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 235 / Friday, December 6, 2013 / Notices 73549 

• Presenters must clearly explain the 

actions that they are requesting CMS to 

take in the appropriate section of the 

form. A presenter’s relationship with 

the organization that they represent 

must also be clearly listed. 

• The form is now available through 

the CMS Forms Web site. The Uniform 

Resource Locator (URL) for linking to 

this form is as follows: http:// 

www.cms.hhs.gov/cmsforms/ 

downloads/cms20017.pdf 

IV. Oral Comments 

In addition to formal oral 

presentations, which are limited to 5 

minutes total per presentation, there 

will be an opportunity during the 

meeting for public oral comments, 

which will be limited to 1 minute for 

each individual and a total of 3 minutes 

per organization. 

V. Meeting Attendance 

The meeting is open to the public; 

however, attendance is limited to space 

available. Priority will be given to those 

who pre-register, and attendance may be 

limited based on the number of 

registrants and the space available. 

Persons wishing to attend this 

meeting, which is located on Federal 

property, must register by following the 

instructions in the ‘‘Meeting 

Registration Timeframe’’ section of this 

notice. A confirmation email will be 

sent to the registrants shortly after 

completing the registration process. 

VI. Security, Building, and Parking 

Guidelines 

The following are the security, 

building, and parking guidelines: 

• Persons attending the meeting, 

including presenters, must be preregistered and on the attendance list by 

the prescribed date. 

• Individuals who are not preregistered in advance may not be 

permitted to enter the building and may 

be unable to attend the meeting. 

• Attendees must present valid photo 

identification to the Federal Protective 

Service or Guard Service personnel 

before entering the building. Without a 

current, valid photo ID, persons may not 

be permitted entry to the building. 

• Security measures include 

inspection of vehicles, inside and out, at 

the entrance to the grounds. 

• All persons entering the building 

must pass through a metal detector. 

• All items brought into CMS 

including personal items, for example, 

laptops and cell phones are subject to 

physical inspection. 

• The public may enter the building 

30 to 45 minutes before the meeting 

convenes each day. 

• All visitors must be escorted in 

areas other than the lower and first-floor 

levels in the Central Building. 

• The main-entrance guards will 

issue parking permits and instructions 

upon arrival at the building. 

VII. Special Accommodations 

Individuals requiring sign-language 

interpretation 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: November 29, 2013. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2013–29185 Filed 12–5–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 209 and 37 CFR Part 404 to 

achieve expeditious commercialization 

of results of federally-funded research 

and development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

FOR FURTHER INFORMATION CONTACT: 

Licensing information and copies of the 

U.S. patent applications listed below 

may be obtained by writing to the 

indicated licensing contact at the Office 

of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852–3804; telephone: 301– 

496–7057; fax: 301–402–0220. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

Use of Antisense Oligodeoxynucleotides 

(ODNs) for Inhibiting JC Virus (JCV) 

Description of Technology: 

Progressive multifocal 

leukoencephalopathy (PML) is a rare, 

fatal demyelinating disease of the brain 

caused by the polyomavirus JC (JCV) 

under immunosuppressive conditions. 

It is pathologically characterized by 

progressive damage of white matter of 

the brain by destroying 

oligodendrocytes at multiple locations. 

Clinically, PML symptoms include 

weakness or paralysis, vision loss, 

impaired speech, and cognitive 

deterioration. The prognosis of PML is 

generally poor. No effective therapy for 

PML has been established. The current 

strategies to develop a PML therapy 

focus on blocking viral infection or 

inhibiting JCV replication. Antisense 

oligodeoxynucleotides (ODNs) that can 

block JCV replication and multiplication 

have been identified and optimized. Use 

of the ODNs provide a method of 

inhibiting JCV replication and thereby 

provide a treatment for PML. 

Potential Commercial Applications: 

• JCV/PML Therapeutics. 

• JCV Diagnostics. 

• JCV Kits. 

Competitive Advantages: 

• Low cost PML therapeutics. 

• Lower cost JCV diagnostics. 

• Ease of synthesis. 

Development Status: 

• Pre-clinical. 

• In vitro data available. 

• In vivo data available (animal). 

Inventors: Laura B. Jaeger, Avindra 

Nath, Eugene O. Major (all of NINDS). 

Intellectual Property: HHS Reference 

No. E–547–2013/0—US Provisional 

Application No. 61/879,833, filed 19 

Sep 2013. 

Licensing Contact: Peter Soukas, J.D.; 

301–435–4646; ps193c@nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Neurological 

Disorders and Stroke is seeking 

statements of capability or interest from 

parties interested in collaborative 


emcdonald on DSK67QTVN1PROD with NOTICES