Federal Register / Vol. 76, No. 223 / Friday, November 18, 2011 / Notices 71569 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number lllll, Room C4– 

26–05, 7500 Security Boulevard, 

Baltimore, Maryland 21244–1850. 

Dated: November 15, 2011. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2011–29840 Filed 11–17–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–10373] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS), Department of Health 

and Human Services, is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the Agency’s function; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Medical Loss 

Ratio (MLR) Quarterly Reporting for 

Mini-Med Plans and Expatriate Plans; 

Use: Under Section 2718 of the 

Affordable Care Act and implementing 

regulations at 45 CFR part 158 (75 FR 

74865, December 1, 2010) as modified 

by technical corrections on December 

30, 2010 (75 FR 82277), a health 

insurance issuer (issuer) offering group 

or individual health insurance coverage 

must submit a report to the Secretary 

concerning the amount the issuer 

spends each year on claims, quality 

improvement expenses, non-claims 

costs, Federal and State taxes and 

licensing or regulatory fees, and the 

amount of earned premium. An issuer 

must provide an annual rebate to 

enrollees if the amount it spends on 

certain costs compared to its premium 

revenue (excluding Federal and States 

taxes and licensing or regulatory fees) 

does not meet a certain ratio, referred to 

as the medical loss ratio (MLR). An 

interim final rule (IFR) implementing 

the MLR was published on December 1, 

2010 (75 FR 74865) and modified by 

technical corrections on December 30, 

2010 (75 FR 82277), which added part 

158 to Title 45 of the Code of Federal 

Regulations. The IFR is effective January 

1, 2011. Issuers are required to submit 

annual MLR reporting data for each 

large group market, small group market, 

and individual market within each State 

in which the issuer conducts business. 

For policies that have a total annual 

limit of $250,000 or less (sometimes 

referred to as ‘‘mini-med plans’’) and for 

group policies that primarily cover 

employees working outside the United 

States (referred to as ‘‘expatriate plans’’), 

the IFR applies a special circumstance 

adjustment to the MLR data for the 2011 

MLR reporting year. In order to evaluate 

the appropriateness of this special 

circumstance adjustment for years 2012 

and beyond, issuers that provide such 

policies are required to submit quarterly 

MLR data to the Secretary for the 2011 

MLR reporting year. We received two 

comment letters in response to the 60- 

day comment period that was associated 

with CMS–10373. We have taken into 

consideration all of the proposed 

suggestions, and as result, have not 

made any changes to the quarterly 

reporting form or to the estimated 

burden that correlates with the form. 

Form Number: CMS–10373 (OCN: 

0938–1132); Frequency: Quarterly; 

Affected Public: Private Sector— 

Business or other for-profits and Notfor-profit institutions; Number of 

Respondents: 75; Total Annual 

Responses: 825; Total Annual Hours: 

3,700. (For policy questions regarding 

this collection contact Carol Jimenez at 

(301) 492–4109. For all other issues call 

(410) 786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS Web Site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or 

Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on December 19, 2011. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS Desk 

Officer, Fax Number: (202) 395–6974, 

Email: OIRA_submission@omb.eop.gov. 

Dated: November 15, 2011. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2011–29838 Filed 11–17–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3253–N] 

Medicare Program; Meeting of the 

Medicare Evidence Development and 

Coverage Advisory Committee— 

January 25, 2012 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of meeting. 

SUMMARY: This notice announces that a 

public meeting of the Medicare 

Evidence Development & Coverage 

Advisory Committee (MEDCAC) 

(‘‘Committee’’) will be held on 

Wednesday, January 25, 2012. The 

Committee generally provides advice 

and recommendations concerning the 

adequacy of scientific evidence needed 

to determine whether certain medical 

items and services can be covered under 

the Medicare statute. This meeting will 

focus on the currently available 

evidence regarding the management of 

carotid atherosclerosis. This meeting is 

open to the public in accordance with 

the Federal Advisory Committee Act 

(5 U.S.C. App. 2, section 10(a)). 

DATES: Meeting Date: The public 

meeting will be held on Wednesday, 

January 25, 2012 from 7:30 a.m. until 

4:30 p.m., Eastern Standard Time (EST). 

Deadline for Submission of Written 

Comments: Written comments must be 

received at the address specified in the 

ADDRESSES section of this notice by 

5 p.m. EST, Monday, December 19, 

2011. Once submitted, all comments are 

final. 

Deadlines for Speaker Registration 

and Presentation Materials: The 

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71570 Federal Register / Vol. 76, No. 223 / Friday, November 18, 2011 / Notices 

deadline to register to be a speaker and 

to submit PowerPoint presentation 

materials and writings that will be used 

in support of an oral presentation is 

5 p.m., EST on Monday, December 19, 

2011. Speakers may register by phone or 

via email by contacting the person listed 

in the FOR FURTHER INFORMATION

CONTACT section of this notice. 

Presentation materials must be received 

at the address specified in the 

ADDRESSES section of this notice. 

Deadline for All Other Attendees 

Registration: Individuals may register 

online at http://www.cms.gov/apps/

events/upcomingevents.asp?strOrder

By=1&type=3 or by phone by contacting 

the person listed in the FOR FURTHER

INFORMATION CONTACT section of this 

notice by 5 p.m. EST, Friday, January 

20, 2012. 

We will be broadcasting the meeting 

live via Webcast at http://www.cms.gov/ 

live/. 

Deadline for Submitting a Request for 

Special Accommodations: Persons 

attending the meeting who are hearing 

or visually impaired, or have a 

condition that requires special 

assistance or accommodations, are 

asked to contact the Executive Secretary 

as specified in the FOR FURTHER

INFORMATION CONTACT section of this 

notice no later than 5 p.m., EST Friday, 

January 6, 2012. 

ADDRESSES: Meeting Location: The 

meeting will be held in the main 

auditorium of the Centers for Medicare 

& Medicaid Services, 7500 Security 

Boulevard, Baltimore, MD 21244. 

Submission of Presentations and 

Comments: Presentation materials and 

written comments that will be presented 

at the meeting must be submitted via 

email to 

MedCACpresentations@cms.hhs.gov or 

by regular mail to the contact listed in 

the FOR FURTHER INFORMATION CONTACT

section of this notice by the date 

specified in the DATES section of this 

notice. 

FOR FURTHER INFORMATION CONTACT: 

Maria Ellis, Executive Secretary for 

MEDCAC, Centers for Medicare & 

Medicaid Services, Office of Clinical 

Standards and Quality, Coverage and 

Analysis Group, S3–02–01, 7500 

Security Boulevard, Baltimore, MD 

21244 or contact Ms. Ellis by phone 

(410) 786–0309 or via email at Maria.

Ellis@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

MEDCAC, formerly known as the 

Medicare Coverage Advisory Committee 

(MCAC), provides advice and 

recommendations to CMS regarding 

clinical issues. (For more information 

on MCAC, see the December 14, 1998 

Federal Register (63 FR 68780). This 

notice announces the Wednesday, 

January 25, 2012, public meeting of the 

Committee. During this meeting, the 

Committee will discuss the currently 

available evidence regarding the 

management of carotid atherosclerosis. 

Background information about this 

topic, including panel materials, is 

available at http://www.cms.gov/

medicare-coverage-database/indexes/

medcac-meetings-index.

aspx?bc=BAAAAAAAAAAA&. CMS 

will no longer be providing paper copies 

of the handouts for the meeting. 

Electronic copies of all the meeting 

materials will be on the CMS Web site 

no later than 2 business days before the 

meeting. We encourage the participation 

of appropriate organizations with 

expertise in the management of carotid 

atherosclerosis. 

II. Meeting Format 

This meeting is open to the public. 

The Committee will hear oral 

presentations from the public for 

approximately 45 minutes. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

CMS may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

December 22, 2011. Your comments 

should focus on issues specific to the 

list of topics that we have proposed to 

the Committee. The list of research 

topics to be discussed at the meeting 

will be available on the following web 

site prior to the meeting: http://

www.cms.gov/medicare-coveragedatabase/indexes/medcac-meetingsindex.aspx?bc=BAAAAAAAAAAA&. 

We require that you declare at the 

meeting whether you have any financial 

involvement with manufacturers (or 

their competitors) of any items or 

services being discussed. 

The Committee will deliberate openly 

on the topics under consideration. 

Interested persons may observe the 

deliberations, but the Committee will 

not hear further comments during this 

time except at the request of the 

chairperson. The Committee will also 

allow a 15-minute unscheduled open 

public session for any attendee to 

address issues specific to the topics 

under consideration. At the conclusion 

of the day, the members will vote and 

the Committee will make its 

recommendation(s) to CMS. 

III. Registration Instructions 

CMS’ Coverage and Analysis Group is 

coordinating meeting registration. While 

there is no registration fee, individuals 

must register to attend. You may register 

online at http://www.cms.gov/apps/

events/upcomingevents.asp?

strOrderBy=1&type=3 or by phone by 

contacting the person listed in the FOR

FURTHER INFORMATION CONTACT section of 

this notice by the deadline listed in the 

DATES section of this notice. Please 

provide your full name (as it appears on 

your state-issued driver’s license), 

address, organization, telephone, fax 

number(s), and email address. You will 

receive a registration confirmation with 

instructions for your arrival at the CMS 

complex or you will be notified that the 

seating capacity has been reached. 

IV. Security, Building, and Parking 

Guidelines 

This meeting will be held in a Federal 

government building; therefore, Federal 

security measures are applicable. We 

recommend that confirmed registrants 

arrive reasonably early, but no earlier 

than 45 minutes prior to the start of the 

meeting, to allow additional time to 

clear security. Security measures 

include the following: 

• Presentation of government-issued 

photographic identification to the 

Federal Protective Service or Guard 

Service personnel. 

• Inspection of vehicle’s interior and 

exterior (this includes engine and trunk 

inspection) at the entrance to the 

grounds. Parking permits and 

instructions will be issued after the 

vehicle inspection. 

• Inspection, via metal detector or 

other applicable means of all persons 

brought entering the building. We note 

that all items brought into CMS, 

whether personal or for the purpose of 

presentation or to support a 

presentation, 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 

presentation or to support a 

presentation. 

Note: 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 45 minutes prior to the 

convening of the meeting. All visitors must 

be escorted in areas other than the lower and 

first floor levels in the Central Building. 

Authority: 5 U.S.C. App. 2, section 10(a). 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

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Federal Register / Vol. 76, No. 223 / Friday, November 18, 2011 / Notices 71571 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: October 18, 2011. 

Patrick Conway, 

CMS Chief Medical Officer and Director, 

Office of Clinical Standards and Quality, 

Centers for Medicare & Medicaid Services. 

[FR Doc. 2011–29782 Filed 11–17–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1431–N] 

Medicare Program; Town Hall Meeting 

on FY 2013 Applications for New 

Medical Services and Technology AddOn Payments Under the Hospital 

Inpatient Prospective Payment System 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of meeting. 

SUMMARY: This notice announces a town 

hall meeting in accordance with to 

discuss fiscal year (FY) 2013 

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 2013 new medical 

services and technologies applications 

meet the substantial clinical 

improvement criterion. 

DATES: Meeting Date: The town hall 

Meeting will be held on Tuesday, 

February 14, 2012. The town hall 

meeting will begin at 9 a.m. eastern 

standard time (e.s.t.) and check-in will 

begin at 8:30 a.m. e.s.t. 

Deadline for Registration of Presenters 

of the Town Hall Meeting: All presenters 

for the town hall meeting, whether 

attending in person or by phone, must 

register and submit their agenda item(s) 

by Monday, January 23, 2012. 

Deadline for Registration of All Other 

Participants for the Town Hall Meeting 

and Submitting Requests for Special 

Accommodations: All other participants 

must register by Tuesday, January 24, 

2012. Requests for special 

accommodations must be received no 

later than 5 p.m., e.s.t. on Tuesday, 

January 31, 2012. 

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 must be received by 

January 23, 2012. In addition to 

materials submitted for discussion at the 

town hall meeting, individuals may 

submit other written comments, 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 March 6, 2012, for 

consideration before publication of the 

FY 2013 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, 7500 Security Boulevard, 

Baltimore, MD 21244–1850. 

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. Registration information and 

special accommodation requests may 

also be mailed to the address listed in 

the ADDRESSES 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 

2013 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 

or sent via regular mail to: Division of 

Acute Care, New Technology Team, 

Mailstop C4–08–06, Centers for 

Medicare and Medicaid Services, 7500 

Security Boulevard, Baltimore, 

Maryland 21244–1850, Attention: 

Michael Treitel or Celeste Beauregard. 

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. 

Alternatively, you may forward your 

requests via email to 

newtech@cms.hhs.gov or regular mail as 

specified in the ADDRESSES section of 

this notice. 

SUPPLEMENTARY INFORMATION: 

I. Background on the Add-On Payments 

for New Medical Services and 

Technologies Under the Hospital 

Inpatient Prospective Payment System 

(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 inpatient hospital 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 FY 2002 

proposed rule (66 FR 22693), May 4, 

2001) and final rule (66 FR 46912), 

September 7, 2001) for a more detailed 

discussion.) 

In the FY 2002 IPPS final rule (66 FR 

46914), we noted that we evaluate 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. 

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