Federal Register / Vol. 78, No. 138 / Thursday, July 18, 2013 / Notices 42957 

resistance. This worrisome trend 

prompted CDC to again update 

treatment recommendations and no 

longer recommend the use of cefixime 

as first-line treatment for gonococcal 

infections. 

Under the GISP protocol, each of the 

30 clinics submit an average of 20 

isolates per clinic per month (i.e., 240 

times per year) recorded on Form 1: 

Demographic/Clinical Data. The 

estimated time for clinical personnel to 

abstract data for Form 1: Demographic/ 

Clinical Data is 11 minutes per 

response. 

Each of the five Regional laboratories 

receives and processes approximately 

20 isolates from each referring clinic per 

month (i.e., 121 isolates per regional 

laboratory per month [based on 2011 

specimen volume]) using Form 2: 

Antimicrobial Susceptibility Testing. 

For Form 2: Antimicrobial 

Susceptibility Testing, the annual 

frequency of responses per respondent 

is 1,452 (121 isolates × 12 months). 

Based on previous laboratory 

experience, the estimated burden of 

completing Form 2 for each 

participating laboratory is 1 hour per 

response, which includes the time 

required for laboratory processing of the 

patient’s isolate, gathering and 

maintaining the data needed, and 

completing and reviewing the collection 

of information. For Form 3: Control 

Strain Susceptibility Testing, a 

‘‘response’’ is defined as the processing 

and recording of Regional laboratory 

data for a set of seven control strains. It 

takes approximately 12 minutes to 

process and record the Regional 

laboratory data on Form 3 for one set of 

seven control strains, of which there are 

4 sets. The number of responses per 

respondent is 48 (4 sets × 12 months). 

There are no additional costs to 

respondents. The total estimated annual 

burden hours are 8,628. 

ESTIMATE OF ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Clinic ....................................... Demographic Clinical Data Form 1 ........................................ 30 240 11/60 

Laboratory ............................... Antimicrobial Susceptibility Testing Form 2 ........................... 5 1,452 1 

Control Strain Susceptibility Testing Form 3 ......................... 5 48 12/60 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2013–17263 Filed 7–17–13; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–10062, CMS– 

10146, CMS–10191, CMS–10308, CMS–R–43 

and CMS–10453] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the 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 functions; (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. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by August 19, 2013: 

ADDRESSES: When commenting on the 

proposed information collections, 

please reference the document identifier 

or OMB control number. To be assured 

consideration, comments and 

recommendations must be received by 

the OMB desk officer via one of the 

following transmissions: OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–6974, or Email: 

OIRA_submission@omb.eop.gov . 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ Web site address at 

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

PaperworkReductionActof1995. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

Reports Clearance Office at (410) 786– 

1326 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. The term ‘‘collection of 

information’’ is defined in 44 U.S.C. 

3502(3) and 5 CFR 1320.3(c) and 

includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires federal agencies 

to publish a 30-day notice in the 

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: Reinstatement with change of a 

previously approved collection; Title of 

Information Collection: Collection of 

Diagnostic Data from Medicare 

Advantage Organizations for Risk 


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42958 Federal Register / Vol. 78, No. 138 / Thursday, July 18, 2013 / Notices 

Adjusted Payments; Use: In the 

Balanced Budget Act of 1997 (BBA), 

Congress created the Medicare+Choice 

(M+C or Part C) program in order to 

expand the types of private entities 

eligible to contract with Medicare and to 

address some perceived flaws in the 

risk-contracting program. Congress 

subsequently refined the M+C program 

through the Balanced Budget 

Refinement Act of 1999 (BBRA) and the 

Medicare, Medicaid, and SCHIP 

Benefits Improvement and Protection 

Act of 2000 (BIPA). Most recently, 

under the Medicare Prescription Drug 

Benefit, Improvement and 

Modernization Act of 2003 (MMA), 

Congress restructured the M+C program 

into the Medicare Advantage (MA) 

program and added an outpatient 

prescription drug benefit, Part D. 

The BBA of 1997 and later legislation 

required CMS to adjust per-beneficiary 

capitation payments with a risk 

adjustment methodology using 

diagnoses to measure relative risk due to 

health status instead of just 

demographic characteristics such as age, 

sex, and Medicaid eligibility. Risk 

adjustment using diagnoses provides 

more accurate payments for MA 

organizations, with higher payments for 

enrollees at risk for being sicker, and 

lower payments for enrollees predicted 

to be healthier. 

The MMA also instituted a bidding 

system in Parts C and D with a 

significant role for risk adjustment. 

Thus, independent of enrollment and 

payment, risk adjustment now plays a 

significant role simply because it is 

central to the bidding process. Under 

the MMA, risk adjustment is used to 

standardize bids. Plans bid on the 

average beneficiary, referred to as a 

‘‘standardized’’ bid for a beneficiary 

with a 1.0 risk score. This enables 

comparison of Part C and D bids against 

a baseline (average) standard, even 

though every plan will have different 

enrollee characteristics and benefit 

packages and will therefore have 

different costs. 

Previously, we received PRA 

clearance to collect inpatient and 

outpatient data for Part C using the 

CMS–HCC model. Currently, we are 

seeking to renew that OMB approval 

and also clearance for changes in data 

collection in order to fulfill new 

mandates under the MMA. Form 

Number: CMS–10062 (OCN: 0938– 

0838); Frequency: Quarterly; Affected 

Public: Private Sector (business or other 

for-profit and not-for-profit institutions); 

Number of Respondents: 766; Total 

Annual Responses: 830,000; Total 

Annual Hours: 40,650; (For policy 

questions regarding this collection 

contact Michael Massimini at 410–786– 

1566.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; 

Title of Information Collection: Notice 

of Denial of Medicare Prescription Drug 

Coverage; Use: Section 1860D–4(g)(1) of 

the Social Security Act, requires that 

Part D plan sponsors who deny 

prescription drug coverage must provide 

a written notice of the denial to the 

enrollee. The written notice must 

include a statement, in understandable 

language, of the reasons for the denial 

and a description of the appeals process. 

The Part D denial notice has been 

revised for clarity and includes new 

optional language for Part D plan 

sponsors to use when explaining their 

denial rationale. Specifically, we added 

optional language in the denial rationale 

section of the notice to allow plans to 

populate text explaining that a drug 

denied under Part D may be (or is) 

covered under a different benefit, such 

as Part B. The instructions have also 

been changed to guide plans on when to 

use this optional text. We solicit 

feedback on this new addition as well 

as other situations where another 

benefit may cover a drug (i.e. employer 

group benefits) and what changes to the 

denial notice may be helpful in 

addressing those situations. We also 

seek comment regarding the potential 

viability and usefulness of developing a 

combined notice for Part C and Part D, 

which would allow MA–PD plans that 

deny a drug under Part D to 

simultaneously issue an approval letter 

under Part B. Form Number: CMS– 

10146 (OCN: 0938–0976); Frequency: 

Occasionally; Affected Public: Private 

sector (business or other for-profits); 

Number of Respondents: 596; Total 

Annual Responses: 1,497,929; Total 

Annual Hours: 374,482; (For policy 

questions regarding this collection 

contact Caroline Baker at 410–786– 

0116.) 

3. Type of Information Collection 

Request: Reinstatement with change of a 

previously approved collection; Title of 

Information Collection: Medicare Parts 

C and D Universal Audit Guide; Use: 

Under the Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 and implementing regulations 

under 42 CFR parts 422 and 423, 

Medicare Part D plan sponsors and 

Medicare Advantage organizations are 

required to comply with all Medicare 

Parts C and D program requirements. In 

2010 the explosive growth of these 

sponsoring organizations forced us to 

develop an audit strategy to ensure we 

continue to obtain meaningful audit 

results. As a result, our audit strategy 

reflected a move to a more targeted, 

data-driven and risk-based audit 

approach that focused on high-risk areas 

having the greatest potential for 

beneficiary harm. 

To accomplish this we have combined 

all Part C and Part D audit elements into 

one universal guide which will also 

promote consistency, effectiveness and 

reduce financial and time burdens for 

both CMS and Medicare-contracting 

entities. The combined Medicare Part C 

& D Universal Audit Guide received 

OMB approval in 2010. The Health Plan 

Management System (HPMS) is the 

current conduit by which organizations 

submit many sources of audit materials 

such as bids and other ongoing updates 

to us. Please note the guide is very 

comprehensive in that it describes all 

areas that could be audited. Due to 

limited resources, we are unable to 

audit all areas for any particular 

sponsor. Some areas could be monitored 

by the account manager, etc. Other areas 

could be the audited in the program 

audits. 

To maximize resources, we will focus 

on assisting the industry to improve 

their operations to ensure beneficiaries 

receive access to care. We will 

accomplish this by developing an 

annual audit strategy which describes 

how sponsors will be selected for audit 

and the areas that will be audited. The 

audit strategy will be shared with the 

industry via the CMS Web site, HPMS 

memo, the Part C & D user call, and 

other conferences. Once the audit areas 

are defined, we will design audit 

protocols describing in detail the focus 

of the audit, the data required for the 

audit, etc. The Engagement Letter and 

Protocols will be sent to all sponsors 

selected for audit 4 weeks prior to 

starting the audit. In addition, the 

protocols will be released to the 

industry at the beginning of each 

calendar year via the same manner as 

the audit strategy. To assist in 

improving the audit process, we send 

the plan sponsors a survey at the end of 

each audit to complete in order to 

obtain the sponsors feedback. The 

sponsor is not required to complete the 

survey. The supporting materials for 

this information collection request have 

been revised since the 60-day Federal 

Register notice published on February 

28, 2013 (78 FR 4412). Form Number: 

CMS–10191 (OCN: 0938–1000); 

Frequency: Yearly; Affected Public: 

Private Sector (business or other forprofit and not-for-profit institutions); 

Number of Respondents: 195; Total 

Annual Responses: 195; Total Annual 

Hours: 24,180. (For policy questions 

regarding this collection contact Tracey 

Roberts at 410–786–8643.) 


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Federal Register / Vol. 78, No. 138 / Thursday, July 18, 2013 / Notices 42959 

4. Type of Information Collection 

Request: Revision of a currently 

approved collection. Title of 

Information Collection: Parts C and D 

Complaints Resolution Performance 

Measures. Use: We seek to conduct a 

survey as part of the Part C and D 

Complaints Resolution Performance 

Measure project. The purpose of the 

project is to develop and support 

implementation of internal monitoring 

tools for the Medicare Advantage (Part 

C) and Prescription Drug (Part D) 

program that represents, from the 

beneficiary’s perspective, the way in 

which plans handle complaints. The 

data collection is necessary because a 

survey is the only way to collect 

information about the resolution process 

from the beneficiary’s perspective. 

Currently, there is no other data source 

that collects such information for Part C 

and Part D Medicare plans. Form 

Number: CMS–10308 (OCN: 0938– 

1107); Frequency: Yearly; Affected 

Public: Individuals or households; 

Number of Respondents: 18,210; Total 

Annual Responses: 18,210; Total 

Annual Hours: 3,035. (For policy 

questions regarding this collection 

contact Carolyn Scott at 410–786–1190.) 

5. Type of Information Collection 

Request: Reinstatement with change of a 

currently approved collection; Title of 

Information Collection: Conditions of 

Coverage for Portable X-ray Suppliers 

and Supporting Regulations; Use: The 

requirements contained in this 

information collection request are 

classified as conditions of participation 

or conditions for coverage. These 

conditions are based on a provision 

specified in law relating to diagnostic Xray tests ‘‘furnished in a place of 

residence used as the patient’s home,’’ 

and are designed to ensure that each 

supplier has a properly trained staff to 

provide the appropriate type and level 

of care, as well as, a safe physical 

environment for patients. We use these 

conditions to certify suppliers of 

portable X-ray services wishing to 

participate in the Medicare program. 

This is standard medical practice and is 

necessary in order to help to ensure the 

well-being, safety and quality 

professional medical treatment 

accountability for each patient. Form 

Number: CMS–R–43 (OCN: 0938–0338); 

Frequency: Yearly; Affected Public: 

Business or other for-profit and Not-forprofit institutions; Number of 

Respondents: 578; Total Annual 

Responses: 578; Total Annual Hours: 

948. (For policy questions regarding this 

collections contact Alesia Hovatter at 

410–786–6861.) 

6. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: The Medicare 

Advantage and Prescription Drug 

Program: Part C Explanation of Benefits 

CFR 422.111(b)(12); Use: We are 

requesting OMB approval for the 

information collection requirements 

referenced in the April 15, 2011 final 

rule revising the Medicare Advantage 

(MA) and Part D programs for calendar 

year 2012 (77 FR 21432–21577). The 

rule revised the MA disclosure 

requirements in 42 CFR 422.111(b) by 

adding the authority for CMS to require 

MA organizations to furnish a written 

explanation of benefits directly to 

enrollees, in a manner we specify and 

in a form easily understandable to 

enrollees, when benefits are provided 

under Part 422. The collection 

instrument that requires OMB approval 

concerns the disclosure requirements in 

paragraph 42 CFR 422.111(b)(12). 

In order to provide all Medicare 

Advantage enrollees with consistent, 

clear, useful information about their 

medical claims, we established a 

requirement, in the April 2011 final 

rule, that MA organizations furnish 

directly to enrollees, in the manner 

specified by CMS and in a form easily 

understandable to such enrollees, a 

written explanation of benefits, when 

benefits are provided under Part 422. 

We finalized this policy based on the 

public comments and input we have 

received from beneficiaries, advocacy 

organizations, health plans and industry 

organizations. This EOB will help 

ensure that people in the Medicare 

Advantage program receive clear, timely 

information, as do people receiving the 

Medicare MSN and the Part D EOB, so 

that they may make confident, informed 

decisions about their healthcare options. 

We stated that we would develop a 

model EOB for Part C benefits modeled 

after the EOB currently required for Part 

D enrollees at § 423.128(e). After 

publication of the final rule in April 

2011, we engaged MA organizations, 

industry and advocacy groups and 

beneficiaries in listening sessions to 

gather ideas and feedback. We 

developed models based on that input, 

as well as the newly redesigned and 

consumer tested Medicare Summary 

Notice and the Part D EOB. We have 

tested models through a small pilot 

program with a volunteer MA 

organization in CY 2012. In designing 

our model EOB, we considered language 

and design from Medicare MSN, 

integration of Part C and Part D EOBs, 

level of detail, and frequency of EOB 

dissemination as part of this process. 

We sought additional public 

comments on the model EOBs that we 

developed through a Health Plan 

Management System (HPMS) memo 

release with a 30 day comment period. 

Our goal was to implement a model Part 

C EOB document in mid-year 2013 

based on this process, and to require all 

MA organizations to periodically send 

an EOB to enrollees for Part C benefits 

in future years. This customized 

information would supplement general 

plan information in the annual notice of 

change (ANOC) and evidence of 

coverage (EOC) documents as well as 

enhance the currently available 

information through tools such as 

Medicare Options Compare (MOC) and 

the Medicare Prescription Drug Plan 

Finder (MPDPF), which provide general 

information about plan costs. Based on 

public comments we received on the 

HPMS memo and November 26, 2012 

Federal Register notice (77 FR 70445) 

and the revisions we made to the initial 

templates and guidance, we are 

extending the timeline for 

implementation to April, 2014. We 

intend for the Part C EOB to provide 

personal information to beneficiaries 

that would help them understand their 

current utilization, keep track of their 

out-of-pocket expenses, and to consider 

using other tools and resources, 

including MOC and MPDPF, to 

determine whether to select a new plan. 

As a result of comments received 

during the 60-day comment period 

associated with the November 26, 2012, 

Federal Register notice (77 FR 70445), 

we revised the collection request. 

Specifically, we shortened the templates 

by removing two sections. One section 

was deemed to include information that 

was not needed and information from 

the second section was incorporated 

into other sections. We clarified and 

streamlined the presentation of the 

information and modified some of the 

language to be more beneficiaryfriendly. Form Number: CMS–10453 

(OCN: 0938-New); Frequency: On 

occasion; Affected Public: Private 

Sector—Business or other for-profits; 

Number of Respondents: 564; Number 

of Responses: 2,256; Total Annual 

Hours: 101,520. (For policy questions 

regarding this collection contact Chris 

McClintick at 410–786–4682.) 

Dated: July 15, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–17317 Filed 7–17–13; 8:45 am] 

BILLING CODE 4120–01–P 


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