36516 Federal Register / Vol. 79, No. 124 / Friday, June 27, 2014 / Notices 

PICOTS (Population, Interventions, 

Comparators, Outcomes, Timing, 

Setting) 

Populations 

I. Adult and pediatric patients with an 

acute RTI and no clear indication for 

antibiotic treatment. Respiratory tract 

infections of interest include: acute 

bronchitis; otitis media; sore throat/

pharyngitis/tonsillitis; rhinitis; sinusitis; 

cough and common cold. 

II. Parents of pediatric patients with 

acute RTI and no clear indication for 

antibiotic treatment. 

III. Healthy adults and/or children 

without a current acute RTI, who may 

develop an acute RTI in the future. 

IV. Clinicians and others who care for 

patients with acute RTI in outpatient 

settings. 

V. Groups whose attendance policies 

may indirectly affect the use of 

antibiotics, such as employers or school 

officials. 

Interventions 

Any strategy for improving 

appropriate use of antibiotics when not 

indicated for acute RTI, which may fall 

into various categories, including: 

I. Educational, behavioral and 

psychological interventions that target 

clinicians, patients, or both. 

II. Strategies to improve 

communication between clinicians and 

patients, such as those designed to 

improve shared decision making. 

III. Clinical strategies, such as delayed 

prescribing of antibiotics, clinical 

prediction rules, use of risk assessment 

or diagnostic prediction, use of nonantibiotic alternatives, or use of relevant 

point-of-care (POC) diagnostic tests. 

A. EPC will include any POC test that 

is available and used in primary care 

settings for diagnostic purposes with the 

ability to provide results within a 

reasonable period (e.g. during the clinic 

visit). Examples include inflammatory 

tests (e.g., procalcitonin, c-reactive 

protein [CRP], white blood cell, etc.), 

rapid multiplex polymerase chain 

reaction (PCR) tests used to rule in/out 

organisms (e.g. rapid strep test, 

influenza, RSV), routine diagnostic 

tests, such as chest x-ray, pulse 

oximetry, and blood gasses, when they 

are specifically evaluated as an 

intervention for improving antibiotic 

use. 

IV. System level strategies, such as 

clinician reminders (paper-based or 

electronic), clinician audit and 

feedback, financial or regulatory 

incentives for clinicians or patients, 

antimicrobial stewardship programs, 

pharmacist review. 

V. Multifaceted approaches that 

include numerous elements of one or 

more of the above strategies. 

Comparators 

I. Different strategies for improving 

appropriate use of antibiotics when not 

indicated for acute RTI. 

II. Standard care without a strategy for 

improving appropriate use of 

antibiotics. 

Outcomes 

Key Question 1 

• Increased appropriate prescription of 

antibiotics (primary outcome) 

• Increased appropriate use of 

antibiotics (primary outcome) 

Note: Studies may vary in how 

appropriateness is defined or determined. We 

will accept and record any definition of 

appropriateness. We will group together 

studies that use similar definitions of 

appropriateness and categorize the different 

groups based on concordance with (e.g., high, 

medium, low) select clinical practice 

guidelines (e.g., AAP, ACCP, AAFP). We will 

then evaluate whether the comparative 

effectiveness of strategies differ across 

categories. We may also find that overall 

reduction in antibiotic prescription or use is 

reported, without a determination of 

appropriateness. While this is not a direct 

measure of the primary outcomes, we will 

report these as indirect measures of the 

impact of the intervention. 

Key Question 2 

• Mortality 

• Antibiotic resistance 

• Medical complications 

• Adverse drug effects, including 

clostridium difficile infections 

Key Question 3 

• Admission to hospital 

• Clinic visits (Index, return and 

subsequent episodes), ED visits 

• Time to return to work and/or school 

• Patient satisfaction 

• Quality of life 

• Improvement in patient symptoms, 

speed of improvement 

• Use of non-antibiotic treatments, such 

as over-the-counter medications 

• Utilization of vaccinations 

• Quality metrics 

Key Question 4 

Intermediate outcomes, such as 

improved knowledge regarding use of 

antibiotics for acute RTI (clinician 

and/or patient), or improved shared 

decision making 

Key Question 5 

Adverse effects of the strategy, such as 

increased time burden on clinicians, 

sustainability of intervention (e.g. 

measures of continued effectiveness 

over time), diagnostic resource use 

associated with POC testing, 

diagnostic coding (e.g. ICD billing 

codes) according to desired action 

(prescribe/not prescribe) 

Timing 

Any duration of follow-up. 

Setting 

I. Outpatient care settings including 

institutional settings 

II. Emergency care settings 

III. Other settings, such as school or 

workplace 

Study Design 

We will prioritize comparative studies 

with concurrent control groups (e.g. 

randomized controlled trial, prospective 

and retrospective cohort studies 

including database studies). For areas in 

which direct comparative evidence is 

lacking, we will include before-after 

studies, with or without a control group 

and with or without repeated measures. 

Dated: June 16 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–14962 Filed 6–26–14; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10526, CMS– 

2540–10, CMS–265–11, CMS–10106 and 

CMS–R–235] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

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 (the 

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 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates or any other aspect of 

this collection of information, including 

any of the following subjects: (1) The 

necessity and utility of the proposed 


wreier-aviles on DSK5TPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 124 / Friday, June 27, 2014 / Notices 36517 

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 must be received by 

August 26, 2014. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number (OCN). To be 

assured consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Numberlll, Room C4–26– 

05, 7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

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: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–10526 Cost Sharing Reduction 

Reconciliation 

CMS–2540–10 Skilled Nursing Facility 

and Skilled Nursing Facility Health 

Care Complex Cost Report 

CMS–265–11 Independent Renal 

Dialysis Facility Cost Report and 

Supporting Regulations 

CMS–10106 Medicare Authorization 

to Disclose Personal Health 

Information 

CMS–R–235 Data Use Agreement 

(DUA) for Data Acquired from the 

Centers for Medicare & Medicaid 

Services (CMS) 

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 

requires federal agencies to publish a 

60-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. 

Information Collection 

1. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Cost Sharing 

Reduction Reconciliation; Use: Under 

established Department of Health and 

Human Services (HHS) regulations, 

qualified health plan (QHP) issuers will 

receive estimated advance payments of 

cost-sharing reductions throughout the 

year. Each issuer will then be subject to 

a reconciliation process at the end of the 

benefit year to ensure that HHS 

reimburses each issuer only for actual 

cost sharing. This information collection 

establishes the data elements that a QHP 

issuer would be required to report to 

HHS in order to establish the costsharing reductions provided on behalf 

of enrollees for the benefit year. 

Form Number: CMS–10526 (OMB 

control number: 0938–NEW); 

Frequency: Annually; Affected Public: 

Private Sector—Business or other forprofits; Number of Respondents: 295; 

Total Annual Responses: 4,000,000; 

Total Annual Hours: 2,469. (For policy 

questions regarding this collection 

contact Patricia Meisol at 410–786– 

1917.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Skilled Nursing 

Facility and Skilled Nursing Facility 

Health Care Complex Cost Report; Use: 

Providers of services participating in the 

Medicare program are required under 

sections 1815(a), 1833(e) and 

1861(v)(1)(A) of the Social Security Act 

(42 U.S.C. 1395g) to submit annual 

information to achieve settlement of 

costs for health care services rendered to 

Medicare beneficiaries. In addition, 

regulations at 42 CFR 413.20 and 413.24 

require adequate cost data and cost 

reports from providers on an annual 

basis. Form CMS–2540–10 is used by 

Skilled Nursing Facilities (SNFs) and 

Skilled Nursing Facility Complexes 

participating in the Medicare program to 

report health care costs to determine the 

amount of reimbursable costs for 

services rendered to Medicare 

beneficiaries. 

Form Number: CMS–2540–10 (OMB 

control number: 0938–0463); Frequency: 

Yearly; Affected Public: Private Sector— 

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

Respondents: 14,185; Total Annual 

Responses: 14,185; Total Annual Hours: 

2,865,370. (For policy questions 

regarding this collection contact Amelia 

Citerone at 410–786–3901.) 

3. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Independent 

Renal Dialysis Facility Cost Report and 

Supporting Regulations; Use: Providers 

of services participating in the Medicare 

program are required under sections 

1815(a) and 1861(v)(1)(A) of the Social 

Security Act (42 U.S.C. 1395g) to submit 

annual information to achieve 

settlement of costs for health care 

services rendered to Medicare 

beneficiaries. In addition, regulations at 

42 CFR 413.20 and 413.24 require 

adequate cost data and cost reports from 

providers on an annual basis. The Form 

CMS–265–11 cost report is needed to 

determine a provider’s reasonable costs 

incurred in furnishing medical services 

to Medicare beneficiaries. 

Form Number: CMS–265–11 (OMB 

control number: 0938–0263); Frequency: 

Yearly; Affected Public: Private Sector— 

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

Respondents: 5,677; Total Annual 

Responses: 5,677; Total Annual Hours: 

369,005. (For policy questions regarding 

this collection contact Gail Duncan at 

410–786–7278.) 

4. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection; 

Title of Information Collection: 

Medicare Authorization to Disclose 

Personal Health Information; Use: 

Unless permitted or required by law, the 


wreier-aviles on DSK5TPTVN1PROD with NOTICES
36518 Federal Register / Vol. 79, No. 124 / Friday, June 27, 2014 / Notices 

Health Insurance Portability and 

Accountability Act (HIPAA) prohibits 

Medicare (a HIPAA covered entity) from 

disclosing an individual’s protected 

health information without a valid 

authorization. In order to be valid, an 

authorization must include specified 

core elements and statements. Medicare 

will make available to Medicare 

beneficiaries a standard, valid 

authorization to enable beneficiaries to 

request the disclosure of their protected 

health information. This standard 

authorization will simplify the process 

of requesting information disclosure for 

beneficiaries and minimize the response 

time for Medicare. Form CMS–10106, 

the Medicare Authorization to Disclose 

Personal Health Information, will be 

used by Medicare beneficiaries to 

authorize Medicare to disclose their 

protected health information to a third 

party. Form Number: CMS–10106 (OMB 

control number: 0938–0930); Frequency: 

Occasionally; Affected Public: 

Individuals or Households; Number of 

Respondents: 1,298,329; Total Annual 

Responses: 1,298,329; Total Annual 

Hours: 324,582. (For policy questions 

regarding this collection contact Sam 

Jenkins at 410–786–3261.) 

5. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Data Use 

Agreement (DUA) for Data Acquired 

from the Centers for Medicare & 

Medicaid Services (CMS); Use: The 

Privacy Act of 1974 allows for 

discretionary releases of data 

maintained in Privacy Act protected 

systems of records under § 552a(b) 

(Conditions of Disclosure). The mandate 

to account for disclosures of data under 

the Privacy Act is found at 

§ 552a(c)(Accounting of Certain 

Disclosures). This section states that 

certain information must be maintained 

regarding disclosures made by each 

agency. This information is: Date, 

Nature, Purpose, and Name/Address of 

Recipient. Section 552a(e) sets the 

overall requirements that each agency 

must meet in order to maintain records 

under the Privacy Act. The Data Use 

Agreement (DUA) form is needed as part 

of the review of each CMS data request 

to ensure compliance with the 

requirements of the Privacy Act for 

disclosures that contain personally 

identifiable information (PII). The DUA 

form also provides data requestors and 

custodians with a formal means to agree 

to the data protection and destruction 

statutory and regulatory requirements of 

CMS’ PII data. The Health Insurance 

Portability and Accountability Act 

(HIPAA) of 1996, § 1173(d) (Security 

Standards for Health Information) 

requires us to protect PII. Additionally, 

the Federal Information Security 

Management Act (FISMA) of 2002, 

§ 3544 (b) (Federal Agency 

Responsibilities—Agency Program) also 

requires us to develop policies and 

procedures for the protection and 

destruction of sensitive data to include 

PII. We use the information collected by 

the DUA to track disclosures, conditions 

for disclosure, accounting of disclosures 

and agency requirements dictated by the 

Privacy Act, HIPAA and FISMA. 

Form Number: CMS–R–235 (OMB 

control number: 0938–0734); Frequency: 

Annually; Affected Public: Private 

sector—business or other for-profits and 

not-for-profit institutions; Number of 

Respondents: 9,220; Total Annual 

Responses: 9,220; Total Annual Hours: 

2,740. (For policy questions regarding 

this collection contact Sharon Kavanagh 

at 410–786–5441.) 

Dated: June 24, 2014. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2014–15075 Filed 6–26–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–370 and CMS– 

377, CMS 437, CMS–10510, CMS–216–94, 

CMS–10494, CMS–10224, CMS–10472 and 

CMS–10499] 

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 July 28, 2014. 

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) 395–5806 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: 


wreier-aviles on DSK5TPTVN1PROD with NOTICES