Federal Register / Vol. 79, No. 168 / Friday, August 29, 2014 / Notices 51569 

• Do facilitators and barriers that 

impact use vary by health care settings 

and systems? 

• Do facilitators and barriers that 

impact use vary by IT system 

characteristics? 

KQ 8: What factors influence 

sustainability of HIE? 

PICOTS (Populations, Interventions, 

Comparators, Outcomes, Timing, 

Setting) 

Populations 

Any individual or group of health 

care providers, patients, managers, 

health care institutions, or regional 

organizations. 

Intervention 

Heath Information Exchange (HIE). 

HIE is defined as the electronic sharing 

of clinical information among users 

such as health care providers, patients, 

administrators or policy makers across 

the boundaries of health care 

institutions, health data repositories, 

States and others, typically not within a 

single organization or among affiliated 

providers, while protecting the integrity, 

privacy, and security of the information. 

Comparators 

• Time period prior to HIE 

implementation 

• Locations (geographic or 

organizational without HIE) 

• Situations in which HIE is not 

available, akin to ‘‘usual care’’ in a 

clinical study 

• Comparisons across types of HIE 

• Comparisons of the characteristics 

of the different settings, health care 

system, and IT systems in which HIE is 

used 

Outcomes (specified for each Key 

Question) 

KQ 1: Effectiveness is defined in 

terms of clinical outcomes (e.g., 

mortality and morbidity), economic 

outcomes (e.g., costs and resource use, 

the value proposition for HIE) and 

population outcomes (e.g., syndromic 

surveillance for the identification of 

trends or clusters). 

KQ 2: Harms include unintended 

negative consequence or adverse events 

experienced by individuals, institutions, 

or organizations. Harms from HIE may 

include negative outcomes or the risk of 

negative outcomes resulting from 

information that is wrong, not provided 

in a timely manner, or in formats that 

inhibit its identification, 

comprehension, and use. Harms also 

may result from too much information 

as well as lack of information. Harms 

can also include negative impacts on 

attitudes (e.g., patients not trusting the 

privacy will be protected, clinicians’ 

concerns about legal liability). 

KQ 3: Intermediate outcomes include 

outcomes such as provider and patient 

experience and perceptions; changes in 

provider behavior and health care 

processes; and changes in the 

availability, completeness, or accuracy 

of information. 

KQ 4: Level of use is the rate of HIE 

use by individuals, health care 

institutions, or regional organizations. 

KQ 5: Usability focuses on the 

function of the HIE in terms of the 

interaction between users and HIE and 

their ability to navigate and accomplish 

tasks. 

KQ 6: Implementation of HIE is 

defined as the realization of an HIE 

project such that the exchange of data is 

operational. 

KQ 7: Use is the incorporation of the 

HIE into the workflow and decisions of 

patients, providers or organizations. 

KQ 8: Sustainability is long-term 

maintenance, and improvement or 

expansion of HIE, after the 

implementation period. 

Timing 

No minimum duration of time lapsed 

from implementation of HIE to the 

measurement of outcomes. 

Settings 

Any aspect of the setting in which 

health information is exchanged for the 

purpose of improving health or health 

care decisions that is hypothesized to 

impact effectiveness, use, usability or 

sustainability. This may include the 

type(s) of clinical environments (e.g., 

ambulatory care, hospital, nursing 

home, etc.), payment/reimbursement 

model(s) (e.g., fee-for-service, managed 

care setting, risk/value-based model 

such as an accountable care 

organization, etc.), and legislative 

requirements (e.g., participation in HIE 

required to participate in Medicaid). 

Dated: August 20, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–20425 Filed 8–28–14; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10147, CMS– 

2540–10, CMS–265–11, CMS–10106 and 

CMS–10537] 

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 September 29, 

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. 


wreier-aviles on DSK5TPTVN1PROD with NOTICES
51570 Federal Register / Vol. 79, No. 168 / Friday, August 29, 2014 / Notices 

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: Extension of a currently 

approved collection; Title of 

Information Collection: Medicare 

Prescription Drug Coverage and Your 

Rights; Use: Through the delivery of this 

standardized notice, Part D plan 

sponsors’ network pharmacies are in the 

best position to inform enrollees (at the 

point of sale) about how to contact their 

Part D plan if their prescription cannot 

be filled and how to request an 

exception to the Part D plan’s formulary. 

The notice restates certain rights and 

protections related to the enrollees 

Medicare prescription drug benefits, 

including the right to receive a written 

explanation from the drug plan about 

why a prescription drug is not covered. 

Form Number: CMS–10147 (OMB 

control number: 0938–0975); Frequency: 

Occasionally; Affected Public: Private 

sector—Business or other for-profits; 

Number of Respondents: 56,000; Total 

Annual Responses: 37,620,000; Total 

Annual Hours: 626,749. (For policy 

questions regarding this collection 

contact Kathryn M. Smith at 410–786– 

7623). 

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 USC 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 

Health Insurance Portability and 

Accountability Act (HIPAA) Privacy 

Rule (§ 164.508) 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: New collection (Request for a 

new control number); Title of 

Information Collection: National 

Implementation of the Hospice 

Experience of Care Survey (CAHPs 

Hospice Survey); Use: We are requesting 

a three-year clearance from the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 to 

implement the Hospice Experience of 

Care Survey (HECS), also called the 

Consumer Assessment of Healthcare 

Providers and Systems (CAHPS®) 

Hospice Survey, and to conduct an 

assessment of the effects of survey 

administration mode. Under Contract 

Number HHSM–500–2014–00350G, the 

project team will implement and 

analyze a hospice experience of care 

survey for primary caregivers (i.e., 

bereaved family members or close 

friends) of patients who died while 

receiving hospice care (‘‘decedents’’). 

Specifically, we will: (1) Implement a 

survey to collect data on experiences of 

hospice care, and (2) conduct an 

experiment to examine effects of survey 

mode (i.e., mail-only, telephone-only, 

and mail with telephone follow-up). 

This survey supports the National 

Quality Strategy developed by the U.S. 

Department of Health and Human 

Services (HHS) that was called for under 

the Affordable Care Act to create 

national aims and priorities to guide 

local, state, and national efforts to 


wreier-aviles on DSK5TPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 168 / Friday, August 29, 2014 / Notices 51571 

improve the quality of health care. This 

strategy has established six priorities 

that support a three-part aim focusing 

on better care, better health, and lower 

costs through improvement. The six 

priorities include: Making care safer by 

reducing harm caused by the delivery of 

care; ensuring that each person and 

family are engaged as partners in their 

care; promoting effective 

communication and coordination of 

care; promoting the most effective 

prevention and treatment practices for 

the leading causes of mortality, starting 

with cardiovascular disease; working 

with communities to promote wide use 

of best practices to enable healthy 

living; and making quality care more 

affordable for individuals, families, 

employers, and governments by 

developing and spreading new health 

care delivery models. Because the 

hospice survey focuses on experiences 

of care, implementation of the survey 

supports the following national 

priorities for improving care: Engaging 

patients and families in care and 

promoting effective communication and 

coordination. In addition, national 

implementation and public reporting of 

hospice survey results will provide data 

on experiences with hospice care that 

enable consumers to make meaningful 

comparisons between hospices across 

the nation. 

Form Number: CMS–10537 (OMB 

control number: 0938–New); Frequency: 

Occasionally; Affected Public: 

Individuals or Households; Number of 

Respondents: 561,026; Total Annual 

Responses: 561,026; Total Annual 

Hours: 98,179.55. (For policy questions 

regarding this collection contact Lori 

Teichman at 410–786–6684.) 

Dated: August 26, 2014. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2014–20589 Filed 8–28–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–10536] 

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 

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 

October 28, 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 Numberlllll, 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–10536 Medicaid Eligibility and 

Enrollment (EE) Implementation 

Advanced Planning Document (IAPD) 

Template 

Under the 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: Medicaid 

Eligibility and Enrollment (EE) 

Implementation Advanced Planning 

Document (IAPD) Template; Use: To 

assess the appropriateness of states’ 

requests for enhanced federal financial 

participation for expenditures related to 

Medicaid eligibility determination 

systems, we will review the submitted 

information and documentation to make 

an approval determination for the 

advanced planning document. 

Form Number: CMS–10536 (OMB 

control number: 0938-New); Frequency: 

Yearly, once, and occasionally; Affected 

Public: State, Local, or Tribal 

Governments; Number of Respondents: 

56; Total Annual Responses: 168; Total 

Annual Hours: 1,344. (For policy 

questions regarding this collection 

contact Christine Gerhardt at 410–786– 

0693). 


wreier-aviles on DSK5TPTVN1PROD with NOTICES