67150 Federal Register / Vol. 78, No. 217 / Friday, November 8, 2013 / Notices 

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 

January 7, 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 Number ____, 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–R–216 Procedures for Advisory 

Opinions Concerning Physicians’ 

Referrals and Supporting Regulations 

Under the Paperwork Reduction Act 

(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 Collections 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Procedures for 

Advisory Opinions Concerning 

Physicians’ Referrals and Supporting 

Regulations; Use: The information 

collection requirements contained in 42 

CFR 411.372 and 411.373 allow us to 

consider requests for advisory opinions 

and provide accurate and useful 

opinions. The information is read and 

analyzed to develop and issue an 

advisory opinion to the individual or 

entity that submitted the information. 

The primary office using the 

information is the Center for Medicare, 

which is responsible for the issuance of 

advisory opinions. Form Number: CMS– 

R–216 (OCN: 0938–0714); Frequency: 

Occasionally; Affected Public: Private 

sector—Business or other for-profits and 

Not-for-profit institutions; Number of 

Respondents: 25; Total Annual 

Responses: 25; Total Annual Hours: 

500. (For policy questions regarding this 

collection contact Jacqueline Proctor at 

410–786–0661). 

Dated: November 5, 2013. 

Martique Jones 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–26829 Filed 11–7–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10171, CMS– 

10207, CMS–10476, CMS–10497, CMS– 

10482, CMS–R–245 and CMS–10495] 

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 December 9, 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, 


TKELLEY on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 217 / Friday, November 8, 2013 / Notices 67151 

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: Revision of a currently 

approved collection; Title of 

Information Collection: Coordination of 

Benefits Between Part D Plans and 

Other Prescription Coverage Providers; 

Use: We will use the information along 

with Part D plans, other health insurers 

or payers, and pharmacies to coordinate 

prescription drug benefits provided to 

Medicare beneficiaries. Form Number: 

CMS–10171 (OCN: 0938–0978); 

Frequency: Occasionally; Affected 

Public: Private sector—Business or other 

for-profits; Number of Respondents: 

57,116; Total Annual Responses: 

2,402,582; Total Annual Hours: 

5,205,128. (For policy questions 

regarding this collection contact Heather 

Rudo at 410–786–7627.) 

2. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection; 

Title of Information Collection: 

Physician Self-Referral Exceptions for 

Electronic Prescribing and Electronic 

Health Records; Use: The collected 

information would be used for 

enforcement purposes. Specifically, if 

we were investigating the financial 

relationships between donors and 

physicians to determine whether the 

provisions in the exceptions at 42 CFR 

411.357 (v) and (w) were met, first, we 

would review the written agreements 

that indicate what items and services 

each entity intended to provide. Form 

Number: CMS–10207 (OCN: 0938– 

1009); Frequency: Monthly; Affected 

Public: Private sector—Business or other 

for-profits and Not-for-profit 

institutions; Number of Respondents: 

9,409; Total Annual Responses: 17,744; 

Total Annual Hours: 1,896. (For policy 

questions regarding this collection 

contact Michael Zleit at 410–786–2050.) 

3. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Medical Loss 

Ratio (MLR) Report for Medicare 

Advantage (MA) Plans and Prescription 

Drug Plans (PDP); Use: We will use the 

data collection of annual reports 

provided by plan sponsors for each 

contract to ensure that beneficiaries are 

receiving value for their premium dollar 

by calculating each contract’s medical 

loss ratio (MLR) and any remittances 

due for the respective MLR reporting 

year. The recordkeeping requirements 

will be used to determine plan sponsors’ 

compliance with the MLR requirements, 

including compliance with how plan 

sponsors’ experience is to be reported, 

and how their MLR and any remittances 

are calculated. Form Number: CMS– 

10476 (OCN: 0938–New); Frequency: 

Yearly; Affected Public: Private sector— 

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

Respondents: 616; Total Annual 

Responses: 616; Total Annual Hours: 

130,004. (For policy questions regarding 

this collection contact Ilina Chaudhuri 

at 410–786–8628.) 

4. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Evaluation of 

the Medicare Health Care Quality 

(MHCQ) Demonstration Evaluation: 

Focus Group and Interview Protocols; 

Use: The Medicare Health Care Quality 

(MHCQ) Demonstration was developed 

to address concerns about the U.S. 

health care system, which typically 

fragments care while also encouraging 

both omissions in and duplication of 

care. To rectify this situation, Congress 

has directed us to test major changes to 

the delivery and payment systems to 

improve the quality of care while also 

increasing efficiency across the health 

care system. This would be achieved 

through several types of interventions: 

adoption and use of information 

technology and decision support tools 

by physicians and their patients, such as 

evidence-based medicine guidelines, 

best practice guidelines, and shared 

decision-making programs; reform of 

payment methodologies; improved 

coordination of care among payers and 

providers serving defined communities; 

measurement of outcomes; and 

enhanced cultural competence in the 

delivery of care. 

The MHCQ Demonstration programs 

are designed to examine the extent to 

which major, multifaceted changes to 

traditional Medicare’s health delivery 

and financing systems lead to 

improvements in the quality of care 

provided to Medicare beneficiaries 

without increasing total program 

expenditures. Each demonstration site 

uses a different approach for changing 

health delivery and financing systems, 

but all share the goal of improving the 

quality and efficiency of medical care 

provided to Medicare beneficiaries. 

Focus groups and individual interviews 

will be conducted at 2 demonstration 

sites that are active in the 

demonstration: Gundersen Health 

System (GHS) and Meridian Health 

System (MHS). 

This MHCQ Demonstration evaluation 

will include analysis of both 

quantitative and qualitative sources of 

information. This multifaceted approach 

will enable this evaluation to consider 

a broad variety of evidence for 

evaluating the nature and impact of 

each site’s interventions. We are seeking 

approval to conduct in-person focus 

groups and individual interviews with 

beneficiaries and their caregivers to 

inform our evaluation of the MHCQ 

Demonstration at the GHS and MHS 

demonstration sites. Form Number: 

CMS–10497 (OCN: 0938–New); 

Frequency: Occasionally; Affected 

Public: Individuals or households; 

Number of Respondents: 36; Total 

Annual Responses: 36; Total Annual 

Hours: 108. (For policy questions 

regarding this collection contact 

Normandy Brangan at 410–786–6640.) 

5. Type of Information Collection 

Request: New Collection (Request for a 

new OMB control number); Title of 

Information Collection: Evaluation of 

the Physician Quality Reporting System 

(PQRS) and Electronic Prescribing (eRx) 

Incentive Program; Use: The Physician 

Quality Reporting System (PQRS) was 

first implemented in 2007 as an 

incentive for voluntary reporting of 

quality measures in accordance with a 

section of the Tax Relief and Health 

Care Act of 2006. The PQRS was further 

extended and enhanced by legislation 

such as the Medicare, Medicaid, and 

State Children’s Health Insurance 

Program (SCHIP) Extension Act of 2007 

(MMSEA) and the Medicare 

Improvements for Patients and 

Providers Act of 2008 (MIPPA). A 

number of changes have been made to 

the PQRS, including group measures, 

the group reporting option, and 


TKELLEY on DSK3SPTVN1PROD with NOTICES
67152 Federal Register / Vol. 78, No. 217 / Friday, November 8, 2013 / Notices 

additional measures. The PQRS was 

extended further with the enactment of 

MMSEA. The MMSEA provided 

professionals greater flexibility for 

participating in the PQRS for 2008 and 

2009 by authorizing us to establish 

alternative reporting criteria and 

alternative reporting periods for the 

reporting measures groups and for the 

submission of data on the PQRS quality 

measures through clinical data 

registries. The MIPPA, enacted in July 

2008, made the PQRS program 

permanent, further enhanced the PQRS, 

and established a new standalone 

incentive program for successful 

electronic prescribers. 

The eRx Incentive Program, the other 

program being evaluated in this project, 

was first implemented in 2009. The eRx 

is another incentive reporting program 

that uses a combination of incentive 

payments and payment adjustments to 

encourage eRx by eligible professionals. 

The program provides an incentive 

payment to practices with eligible 

professionals who successfully eprescribe for covered Physician Fee 

Schedule services furnished to Medicare 

Part B Fee-For-Service (FFS) 

beneficiaries. Eligible professionals do 

not need to participate in PQRS to 

participate in the eRx Incentive 

Program. 

In support of an evaluation the PQRS 

and the eRx Incentive Program, we will 

conduct three surveys. The surveys will 

include: Medicare beneficiaries, eligible 

professionals, and administrators. This 

evaluation is designed to determine how 

well the PQRS and the eRx Incentive 

Program are contributing to better and 

affordable health care for Medicare 

beneficiaries. The PQRS is a voluntary 

reporting program that provides an 

incentive payment to eligible 

professionals who satisfactorily report 

data on quality measures. We use 

quality measures to promote 

improvements in care delivery and 

payment and to increase transparency. 

The PQRS program rewards eligible 

professionals based on a percentage of 

the estimated Medicare Physician Fee 

Schedule of their allowed Part B charges 

if they meet the defined reporting 

requirements. The PQRS was initially 

referred to as the Physician Quality 

Reporting Initiative (PQRI). 

Subsequent to the publication of the 

60-day Federal Register notice (78 FR 

35936), there has been an increase in 

burden due to the increase in the 

sample size of eligible professionals and 

administrators. Also, the surveys have 

been changed by revising lists of 

specialties and revising questions. Form 

Number: CMS–10482 (OCN: 0938– 

NEW); Frequency: Yearly; Affected 

Public: Individuals and households, 

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

Number of Respondents: 12,650; Total 

Annual Responses: 12,650; Total 

Annual Hours: 3,805. (For policy 

questions regarding this collection 

contact Lauren Fuentes at 410–786– 

2290.) 

6. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: OASIS 

Collection Requirements as Part of the 

CoPs for HHAs and Supporting 

Regulations; Use: The Outcome and 

Assessment Information Set (OASIS) is 

currently mandated for use by Home 

Health Agencies (HHAs) as a condition 

of participation (CoP) in the Medicare 

program. Since 1999, the Medicare CoPs 

have mandated that HHAs use the 

OASIS data set when evaluating adult 

non-maternity patients receiving skilled 

services. The OASIS is a core standard 

assessment data set that agencies 

integrate into their own patient-specific, 

comprehensive assessment to identify 

each patient’s need for home care that 

meets the patient’s medical, nursing, 

rehabilitative, social, and discharge 

planning needs. Subsequent to the 

publication of the 60-day Federal 

Register notice (78 FR 37542), the data 

set was revised by rewording the text. 

Form Number: CMS–R–245 (OCN: 

0938–0760); Frequency: Occasionally; 

Affected Public: Private Sector— 

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

Respondents: 12,014; Total Annual 

Responses: 17,268,890; Total Annual 

Hours: 15,305,484. (For policy questions 

regarding this collection contact Robin 

Dowell at 410–786–0060.) 

7. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Registration, 

Attestation, Dispute & Resolution, 

Assumptions Document and Data 

Retention Requirements for Open 

Payments; Use: Section 6002 of the 

Affordable Care Act added section 

1128G to the Social Security Act (Act), 

which requires applicable 

manufacturers and applicable group 

purchasing organizations (GPOs) of 

covered drugs, devices, biologicals, or 

medical supplies to report annually to 

CMS certain payments or other transfers 

of value to physicians and teaching 

hospitals, as well as, certain information 

regarding the ownership or investment 

interests held by physicians or their 

immediate family members in 

applicable manufacturers or applicable 

GPOs. 

Specifically, applicable manufacturers 

of covered drugs, devices, biologicals, 

and medical supplies are required to 

submit on an annual basis the 

information required in section 

1128G(a)(1) of the Act about certain 

payments or other transfers of value 

made to physicians and teaching 

hospitals (collectively called covered 

recipients) during the course of the 

preceding calendar year. Similarly, 

section 1128G(a)(2) of the Act requires 

applicable manufacturers and 

applicable GPOs to disclose any 

ownership or investment interests in 

such entities held by physicians or their 

immediate family members, as well as 

information on any payments or other 

transfers of value provided to such 

physician owners or investors. 

Applicable manufacturers must report 

the required payment and other transfer 

of value information annually to CMS in 

an electronic format. The statute also 

provides that applicable manufacturers 

and applicable GPOs must report 

annually to CMS the required 

information about physician ownership 

and investment interests, including 

information on any payments or other 

transfers of value provided to physician 

owners or investors, in an electronic 

format by the same date. Applicable 

manufacturers and applicable GPOs are 

subject to civil monetary penalties 

(CMPs) for failing to comply with the 

reporting requirements of the statute. 

We are required by statute to publish 

the reported data on a public Web site. 

The data must be downloadable, easily 

searchable, and aggregated. In addition, 

we must submit annual reports to the 

Congress and each state summarizing 

the data reported. Finally, section 

1128G of the Act generally preempts 

state laws that require disclosure of the 

same type of information by 

manufacturers. 

We published a final rule in 2013 to 

implement this program, which 

included several information collections 

subject to the Paperwork Reduction Act. 

This information collection request is to 

inform the public about information 

collected that is necessary for 

registration, attestation, dispute 

resolution and corrections, record 

retention, and submitting an 

assumptions document within Open 

Payments. Form Number: CMS–10495 

(OCN: 0938-New); Frequency: Once; 

Affected Public: Private sector— 

Business or other for-profits; Number of 

Respondents: 451,582; Total Annual 

Responses: 451,582; Total Annual 

Hours: 949,005. (For policy questions 

regarding this collection contact Melissa 

Heesters at 410–786–0618.) 


TKELLEY on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 217 / Friday, November 8, 2013 / Notices 67153 

Dated: November 5, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–26822 Filed 11–7–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–9081–N] 

Medicare and Medicaid Programs; 

Quarterly Listing of Program 

Issuances—July Through September 

2013 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This quarterly notice lists 

CMS manual instructions, substantive 

and interpretive regulations, and other 

Federal Register notices that were 

published from July through September 

2013, relating to the Medicare and 

Medicaid programs and other programs 

administered by CMS. 

FOR FURTHER INFORMATION CONTACT: It is 

possible that an interested party may 

need specific information and not be 

able to determine from the listed 

information whether the issuance or 

regulation would fulfill that need. 

Consequently, we are providing contact 

persons to answer general questions 

concerning each of the addenda 

published in this notice. 

I. Background 

The Centers for Medicare & Medicaid 

Services (CMS) is responsible for 

administering the Medicare and 

Medicaid programs and coordination 

and oversight of private health 

insurance. Administration and oversight 

of these programs involves the 

following: (1) Furnishing information to 

Medicare and Medicaid beneficiaries, 

health care providers, and the public; 

and (2) maintaining effective 

communications with CMS regional 

offices, state governments, state 

Medicaid agencies, state survey 

agencies, various providers of health 

care, all Medicare contractors that 

process claims and pay bills, National 

Association of Insurance Commissioners 

(NAIC), health insurers, and other 

stakeholders. To implement the various 

statutes on which the programs are 

based, we issue regulations under the 

authority granted to the Secretary of the 

Department of Health and Human 

Services under sections 1102, 1871, 

1902, and related provisions of the 

Social Security Act (the Act) and Public 

Health Service Act. We also issue 

various manuals, memoranda, and 

statements necessary to administer and 

oversee the programs efficiently. 

Section 1871(c) of the Act requires 

that we publish a list of all Medicare 

manual instructions, interpretive rules, 

statements of policy, and guidelines of 

general applicability not issued as 

regulations at least every 3 months in 

the Federal Register. 

II. Revised Format for the Quarterly 

Issuance Notices 

While we are publishing the quarterly 

notice required by section 1871(c) of the 

Act, we will no longer republish 

duplicative information that is available 

to the public elsewhere. We believe this 

approach is in alignment with CMS’ 

commitment to the general principles of 

the President’s Executive Order 13563 

released January 2011entitled 

‘‘Improving Regulation and Regulatory 

Review,’’ which promotes modifying 

and streamlining an agency’s regulatory 

program to be more effective in 

achieving regulatory objectives. Section 

6 of Executive Order 13563 requires 

agencies to identify regulations that may 

be ‘‘outmoded, ineffective, insufficient, 

or excessively burdensome, and to 

modify, streamline, expand or repeal 

them in accordance with what has been 

learned.’’ This approach is also in 

alignment with the President’s Open 

Government and Transparency Initiative 

that establishes a system of 

transparency, public participation, and 

collaboration. 

Therefore, this quarterly notice 

provides only the specific updates that 

have occurred in the 3-month period 

along with a hyperlink to the full listing 

that is available on the CMS Web site or 

the appropriate data registries that are 

used as our resources. This information 

is the most current up-to-date 

information and will be available earlier 

than we publish our quarterly notice. 

We believe the Web site list provides 

more timely access for beneficiaries, 

providers, and suppliers. We also 

believe the Web site offers a more 

convenient tool for the public to find 

the full list of qualified providers for 

these specific services and offers more 

flexibility and ‘‘real time’’ accessibility. 

In addition, many of the Web sites have 

listservs; that is, the public can 

subscribe and receive immediate 

notification of any updates to the Web 

site. These listservs avoid the need to 

check the Web site, as notification of 


TKELLEY on DSK3SPTVN1PROD with NOTICESEN08NO13.000</GPH>