Federal Register / Vol. 80, No. 79 / Friday, April 24, 2015 / Notices 23011 

of Diabetes Educators’ (AADE) request 

for the Secretary’s approval of its 

accreditation program for outpatient 

DSMT services. The AADE submitted 

all the necessary materials to enable us 

to make a determination concerning its 

request for re-approval as a deeming 

organization for DSMTs. AADE was 

initially accredited on August 27, 2012, 

for a period of 3 years. This application 

was determined to be complete on 

February 27, 2015. This notice also 

solicits public comments on the ability 

of the AADE to continue to develop 

standards that meet or exceed the 

Medicare conditions for coverage and 

apply them to entities furnishing 

outpatient. 

The regulations specifying the 

Medicare conditions for coverage for 

outpatient diabetes self-management 

training services are located in parts 

410, subpart H. These conditions 

implement section 1861(qq) of the Act, 

which provides for Medicare Part B 

coverage of outpatient DSMT services 

specified by the Secretary. 

Under section 1865(a)(2) of the Act 

and our regulations at § 410.142 (CMS 

process for approving accreditation 

organizations) and § 410.143 

(Requirements for approved 

accreditation organizations), we review 

and evaluate a national accreditation 

organization based on (but not 

necessarily limited to) the criteria set 

forth in § 410.142(b). 

We may conduct on-site inspections 

of a national accreditation 

organization’s operations and office to 

verify information in the organization’s 

application and assess the 

organization’s compliance with its own 

policies and procedures. The on-site 

inspection may include, but is not 

limited to, reviewing documents, 

auditing documentation of meetings 

concerning the accreditation process, 

evaluating accreditation results or the 

accreditation status decision making 

process, and interviewing the 

organization’s staff. 

IV. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

V. Response to Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. Upon 

completion of our evaluation, including 

evaluation of comments received as a 

result of this notice, we will publish a 

notice in the Federal Register 

announcing the result of our evaluation. 

Dated: April 7, 2015. 

Andrew M. Slavitt, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2015–09610 Filed 4–23–15; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10392 and CMS– 

10418] 

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 May 26, 2015. 

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: 

1. Type of Information Collection 

Request: Revision of a currently 

approved information collection; Title 

of Information Collection: Consumer 

Operated and Oriented (CO–OP) 

Program; Use: The Consumer Operated 

and Oriented Plan (CO–OP) program 

was established by Section 1322 of the 

Affordable Care Act. This program 

provides for loans to establish at least 

one consumer-operated, qualified 

nonprofit health insurance issuer in 

each State. Issuers supported by the 


tkelley on DSK3SPTVN1PROD with NOTICES
23012 Federal Register / Vol. 80, No. 79 / Friday, April 24, 2015 / Notices 

CO–OP program will offer at least one 

qualified health plan at the silver level 

of benefits and one at the gold level of 

benefits in the individual market State 

Health Benefit Exchanges (Exchanges). 

At least two-thirds of policies or 

contracts offered by a CO–OP will be 

open to individuals and small 

employers. Profits generated by the 

nonprofit CO–OPs will be used to lower 

premiums, improve benefits, improve 

the quality of health care delivered to 

their members, expand enrollment, or 

otherwise contribute to the stability of 

coverage offered by the CO–OP. By 

increasing competition in the health 

insurance market and operating with a 

strong consumer focus, the CO–OP 

program will provide consumers more 

choices, greater plan accountability, 

increased competition to lower prices, 

and better models of care, benefiting all 

consumers, not just CO–OP members. 

The CO–OP program will provide 

nonprofits with loans to fund start-up 

costs and State reserve requirements, in 

the form of Start-up Loans and Solvency 

Loans. An applicant may apply for (1) 

joint Start-up and Solvency Loans; or (3) 

only a Solvency Loan. Planning Loans 

are intended to help loan recipients 

determine the feasibility of operating a 

CO–OP in a target market. Start-up 

Loans are intended to assist loan 

recipients with the many start-up costs 

associated with establishing a new 

health insurance issuer. Solvency Loans 

are intended to assist loan recipients 

with meeting the solvency requirements 

of States in which the applicant seeks to 

be licensed to issue qualified health 

plans. Form Number: CMS–10392 (OMB 

control number 0938–1139); Frequency: 

Occasionally; Affected Public: Private 

Sector (Not-for-profit institutions); 

Number of Respondents: 23; Total 

Annual Responses: 675; Total Annual 

Hours: 93,220. (For policy questions 

regarding this collection contact Deepti 

Loharikar at 301–492–4126.) 

2. Type of Information Collection 

Request: Revision of currently approved 

collection; Title of Information 

Collection: Annual MLR and Rebate 

Calculation Report and MLR Rebate 

Notices; Use: Under Section 2718 of the 

Affordable Care Act and implementing 

regulation at 45 CFR part 158, a health 

insurance issuer (issuer) offering group 

or individual health insurance coverage 

must submit a report to the Secretary 

concerning the amount the issuer 

spends each year on claims, quality 

improvement expenses, non-claims 

costs, Federal and State taxes and 

licensing and regulatory fees, the 

amount of earned premium, and 

beginning with the 2014 reporting year, 

the amounts related to the reinsurance, 

risk corridors, and risk adjustment 

programs established under sections 

1341, 1342, and 1343, respectively, of 

the Affordable Care Act. An issuer must 

provide an annual rebate if the amount 

it spends on certain costs compared to 

its premium revenue (excluding Federal 

and States taxes and licensing and 

regulatory fees) does not meet a certain 

ratio, referred to as the medical loss 

ratio (MLR). An interim final rule (IFR) 

implementing the MLR was published 

on December 1, 2010 (75 FR 74865) and 

modified by technical corrections on 

December 30, 2010 (75 FR 82277), 

which added Part 158 to Title 45 of the 

Code of Federal Regulations. The IFR is 

effective January 1, 2011. A final rule 

regarding selected provisions of the IFR 

was published on December 7, 2011 (76 

FR 76574, CMS–9998–FC) and an 

interim final rule regarding an issue not 

included in issuers’ reporting 

obligations (disbursement of rebates by 

non-federal governmental plans) was 

also published December 7, 2011 (76 FR 

76596, CMS–9998–IFC2). Both rules 

published on December 7, 2011 are 

effective January 1, 2012. Each issuer is 

required to submit annually MLR data, 

including information about any rebates 

it must provide, on a form prescribed by 

CMS, for each State in which the issuer 

conducts business. Each issuer is also 

required to provide a rebate notice to 

each policyholder that is owed a rebate 

and each subscriber of policyholders 

that are owed a rebate for any given 

MLR reporting year. Additionally, each 

issuer is required to maintain for a 

period of seven years all documents, 

records and other evidence that support 

the data included in each issuer’s 

annual report to the Secretary. 

Under Section 1342 of the Patient 

Protection and Affordable Care Act and 

implementing regulation at 45 CFR part 

153, issuers of qualified health plans 

(QHPs) must participate in a risk 

corridors program. A QHP issuer will 

pay risk corridors charges or be eligible 

to receive risk corridors payments based 

on the ratio of the issuer’s allowable 

costs to the target amount. A final rule 

(Premium Stabilization Rule) 

implementing the risk corridors 

program was published on March 23, 

2012 (77 FR 17220), which added part 

153 to title 45 of the Code of Federal 

Regulations. The Premium Stabilization 

Rule is effective May 22, 2012. Final 

rules (2014 Payment Notice, 2015 

Payment Notice, and 2016 Payment 

Notice) outlining the risk corridors 

benefit and payment parameters for the 

2014, 2015, and 2016 benefit years were 

published on March 11, 2013 (78 FR 

15410), March 11, 2014 (79 FR 13744), 

and February 27, 2015 (80 FR 10750), 

respectively. Additionally, on October 

30, 2013, HHS published the Second 

Final Program Integrity rule (78 FR 

65076) to align the risk corridors 

program with the requirements of the 

single risk pool provision at 45 CFR 

156.80. The risk corridors data 

collection applies to QHP issuers the 

individual and small group markets. 

Each QHP issuer is required to submit 

an annual report to CMS concerning the 

issuer’s allowable costs, allowable 

administrative costs, premium, and 

proportion of market premium in QHPs. 

Risk corridors premium information 

that is specific to an issuer’s QHPs is 

collected through a separate data 

reporting form. CMS is publishing the 

risk corridors plan-level reporting form, 

and instructions for completing the form 

for public comment as part of the 

proposed revision to this information 

collection requirement. 

On January 30, 2015, CMS published 

a 60-day notice in the Federal Register 

(80 FR 5118) for the public to submit 

written comments on this information 

collection; the public comment period 

closed on March 31, 2015. As part of the 

60-day notice, CMS updated its annual 

burden hour estimates, including to 

reflect the additional burden (published 

in the 2015 Payment Notice) related to 

the risk corridors data submission 

requirements. The proposed revisions in 

the 60-day notice also made changes 

regarding the new MLR reporting and 

rebate distribution deadlines and the 

accounting for the reinsurance, risk 

adjustment, and risk corridors. We 

received a total of 3 public comments on 

a number of specific issues regarding 

the notice of the revised MLR PRA 

package. We have taken into 

consideration all of the comments and 

has modified the 2014 MLR Annual 

Reporting Form, the Risk Corridors Plan 

Level Data Form, and the accompanying 

Instructions in order to correct minor 

errors and to provide additional 

clarifications. These modifications do 

not affect the previously estimated 

burden hours or costs. Form Number: 

CMS–10418 (OMB control number: 

0938–1164); Frequency: Annually; 

Affected Public: Private sector (Business 

or other for-profits and Not-for-profit 

institutions); Number of Respondents: 

517; Number of Responses: 3,307; Total 

Annual Hours: 271,600. (For policy 

questions regarding this collection, 

contact Julie McCune at (301) 492– 

4196.) 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 79 / Friday, April 24, 2015 / Notices 23013 

Dated: April 21, 2015. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2015–09591 Filed 4–23–15; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–9091–N] 

Medicare and Medicaid Programs; 

Quarterly Listing of Program 

Issuances—January through March 

2015 

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 January through March 

2015, 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. 

Addenda Contact Phone number 

I CMS Manual Instructions .................................................................................................................. Ismael Torres .............. (410) 786–1864 

II Regulation Documents Published in the Federal Register ............................................................. Terri Plumb ................. (410) 786–4481 

III CMS Rulings .................................................................................................................................... Tiffany Lafferty ............ (410)786–7548 

IV Medicare National Coverage Determinations ................................................................................. Wanda Belle ................ (410) 786–7491 

V FDA-Approved Category B IDEs ..................................................................................................... John Manlove .............. (410) 786–6877 

VI Collections of Information ................................................................................................................ Mitch Bryman .............. (410) 786–5258 

VII Medicare –Approved Carotid Stent Facilities ................................................................................. Lori Ashby ................... (410) 786–6322 

VIII American College of Cardiology-National Cardiovascular Data Registry Sites ........................... Marie Casey, BSN, 

MPH.

(410) 786–7861 

IX Medicare’s Active Coverage-Related Guidance Documents .......................................................... JoAnna Baldwin .......... (410) 786–7205 

X One-time Notices Regarding National Coverage Provisions ........................................................... JoAnna Baldwin .......... (410) 786–7205 

XI National Oncologic Positron Emission Tomography Registry Sites ............................................... Stuart Caplan, RN, 

MAS.

(410) 786–8564 

XII Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities ............................ Marie Casey, BSN, 

MPH.

(410) 786–7861 

XIII Medicare-Approved Lung Volume Reduction Surgery Facilities .................................................. Marie Casey, BSN, 

MPH.

(410) 786–7861 

XIV Medicare-Approved Bariatric Surgery Facilities ........................................................................... Jamie Hermansen ....... (410) 786–2064 

XV Fluorodeoxyglucose Positron Emission Tomography for Dementia Trials ................................... Stuart Caplan, RN, 

MAS.

(410) 786–8564 

All Other Information ............................................................................................................................ Annette Brewer ........... (410) 786–6580 

SUPPLEMENTARY INFORMATION: 

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. Format for the Quarterly Issuance 

Notices 

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 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 updates is automatic and 

sent to the subscriber as they occur. If 

assessing a Web site proves to be 

difficult, the contact person listed can 

provide information. 


tkelley on DSK3SPTVN1PROD with NOTICES