77470 Federal Register / Vol. 78, No. 246 / Monday, December 23, 2013 / Notices 

1Certain authority under the Affordable Care Act 

has been delegated from the Secretary to the 

Administrator of CMS. 76 FR 53903 through 53906, 

(August 30, 2011). 

2Patient Protection and Affordable Care Act; 

Standards Related to Essential Health Benefits, 

Actuarial Value, and Accreditation; Final Rule, 78 

FR 12834, 12854–12855 (February 25, 2013) (45 

CFR 156.275(c)). 

3Health Insurance Exchanges; Application by the 

Accreditation Association for Ambulatory Health 

Care To Be a Recognized Accrediting Entity for the 

Accreditation of Qualified Health Plans; 78 FR 

56711–56714 (September 13, 2013). 

recommendations must be received in 

one of the following ways by January 2, 

2014: 

1. Electronically. You may submit 

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) 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 (CMS– 

10510), Room C4–26–05, 7500 Security 

Boulevard, Baltimore, Maryland 21244– 

1850 and, OMB Office of Information 

and Regulatory Affairs, Attention: CMS 

Desk Officer, New Executive Office 

Building, Room 10235, Washington, DC 

20503, Fax Number: 202–395–6974. 

Dated: December 17, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–30434 Filed 12–18–13; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–9953–FN] 

Health Insurance Exchanges; Approval 

of an Application by the Accreditation 

Association for Ambulatory Health 

Care (AAAHC) To Be a Recognized 

Accrediting Entity for the Accreditation 

of Qualified Health Plans 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final notice. 

SUMMARY: This final notice announces 

our decision to approve the 

Accreditation Association for 

Ambulatory Health Care (AAAHC) for 

recognition as an accrediting entity for 

the purposes of fulfilling the 

accreditation requirement as part of 

qualified health plan (QHP) 

certification. 

DATE: This notice is effective on 

December 23, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Rebecca Zimmermann, (301) 492–4396. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Regulations at 45 CFR 156.275(c) 

require qualified health plan (QHP) 

issuers to be accredited on the basis of 

local performance of its QHPs by an 

accrediting entity recognized by the 

Secretary (the Secretary) of the 

Department of Health and Human 

Services (HHS). In a final rule published 

on July 20, 2012 titled, ‘‘Data Collection 

To Support Standards Related to 

Essential Health Benefits; Recognition of 

Entities for the Accreditation of 

Qualified Health Plans (77 FR 42658),’’ 

we established the first phase of an 

intended two-phase approach to 

recognize accrediting entities and 

proposed both the National Committee 

for Quality Assurance (NCQA) and 

URAC as recognized accrediting 

entities. On November 23, 2012, we 

notified the public that NCQA and 

URAC had both met the requirements in 

the July 2012 final rule to be recognized 

as accrediting entities 

(§ 156.275(c)(1)(iv)) and were 

recognized by the Secretary 1 as 

accrediting entities for the purposes of 

QHP certification. 

On February 25, 2013, we published 

a subsequent final rule, titled, 

‘‘Standards Related to Essential Health 

Benefits, Actuarial Value, and 

Accreditation’’ (78 FR 12834),2 which 

amended § 156.275(c) to establish an 

application and review process to allow 

additional accrediting entities to seek 

recognition. The application submitted 

by an accrediting entity must include 

documentation described in 

§ 156.275(c)(4) and demonstrate, in a 

concise and organized fashion, how the 

accrediting entity meets the 

requirements of § 156.275(c)(2) and (3). 

Specifically, to be recognized, an 

accrediting entity must provide current 

accreditation standards and 

requirements, processes, and measure 

specifications for performance measures 

to demonstrate via a crosswalk that it 

meets the conditions described in 

§ 156.275(c)(2) and (c)(3). Further, once 

recognized, § 156.275(c)(4)(ii) requires 

accrediting entities to provide the 

Secretary with any proposed changes or 

updates to the accreditation standards 

and requirements, processes, and 

measure specifications for performance 

measures with 60 days’ notice prior to 

public notification. Lastly, 

§ 156.275(c)(5) requires recognized 

accrediting entities, when authorized by 

an accredited QHP issuer, to provide 

specific QHP issuer accreditation survey 

data elements, other than personally 

identifiable information, to the 

Exchange in which the issuer plans to 

operate one or more QHPs during the 

annual certification or as changes occur 

in the data elements throughout the 

coverage year. 

II. Provisions of the Proposed Notice 

On September 13, 2013, we published 

in the Federal Register a proposed 

notice 3 announcing the receipt of an 

application from the Accreditation 

Association for Ambulatory Health Care 

(AAAHC) to be a recognized accrediting 

entity for the purposes of fulfilling the 

accreditation requirement as part of 

qualified health plan certification. In the 

proposed notice, we provided a detailed 

analysis of whether AAAHC meet the 

requirements as specified in our 

regulations at § 156.275. In addition, we 

solicited public comments on whether it 

was appropriate to recognize AAAHC as 

an accrediting entity for the purpose of 

QHP certification; AAAHC’s 

accreditation standards for QHP issuers 

including whether or not AAAHC’s 

standards meet the requirements in 

§ 156.275; whether AAAHC had any 

deficiencies in its standards; the content 

of the proposed clinical quality 

measures and their appropriateness for 

use in QHP accreditation; the rigor of 

the scoring methodology; and if the 

network adequacy standards will ensure 

sufficient network of providers for QHP 

enrollees. 

III. Analysis of and Response to Public 

Comments on the Proposed Notice 

We received nine public comments in 

response to the September 13, 2013 

proposed notice. Five commenters 

supported the recommendation to 

recognize AAAHC as an accrediting 

entity for the purposes of QHP 

accreditation; whereas two commenters 

did not support the proposal to 

recognize AAAHC as an accrediting 

entity. Two commenters provided 

comments that were outside the scope 

of the proposed notice. 

One commenter questioned the 

comparability of AAAHC’s standards to 

other HHS-recognized accrediting 

entities. Another commenter requested 

that more child measures be included in 

the clinical quality metrics. Both of 

these commenters thought that the 

accreditation standards were not 

sufficiently transparent. 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 246 / Monday, December 23, 2013 / Notices 77471 

4 Delegated to CCIIO, 76 FR 53903 through 53906 

(August 30, 2011). 

While there may be some instances 

where AAAHC’s standards differ from 

other recognized accrediting entities, 

AAAHC has met the criteria to be 

recognized by HHS based on our 

standards in § 156.275(c). We believe 

there is a sufficient number of measures 

applicable to children included in the 

proposed clinical quality metrics and 

further note that the AAAHC’s measure 

set is identical to the set used by a 

different HHS-recognized accrediting 

entity (that is, URAC). Lastly, the 

accreditation standards are propriety 

documents and we have not required 

any of the recognized accrediting 

entities to make their standards public. 

Therefore, we cannot require AAAHC to 

make their standards public. 

In addition, we have previously 

indicated that we may, at a later date, 

modify the recognition process of 

accrediting entities and will solicit 

comments on any proposed future 

rulemaking that time. 

IV. Provisions of the Final Notice 

Upon completion of our analysis, 

including evaluation of comments 

received as a result of the proposed 

notice, we have determined that the 

AAAHC meets the requirements and 

criteria described in the July 20, 2012 

final rule, titled ‘‘Data Collection To 

Support Standards Related to Essential 

Health Benefits; Recognition of Entities 

for the Accreditation of Qualified Health 

Plans’’ (77 FR 42658) to be recognized 

as an accrediting entity. This final 

notice acknowledges the approval of 

AAAHC’s application. The AAAHC is 

now recognized by the Secretary of 

HHS 4 as an accrediting entity for the 

purposes of QHP certification. 

V. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995. 

Dated: December 17, 2013. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2013–30522 Filed 12–20–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License for: Convection Enhanced 

Delivery of a Therapeutic Agent With a 

Surrogate Tracer for Treating Cancer 

and Urological Diseases 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: This is notice, in accordance 

with 35 U.S.C. 209 and 37 CFR 404.7, 

that the National Institutes of Health 

(NIH), Department of Health and Human 

Services, is contemplating the grant of 

an exclusive worldwide license to 

practice the inventions embodied in: 

HHS Ref. No E–202–2002/0 ‘‘Method for 

Convection Enhanced Delivery of 

Therapeutic Agents’’, U.S. Provisional 

Patent Application 60/413,673 (filed 

September 24, 2002; expired), 

International Patent Application No. 

PCT/US2003/30155 (filed September 24, 

2003; nationalized), U.S. Patent 

Application 7,371,225, European Patent 

Application 03756863.1, Australian 

Patent 2003299140, to Medicenna 

Therapeutics, Inc. having a principle 

place of business in 1075 West Georgia 

St., Vancouver, BC, Canada V6E 3C9. 

The United States of America is an 

assignee to the patent rights of these 

inventions. 

The contemplated exclusive license 

may be in a field of use directed to the 

treatment of cancers and urological 

disorders that express IL–4 receptor on 

their cell surface by administering 

cpIL4–PE38KDEL by convection 

enhanced deliver along with a Gd-DTPA 

surrogate tracer. 

DATES: Only written comments and/or 

applications for a license that are 

received by the NIH Office of 

Technology Transfer on or before 

January 22, 2014 will be considered. 

ADDRESSES: Requests for a copy of the 

patent application, inquiries, comments 

and other materials relating to the 

contemplated license should be directed 

to: Michael Shmilovich, Esq, CLP, 

Senior Licensing and Patent Manager, 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, MD 

20852–3804; Telephone: (301) 435– 

5019; Facsimile: (301) 402–0220; Email: 

shmilovm@mail.nih.gov. A signed 

confidential disclosure agreement may 

be required to receive copies of the 

patent application assuming it has not 

already been published under either the 

publication rules of either the U.S. 

Patent and Trademark Office or the 

World Intellectual Property 

Organization. 

SUPPLEMENTARY INFORMATION: The 

invention is a method for monitoring 

the spatial distribution of therapeutic 

substances by MRI or CT that have been 

administered to tissue using convection 

enhanced delivery, a technique that is 

the subject of now expired NIH-owned 

U.S. Patent No. 5,720,720 (HHS Ref. E– 

173–1992/0). The tracer is a molecule, 

detectable by MRI or CT, which 

functions as a surrogate for the motion 

of the therapeutic agent through the 

solid tissue. In other particular 

embodiments, the tracer is the 

therapeutic agent conjugated to an 

imaging moiety. The method of this 

invention uses non-toxic 

macromolecular MRI contrast agents 

such as chelated Gd(III). These 

macromolecular imaging agents have 

clearance properties that mimic the 

pharmacokinetic properties of coadministrated drugs, so as to be useful 

in quantifying the range and dosage 

level of therapeutic drugs using MR 

imaging. 

The prospective exclusive license will 

be royalty-bearing and comply with the 

terms and conditions of 35 U.S.C. 209 

and 37 CFR 404.7. The prospective 

exclusive license may be granted unless, 

within 30 days from the date of this 

published notice, NIH receives written 

evidence and argument that establishes 

that the grant of the license would not 

be consistent with the requirements of 

35 U.S.C. 209 and 37 CFR 404.7. 

Properly filed competing applications 

for a license filed in response to this 

notice will be treated as objections to 

the contemplated license. Comments 

and objections submitted in response to 

this notice will not be made available 

for public inspection, and, to the extent 

permitted by law, will not be released 

under the Freedom of Information Act, 

5 U.S.C. 552. 

Dated: December 17, 2013. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2013–30430 Filed 12–20–13; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Clinical Center; Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 


tkelley on DSK3SPTVN1PROD with NOTICES