Federal Register / Vol. 77, No. 165 / Friday, August 24, 2012 / Notices 51537 

reactions to vaccines. The National 

Vaccine Advisory Committee was 

established to provide advice and make 

recommendations to the Director of the 

National Vaccine Program on matters 

related to the Program’s responsibilities. 

The Assistant Secretary for Health 

serves as Director of the National 

Vaccine Program. 

Among the topics to be discussed at 

the NVAC meeting are: Implementation 

of the National Vaccine Plan, pertussis, 

immunizations and health information 

technology, Healthy People 2020, 

immunization goals, and vaccine 

hesitancy. The meeting agenda will be 

posted on the NVAC Web site: http:// 

www.hhs.gov/nvpo/nvac prior to the 

meeting. 

Public attendance at the meeting is 

limited to space available. Individuals 

who plan to attend and need special 

assistance, such as sign language 

interpretation or other reasonable 

accommodations, should notify the 

National Vaccine Program Office at the 

address/phone listed above at least one 

week prior to the meeting. Members of 

the public will have the opportunity to 

provide comments at the NVAC meeting 

during the public comment periods on 

the agenda. Individuals who would like 

to submit written statements should 

email or fax their comments to the 

National Vaccine Program Office at least 

five business days prior to the meeting. 

Dated: August 21, 2012. 

Bruce Gellin, 

Director, National Vaccine Program Office, 

Executive Secretary, National Vaccine 

Advisory Committee. 

[FR Doc. 2012–20910 Filed 8–23–12; 8:45 am] 

BILLING CODE 4150–44–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meetings of the National Biodefense 

Science Board 

AGENCY: Department of Health and 

Human Services, Office of the Secretary. 

ACTION: Notice. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, the U.S. 

Department of Health and Human 

Services is hereby giving notice that the 

National Biodefense Science Board 

(NBSB) will be holding a closed session 

under exemption 9(B) of the 

Government in Sunshine Act, 5 U.S.C. 

section 552b(c). 

DATES: The closed session of the NBSB 

will take place on September 17, 2012, 

and is tentatively scheduled from 1:30 

p.m. to 3:30 p.m. EST. The agenda and 

time for the session are subject to 

change as priorities dictate. Please 

check the NBSB Web site for the most 

up-to-date information. 

ADDRESSES: The closed session will be 

held by teleconference and/or webinar 

and will not be open to the public as 

stipulated under exemption 9(B) of the 

Government in Sunshine Act, 5 U.S.C. 

section 552b(c). 

FOR FURTHER INFORMATION CONTACT: The 

National Biodefense Science Board 

mailbox: NBSB@HHS.GOV. 

SUPPLEMENTARY INFORMATION: Pursuant 

to section 319M of the Public Health 

Service Act (42 U.S.C. 247d–7f) and 

section 222 of the Public Health Service 

Act (42 U.S.C. 217a), the Department of 

Health and Human Services established 

the National Biodefense Science Board. 

The Board shall provide expert advice 

and guidance to the Secretary on 

scientific, technical, and other matters 

of special interest to the Department of 

Health and Human Services (HHS) 

regarding current and future chemical, 

biological, nuclear, and radiological 

agents, whether naturally occurring, 

accidental, or deliberate. The Board may 

also provide advice and guidance to the 

Secretary and/or the Assistant Secretary 

for Preparedness and Response (ASPR) 

on other matters related to public health 

emergency preparedness and response. 

Background: The NBSB continues to 

review and evaluate the 2012 Public 

Health Emergency Medical 

Countermeasures Enterprise (PHEMCE) 

Strategy and Implementation Plan (SIP). 

Therefore, the Board’s deliberations on 

the PHEMCE SIP task are being 

conducted in closed sessions in 

accordance with provisions set forth 

under exemption 9(B) of the 

Government in Sunshine Act, 5 U.S.C. 

section 552b(c), and with approval by 

the ASPR. For a full description for the 

basis for closing this session, please see 

the previous meeting notice published 

at 77 FR 13129 (2012). 

Availability of Materials: The meeting 

agenda and materials will be posted on 

the NBSB Web site at www.PHE.GOV/ 

NBSB. 

Procedures for Providing Public Input: 

All written comments should be sent by 

email to NBSB@HHS.GOV with ‘‘NBSB 

Public Comment’’ as the subject line. 

Dated: August 20, 2012. 

Nicole Lurie, 

Assistant Secretary for Preparedness and 

Response. 

[FR Doc. 2012–20930 Filed 8–23–12; 8:45 am] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3258–FN] 

Medicare and Medicaid Programs; 

Continued Approval of Det Norske 

Veritas Healthcare’s (DNVHC’s) 

Hospital Accreditation Program 

AGENCY: Centers for Medicare and 

Medicaid Services, HHS. 

ACTION: Final notice. 

SUMMARY: This final notice announces 

our decision to approve the Det Norske 

Veritas Healthcare (DNVHC) for 

continued recognition as a national 

accrediting organization for hospitals 

that wish to participate in the Medicare 

or Medicaid programs. A hospital that 

participates in Medicaid must also meet 

the Medicare conditions of participation 

as referenced in 42 CFR 488.5(3)(b) and 

42 CFR 488.6(b). This approval is 

effective September 26, 2012, through 

September 26, 2018. 

DATES: This final notice is effective 

September 26, 2012, through September 

26, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Barbara Easterling, (410) 786–0482; 

Cindy Melanson, (410) 786–0310; or 

Patricia Chmielewski, (410) 786–6899. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services in a hospital provided certain 

requirements are met. Section 1861(e) of 

the Social Security Act (the Act) 

establishes distinct criteria for facilities 

seeking designation as a hospital. 

Regulations concerning provider 

agreements are at 42 CFR part 489 and 

those pertaining to activities relating to 

the survey and certification of facilities 

are at part 488. The regulations at part 

482 specify the conditions that a 

hospital must meet to participate in the 

Medicare program, the scope of covered 

services and the conditions for Medicare 

payment for hospitals. 

Generally, to enter into an agreement, 

a hospital must first be certified by a 

state survey agency as complying with 

the conditions or requirements set forth 

in part 482. Thereafter, the hospital is 

subject to regular surveys by a state 

survey agency to determine whether it 

continues to meet these requirements. 

However, there is an alternative to 

surveys by state agencies. Certification 

by a nationally recognized accreditation 

program can substitute for ongoing state 

review. 


erowe on DSK2VPTVN1PROD with 
51538 Federal Register / Vol. 77, No. 165 / Friday, August 24, 2012 / Notices 

Section 1865(a)(1) of the Act provides 

that, if a provider entity demonstrates 

through accreditation by an approved 

national accrediting organization (AO) 

that all applicable Medicare conditions 

are met or exceeded, we will deem those 

provider entities as having met the 

requirements. Accreditation by an 

accrediting organization is voluntary 

and is not required for Medicare 

participation. 

If an accrediting organization is 

recognized by the Secretary of the 

Department of Health and Human 

Services as having standards for 

accreditation that meet or exceed 

Medicare requirements, any provider 

entity accredited by the national 

accrediting body’s approved program 

would be deemed to have met the 

Medicare conditions. A national 

accrediting organization applying for 

approval of its accreditation program 

under part 488, subpart A, must provide 

us with reasonable assurance that the 

accrediting organization requires the 

accredited provider entities to meet 

requirements that are at least as 

stringent as the Medicare conditions. 

Our regulations concerning the approval 

of accrediting organizations are set forth 

at § 488.4 and § 488.8(d)(3). The 

regulations at § 488.8(d)(3) require 

accrediting organizations to reapply for 

continued approval of its accreditation 

program every 6 years or sooner as 

determined by us. 

Det Norske Veritas Healthcare’s 

current term of approval for their 

hospital accreditation program expires 

September 26, 2012. 

II. Application Approval Process 

Section 1865(a)(3)(A) of the Act 

provides a statutory timetable to ensure 

that our review of applications for CMSapproval of an accreditation program is 

conducted in a timely manner. The 

statute provides CMS 210 days after the 

date of receipt of a complete 

application, with any documentation 

necessary to make the determination, to 

complete our survey activities and 

application process. Within 60 days 

after receiving a complete application, 

we must publish a notice in the Federal 

Register that identifies the national 

accrediting body making the request, 

describes the request, and provides no 

less than a 30-day public comment 

period. At the end of the 210-day 

period, we must publish a notice in the 

Federal Register approving or denying 

the application. 

III. Provisions of the Proposed Notice 

In the March 23, 2012 Federal 

Register (77 FR 17070), we published a 

proposed notice in the announcing 

DNVHC’s request for approval of its 

hospital accreditation program. In the 

March 23, 2012 proposed notice, we 

detailed our evaluation criteria. Under 

section 1865(a)(2) of the Act and in our 

regulations at § 488.4 and § 488.8, we 

conducted a review of DNVHC’s 

application in accordance with the 

criteria specified by our regulations, 

which include, but are not limited to the 

following: 

• An onsite administrative review of 

DNVHC’s: (1) Corporate policies; (2) 

financial and human resources available 

to accomplish the proposed surveys; (3) 

procedures for training, monitoring, and 

evaluation of its surveyors; (4) ability to 

investigate and respond appropriately to 

complaints against accredited facilities; 

and (5) survey review and decisionmaking process for accreditation. 

• The comparison of DNVHC’s 

accreditation to our current Medicare 

hospital conditions of participation. 

• A documentation review of 

DNVHC’s survey process to determine 

the following: 

+ Determine the composition of the 

survey team, surveyor qualifications, 

and DNVHC’s ability to provide 

continuing surveyor training. 

+ Compare DNVHC’s processes to 

those of state survey agencies, including 

survey frequency, and the ability to 

investigate and respond appropriately to 

complaints against accredited facilities. 

+ Evaluate DNVHC’s procedures for 

monitoring hospitals out of compliance 

with DNVHC’s program requirements. 

The monitoring procedures are used 

only when DNVHC identifies 

noncompliance. If noncompliance is 

identified through validation reviews, 

the state survey agency monitors 

corrections as specified at § 488.7(d). 

+ Assess DNVHC’s ability to report 

deficiencies to the surveyed facilities 

and respond to the facility’s plan of 

correction in a timely manner. 

+ Establish DNVHC’s ability to 

provide us with electronic data and 

reports necessary for effective validation 

and assessment of the organization’s 

survey process. 

+ Determine the adequacy of staff and 

other resources. 

+ Confirm DNVHC’s ability to 

provide adequate funding for 

performing required surveys. 

+ Confirm DNVHC’s policies with 

respect to whether surveys are 

announced or unannounced. 

+ Obtain DNVHC’s agreement to 

provide us with a copy of the most 

current accreditation survey together 

with any other information related to 

the survey as we may require, including 

corrective action plans. 

In accordance with section 

1865(a)(3)(A) of the Act, the March 23, 

2012 proposed notice also solicited 

public comments regarding whether 

DNVHC’s requirements met or exceeded 

the Medicare conditions of participation 

for hospitals. We received two 

comments in response to our proposed 

notice. The commenters expressed 

continued support for DNVHC’s 

hospital accreditation program. In 

addition, the commenters stated 

DNVHC’s standards are closely aligned 

with the hospital conditions of 

participation, thus allowing hospitals to 

be in compliance with the Medicare 

requirements. 

IV. Provisions of the Final Notice 

A. Differences Between DNVHC’s 

Standards and Requirements for 

Accreditation and Medicare’s 

Conditions and Survey Requirements 

We compared DNVHC’s hospital 

requirements and survey process with 

the Medicare conditions of participation 

and survey process as outlined in the 

State Operations Manual (SOM). Our 

review and evaluation of DNVHC’s 

hospital application, which were 

conducted as described in section III. of 

this final notice, yielded the following: 

• To meet the requirements at 

§ 482.13(a), DNVHC revised its 

standards to include language to address 

the hospital’s responsibility to protect 

and promote each patient’s rights. 

• To meet the requirements at 

§ 482.13(a)(2), DNVHC revised its 

standards to require prompt resolution 

of patient grievances. 

• To meet the requirements at 

§ 482.13(b)(3), DNVHC revised its 

standards to include the requirements at 

§ 489.100, § 489.102, § 489.104 

regarding advanced directive. 

• To meet the requirements at 

§ 482.52(b), DNVHC revised its 

standards to ensure anesthesia services 

are consistent with the needs and 

resources of the hospital. 

• To meet the requirements at 

§ 489.13, DNVHC modified its policies 

related to the accreditation effective 

date. 

• To meet the survey process 

requirements in Appendix A of the 

SOM, DNVHC revised its policy 

outlining the minimum number of 

inpatient records required for review 

during an accreditation survey. 

• To meet the requirements at § 488.4, 

DNVHC revised its policies to require a 

copy of the surveyor’s annual evaluation 

be included in the surveyor’s file. 

• DNVHC revised its complaint 

policies to ensure all complaint 

investigations are conducted in 


erowe on DSK2VPTVN1PROD with 
Federal Register / Vol. 77, No. 165 / Friday, August 24, 2012 / Notices 51539 

accordance with the requirements at 

SOM chapter five. 

• DNVHC revised its policies and 

procedures to clarify that they do not 

have authority to advise facilities 

regarding certification issues. Instead, 

DNVHC must contact the CMS Regional 

Office on facility specific certification 

issues for consultation and direction. 

B. Term of Approval 

Based on our review and observations 

described in section III. of this final 

notice, we have determined that 

DNVHC’s requirements for hospitals 

meet or exceed our requirements. 

Therefore, we approve DVNHC as a 

national accreditation organization for 

hospitals that request participation in 

the Medicare program, effective 

September 26, 2012, through September 

26, 2018. 

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 (44 

U.S.C. 35). 

Authority: Section 1865 of the Social 

Security Act (42 U.S.C. 1395bb). 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program; No. 93.773, Medicare—Hospital 

Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: August 9, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2012–20199 Filed 8–23–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1452–NC] 

Medicare and Medicaid Programs; 

Announcement of Application From a 

Hospital Requesting Waiver for Organ 

Procurement Service Area 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice with comment period. 

SUMMARY: This notice with comment 

period announces a hospital’s request 

for a waiver from the requirement to 

have an agreement with its designated 

Organ Procurement Organization (OPO). 

The request was made in accordance 

with section 1138(a)(2) of the Social 

Security Act (the Act). In addition, this 

notice requests comments from OPOs 

and the general public for our 

consideration in determining whether 

we should grant the requested waiver. 

DATES: Comment Date: To be assured 

consideration, comments must be 

received at one of the addresses 

provided below, no later than 5 p.m. on 

October 23, 2012. 

ADDRESSES: In commenting, please refer 

to file code CMS–1452–NC. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Attention: CMS–1452– 

NC, P.O. Box 8010, Baltimore, MD 

21244–1850. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Attention: CMS–1452– 

NC, Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. Alternatively, 

you may deliver (by hand or courier) 

your written comments ONLY to the 

following addresses: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

Federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, call 

telephone number (410) 786–9994 in 

advance to schedule your arrival with 

one of our staff members. 

Comments erroneously mailed to the 

addresses indicated as appropriate for 

hand or courier delivery may be delayed 

and received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Patricia Taft, (410) 786–4561. 

SUPPLEMENTARY INFORMATION: Inspection 

of Public Comments: All comments 

received before the close of the 

comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http:// 

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

Organ Procurement Organizations 

(OPOs) are not-for-profit organizations 

that are responsible for the 

procurement, preservation, and 

transport of organs to transplant centers 

throughout the country. Qualified OPOs 

are designated by the Centers for 

Medicare & Medicaid Services (CMS) to 

recover or procure organs in CMSdefined exclusive geographic service 

areas, pursuant to section 371(b)(1) of 

the Public Health Service Act (42 U.S.C. 

273(b)(1)) and our regulations at 42 CFR 

486.306. Once an OPO has been 

designated for an area, hospitals in that 

area that participate in Medicare and 

Medicaid are required to work with that 

OPO in providing organs for transplant, 

pursuant to section 1138(a)(1)(C) of the 

Social Security Act (the Act) and our 

regulations at 42 CFR 482.45. 

Section 1138(a)(1)(A)(iii) of the Act 

provides that a hospital must notify the 


erowe on DSK2VPTVN1PROD with