64344 Federal Register / Vol. 77, No. 203 / Friday, October 19, 2012 / Notices 

(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. 

1. Type of Information Collection 

Request: New collection; Title of 

Information Collection: Minimum Data 

Set for Medicaid Incentives for 

Prevention of Chronic Diseases Program 

Grantees; Use: The Medicaid Incentives 

for Prevention of Chronic Diseases 

(MIPCD) demonstration program 

provides grants to states to implement 

programs that provide incentives to 

Medicaid beneficiaries of all ages who 

participate in prevention programs and 

demonstrate changes in health risk and 

outcomes, including the adoption of 

healthy behaviors. The prevention 

programs address at least one of the 

following prevention goals: tobacco 

cessation, controlling or reducing 

weight, lowering cholesterol, lowering 

blood pressure, and avoiding the onset 

of diabetes or in the case of a diabetic, 

improving the management of the 

condition. The programs are also 

comprehensive, widely available, easily 

accessible, and based on relevant 

evidence-based research and resources, 

including: the Guide to Community 

Preventive Services; the Guide to 

Clinical Preventive Services; and the 

National Registry of Evidence-Based 

Programs. 

The proposed information collection, 

the MIPCD Minimum Data Set (MDS), is 

intended to collect data for program 

performance monitoring and evaluation. 

The MDS is a secondary data collection 

that assembles information already 

collected by grantees in the course of 

tracking beneficiary participation and 

outcomes and performing their own 

evaluation activities. Data collected 

through the MDS will be used to report 

on program implementation and 

evaluation to CMS and the Congress. 

Form Number: CMS–10444 (OCN: 

0938–New); Frequency: Quarterly; 

Affected Public: State, Local, or Tribal 

Governments; Number of Respondents: 

10; Total Annual Responses: 40; Total 

Annual Hours: 3,467. (For policy 

questions regarding this collection 

contact Sherrie Fried at 410–786–6619. 

For all other issues call 410–786–1326.) 

2. Type of Information Collection 

Request: Extension without change of a 

currently approved collection. Title of 

Information Collection: Medicaid 

Statistical Information System (MSIS). 

Use: The Balanced Budget Act of 1997 

mandated that states report their 

Medicaid data via MSIS. MSIS is used 

by states and other jurisdictions to 

report fundamental statistical data on 

the operation of their Medicaid 

program. Data provided on eligibles, 

beneficiaries, payments and services are 

vital to those studying and assessing 

Medicaid policies and costs. Medicaid 

statistical data are routinely requested 

by CMS, Department agencies, the 

Congress and their research offices, state 

Medicaid agencies, research 

organizations, social service interest 

groups, universities and colleges, and 

the health care industry. The data 

provides the only national level 

information available on enrollees, 

beneficiaries, and expenditures. It also 

provides the only national level 

information available on Medicaid 

utilization. This information is the basis 

for analyses and for cost savings 

estimates for the Department’s cost 

sharing legislative initiatives to the 

Congress. The data is also crucial to 

CMS and HHS actuarial forecasts. Form 

Number: CMS–R–284 (OCN 0938–0345). 

Frequency: Quarterly. Affected Public: 

State, Local, or Tribal Governments. 

Number of Respondents: 51. Total 

Annual Responses: 204. Total Annual 

Hours: 2,040. (For policy questions 

regarding this collection contact Kay 

Spence at 410–786–1617. For all other 

issues call 410–786–1326.) 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on November 19, 2012. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS 

Desk Officer, Fax Number: (202) 395– 

6974, Email: 

OIRA_submission@omb.eop.gov. 

Dated: October 16, 2012. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2012–25772 Filed 10–18–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3266–FN] 

Medicare and Medicaid Programs; 

Approval of the Community Health 

Accreditation Program for Continued 

Deeming Authority for Hospices 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final notice. 

SUMMARY: This notice announces our 

decision to approve the Community 

Health Accreditation Program (CHAP) 

for continued recognition as a national 

accrediting organization for hospices 

that wish to participate in the Medicare 

or Medicaid programs. A hospice that 

participates in Medicaid must also meet 

the Medicare conditions of participation 

(CoPs) as referenced in our regulations. 

DATES: Effective Date: This final notice 

is effective November 20, 2012 through 

November 20, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Lillian Williams, (410) 786–8636. 

Cindy Melanson, (410) 786–0310. 

Patricia Chmielewski, (410) 786–6899. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services in a hospice, provided certain 

requirements are met. Section 

1861(dd)(1) of the Social Security Act 

(the Act) establishes distinct criteria for 

entities seeking designation as a hospice 

program. 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 42 CFR part 488. The 

regulations at 42 CFR part 418 specify 

the conditions that a hospice must meet 

in order to participate in the Medicare 

program, the scope of covered services, 

and the conditions for Medicare 

payment for hospice care. 

Generally, to enter into an agreement, 

a hospice must first be certified by a 

State survey agency as complying with 

conditions or requirements set forth in 

part 418. Thereafter, the hospice 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. 

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

that, if a provider entity demonstrates 

through accreditation by an approved 

national accrediting organization 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 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 meet the 


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Federal Register / Vol. 77, No. 203 / Friday, October 19, 2012 / Notices 64345 

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 reapproval 

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 deeming 

authority every 6 years, or sooner as 

determined by CMS. CHAP’s current 

term of approval for their hospice 

accreditation program expires 

November 20, 2012. 

II. Deeming 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 Act 

provides us with 210 calendar days after 

the date of receipt of an application to 

complete our survey activities and 

decision-making process. Within 60 

days of 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 of approving or 

denying the application. 

III. Provisions of the Proposed Notice 

On May 25, 2012, we published a 

proposed notice (77 FR 31362) 

announcing CHAP’s request for 

approval of its hospice accreditation 

program. In the proposed notice, we 

detailed our evaluation criteria. Under 

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

regulations at § 488.4 (Application and 

reapplication procedures for accrediting 

organizations), we conducted a review 

of CHAP’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 

CHAP’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 CHAP’s hospice 

accreditation standards to our current 

Medicare conditions of participation. 

• A documentation review of CHAP’s 

survey processes to— 

++ Determine the composition of the 

survey team, surveyor qualifications, 

and the ability of CHAP to provide 

continuing surveyor training. 

++ Compare CHAP’s processes to that 

of State survey agencies, including 

survey frequency, and the ability to 

investigate and respond appropriately to 

complaints against accredited facilities. 

++ Evaluate CHAP’s procedures for 

monitoring providers or suppliers found 

to be out of compliance with CHAP 

program requirements. The monitoring 

procedures are used only when the 

CHAP identifies noncompliance. If 

noncompliance is identified through 

validation reviews, the survey agency 

monitors corrections as specified at 

§ 488.7(d). 

++ Assess CHAP’s ability to report 

deficiencies to the surveyed facilities 

and respond to the facility’s plan of 

correction in a timely manner. 

++ Establish CHAP’s ability to 

provide CMS with electronic data and 

reports necessary for effective validation 

and assessment of CHAP’s survey 

process. 

++ Determine the adequacy of staff 

and other resources. 

++ Review CHAP’s ability to provide 

adequate funding for performing 

required surveys. 

++ Confirm CHAP’s policies with 

respect to whether surveys are 

announced or unannounced. 

++ Obtain CHAP’s agreement to 

provide CMS 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 May 25, 

2012 proposed notice (77 FR 31362) also 

solicited public comments regarding 

whether CHAP’s requirements meet or 

exceed the Medicare CoPs for hospices. 

We received no public comments in 

response to our proposed notice. 

IV. Provisions of the Final Notice 

A. Differences Between CHAP’s 

Standards and Requirements for 

Accreditation and Medicare’s 

Conditions and Survey Requirements 

We compared the standards contained 

in CHAP’s accreditation requirements 

and survey process with the Medicare 

hospice CoPs and survey process as 

outlined in the State Operations Manual 

(SOM). Our review and evaluation of 

CHAP’s deeming application, which 

were conducted as described in section 

III of this final notice, yielded the 

following: 

• To meet the requirements at 

§ 488.4(a)(4), CHAP implemented a 

monitoring plan to ensure all personnel 

files include a current license. 

• To meet the requirements at 

§ 488.4(a)(5), CHAP modified its 

policies and procedures related to the 

establishment of an accreditation 

effective date for participation in 

Medicare. 

• To meet the requirements in 

Appendix M of the SOM, CHAP 

developed a monitoring plan to ensure 

the minimum number of medical record 

reviews with home visits is completed 

during a survey. 

• To meet the requirements at section 

2728B of the SOM, CHAP revised its 

policies to ensure accepted plans of 

correction include a monitoring plan to 

ensure deficiencies stay corrected. 

• To meet the requirements at section 

5075.9 of the SOM, CHAP revised its 

policies to ensure complaint 

investigations triaged as non-immediate 

jeopardy medium are conducted within 

45 calendar days following receipt of a 

complaint. 

• To meet the requirements at 

§ 418.54(c)(7), CHAP revised its 

standards to address the needs of ‘‘other 

individuals’’ in the bereavement 

assessment. In addition, CHAP included 

language to ensure ‘‘information 

gathered from the initial bereavement 

assessment must be incorporated into 

the plan of care and considered in the 

bereavement plan of care.’’ 

• To meet the requirements at 

§ 418.64(b)(3), CHAP revised its 

standards to include language that 

addresses the provision of highly 

specialized nursing services provided so 

infrequently by direct hospice 

employees would be impracticable and 

prohibitively expensive. 

• To meet the requirements at 

§ 418.100, CHAP revised its standards to 

address the hospice’s responsibility to 

‘‘organize, manage, and administer its 

resources to provide hospice care and 

services.’’ 

• To meet the requirements at 

§ 418.100(c), CHAP revised its standards 

to specify that a hospice must be 

primarily engaged in providing care and 

services consistent with accepted 

standards of practice. 

• To meet the requirements at 

§ 418.110(d), CHAP revised its 

standards to include language that 

addresses the waiver of space and 

occupancy and alcohol-based hand rub 

requirements. 

• CHAP revised its crosswalk to 

ensure that all current CHAP standards 


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64346 Federal Register / Vol. 77, No. 203 / Friday, October 19, 2012 / Notices 

clearly address the following sections of 

the CFRs: § 418.52, § 418.54(e)(2), 

§ 418.56(a), § 418.56(d), § 418.56(e), 

§ 418.58, § 418.58(a)(2), § 418.58(c)(2), 

§ 418.58(d)(1), § 418.60(b)(2)(ii), 

§ 418.62(b), § 418.62(c), § 418.64(a)(1–3), 

§ 418.64(b)(1), § 418.64(d)(3)(iv), 

§ 418.72, § 418.76(a)(1), § 418.76(b)(3)(i), 

§ 418.76(c), § 418.76(e), § 418.76(h)(1), 

§ 418.76(j)(2), § 418.76(k), § 418.76(k)(2), 

§ 418.100(b), § 418.100(c)(2), 

§ 418.100(f)(1)(i), § 418.100(g)(3), 

§ 418.104(d), § 418.104(f), 

§ 418.106(b)(1), § 418.106(c)(1), 

§ 418.106(e)(1), § 418.108(c)(3), 

§ 418.110(a), § 418.110(c)(1)(i), 

§ 418.110(c)(1)(ii), § 418.110(e), 

§ 418.110(e)(2), § 418.110(f)(1), 

§ 418.110(f)(3)(iv), § 418.110(f)(3)(vi), 

§ 418.112(f), and § 418.116(b)(2). 

B. Term of Approval 

Based on the review and observations 

described in section III of this final 

notice, we have determined that CHAP’s 

accreditation program for hospices meet 

or exceed our requirements. Therefore, 

we approve CHAP as a national 

accreditation organization for hospices 

that request participation in the 

Medicare program, effective November 

20, 2012 through November 20, 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). 

VI. Regulatory Impact Statement 

In accordance with the provisions of 

Executive Order 12866, this proposed 

notice was not reviewed by the Office of 

Management and Budget. 

(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: September 10, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2012–25467 Filed 10–18–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Endocrinologic and Metabolic Drugs 

Advisory Committee; Amendment of 

Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

The Food and Drug Administration 

(FDA) is announcing an amendment to 

the notice of meeting of the 

Endocrinologic and Metabolic Drugs 

Advisory Committee. This meeting was 

announced in the Federal Register of 

October 10, 2012 (77 FR 61609). The 

amendment is being made to reflect a 

change in the Location and Procedure 

portions of the document. There are no 

other changes. 

FOR FURTHER INFORMATION CONTACT: Paul 

Tran, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, Rm. 2417, Silver Spring, 

MD 20993–0002, 301–796–9001; FAX: 

301–847–8533, email: 

EMDAC@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. Please call the Information Line for 

up-to-date information on this meeting. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of October 10, 2012, 

FDA announced that a meeting of the 

Endocrinologic and Metabolic Drugs 

Advisory Committee would be held on 

November 8, 2012. On page 61609, in 

the second column, the Location portion 

of the document is changed to read as 

follows: 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room, 

(Rm. 1503), Silver Spring, MD 20993– 

0002. Information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: http://www.fda.gov/ 

AdvisoryCommittees/default.htm; under 

the heading ‘‘Resources for You,’’ click 

on ‘‘Public Meetings at the FDA White 

Oak Campus.’’ Please note that visitors 

to the White Oak Campus must enter 

through Building 1. 

On page 61609, in the third column, 

the Procedure portion of the document 

is changed to read as follows: 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before November 2, 2012. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 p.m. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before October 

25, 2012. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by October 26, 2012. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to the advisory committees. 

Dated: October 15, 2012. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2012–25741 Filed 10–18–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Nonprescription Drugs Advisory 

Committee; Amendment of Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

The Food and Drug Administration 

(FDA) is announcing an amendment to 

the notice of meeting of the 

Nonprescription Drugs Advisory 

Committee. This meeting was 

announced in the Federal Register of 

August 30, 2012 (77 FR 52743). The 

amendment is being made to reflect a 

change in the Location and Contact 

Person portions of the document. There 

are no other changes. 

FOR FURTHER INFORMATION CONTACT: 

Minh Doan, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Building 31, Rm. 2417, Silver 

Spring, MD 20993–0002, 301–796–9001, 


tkelley on DSK3SPTVN1PROD with NOTICES