10598 Federal Register / Vol. 76, No. 38 / Friday, February 25, 2011 / Notices 

(1) Identify, obtain, and organize sales information, prepare response: 30–70 hours 

(2) Identify, obtain, and organize information on advertising and marketing expenditures, prepare response: 50–130 hours 

(3) Identify, obtain, and organize placement information, prepare response: 240–560 hours 

(4) Identify, obtain, and organize information regarding compliance review, prepare response: 20–40 hours 

(5) Identify, obtain, and organize information regarding data collection, prepare 

response: 

20–40 hours 

The staff anticipates that the 

cumulative hours burden to respond to 

the information requests will be 

between 360 and 840 hours per 

company. Nonetheless, in order to be 

conservative, the staff estimates that the 

burden per company for each of up to 

fourteen intended recipients will be 840 

hours. Accordingly, the staff estimates a 

total burden for these companies of 

approximately 11,760 hours (14 

companies × 840 average burden hours 

per company). These estimates include 

any time spent by separately 

incorporated subsidiaries and other 

entities affiliated with the ultimate 

parent company that has received the 

information request. 

Estimated Cost Burden: $252,000. 

It is difficult to calculate with 

precision the labor costs associated with 

the information requests, as the costs 

entail varying compensation levels of 

management and/or support staff among 

companies of different sizes. Financial, 

legal, marketing, and clerical personnel 

may be involved in the information 

collection process. The staff has 

assumed that professional personnel 

and outside legal counsel will handle 

most of the tasks involved in gathering 

and producing responsive information, 

and has applied an average hourly wage 

of $300/hour for their labor. Thus, the 

staff estimates that the total labor costs 

per company will range between 

$108,000 ($300 × 360 hours) and 

$252,000 ($300 × 840 hours). 

The staff estimates that the capital or 

other non-labor costs associated with 

the information requests will be 

minimal. Although the information 

requests may necessitate that industry 

members maintain the requested 

information provided to the 

Commission, they should already have 

in place the means to compile and 

maintain business records. 

By direction of the Commission. 

Donald S. Clark, 

Secretary. 

[FR Doc. 2011–4196 Filed 2–24–11; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the National Coordinator for 

Health Information Technology; 

Recommendations Received From the 

HIT Policy Committee 

AGENCY: Office of the National 

Coordinator for Health Information 

Technology (ONC), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: Section 3002(e) of the Public 

Health Service Act, as amended by the 

Health Information Technology for 

Economic and Clinical Health (HITECH) 

Act, requires the National Coordinator 

for Health Information Technology to 

publish in the Federal Register and post 

on the internet all policy 

recommendations made by the HIT 

Policy Committee. 

Policy recommendations presented at 

the February 2, 2011 HIT Policy 

Committee meeting have been 

transmitted from the HIT Policy 

Committee to the National Coordinator 

and are available on the ONC Web site: 

http://healthit.hhs.gov/portal/server.pt/

community/healthit_hhs_gov__policy_

recommendations/1815. 

Dated: February 14, 2011. 

Judith Sparrow, 

Office of Programs and Coordination, Office 

of the National Coordinator for Health 

Information Technology. 

[FR Doc. 2011–4290 Filed 2–24–11; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–2326–FN] 

Medicare and Medicaid Programs; 

Approval of the Joint Commission for 

Deeming Authority for Psychiatric 

Hospitals 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final notice. 

SUMMARY: This notice announces our 

decision to approve the Joint 

Commission for recognition as a 

national accreditation program for 

psychiatric hospitals seeking to 

participate in the Medicare or Medicaid 

programs. This initial 4-year approval is 

effective February 25, 2011, through 

February 25, 2015. 

DATES: Effective Date: This final notice 

is effective February 25, 2011. 

FOR FURTHER INFORMATION CONTACT: L. 

Tyler Whitaker, (410) 786–5236; Patricia 

Chmielewski, (410) 786–6899. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services in a psychiatric hospital 

provided certain requirements are met. 

Section 1861(f) of the Social Security 

Act (the Act) establishes distinct criteria 

for facilities seeking designation as a 

psychiatric hospital. The regulations at 

42 CFR part 482, subpart E specify, 

among other things, the conditions that 

a psychiatric hospital must meet to 

participate in the Medicare program. 

Regulations concerning provider 

agreements are located at 42 CFR part 

489 and those pertaining to survey and 

certification of facilities are at 42 CFR 

part 488. 

Generally, in order to enter into a 

provider agreement, a psychiatric 

hospital must first be certified by a State 

survey agency as complying with the 

conditions or requirements set forth in 

section 1861(f) of the Act, and 42 CFR 

part 482, including the special 

provisions applying to psychiatric 

hospitals in subpart E of our regulations. 

Thereafter, the psychiatric hospital is 

subject to ongoing review by a State 

survey agency to determine whether it 

continues to meet the Medicare 

requirements. However, there is an 

alternative to State compliance surveys. 

Accreditation by a nationallyrecognized accreditation program can 

substitute for ongoing State review. 

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

that, if a provider entity demonstrates 

through accreditation by an approved 

national accreditation organization (AO) 

that all applicable Medicare conditions 

are met or exceeded, we may ‘‘deem’’ 

that provider entity as having met the 

requirements. Accreditation by an AO is 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 38 / Friday, February 25, 2011 / Notices 10599 

voluntary and is not required for 

Medicare participation. A national AO 

applying for deeming authority under 

42 CFR part 488, subpart A must 

provide CMS with reasonable assurance 

that the AO requires the accredited 

provider entities to meet requirements 

that are at least as stringent as the 

Medicare conditions. 

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 

deeming authority is conducted in a 

timely manner. The statute provides 210 

calendar days after the date of receipt of 

a complete application, with any 

documentation necessary to make a 

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 accreditation 

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 

and Response to Comments 

In the October 22, 2010 Federal 

Register (75 FR 65360), we published a 

proposed notice announcing the Joint 

Commission’s request for approval as a 

deeming organization for psychiatric 

hospitals. In that notice, we detailed our 

evaluation criteria. Under section 

1865(a)(2) of the Act and § 488.4 

(Application and reapplication 

procedures for accreditation 

organizations), we conducted a review 

of the Joint Commission’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 

the Joint Commission’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. 

• A comparison of the Joint 

Commission’s psychiatric hospital 

accreditation standards to our current 

Medicare psychiatric hospital 

conditions of participation (CoPs). 

• A documentation review of the 

Joint Commission’s survey processes to: 

+ Determine the composition of the 

survey team, surveyor qualifications, 

and the Joint Commission’s ability to 

provide continuing surveyor training. 

+ Compare the Joint Commission’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 the Joint Commission’s 

procedures for monitoring psychiatric 

hospitals determined to be out of 

compliance with the Joint Commission’s 

program requirements. The monitoring 

procedures are used only when the Joint 

Commission identifies noncompliance. 

If noncompliance is identified through 

validation reviews, the State survey 

agency monitors corrections as specified 

at § 488.7(d). 

+ Assess the Joint Commission’s 

ability to report deficiencies to the 

surveyed facilities and respond to the 

facility’s plan of correction in a timely 

manner. 

+ Establish the Joint Commission’s 

ability to provide us with electronic 

data and reports necessary for effective 

validation and assessment of the Joint 

Commission’s survey process. 

+ Determine the adequacy of staff and 

other resources. 

+ Review the Joint Commission’s 

ability to provide adequate funding for 

performing required surveys. 

+ Confirm the Joint Commission’s 

policies with respect to whether surveys 

are announced or unannounced. 

+ Obtain the Joint Commission’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 October 22, 

2010 proposed notice also solicited 

public comments regarding whether the 

Joint Commission’s requirements met or 

exceeded the Medicare CoPs for 

psychiatric hospitals. We received 4 

comments in response to our proposed 

notice. 

All of the commenters expressed 

strong support for the Joint 

Commission’s application for 

psychiatric hospital deeming authority. 

The commenters stated that the Joint 

Commission’s standards are clearly 

written and closely align with the 

Medicare CoPs, and that the Joint 

Commission’s accreditation program 

provides psychiatric hospitals with a 

viable alternative to other healthcare 

accreditation organizations. 

IV. Provisions of the Final Notice 

A. Differences Between the Joint 

Commission’s Standards and 

Requirements for Accreditation and 

Medicare’s Conditions and Survey 

Requirements 

We compared the Joint Commission’s 

psychiatric hospital accreditation 

requirements and survey process with 

the Medicare CoPs and survey process 

as outlined in the State Operations 

Manual (SOM). Our review and 

evaluation of the Joint Commission’s 

deeming application, which were 

conducted as described in section III. of 

this final notice, yielded the following: 

• To meet the requirements at 

Appendix AA of the SOM, the Joint 

Commission revised its policies to 

ensure surveyors draw a representative 

number of patients from each distinct 

program area for observation and 

interview based on the size of that 

program. 

• To meet the requirements at 

§ 482.13(e), the Joint Commission 

revised its crosswalk to address the 

requirement that all patients have the 

right to be free from physical or mental 

and corporal punishment. 

• To meet the requirements at 

§ 482.24(b)(2), the Joint Commission 

revised its standards to address the 

requirement that the medical record 

system must allow for timely retrieval of 

patient information by diagnosis and 

procedure. 

• To meet the requirements at 

§ 482.26(b)(1), the Joint Commission 

revised its crosswalk to ensure the 

hospital maintains proper safety 

precautions against radiation hazards. 

• To meet the requirements at 

§ 482.41(a), the Joint Commission 

modified its standards to prevent 

hospitals from conducting back-to-back 

emergency preparedness response drills. 

• To meet the requirements at 

§ 482.41(a)(1), the Joint Commission 

revised its standards to include all of 

the essential electrical system specific 

requirements, per National Fire 

Protection Association (NFPA) 99:1999: 

12–3.3 and corresponding Chapter 3 

requirements. 

• To meet the requirements at 

§ 482.41(b)(1)(i), the Joint Commission 

revised its standards to address the 

availability of the fire safety plan, and 

ensure that all required fire safety 

elements are addressed. In addition, the 

Joint Commission revised its standards 

to require quarterly testing of tamper 

and water flow devices, and ensure no 

gaps exist around penetrations. 

• To meet the requirements at 

§ 482.41(b)(9)(i) through (iii) and 

§ 482.41(b)(9)(v), the Joint Commission 


srobinson on DSKHWCL6B1PROD with NOTICES
10600 Federal Register / Vol. 76, No. 38 / Friday, February 25, 2011 / Notices 

revised its Web site to ensure it includes 

all of the alcohol-based hand rub 

dispenser requirements. 

• To meet the requirements at 

§ 482.45(b)(3), the Joint Commission 

revised its standards to address the 

hospital’s responsibility to provide 

organ transplant data directly to the 

Department of Health and Human 

Services when requested by the 

Secretary. 

• To meet the requirements at 

§ 482.56, the Joint Commission revised 

its crosswalk to ensure that if the 

hospital provides rehabilitation, 

physical therapy, occupational therapy, 

audiology, or speech pathology services, 

the services are organized and staffed to 

ensure the health and safety of patients. 

• To meet the requirements at 

§ 482.61(a)(3), the Joint Commission 

revised its standards to ensure 

psychiatric hospitals clearly document 

the reason for admission as stated by the 

patient and/or others significantly 

involved in the patient’s care. 

• To meet the requirements at 

§ 482.61(a)(5), the Joint Commission 

revised its standards to address the 

requirement that, when indicated, a 

complete neurological examination be 

recorded at the time of the admission 

physical examination. 

• To meet the requirements at 

§ 482.61(c)(1)(ii), the Joint Commission 

revised its standards to include both 

short-term and long-range patient goals. 

• To meet the requirements at 

§ 482.61(c)(1)(iv), the Joint Commission 

revised its standards to ensure the 

patient’s treatment plan includes the 

responsibilities of each member of the 

treatment team. 

• To meet the requirements at 

§ 482.62, the Joint Commission revised 

its crosswalk to address the psychiatric 

hospital’s responsibility to formulate 

written, individualized, comprehensive 

treatment plans, provide active 

treatment measures, and engage in 

discharge planning. 

• To meet the requirements at 

§ 482.62(f), the Joint Commission 

revised its standard to ensure that the 

hospital has a director of social services 

who monitors and evaluates the quality 

and appropriateness of social services 

furnished. 

• The Joint Commission revised its 

psychiatric hospital survey procedures 

to ensure all applicable hospital CoPs at 

42 CFR part 482 are adequately 

evaluated for compliance. 

B. Term of Approval 

Based on the review and observations 

described in section III. of this final 

notice, we have determined that the 

Joint Commission’s requirements for 

psychiatric hospitals meet or exceed our 

requirements. Therefore, we approve the 

Joint Commission as a national 

accreditation organization for 

psychiatric hospitals that request 

participation in the Medicare program 

effective February 25, 2011 through 

February 25, 2015. 

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 regulation 

was not reviewed by the Office of 

Management and Budget. 

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) 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: February 18, 2011. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2011–4294 Filed 2–24–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1347–N] 

Medicare Program; Public Meeting in 

Calendar Year 2011 for New Clinical 

Laboratory Tests Payment 

Determinations 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces a 

public meeting to receive comments and 

recommendations (including 

accompanying data on which 

recommendations are based) from the 

public on the appropriate basis for 

establishing payment amounts for a 

specified list of new Clinical Procedural 

Terminology (CPT) codes for clinical 

laboratory tests in calendar year (CY) 

2012. The meeting provides a forum for 

interested parties to make presentations 

and submit written comments on the 

new codes that will be included in 

Medicare’s Clinical Laboratory Fee 

Schedule for CY 2012, which will be 

effective on January 1, 2012. The 

development of the codes for clinical 

laboratory tests is largely performed by 

the CPT Editorial Panel and will not be 

further discussed at the meeting. 

DATES: Meeting Date: The public 

meeting is scheduled for Monday, July 

18, 2011 from 9 a.m. to 2 p.m., Eastern 

Standard Time (E.S.T.). 

Deadline for Registration of 

Presenters: All presenters for the public 

meeting must register by July 11, 2011. 

Deadline for Submitting Requests for 

Special Accommodations: Requests for 

special accommodations must be 

received no later than 5 p.m., E.S.T. on 

July 11, 2011. 

Deadline for Submission of Written 

Comments: Interested parties may 

submit written comments on the 

proposed payment determinations by 

September 23, 2011, to the address 

specified in the ADDRESSES section of 

this notice. We note that comments 

submitted should pertain to the 

payment basis for a specified list of new 

Clinical Procedural Terminology (CPT) 

codes. 

ADDRESSES: The public meeting will be 

held in the main auditorium of the 

central building of the Centers for 

Medicare & Medicaid Services (CMS), 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

FOR FURTHER INFORMATION CONTACT: 

Glenn McGuirk, (410) 786–5723. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 531(b) of the Medicare, 

Medicaid, and SCHIP Benefits 

Improvement and Protection Act of 

2000 (BIPA) (Pub. L. 106–554) requires 

the Secretary to establish procedures for 

coding and payment determinations for 

new clinical diagnostic laboratory tests 

under Part B of title XVIII of the Social 

Security Act (the Act) that permit public 

consultation in a manner consistent 

with the procedures established for 

implementing coding modifications for 

International Classification of Diseases 

(ICD–9–CM). The procedures and public 

meeting announced in this notice for 

new clinical laboratory tests are in 

accordance with the procedures 

published on November 23, 2001 in the 

Federal Register (66 FR 58743) to 

implement section 531(b) of BIPA. 

Section 942(b) of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA) (Pub. 


srobinson on DSKHWCL6B1PROD with NOTICES