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
Federal Register / Vol. 76, No. 38 / Friday, February 25, 2011 / Notices 10601 

L. 108–173) added section 1833(h)(8) of 

the Act. Section 1833(h)(8)(A) of the Act 

requires the Secretary to establish by 

regulation procedure for determining 

the basis for, and amount of, payment 

for any clinical diagnostic laboratory 

tests with respect to which a new or 

substantially revised Healthcare 

Common Procedures Coding System 

(HCPCS) code is assigned on or after 

January 1, 2005 (hereinafter referred to 

as, ‘‘new test’’ or ‘‘new clinical laboratory 

test’’). Section 1833(h)(8)(B) of the Act 

sets forth the process for determining 

the basis for, and the amount of, 

payment for new tests. Pertinent to this 

notice, section 1833(h)(8)(B)(i) and 

section 1833(h)(8)(B)(ii) of the Act 

requires the Secretary to make available 

to the public a list that includes new 

tests for which establishment of a 

payment amount is being considered for 

a year and, on the same day that the list 

is made available, to publish in the 

Federal Register a notice of a 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 new 

tests. Section 1833(h)(8)(B)(iii) of the 

Act requires that we convene a public 

meeting not less than 30 days after 

publication of the notice in the Federal 

Register. These requirements are 

codified at 42 CFR part 414, subpart G. 

A newly created Current Procedural 

Terminology (CPT) code can represent 

either a refinement or modification of 

existing test methods, or a substantially 

new test method. The preliminary list of 

newly created CPT codes for calendar 

year (CY) 2012 will be published on our 

Web site as soon as possible at http:// 

www.cms.hhs.gov/ClinicalLabFeeSched. 

Two methods are used to establish 

payment amounts for new tests 

included in the CY 2012 Clinical 

Laboratory Fee Schedule. The first 

method called ‘‘cross-walking’’ is used 

when a new test is determined to be 

comparable to an existing test, multiple 

existing test codes, or a portion of an 

existing test code. The new test code is 

then assigned to the related existing 

local fee schedule amounts and the 

related existing national limitation 

amount. Payment for the new test is 

made at the lesser of the local fee 

schedule amount or the national 

limitation amount. We refer readers to 

§ 414.508(a). 

The second method called ‘‘gapfilling’’ is used when no comparable 

existing test is available. When using 

this method, instructions are provided 

to each Medicare carrier or Part A and 

Part B Medicare Administrative 

Contractor (MAC) to determine a 

payment amount for its geographic 

area(s) for use in the first year. These 

determinations are based on the 

following sources of information, if 

available: Charges for the test and 

routine discounts to charges; resources 

required to perform the test; payment 

amounts determined by other payers; 

and charges, payment amounts, and 

resources required for other tests that 

may be comparable or otherwise 

relevant. The carrier-specific amounts 

are used to establish a national 

limitation amount for the following 

years. We refer readers to § 414.508(b). 

For each new clinical laboratory test 

code, a determination must be made to 

either cross-walk or gap-fill. 

II. Format 

This meeting to receive comments 

and recommendations (including 

accompanying data on which 

recommendations are based) on the 

appropriate payment basis for the 

specified list of new CPT codes is open 

to the public. The on-site check-in for 

visitors will be held from 8:30 a.m., 

E.S.T. to 9 a.m., E.S.T., followed by 

opening remarks. Registered persons 

from the public may discuss and 

recommend payment determinations for 

specific new test codes for the CY 2012 

Clinical Laboratory Fee Schedule. 

Presentations must be brief and 

accompanied by three written copies. 

CMS recommends that presenters make 

copies available for approximately 50 

meeting participants, since CMS will 

not be providing additional copies. 

Presentations must also be 

electronically submitted to CMS on or 

before July 1, 2011. Presentations 

should be sent via e-mail to Glenn 

McGuirk, at 

Glenn.McGuirk@cms.hhs.gov. Once the 

presentations are collected, CMS will 

post them on the Clinical Laboratory 

Web site at http://www.cms.hhs.gov/ 

ClinicalLabFeeSched. Presenters should 

address the following items: 

• New test code(s) and descriptor. 

• Test purpose and method. 

• Costs. 

• Charges. 

• Make a recommendation with 

rationale for one of two methods (crosswalking or gap-fill) for determining 

payment for new tests. 

Additionally, the presenters should 

provide the data on which their 

recommendations are based. 

Presentations that do not address the 

above 5 items may be considered 

incomplete and may not be considered 

by CMS when making a payment 

determination. CMS may request 

missing information following the 

meeting in order to prevent a 

recommendation from being considered 

incomplete. 

A summary of the proposed new test 

codes and the payment 

recommendations that are presented 

during the public meeting will be 

posted on the CMS Web site by early 

September 2011 and can be accessed at 

http://www.cms.hhs.gov/ 

ClinicalLabFeeSched. The summary on 

the CMS website will include a list of 

all comments received by August 8, 

2011 (15 business days after the 

meeting). The summary will also 

include our proposed determinations 

with respect to the appropriate basis for 

establishing a payment amount for each 

code, an explanation of the reasons for 

each determination, the data on which 

the determinations are based, and a 

request for public written comments on 

the proposed determinations. 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. Final 

payment determinations will be posted 

on our website in October 2011. Each 

determination will include a rationale, 

data on which the determination is 

based, and responses to comments and 

suggestions received from the public. 

After the final payment 

determinations have been posted on our 

Web site, the public may request 

reconsideration of the basis for and 

amount of payment for a new test as set 

forth in § 414.509. We also refer readers 

to the November 27, 2007 final rule (72 

FR 66275 through 66280). 

III. Registration Instructions 

The Division of Ambulatory Services 

in CMS is coordinating the public 

meeting registration. Beginning June 20, 

2011, registration may be completed online at the following Web address: 

http://www.cms.hhs.gov/ 

ClinicalLabFeeSched. The following 

information must be submitted when 

registering: 

• Name. 

• Company name. 

• Address. 

• Telephone number(s). 

• E-mail address(es). 

When registering, individuals who 

want to make a presentation must also 

specify on which new clinical 

laboratory test code(s) they will be 

presenting comments. A confirmation 

will be sent upon receipt of the 

registration. Individuals must register by 

the date specified in the DATES section 

of this notice. 


srobinson on DSKHWCL6B1PROD with NOTICES
10602 Federal Register / Vol. 76, No. 38 / Friday, February 25, 2011 / Notices 

IV. Security, Building, and Parking 

Guidelines 

The meeting will be held in a Federal 

government building; therefore, Federal 

security measures are applicable. In 

planning your arrival time, we 

recommend allowing additional time to 

clear security. It is suggested that you 

arrive at the CMS facility between 8:15 

a.m and 8:30 a.m., E.S.T. so that you 

will be able to arrive promptly at the 

meeting by 9 a.m., E.S.T. Individuals 

who are not registered in advance will 

not be permitted to enter the building 

and will be unable to attend the 

meeting. The public may not enter the 

building earlier than 8:15 a.m., E.S.T. 

(45 minutes before the convening of the 

meeting). 

Security measures include the 

following: 

• Presentation of government-issued 

photographic identification to the 

Federal Protective Service or Guard 

Service personnel. Persons without 

proper identification may be denied 

access to the building. 

• Interior and exterior inspection of 

vehicles (this includes engine and trunk 

inspection) at the entrance to the 

grounds. Parking permits and 

instructions will be issued after the 

vehicle inspection. 

• Passing through a metal detector 

and inspection of items brought into the 

building. 

We note that all items brought to 

CMS, whether personal or for the 

purpose of demonstration or to support 

a demonstration, are subject to 

inspection. We cannot assume 

responsibility for coordinating the 

receipt, transfer, transport, storage, setup, safety, or timely arrival of any 

personal belongings or items used for 

demonstration or to support a 

demonstration. 

V. Special Accommodations 

Individuals attending the meeting 

who are hearing or visually impaired 

and have special requirements, or a 

condition that requires special 

assistance, should provide the 

information upon registering for the 

meeting. The deadline for such 

registrations is listed in the DATES

section of this notice. 

VI. 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). 

(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. 2011–4295 Filed 2–24–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1515–N] 

Medicare Program; Public Meetings in 

Calendar Year 2011 for All New Public 

Requests for Revisions to the 

Healthcare Common Procedure Coding 

System (HCPCS) Coding and Payment 

Determinations 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

dates, time, and location of the 

Healthcare Common Procedure Coding 

System (HCPCS) public meetings to be 

held in calendar year 2011 to discuss 

our preliminary coding and payment 

determinations for all new public 

requests for revisions to the HCPCS. 

These meetings provide a forum for 

interested parties to make oral 

presentations or to submit written 

comments in response to preliminary 

coding and payment determinations. 

The discussion will be focused on 

responses to our specific preliminary 

recommendations and will include all 

items on the public meeting agenda. 

DATES: Meeting Dates: The following are 

the 2011 HCPCS public meeting dates: 

1. Tuesday, May 17, 2011, 9 a.m. to 

5 p.m. eastern daylight time (e.d.t.) 

(Drugs/Biologicals/ 

Radiopharmaceuticals/Radiologic 

Imaging Agents). 

2. Wednesday, May 18, 2011, 9 a.m. 

to 5 p.m. e.d.t. (Drugs/Biologicals/ 

Radiopharmaceuticals/Radiologic 

Imaging Agents). 

3. Tuesday, May 24, 2011, 9 a.m. to 

5 p.m. e.d.t. (Supplies and Other). 

4. Wednesday, May 25, 2011, 9 a.m. 

to 5 p.m. e.d.t. (Supplies and Other). 

5. Tuesday, June 7, 2011, 9 a.m. to 5 

p.m. e.d.t. (Orthotics and Prosthetics). 

6. Wednesday, June 8, 2011, 9 a.m. to 

5 p.m. e.d.t. (Durable Medical 

Equipment (DME) and Accessories). 

Deadlines for Primary Speaker 

Registration and Presentation Materials: 

The deadline for registering to be a 

primary speaker and submitting 

materials and writings that will be used 

in support of an oral presentation are as 

follows: 

• May 3, 2011 for the May 17, 2011 

and May 18, 2011 public meetings. 

• May 10, 2011 for the May 24, 2011 

and May 25, 2011 public meetings. 

• May 24, 2011 for the June 7, 2011 

and June 8, 2011 public meetings. 

Deadline for Attendees that are 

Foreign Nationals (reside outside the 

U.S.) Registration: Attendees that are 

Foreign Nationals (reside outside the 

U.S.) are required to identify themselves 

as such, and provide the necessary 

information for security clearance (as 

described in section IV. of this notice) 

to the public meeting coordinator at 

least 12 business days in advance of the 

date of the public meeting date the 

individual plans to attend. Therefore, 

the deadlines for attendees that are 

Foreign Nationals are as follows: 

• April 29, 2011 for the May 17, 2011 

and May 18, 2011 public meetings. 

• May 6, 2011 for the May 24, 2011 

and May 25, 2011 public meetings. 

• May 19, 2011 for the June 7, 2011 

and June 8, 2011 public meetings. 

Deadlines for all Other Attendees 

Registration: All other individuals who 

plan to enter the building to attend the 

public meeting must register for each 

date that they plan on attending. The 

registration deadlines are different for 

each meeting. Registration deadlines are 

as follows: 

• May 10, 2011 for the May 17, 2011 

and May 18, 2011 public meeting dates. 

• May 17, 2011 for the May 24, 2011 

and May 25, 2011 public meeting dates. 

• May 31, 2011 for the June 7, 2011 

and June 8, 2011 public meeting dates. 

Deadlines for Requesting Special 

Accommodations: Individuals who plan 

to attend the public meetings and 

require sign-language interpretation or 

other special assistance must request 

these services by the following 

deadlines: 

• May 3, 2011 for the May 17, 2011 

and May 18, 2011 public meetings. 

• May 10, 2011 for the May 24, 2011 

and May 25, 2011 public meetings. 

• May 24, 2011 for the June 7, 2011 

and June 8, 2011 public meetings. 

Deadline for Submission of Written 

Comments: Written comments must be 

received by the date of the meeting at 

which the code request is scheduled for 

discussion. 

ADDRESSES: Meeting Location: The 

public meetings will be held in the main 

auditorium of the central building of the 

Centers for Medicare and Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, MD 21244–1850. 


srobinson on DSKHWCL6B1PROD with NOTICES