Federal Register / Vol. 76, No. 78 / Friday, April 22, 2011 / Notices 22709 

the authority to sign Federal Register 

Notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention, and the Agency for Toxic 

Substances and Disease Registry. 

Dated: April 15, 2011. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2011–9879 Filed 4–21–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–R–21] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS), Department of Health 

and Human Services, is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the Agency’s function; 

(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: Extension of a currently 

approved collection; Title of 

Information Collection: Withholding 

Medicare Payments to Recover 

Medicaid Overpayments and 

Supporting Regulations in 42 CFR 

447.31; Form No.: CMS–R–21 (OMB#: 

0938–0287); Use: Section 2104 of the 

Omnibus Reconciliation Act of 1981 

provides CMS with the authority to 

withhold Medicare payments to recover 

Medicaid overpayments that the 

Medicaid State Agency has been unable 

to recover. When the CMS Regional 

Office (RO) receives an overpayment 

case from a State Agency, the case file 

is examined to determine whether the 

conditions for withholding Medicare 

payments have been met. If the RO 

determines that the case is appropriate 

for withholding Medicare payments, the 

RO will contact the institution’s 

intermediary or individual’s carrier to 

determine the amount of Medicare 

payments to which the entity would 

otherwise be entitled. The RO will then 

give notice to the intermediary/carrier to 

withhold the entity’s Medicare 

payment; Frequency: Occasionally; 

Affected Public: State, Local, or Tribal 

Governments; Number of Respondents: 

54; Total Annual Responses: 27; Total 

Annual Hours: 81. (For policy questions 

regarding this collection contact Rory 

Howe at 410–786–4878. 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 May 23, 2011. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS Desk 

Officer, Fax Number: (202) 395–6974, Email: OIRA_submission@omb.eop.gov. 

Dated: April 19, 2011. 

Martique Jones, 

Director, Regulations Development Group— 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2011–9846 Filed 4–21–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–2332–FN] 

Medicare and Medicaid Programs; 

Approval of the American Association 

for Accreditation of Ambulatory 

Surgery Facilities, Inc. for Deeming 

Authority for Organizations That 

Provide Outpatient Physical Therapy 

and Speech-Language Pathology 

Services 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final notice. 

SUMMARY: This notice announces our 

decision to approve the American 

Association for Accreditation of 

Ambulatory Surgery Facilities 

(AAAASF) for recognition as a national 

accreditation program for organizations 

that provide outpatient physical therapy 

and speech-language pathology services 

seeking to participate in the Medicare or 

Medicaid programs. 

DATES: Effective Date: This final notice 

is effective April 22, 2011 through April 

22, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Alexis Prete, (410) 786–0375. Patricia 

Chmielewski, (410) 786–6899. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive outpatient 

physical therapy and speech language 

pathology covered services from a 

provider of services, a clinic, a 

rehabilitation agency, a public health 

agency, or by others under an 

arrangement with and under the 

supervision of such provider, clinic, 

rehabilitation agency, or public health 

agency (collectively, ‘‘organizations’’), 

provided certain requirements are met. 

Section 1861(p)(4) of the Social Security 

Act (the Act) establishes distinct criteria 

for organizations seeking approval to 

provide outpatient physical therapy and 

speech language pathology services. The 

regulations at 42 CFR part 485, subpart 

H specify, among other things, the 

conditions that an organization 

providing outpatient physical therapy 

and speech-language pathology services 

must meet to participate in the Medicare 

program. Regulations concerning 

provider agreements are located at 42 

CFR part 489 (Provider Agreements and 

Supplier Approval) and those pertaining 

to survey and certification of facilities at 

42 CFR part 488. 

Generally, in order to enter into a 

provider agreement, an organization 

offering outpatient physical therapy and 

speech language pathology services 

must first be certified by a State survey 

agency as complying with the 

conditions or requirements set forth in 

section 1861(p)(4) of the Act, and 42 

CFR part 485, subpart H. Thereafter, the 

organization is subject to ongoing 

review by a State survey agency to 

determine whether it continues to meet 

the Medicare requirements. There is an 

alternative, however, to State 

compliance surveys. Accreditation by a 

nationally-recognized 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 

accreditation organization is voluntary 

and is not required for Medicare 

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22710 Federal Register / Vol. 76, No. 78 / Friday, April 22, 2011 / Notices 

participation. A national AO applying 

for deeming authority under part 488 

subpart A, must provide us 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 Act provides us 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 

On November 29, 2010, we published 

a proposed notice in the Federal 

Register (75 FR 73088) announcing 

AAAASF’s request for approval as a 

deeming organization for organizations 

that provide outpatient physical therapy 

and speech-language pathology services. 

In that 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 

accreditation organizations), we 

conducted a review of AAAASF’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 

AAAASF’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 decision-making 

process for accreditation. 

• A comparison of AAAASF’s 

outpatient physical therapy and speechlanguage pathology services 

accreditation standards to our current 

Medicare outpatient physical therapy 

and speech-language pathology services 

conditions of participation (CoPs). 

• A documentation review of 

AAAASF’s survey processes to: 

+ Determine the composition of the 

survey team, surveyor qualifications, 

and AAAASF’s ability to provide 

continuing surveyor training. 

+ Compare AAAASF’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 AAAASF’s procedures for 

monitoring organizations providing 

outpatient physical therapy and speechlanguage pathology services found to be 

out of compliance with AAAASF’s 

program requirements. The monitoring 

procedures are used only when the 

AAAASF identifies noncompliance. If 

noncompliance is identified through 

validation reviews, the State survey 

agency monitors corrections as specified 

at § 488.7(d). 

+ Assess AAAASF’s ability to report 

deficiencies to the surveyed 

organizations and respond to the 

facility’s plan of correction in a timely 

manner. 

+ Establish AAAASF’s ability to 

provide us with electronic data and 

reports necessary for effective validation 

and assessment of AAAASF’s survey 

process. 

+ Determine the adequacy of staff and 

other resources. 

+ Review AAAASF’s ability to 

provide adequate funding for 

performing required surveys. 

+ Confirm AAAASF’s policies with 

respect to whether surveys are 

announced or unannounced. 

+ Obtain AAAASF’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 November 

26, 2010 proposed notice also solicited 

public comments regarding whether 

AAAASF’s requirements meet or exceed 

the Medicare CoPs for outpatient 

physical therapy and speech-pathology 

services. We received 2 comments in 

response to our proposed notice. 

Comment: One commenter expressed 

concern that AAAASF does not have 

adequate experience and familiarity 

with organizations that provide 

outpatient physical therapy and speechpathology services, nor does AAAASF 

have accreditation standards that exceed 

the current Medicare requirements. 

Response: Regulations at § 488.4 and 

§ 488.8 specify the process to be 

followed for application, review, 

approval and renewal of deeming 

authority for AOs. A national AO 

applying for approval of deeming 

authority under part 488, subpart A, 

must provide CMS with reasonable 

assurance that the AO requires 

accredited provider entities to meet the 

requirements that are at least as 

stringent as the Medicare conditions. 

AO standards may, but are not required 

to, exceed our requirements. AAAASF’s 

application was thoroughly reviewed in 

accordance with these requirements and 

found to meet the Medicare 

requirements. 

Comment: One commenter expressed 

concern that AAAASF’s application did 

not include occupational therapy 

services. 

Response: The regulations at 42 CFR 

part 485, subpart H specify, among other 

things, the conditions that an 

organization providing outpatient 

physical therapy and speech-language 

pathology services must meet to 

participate in the Medicare program. 

These regulations do not include a 

requirement for occupational therapy 

services. Therefore, it was not necessary 

for occupational therapy services to be 

addressed in AAAASF’s application. 

IV. Provisions of the Final Notice 

A. Differences Between AAAASF’s 

Standards and Requirements for 

Accreditation and Medicare’s 

Conditions and Survey Requirements 

We compared AAAASF’s outpatient 

physical therapy and speech-pathology 

services 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 AAAASF’s 

deeming application, which were 

conducted as described in section III of 

this final notice, yielded the following: 

• AAAASF revised its standards to 

ensure social workers meet the 

requirements outlined in 42 CFR part 

484 for States that do not require 

licensure. 

• AAAASF revised its crosswalk to 

include the requirements that all 

vocational specialists must meet to 

comply with the requirements at 

§ 485.705(c)(7)(i) through (iii). 

• AAAASF revised its policies to 

ensure its survey files were complete, 

accurate and consistent with the 

Medicare requirements at § 488.6(a). 

• AAAASF revised its accreditation 

decision letters to ensure they are 

accurate and contain all of the elements 

necessary for the CMS Regional Office 

to render a decision regarding deemed 

status of an organization that provides 

outpatient physical therapy and speechlanguage pathology services. 

• AAAASF modified its policies 

regarding timeframes for sending and 

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Federal Register / Vol. 76, No. 78 / Friday, April 22, 2011 / Notices 22711 

receiving a required plan of correction 

in accordance with the requirements at 

section 2728 of the SOM. 

B. Term of Approval 

Based on the review and observations 

described in section III of this final 

notice, we have determined that 

AAAASF’s requirements for 

organizations providing outpatient 

physical therapy and speech-language 

pathology services meet or exceed our 

requirements. Therefore, we approve 

AAAASF as a national accreditation 

organization for organizations that 

provide outpatient physical therapy and 

speech-language pathology services that 

request participation in the Medicare 

program, effective April 22, 2011 

through April 22, 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. Chapter 35). 

In accordance with the provisions of 

Executive Order 12866, this notice was 

not reviewed by the Office of 

Management and Budget. 

(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: March 30, 2011. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2011–9176 Filed 4–21–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–2372–N] 

Announcement of the Re-Approval of 

the American Society of 

Histocompatibility and 

Immunogenetics (ASHI) as an 

Accreditation Organization Under the 

Clinical Laboratory Improvement 

Amendments of 1988 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

application of the American Society for 

Histocompatibility and Immunogenetics 

(ASHI) for re-approval as an 

accreditation organization for clinical 

laboratories under the Clinical 

Laboratory Improvement Amendments 

of 1988 (CLIA) program for the 

following specialty and subspecialty 

areas: General Immunology; 

Histocompatibility; and ABO/Rh typing. 

We have determined that the ASHI 

meets or exceeds the applicable CLIA 

requirements. We are announcing the 

re-approval and grant ASHI deeming 

authority for a period of 5 years. 

DATES: Effective Date: This notice is 

effective from April 22, 2011 to April 

22, 2016. 

FOR FURTHER INFORMATION CONTACT: 

Penelope Meyers, (410) 786–3366. 

SUPPLEMENTARY INFORMATION: 

I. Background and Legislative 

Authority 

On October 31, 1988, the Congress 

enacted the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) (Pub. L. 100–578). CLIA 

amended section 353 of the Public 

Health Service Act. We issued a final 

rule implementing the accreditation 

provisions of CLIA on July 31, 1992 (57 

FR 33992). Under those provisions, 

CMS may grant deeming authority to an 

accreditation organization if its 

requirements for laboratories accredited 

under its program are equal to or more 

stringent than the applicable CLIA 

program requirements in 42 CFR part 

493 (Laboratory Requirements). Subpart 

E of part 493 (Accreditation by a Private, 

Nonprofit Accreditation Organization or 

Exemption Under an Approved State 

Laboratory Program) specifies the 

requirements an accreditation 

organization must meet to be approved 

by CMS as an accreditation organization 

under CLIA. 

II. Notice of Approval of the ASHI as 

an Accreditation Organization 

In this notice, we approve ASHI as an 

organization that may accredit 

laboratories for purposes of establishing 

its compliance with CLIA requirements 

for the subspecialty of General 

Immunology, the specialty of 

Histocompatibility, and the subspecialty 

of ABO/Rh typing. We have examined 

the initial ASHI application and all 

subsequent submissions to determine its 

accreditation program’s equivalency 

with the requirements for approval of an 

accreditation organization under 

subpart E of part 493. We have 

determined that the ASHI meets or 

exceeds the applicable CLIA 

requirements. We have also determined 

that the ASHI will ensure that its 

accredited laboratories will meet or 

exceed the applicable requirements in 

subparts H, I, J, K, M, Q, and the 

applicable sections of R. Therefore, we 

grant the ASHI approval as an 

accreditation organization under 

subpart E of part 493, for the period 

stated in the DATES section of this notice 

for the subspecialty of General 

Immunology, the specialty of 

Histocompatibility, and the subspecialty 

of ABO/Rh typing. As a result of this 

determination, any laboratory that is 

accredited by the ASHI during the time 

period stated in the DATES section of this 

notice will be deemed to meet the CLIA 

requirements for the listed 

subspecialties and specialties, and 

therefore, will generally not be subject 

to routine inspections by a State survey 

agency to determine its compliance with 

CLIA requirements. The accredited 

laboratory, however, is subject to 

validation and complaint investigation 

surveys performed by CMS, or its 

agent(s). 

III. Evaluation of the ASHI Commission 

Request for Approval as an 

Accreditation Organization Under 

CLIA 

The following describes the process 

used to determine that the ASHI 

accreditation program meets the 

necessary requirements to be approved 

by CMS and that, as such, CMS may 

approve ASHI as an accreditation 

program with deeming authority under 

the CLIA program. ASHI formally 

applied to CMS for approval as an 

accreditation organization under CLIA 

for the subspecialty of General 

Immunology, the specialty of 

Histocompatibility, and the subspecialty 

of ABO/Rh typing. In reviewing these 

materials, we reached the following 

determinations for each applicable part 

of the CLIA regulations: 

A. Subpart E—Accreditation by a 

Private, Nonprofit Accreditation 

Organization or Exemption Under an 

Approved State Laboratory Program 

The ASHI submitted its mechanism 

for monitoring compliance with all 

requirements equivalent to conditionlevel requirements, a list of all its 

current laboratories and the expiration 

date of their accreditation, and a 

detailed comparison of the individual 

accreditation requirements with the 

comparable condition-level 

requirements. The ASHI policies and 

procedures for oversight of laboratories 

performing laboratory testing for the 

subspecialty of General Immunology, 

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