Federal Register / Vol. 74, No. 58 / Friday, March 27, 2009 / Notices 13439 

timeframe. CLIA regulations do not have 

this requirement. 

H. Subpart R—Enforcement Procedures 

The CAP meets the requirements of 

subpart R to the extent that they apply 

to accreditation organizations. The CAP 

policy stipulates the actions it takes 

when laboratories it accredits do not 

comply with its requirements and 

standards for accreditation. As 

demonstrated during its first two 

periods of approval, the CAP denies 

accreditation to a laboratory when 

appropriate, and reports the denial to 

CMS within 30 days. The CAP also 

provides an appeal process for 

laboratories that have had accreditation 

denied. 

Some specific actions the CAP takes 

in response to non-compliance or 

violation of its requirements or 

standards for accreditation include: 

—The enrollment monitoring process 

runs continuously throughout the 

year. When no enrollment data or 

incomplete enrollment data are 

received based on the laboratory’s test 

menu, letters are sent notifying the 

laboratory of its missing enrollments. 

If no enrollment is found after 60 

days, the laboratory is sent a ‘‘cease 

testing’’ letter for the analytes not 

properly enrolled in PT. 

—For all analytes listed in subpart I that 

the CAP accredited laboratories 

perform, the CAP technical staff 

reviews such testing to verify two 

previous PT performances, reviews 

PT evaluation to detect trends and 

repeats failures, contacts the 

laboratory to alert them if the status 

is critical, and issues cease testing 

letters when appropriate. 

—When an accredited laboratory has 

unsatisfactory performance, a letter is 

sent instructing it to investigate and 

document the cause of the erroneous 

result and the corrective actions it 

takes to prevent recurrence. 

—When there is an initial unsuccessful 

performance, the laboratory may 

either provide documentation of 

investigation and corrective action or 

the laboratory is given the option to 

voluntarily cease testing the 

unsuccessful analyte(s). 

—If the laboratory indicates it will 

permanently cease testing of a noninitial unsuccessful PT performance, 

the activity is removed from the 

laboratory’s test menu. If the 

laboratory wishes to resume testing at 

a later date, it must successfully 

perform two consecutive reinstatement PT testing events. 

—When the CAP becomes aware of a 

problem in an accredited laboratory 

that is so severe and extensive that it 

could cause a serious risk of harm (an 

immediate jeopardy situation), an 

expedited evaluation is immediately 

undertaken by the Chair and Vice 

Chair of the Accreditation Committee, 

the Regional Commissioner and the 

Director of the Laboratory 

Accreditation Program. If it is 

determined that an immediate 

jeopardy situation exists, the 

laboratory is required to remove the 

jeopardy situation immediately or 

accreditation would be revoked and 

reported to CMS. An on-site focused 

re-inspection may be performed to 

verify that the immediate jeopardy no 

longer exists. These actions are 

similar to CMS actions for immediate 

jeopardy. 

—The CAP requires its accredited 

laboratories to correct all deficiencies 

within 30 days. CLIA deficiencies that 

are not condition level must be 

corrected in a timeframe that is 

acceptable to CMS, but no longer than 

12 months. CLIA deficiencies that are 

condition level that are not 

considered immediate jeopardy must 

be corrected in an acceptable 

timeframe; however, CMS may 

impose one or more alternate 

sanctions or a principal sanction to 

motivate laboratories to correct these 

deficiencies. The CAP timeframe for 

correction of deficiencies, when taken 

as a whole, is more stringent than 

CLIA. 

We have determined that the CAP’s 

laboratory enforcement and policies are 

equivalent to the requirements of this 

subpart as they apply to accreditation 

organizations. 

IV. Federal Validation Inspections and 

Continuing Oversight 

The Federal validation inspections of 

laboratories accredited by the CAP may 

be conducted on a representative 

sample basis or in response to 

substantial allegations of 

noncompliance (that is, complaint 

inspections). The outcome of those 

validation inspections, performed by 

CMS or our agents, the State survey 

agencies, will be our principal means 

for verifying that the laboratories 

accredited by CAP remain in 

compliance with CLIA requirements. 

This Federal monitoring is an ongoing 

process. 

V. Removal of Approval as an 

Accrediting Organization 

Our regulations provide that we may 

rescind the approval of an accreditation 

organization, such as that of the CAP, 

for cause, before the end of the effective 

date of approval. If we determine that 

the CAP has failed to adopt, maintain 

and enforce requirements that are equal 

to, or more stringent than, the CLIA 

requirements, or that systemic problems 

exist in its monitoring, inspection or 

enforcement processes, we may impose 

a probationary period, not to exceed 1 

year, in which the CAP would be 

allowed to address any identified issues. 

Should the CAP be unable to address 

the identified issues within that time 

frame, CMS may, in accordance with the 

applicable regulations, revoke CAP’s 

deeming authority under CLIA. 

Should circumstances result in our 

withdrawal of the CAP’s approval, we 

will publish a notice in the Federal 

Register explaining the basis for 

removing its approval. 

VI. Collection of Information 

Requirements 

This notice does not impose any 

information collection and record 

keeping requirements subject to the 

Paperwork Reduction Act (PRA). 

Consequently, it does not need to be 

reviewed by the Office of Management 

and Budget (OMB) under the authority 

of the PRA. The requirements associated 

with the accreditation process for 

clinical laboratories under the Clinical 

Laboratory Improvement Amendments 

of 1988 (CLIA) program, and the 

implementing regulations in 42 CFR 

part 493, subpart E, are currently 

approved under OMB control number 

0938–0686. 

Authority: Section 353(p) of the Public 

Health Service Act (42 U.S.C. 263a). 

Dated: February 26, 2009. 

Charlene Frizzera, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E9–6903 Filed 3–26–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–2294–FN] 

Medicare and Medicaid Programs; 

Approval of the Joint Commission for 

Continued Deeming Authority for 

Hospices 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final notice. 

SUMMARY: This final notice announces 

the approval of a deeming application 

from the Joint Commission for 

continued recognition as a national 

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13440 Federal Register / Vol. 74, No. 58 / Friday, March 27, 2009 / Notices 

accreditation program for hospices that 

request participation in the Medicare or 

Medicaid programs. 

EFFECTIVE DATE: This final notice is 

effective June 18, 2009 through June 18, 

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 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 

facilities seeking designation as a 

hospice program. Under this authority, 

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. 

Provider agreement regulations are 

located in 42 CFR part 489 and 

regulations pertaining to the survey and 

certification of facilities are located in 

42 CFR part 488. 

Generally, in order to enter into an 

agreement, a hospice facility must first 

be certified by a State survey agency as 

complying with the conditions or 

requirements set forth in part 418 of our 

regulations. Then, the hospice is subject 

to regular surveys by a State survey 

agency to determine whether it 

continues to meet these requirements. 

There is an alternative, however, to 

surveys by State agencies. 

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

redesignated under section 125 of the 

Medicare Improvements for Patients and 

Providers Act of 2008 (MIPPA) (Pub. L. 

110–275)) provides that, if a provider 

entity demonstrates through 

accreditation by an approved national 

accreditation organization that all 

applicable Medicare conditions are met 

or exceeded, we would ‘‘deem’’ those 

provider entities as having met the 

requirements. (We note that section 125 

of MIPPA redesignated subsections (b) 

and (e) of subsection 1865 of the Act as 

(a) and (d) respectively.) Accreditation 

by an accreditation organization is 

voluntary and is not required for 

Medicare participation. 

If an accreditation 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 

Medicare conditions. A national 

accreditation organization applying for 

approval of deeming authority under 

part 488, subpart A must provide us 

with reasonable assurance that the 

accreditation 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 

accreditation organizations to reapply 

for continued approval of deeming 

authority every 6 years or sooner as 

determined by CMS. The Joint 

Commission’s term of approval as a 

recognized accreditation program for 

Hospice facilities expires June 18, 2009. 

II. Deeming Applications Approval 

Process 

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

provides a statutory timetable to ensure 

that our review of deeming applications 

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 

application review process. Within 60 

days of receiving a completed 

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 of our approval or 

denial of the application. 

III. Proposed Notice 

On November 28, 2008 we published 

a proposed notice (73 FR 72487) 

announcing the Joint Commission’s 

request for reapproval as a deeming 

organization for hospices. In this notice 

we specified in detail 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 the Joint Commission’s application in 

accordance with the criteria specified in 

our regulation, which include, but are 

not limited to the following: 

• An onsite administrative review of 

the Joint Commissions—(1) corporate 

policies; (2) financial and human 

resources available to accomplish the 

proposed surveys; (3) procedures for 

training, monitoring, and evaluation of 

its surveyor; (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 hospice accreditation 

standards to our current Medicare 

conditions for participation. 

• A documentation review of the 

Joint Commission’s survey processes to: 

• Determine the composition of the 

survey team, surveyor qualifications, 

and the ability of the Joint Commission 

to provide continuing surveyor training. 

• Compare the Joint Commission’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 the Joint Commission’s 

procedures for monitoring providers or 

suppliers found to be out of compliance 

with the Joint Commission program 

requirements. The monitoring 

procedures are used only with the Joint 

Commission identifies noncompliance. 

If noncompliance is identified through 

validation reviews, the 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 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 

28, 2008 proposed notice (73 FR 72487) 

also solicited public comments 

regarding whether the Joint 

Commission’s requirements met or 

exceeded the Medicare conditions of 

participation for hospices. We received 

no public comments in response to our 

proposed notice. 

IV. Provisions of the Final Notice 

A. Differences Between the Joint 

Commission Standards and 

Requirements and Medicare’s 

Conditions and Survey Requirements 

We compared the standards contained 

in the Joint Commission’s 

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Federal Register / Vol. 74, No. 58 / Friday, March 27, 2009 / Notices 13441 

‘‘Comprehensive Accreditation Manual 

for Home Care’’ (CAMHC) and its survey 

process in the ‘‘Surveyor Activity 

Guide’’ with the Medicare hospice 

conditions for participation and our 

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 notice yielded the 

following: 

• On June 5, 2008, CMS published a 

final rule (73 FR 32088) that revised the 

existing conditions of participation that 

hospices must meet to participate in the 

Medicare and Medicaid Program. In 

accordance with the regulations at 

§ 488.4(a)(3)(iv), the Joint Commission 

updated and revised their standards and 

survey procedures to meet the Medicare 

requirements. 

• To meet the Medicare requirements 

at section 2728 of the SOM, the Joint 

Commission modified its policies for 

posting the deemed status survey results 

within 10 days onto its extranet site. 

• The Joint Commission will conduct 

all for-cause surveys on an 

unannounced basis. 

• The Joint Commission modified its 

executive summary statement to clearly 

indicate that providers must meet all 

accreditation standards in order to be 

recommended for deemed status. 

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 

hospices meet or exceed our 

requirements. Therefore, we recognize 

the Joint Commission as a national 

accreditation organization for hospices 

that request participation in the 

Medicare program, effective June 18, 

2009 through June 18, 2015. 

V. Collection of Information 

Requirements 

This final notice does not impose any 

information collection and record 

keeping requirements. Consequently, it 

does not need to be reviewed by the 

Office of Management and Budget 

(OMB) under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 35). 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program; No. 93.773 Medicare—Hospital 

Insurance Program; and No. 93.774, 

Medicare—Supplemental Medical Insurance 

Program) 

Dated: March 4, 2009. 

Charlene Frizzera, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E9–6775 Filed 3–26–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3212–N] 

Medicare Program; Request for 

Nominations for Members for the 

Medicare Evidence Development & 

Coverage Advisory Committee 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces a 

request for nominations for 

consideration for membership on the 

Medicare Evidence Development & 

Coverage Advisory Committee 

(MEDCAC). Among other things, the 

MEDCAC advises the Secretary of the 

Department of Health and Human 

Services (the Secretary) and the 

Administrator of the Centers for 

Medicare & Medicaid Services on 

whether medical items and services are 

‘‘reasonable and necessary’’ and 

therefore eligible for coverage under 

Title XVIII of the Social Security Act. 

We are requesting nominations for 

both voting and nonvoting members to 

serve on the MEDCAC. Nominees are 

selected based upon their individual 

qualifications and not as representatives 

of professional associations or societies. 

We have a special interest in ensuring 

that women, minority groups, and 

physically challenged individuals are 

adequately represented on the 

MEDCAC. Therefore, we encourage 

nominations of qualified candidates 

from these groups. 

The MEDCAC reviews and evaluates 

medical literature, reviews technology 

assessments, and examines data and 

information on the effectiveness and 

appropriateness of medical items and 

services that are covered or eligible for 

coverage under Medicare. 

DATES: Nominations for membership 

will be considered if postmarked by 

April 27, 2009 and mailed to the contact 

person specified in the FOR FURTHER

INFORMATION CONTACT section of this 

notice to the designated address, as 

provided in the ADDRESSES section of 

this notice. 

ADDRESSES: You may mail nominations 

for membership to the following: 

Attention: Maria Ellis, Office of Clinical 

Standards and Quality, Centers for 

Medicare & Medicaid Services, 7500 

Security Boulevard, Mail Stop: C1–09– 

06, Baltimore, MD 21244–1850. 

FOR FURTHER INFORMATION CONTACT: 

Maria Ellis, Executive Secretary for 

MEDCAC, Centers for Medicare & 

Medicaid Services OCSQ—Coverage 

and Analysis Group, Mailstop: C1–09– 

06, 7500 Security Boulevard, Baltimore, 

MD 21244, or contact Ms. Ellis by phone 

at 410–786–0309; or via e-mail at 

Maria.Ellis@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On December 14, 1998, we published 

a notice in the Federal Register (63 FR 

68780) announcing establishment of the 

Medicare Coverage Advisory Committee 

(MCAC). The Secretary signed the initial 

charter for the Medicare Coverage 

Advisory Committee on November 24, 

1998. On January 26, 2007 the Secretary 

published a notice in the Federal 

Register (72FR 3853), changing the 

Committee’s name to the Medicare 

Evidence Development and Coverage 

Advisory Committee (MEDCAC). The 

charter for the committee was renewed 

by the Secretary and will terminate on 

November 24, 2010, unless renewed 

again by the Secretary. 

The MEDCAC is governed by 

provisions of the Federal Advisory 

Committee Act, Public Law 92–463, as 

amended (5 U.S.C. App. 2), which sets 

forth standards for the formulation and 

use of advisory committees, and is 

authorized by section 222 of the Public 

Health Service Act as amended (42 

U.S.C. 217a). 

The MEDCAC consists of a pool of 

100 appointed members including: 6 

patient advocates, who are standard 

voting members, and 6 representatives 

of industry interests, who are nonvoting 

members. Members are selected from 

among authorities in clinical medicine 

of all specialties, administrative 

medicine, public health, biologic and 

physical sciences, health care data and 

information management and analysis, 

patient advocacy, the economics of 

health care, medical ethics, and other 

related professions such as 

epidemiology and biostatistics, and 

methodology of trial design. 

The MEDCAC functions on a 

committee basis. The Committee 

reviews and evaluates medical 

literature, reviews technology 

assessments, and examines data and 

information on the effectiveness and 

appropriateness of medical items and 

services that are covered or eligible for 

coverage under Medicare. The 

mstockstill on PROD1PC66 with NOTICES