8174 Federal Register / Vol. 72, No. 36 / Friday, February 23, 2007 / Notices 

of accredited laboratories; and its 

announced or unannounced inspection 

process. 

Our evaluation identified Joint 

Commission requirements pertaining to 

waived testing that are more stringent 

than the CLIA requirements. The Joint 

Commission waived testing 

requirements include the following: 

• Defining the extent that waived test 

results are used in patient care. 

• Identifying the personnel 

responsible for performing and 

supervising waived testing. 

• Assuring that personnel performing 

waived testing have adequate, specific 

training and orientation to perform the 

testing and can demonstrate satisfactory 

levels of performance. 

• Making certain that policies and 

procedures governing waived testingrelated processes are current and readily 

available. 

• Conducting defined quality control 

checks. 

• Maintaining quality control and test 

records. 

The CLIA requirements at § 493.15 

only require that a laboratory follow 

manufacturer’s instructions and obtain a 

certificate of waiver. 

Subpart H—Participation in Proficiency 

Testing for Laboratories Performing 

Nonwaived Testing 

The Joint Commission’s requirements 

are equal to the CLIA requirements at 

§ 493.801 through § 493.865. 

Subpart J—Facility Administration for 

Nonwaived Testing 

The Joint Commission requirements 

are equal to the CLIA requirements at 

§ 493.1100 through § 493.1105. 

Subpart K—Quality System for 

Nonwaived Testing 

The Joint Commission requirements 

are equal to or more stringent than the 

CLIA requirements at § 493.1200 

through § 493.1299. We have 

determined that Joint Commission’s 

requirements, when taken as a whole, 

are more stringent than the CLIA 

requirements. For instance, the Joint 

Commission has control procedure 

requirements for all waived complexity 

testing performed. 

Subpart M—Personnel for Nonwaived 

Testing 

We have determined that the Joint 

Commission requirements are equal to 

or more stringent than the CLIA 

requirements at § 493.1403 through 

§ 493.1495 for laboratories that perform 

moderate and high complexity testing. 

Subpart Q—Inspections 

We have determined that the Joint 

Commission requirements are equal to 

or more stringent than the CLIA 

requirements at § 493.1771 through 

§ 493.1780. The Joint Commission will 

continue to perform onsite inspections 

every 2 years. 

Subpart R—Enforcement Procedures 

The Joint Commssion meets the 

requirements of subpart R to the extent 

that it applies to accreditation 

organizations. The Joint Commission 

policy sets forth the actions the 

organization takes when laboratories it 

accredits do not comply with its 

requirements and standards for 

accreditation. When appropriate, the 

Joint Commission will deny, suspend, 

or, revoke accreditation in a laboratory 

accredited by the Joint Commission and 

report that action to us within 30 days. 

The Joint Commission also provides an 

appeal process for laboratories that have 

had accreditation denied, suspended, or 

revoked. 

We have determined that the Joint 

Commission’s laboratory enforcement 

and appeal policies are equal to or more 

stringent than the requirements of part 

493 subpart R as they apply to 

accreditation organizations. 

IV. Federal Validation Inspections and 

Continuing Oversight 

The Federal validation inspections of 

Joint Commission accredited 

laboratories 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 us 

or our agents, or the State survey 

agencies, will be our principal means 

for verifying that the laboratories 

accredited by the Joint Commission 

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 Joint 

Commission, for cause, before the end of 

the effective date of approval. If we 

determine that the Joint Commission 

failed to adopt requirements that are 

equal to, or more stringent than, the 

CLIA requirements, or that systemic 

problems exist in its inspection process, 

we may give it a probationary period, 

not to exceed 1 year to allow the Joint 

Commission to adopt comparable 

requirements. 

Should circumstances result in our 

withdrawal of the Joint Commission’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, codified in 42 

CFR part 493 subpart E, are currently 

approved by OMB under OMB approval 

number 0938–0686. 

VII. Executive Order 12866 Statement 

In accordance with the provisions of 

Executive Order 12866, this notice was 

not reviewed by the Office of 

Management and Budget. 

Authority: Section 353 of the Public Health 

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

Dated: December 7, 2006. 

Leslie V. Norwalk, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E7–3030 Filed 2–22–07; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1391–NC] 

Medicare and Medicaid Programs; 

Announcement of an Application From 

a Hospital Requesting Waiver for 

Organ Procurement Service Area 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice with comment period. 

SUMMARY: This notice announces a 

hospital’s request for a waiver from 

entering into an agreement with its 

designated organ procurement 

organization (OPO), in accordance with 

section 1138(a)(2) of the Social Security 

Act (the Act). This notice requests 

comments from OPOs and the general 

public for our consideration in 

determining whether we should grant 

the requested waiver. 

DATES: Comment Date: To be assured 

consideration, comments must be 


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Federal Register / Vol. 72, No. 36 / Friday, February 23, 2007 / Notices 8175 

received at one of the addresses 

provided below, no later than 5 p.m. on 

April 24, 2007. 

ADDRESSES: In commenting, please refer 

to file code CMS–1391–NC. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (no duplicates, please): 

1. Electronically. You may submit 

electronic comments on specific issues 

in this regulation to http:// 

www.cms.hhs.gov/eRulemaking. Click 

on the link ‘‘Submit electronic 

comments on CMS regulations with an 

open comment period.’’ (Attachments 

should be in Microsoft Word, 

WordPerfect, or Excel; however, we 

prefer Microsoft Word.) 

2. By regular mail. You may mail 

written comments (one original and two 

copies) to the following address ONLY: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Attention: CMS–1391–

NC, P.O. Box 8017, Baltimore, MD 

21244–8017. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments (one 

original and two copies) to the following 

address only: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–1391–NC, Mail Stop C4–26–05, 

7500 Security Boulevard, Baltimore, MD 

21244–1850. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments (one original 

and two copies) before the close of the 

comment period to one of the following 

addresses. If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786–

9994 in advance to schedule your 

arrival with one of our staff members. 

Room 445–G, Hubert H. Humphrey 

Building, 200 Independence Avenue, 

SW., Washington, DC 20201; or 7500 

Security Boulevard, Baltimore, MD 

21244–1850. 

(Because access to the interior of the 

HHH Building is not readily available to 

persons without Federal Government 

identification, commenters are 

encouraged to leave their comments in 

the CMS drop slots located in the main 

lobby of the building. A stamp-in clock 

is available for persons wishing to retain 

a proof of filing by stamping in and 

retaining an extra copy of the comments 

being filed.) 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

FOR FURTHER INFORMATION CONTACT: 

Mark A. Horney, (410) 786–4554. 

SUPPLEMENTARY INFORMATION: 

Submitting Comments: We welcome 

comments from the public on all issues 

set forth in this proposed notice to assist 

us in fully considering the issues. You 

can assist us by referencing the file code 

CMS–1391–NC and the specific ‘‘issue 

identifier’’ that precedes the section on 

which you choose to comment. 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all electronic 

comments received before the close of 

the comment period on its public Web 

site as soon as possible after they have 

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

eRulemaking. Click on the link 

‘‘Electronic Comments on CMS 

Regulations’’ on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

[If you choose to comment on issues 

in this section, please include the 

caption ‘‘BACKGROUND’’ at the 

beginning of your comments.] 

Organ Procurement Organizations 

(OPOs) are not-for-profit organizations 

that are responsible for the 

procurement, preservation, and 

transport of transplantable organs to 

transplant centers throughout the 

country. Qualified OPOs are designated 

by the Centers for Medicare & Medicaid 

Services (CMS) to recover or procur 

organs in CMS-defined exclusive 

geographic service areas, according to 

section 371(b)(1)(F) of the Public Health 

Service Act (42 U.S.C. 273(b)(1)(F)) and 

our regulations at 42 CFR 486.306. Once 

an OPO has been designated for an area, 

hospitals in that area that participate in 

Medicare and Medicaid are required to 

work with that OPO in providing organs 

for transplant, according to section 

1138(a)(1)(C) of the Social Security Act 

(the Act), and our regulations at 42 CFR 

482.45. 

Section 1138(a)(1)(A)(iii) of the Act 

provides that a hospital must notify the 

designated OPO (for the service area in 

which it is located) of potential organ 

donors. Under section 1138(a)(1)(C) of 

the Act, every participating hospital 

must have an agreement to identify 

potential donors only with its 

designated OPO. 

However, section 1138(a)(2)(A) of the 

Act provides that a hospital may obtain 

from the Secretary, a waiver of the 

above requirements under certain 

specified conditions. A waiver allows 

the hospital to have an agreement with 

an OPO other than the one initially 

designated by CMS, if the hospital 

meets certain conditions specified in 

section 1138(a)(2)(A) of the Act. In 

addition, the Secretary may review 

additional criteria described in section 

1138(a)(2)(B) of the Act to evaluate the 

hospital’s request for a waiver. 

Section 1138(a)(2)(A) of the Act states 

that in granting a waiver, the Secretary 

must determine that the waiver—(1) is 

expected to increase organ donations; 

and (2) will ensure equitable treatment 

of patients referred for transplants 

within the service area served by the 

designated OPO and within the service 

area served by the OPO with which the 

hospital seeks to enter into an 

agreement under the waiver. In making 

a waiver determination, section 

1138(a)(2)(B) of the Act provides that 

the Secretary may consider, among 

other factors: (1) Cost-effectiveness; (2) 

improvements in quality; (3) whether 

there has been any change in a 

hospital’s designated OPO due to the 

changes made in definitions for 

metropolitan statistical areas; and (4) 

the length and continuity of a hospital’s 

relationship with an OPO other than the 

hospital’s designated OPO. Under 

section 1138(a)(2)(D) of the Act, the 

Secretary is required to publish a notice 

of any waiver application received from 

a hospital within 30 days of receiving 

the application, and to offer interested 

parties an opportunity to comment in 

writing during the 60-day period 

beginning on the publication date in the 

Federal Register. 

The criteria that the Secretary uses to 

evaluate the waiver in these cases are 

the same as those described above under 

sections 1138(a)(2)(A) and (B) of the Act 

and have been incorporated into the 

regulations at 42 CFR 486.308(e) and (f). 

II. Waiver Request Procedures 

[If you choose to comment on issues 

in this section, please include the 

caption ‘‘Waiver Request Procedures’’ at 

the beginning of your comments.] 

In October 1995, we issued a Program 

Memorandum (Transmittal No. A–95–


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8176 Federal Register / Vol. 72, No. 36 / Friday, February 23, 2007 / Notices 

11) detailing the waiver process and 

discussing the information that 

hospitals must provide in requesting a 

waiver. We indicated that upon receipt 

of a waiver request, we would publish 

a Federal Register notice to solicit 

public comments, as required by section 

1138(a)(2)(D) of the Act. 

According to these requirements, we 

will review the request and comments 

received. During the review process, we 

may consult on an as-needed basis with 

the Public Health Service’s Division of 

Transplantation, the United Network for 

Organ Sharing, and our regional offices. 

If necessary, we may request additional 

clarifying information from the applying 

hospital or others. We will then make a 

final determination on the waiver 

request and notify the hospital and the 

designated and requested OPOs. 

III. Hospital Waiver Request 

[If you choose to comment on issues 

in this section, please include the 

caption ‘‘Hospital Waiver Request’’ at 

the beginning of your comments.] 

As permitted by 42 CFR 486.308(e), 

Methodist Hospital, of Henderson, 

Kentucky has requested a waiver in 

order to enter into an agreement with a 

designated OPO other than the OPO 

designated for the service area in which 

the hospital is located. 

Methodist Hospital is requesting a 

waiver to work with: Kentucky Organ 

Donor Affiliates, 106 East Broadway, 

Louisville, Kentucky 40202. 

Methodist Hospital’s Designated OPO 

is: Indiana Organ Procurement 

Organization, 429 N. Pennsylvania, 

Suite 201, Indianapolis, Indiana 46204. 

Authority: Section 1138 of the Social 

Security Act (42 U.S.C. 1320b–8). 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; Program No. 93.774, Medicare—

Supplementary Medical Insurance, and 

Program No. 93.778, Medical Assistance 

Program) 

Dated: February 15, 2007. 

Leslie V. Norwalk, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E7–3044 Filed 2–22–07; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1553–N] 

Medicare Program; Notice of 

Supplemental Election Period for 

Provider Participation in the Calendar 

Year (CY) 2007 Competitive 

Acquisition Plan for Part B Drugs 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces an 

additional physician election period for 

physicians who are not currently 

participating in the competitive 

acquisition program (CAP) for Medicare 

Part B drugs for calendar year (CY) 

2007. The additional physician election 

period begins on May 1, 2007 and ends 

on June 15, 2007. Physicians who elect 

to join the CAP during this additional 

election period will enter into a 

physician election agreement effective 

August 1, 2007 through December 31, 

2007. 

DATES: The additional CAP physician 

election period will begin on May 1, 

2007 and end on June 15, 2007. 

Physicians electing to join the CAP 

during this period will participate in the 

CAP effective August 1, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Edmund Kasaitis (410) 786–4545. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (Pub. L. 108–173) (MMA) requires 

the implementation of a competitive 

acquisition program (CAP) for certain 

Medicare Part B drugs not paid on a cost 

or prospective payment system basis. 

Physicians who elect to participate in 

the CAP obtain Medicare covered drugs 

from vendors selected through a 

competitive bidding process. Physicians 

who do not elect to participate in the 

CAP purchase these drugs and are paid 

under the average sales price (ASP) 

system. (For more information on the 

CAP, see the March 4, 2005 proposed 

rule (70 FR 10746), July 6, 2005 interim 

final rule with comment period (70 FR 

39022), and November 21, 2005 final 

rule (70 FR 70116).) In accordance with 

the CAP statute and regulations, the 

regular, annual CAP physician election 

period for CY 2008 will occur in the fall 

of 2007. 

II. Provisions of the Notice 

Under the authority described in 

section 1847B(a)(5)(A)(i) of Social 

Security Act (the Act) and 

§ 414.908(a)(2) of our regulations, which 

allows for physician election at times 

other than the regular, annual election 

period in such exigent circumstances as 

defined by CMS, we are designating an 

additional election period for 

physicians who wish to join the CAP. 

We are providing for this additional 

election period in recognition of the 

statutory change to the CAP under 

division B, title I, section 108 of the Tax 

Relief and Health Care Act of 2006 (Pub. 

L. 109–432) (TRHCA), effective for 

drugs supplied under the CAP as of 

April 1, 2007. We expect to provide 

program instructions or other guidance 

in the near future to implement changes 

to the CAP resulting from the new 

statutory provisions. Although the 

statutory change does not directly affect 

participating CAP physicians, it will 

require additional implementation 

efforts by CMS and was enacted after 

the close of the CAP physician election 

period for CY 2007. Thus, we believe 

this is an ‘‘exigent circumstance’’ for 

which we should allow physicians an 

additional opportunity to join the CAP. 

The additional election period—

• Begins May 1, 2007 and end June 

15, 2007; and 

• Is only for physicians as defined in 

section 1861(r) of the Act who are not 

currently participating in the CY 2007 

CAP. 

The procedures and forms used for 

the regular, annual election period for 

CY 2007 also will be used for this 

additional CY 2007 election period. The 

aforementioned forms include the 

Competitive Acquisition Program (CAP) 

for Medicare Part B Drugs CAP 

Physician Election Agreement, which is 

currently approved under the Office of 

Management and Budget control 

number 0938–0987, with an expiration 

date of April 30, 2009. Physicians who 

wish to join the CAP during this 

election period may obtain a Physician 

Election Agreement form from the 

download section of the CAP 

Information for Physicians webpage on 

the CMS Web site at http:// 

www.cms.hhs.gov/ 

CompetitiveAcquisforBios/ 

02_infophys.asp#TopOfPage. 

Physicians who elect to participate in 

the CAP during the additional CY 2007 

election period will have their CAP 

election agreement effective from 

August 1, 2007 through December 31, 

2007. We note that participation in the 

CAP for CY 2008 requires renewal of 

CAP election during the regular fall 


cprice-sewell on PROD1PC61 with NOTICES