72830 Federal Register / Vol. 75, No. 227 / Friday, November 26, 2010 / Notices 

safety and effectiveness summaries of 

PMA approvals and denials that were 

announced during that quarter. The 

following is a list of approved PMAs for 

which summaries of safety and 

effectiveness were placed on the 

Internet from July 1, 2010, through 

September 30, 2010. There were no 

denial actions during this period. The 

list provides the manufacturer’s name, 

the product’s generic name or the trade 

name, and the approval date. 

TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JULY 1, 

2010, THROUGH SEPTEMBER 30, 2010 

PMA No. 

Docket No. Applicant Trade name Approval date 

P080027, FDA–2010–M–0402 ............... OraSure Technologies, Inc ................... ORAQUICK HCV RAPID ANTIBODY 

TEST.

June 25, 2010. 

P050034, FDA–2010–M–0361 ............... Vision Care Ophthalmic Technologies, 

Ltd.

IMPLANTABLE MINIATURE TELESCOPE.July 1, 2010. 

P080026, FDA–2010–M–0519 ............... Abbott Molecular, Inc ............................ ABBOTT REALTIME HBV ASSAY ....... August 13, 2010. 

II. Electronic Access 

Persons with access to the Internet 

may obtain the documents at http:// 

www.fda.gov/cdrh/pmapage.html. 

Dated: November 18, 2010. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2010–29731 Filed 11–24–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3229–N] 

Medicare Program; Quality 

Improvement Organization (QIO) 

Contracts: Solicitation of Proposals 

From In-State QIOs—Idaho, Maine, 

South Carolina, and Vermont 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice fulfills the 

Secretary’s obligation under section 

1153(i) of the Social Security Act (the 

Act) to provide at least 6 months’ 

advance notice of the expiration dates of 

contracts with out-of-State Quality 

Improvement Organizations (QIOs) 

before renewing any of those QIOs’ 

contracts. It also specifies the period of 

time in which in-State QIOs may submit 

a proposal for those contracts. 

DATES: Interested organizations may 

submit a proposal to perform the QIO 

work in any of the States listed in this 

announcement. The request for proposal 

(RFP) will be made available to all 

interested organizations through the 

Federal Business Opportunities (http:// 

www.fedbizopps.gov) Web site. CMS 

anticipates that the RFP for the QIO 

contracts will be released sometime 

during the month of February 2011. 

Interested organizations should monitor 

the Federal Business Opportunities Web 

site for all information relating to the 

RFP. 

ADDRESSES: Proposals for the contracts 

must be submitted to the Centers for 

Medicare & Medicaid Services, 

Acquisitions and Grants Groups, 

OAGM, Attn.: Naomi Haney-Ceresa, 

7500 Security Boulevard, Mail Stop C2– 

21–15, Baltimore, Maryland 21244– 

1850. 

FOR FURTHER INFORMATION CONTACT: 

Alfreda Staton, (410) 786–4194. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Peer Review Improvement Act of 

1982 (title I, subtitle C of the Tax Equity 

and Fiscal Responsibility Act of 1982 

(TEFRA), Pub. L. 97–248) amended Part 

B of title XI of the Act (the Act) by 

establishing the Utilization and Quality 

Control Peer Review Organization 

program. 

Utilization and Quality Control Peer 

Review Organizations, now known as 

Quality Improvement Organizations 

(QIOs), currently review certain health 

care services furnished under title XVIII 

of the Social Security Act (the Act) 

(Medicare) to determine whether those 

services are reasonable, medically 

necessary, provided in the appropriate 

setting, and are of a quality that meets 

professionally recognized standards. 

QIO activities are a part of the Health 

Care Quality Improvement Program 

(HCQIP), a program that supports our 

mission to ensure health care quality for 

our beneficiaries. The HCQIP rests on 

the belief that a plan’s, provider’s, or 

practitioner’s own internal quality 

management system is key to good 

performance. The HCQIP is carried out 

locally by the QIO in each State. Under 

the HCQIP, QIOs provide critical tools 

(for example, quality indicators and 

information) for plans, providers, and 

practitioners to improve the quality of 

care provided to Medicare beneficiaries. 

The Congress created the QIO program 

in part to redirect, simplify, and 

enhance the cost-effectiveness and 

efficiency of the peer review process. 

In June 1984, we began awarding 

contracts to QIOs. We currently 

maintain 53 QIO contracts with 

organizations that provide medical 

review activities for the 50 States, the 

District of Columbia, Puerto Rico, and 

the Virgin Islands. The organizations 

that are eligible to contract as QIOs have 

satisfactorily demonstrated that they are 

either physician-sponsored or 

physician-access organizations in 

accordance with section 1152 of the Act 

and our regulations at 42 CFR 475.102 

and 475.103. A physician-sponsored 

organization is one that is both 

composed of a substantial number of the 

licensed doctors of medicine and 

osteopathy practicing medicine or 

surgery in the respective review area 

and who are representative of the 

physicians practicing in the review area. 

A physician-access organization is one 

that has available to it, by arrangement 

or otherwise, the services of a sufficient 

number of licensed doctors of medicine 

or osteopathy practicing medicine or 

surgery in the review area to ensure 

adequate peer review of the services 

furnished by the various medical 

specialties and subspecialties. In 

addition, a QIO cannot be a health care 

facility, health care facility association, 

a health care facility affiliate, or in most 

cases a payor organization. (The 

regulations provide that, in the event 

CMS determines no otherwise qualified 

non-payor organization is available to 

undertake a given QIO contract, CMS 

may select a payor organization which 

otherwise meets certain requirements to 

be eligible to conduct Utilization and 

Quality Control Peer Review as 

specified in Part B of Title XI of the Act 

and its implementing regulations.) 

Section 1152(2) of the Act requires QIOs 

to perform review functions in an 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 227 / Friday, November 26, 2010 / Notices 72831 

efficient and effective manner, and 

perform reviews of quality of care in an 

area of medical practice where actual 

performance is measured against 

objective criteria, which defines 

acceptable and adequate practice. The 

selected organization must have a 

consumer representative on its 

governing board. 

The Omnibus Budget Reconciliation 

Act of 1987 (Pub. L. 100–203) amended 

section 1153 of the Act by adding 

paragraph (i). This provision prohibits 

CMS from renewing the contract of any 

QIO that is not an in-State QIO without 

first publishing in the Federal Register 

a notice announcing when the contract 

will expire. This notice must be 

published no later than 6 months before 

the date the contract expires and must 

specify the period of time during which 

an in-State organization may submit a 

proposal for the QIO contract for that 

State. If one or more qualified in-State 

organizations submit a proposal for the 

QIO contract within the specified period 

of time, we cannot automatically renew 

the current contract on a 

noncompetitive basis, but must instead 

provide for competition for the contract 

in the same manner used for a new 

contract under section 1153(b) of the 

Act. An in-State QIO is defined under 

section 1153(i)(3) of the Act as a QIO 

that has its primary place of business in 

the State in which review will be 

conducted (or, be a subsidiary of a 

parent corporation, whose headquarters 

is located in that State). 

There are currently 4 QIO contracts 

with entities that do not meet the 

statutory definition of an in-State QIO. 

The areas affected for purposes of this 

notice along with the respective contract 

expiration dates are as follows: 

Vermont—July 31, 2011 

Maine—July 31, 2011 

Idaho—July 31, 2011 

South Carolina—July 31, 2011 

II. Provisions of the Notice 

This notice announces the scheduled 

expiration dates of the current contracts 

between CMS and the out-of-State QIOs 

responsible for review in the areas 

mentioned above. 

Interested in-State organizations may 

submit a proposal in competing to 

become the QIO for these States. In 

order to be eligible for contract award, 

the organization must have its primary 

place of business in the States in which 

review will be conducted or be a 

subsidiary of a parent corporation, 

whose headquarters is located in that 

State. In order to be eligible for contract 

award, each interested organization 

must further demonstrate that it meets 

the following requirements: 

A. Be Either a Physician-Sponsored or a 

Physician-Access Organization 

1. Physician-Sponsored Organization 

a. The organization must be composed 

of a substantial number of the licensed 

doctors of medicine and osteopathy 

practicing medicine or surgery in the 

review area, who are representative of 

the physicians practicing in the review 

area. 

b. The organization must not be a 

health care facility, health care facility 

association, health care facility affiliate, 

or payor organization. However, statutes 

and regulations provide that, in the 

event CMS determines no otherwise 

qualified non-payor organization is 

available to undertake a given QIO 

contract, CMS may select a payor 

organization which otherwise meets 

requirements to be eligible to conduct 

Utilization and Quality Control Peer 

Review as specified in Part B of Title XI 

of the Act and its implementing 

regulations. 

c. In order to meet the ‘‘substantial 

number of doctors of medicine and 

osteopathy’’ requirements as specified 

above in paragraph A.1.a, an 

organization must state and have 

documentation in its files showing that 

it is composed of at least 10 percent of 

the licensed doctors of medicine and 

osteopathy practicing medicine or 

surgery in the review area. In order to 

meet the representation requirements as 

specified above in paragraph A.1.a, an 

organization must state and have 

documentation in its files demonstrating 

that it is composed of at least 20 percent 

of the licensed doctors of medicine and 

osteopathy practicing medicine or 

surgery in the review area. 

Alternatively, if the organization does 

not demonstrate that it is composed of 

at least 20 percent of the licensed 

doctors of medicine and osteopathy 

practicing medicine or surgery in the 

review area, the organization must 

demonstrate in its proposal, through 

letters of support from physicians or 

physician organizations, or through 

other means, that it is representative of 

the area physicians. 

2. Physician-Access Organization 

a. The organization must have 

available to it, by arrangement or 

otherwise, the services of a sufficient 

number of licensed doctors of medicine 

or osteopathy practicing medicine or 

surgery in the review area to ensure 

adequate peer review of the services 

furnished by the various medical 

specialties and subspecialties. 

b. The organization must not be a 

health care facility, health care facility 

association, health care facility affiliate, 

or payor organization. 

c. An organization meets the 

requirements specified above in 

paragraph A.2.a., if it demonstrates that 

it has available to it at least one 

physician in every generally recognized 

specialty and has an arrangement or 

arrangements with physicians under 

which the physicians would conduct 

review for the organization. 

B. Have at Least One Individual Who Is 

a Representative of Consumers on Its 

Governing Board 

If one or more organizations meet the 

above requirements in a QIO area and 

submit proposals for the contracts in 

accordance with this notice, we will 

consider those organizations to be 

potential sources for the 4 contracts 

upon their expiration. These 

organizations will be entitled to 

participate in a full and open 

competition for the QIO contract to 

perform the QIO statement of work. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance Program; and No. 93.774, 

Medicare-Supplementary Medical Insurance 

Program) 

Dated: October 28, 2010. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2010–28817 Filed 11–24–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Advisory Committee to the Director 

(ACD), Centers for Disease Control and 

Prevention (CDC)—Ethics 

Subcommittee (ES) 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the CDC announces 

the following meeting of the 

aforementioned subcommittee: 

Time and Date: 2 p.m.—3:30 p.m. Eastern 

Standard Time, January 4, 2011. 

Place: Teleconference. 

Status: Open to the public, limited only by 

availability of telephone ports. The public is 

welcome to participate during the public 

comment period. A public comment period 

is tentatively scheduled from 3 p.m.—3:15 

p.m. To participate in the teleconference, 

please dial 1–877–928–1204 and enter 

conference code 4305992. 

Purpose: The ES will provide counsel to 

the ACD, CDC, regarding a broad range of 

public health ethics questions and issues 

arising from programs, scientists and 

practitioners. 


srobinson on DSKHWCL6B1PROD with NOTICES