16412 Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices 

• Costs of federal inspections of 

laboratories in the state to verify that 

New York State’s laboratory licensure 

program requirements are equivalent to 

or more stringent than those in the CLIA 

program, and that they are enforced in 

an appropriate manner. The average 

federal hourly rate is multiplied by the 

total hours required to perform federal 

validation surveys within the state. 

• Costs incurred for federal surveys, 

including investigations of complaints 

that are substantiated. We will bill the 

State of New York on a semiannual 

basis. 

• The State of New York’s 

proportionate share of the costs 

associated with establishing, 

maintaining, and improving the CLIA 

computer system, based on the portion 

of those services from which the State 

of New York received direct benefit or 

which contributed to the CLIA program 

in the state. Thus, the State of New York 

is being charged for a portion of our 

direct and indirect costs of 

administering the CLIA program. Such 

costs will be incurred by CMS, the 

Centers for Disease Control and 

Prevention (CDC), the Food and Drug 

Administration (FDA) and contractors 

working on behalf of these respective 

agencies. 

To estimate the State of New York’s 

proportionate share of the general 

overhead costs to develop and 

implement CLIA, we determined the 

ratio of laboratories in the state to the 

total number of laboratories nationally. 

Approximately 1.5 percent of the 

registered laboratories are in the State of 

New York. We determined that a 

corresponding percentage of the 

applicable CMS, CDC, FDA, and their 

respective contractor costs should be 

borne by the State of New York. 

The State of New York has agreed to 

pay the state’s pro rata share of the 

anticipated overhead costs and costs of 

actual validation (including complaint 

investigation surveys). A final 

reconciliation for all laboratories and all 

expenses will be made. We will 

reimburse the state for any overpayment 

or bill it for any balance. 

II. Approval 

In light of the foregoing, we grant 

approval of the State of New York’s 

laboratory licensure program, CLEP, 

under subpart E. All laboratories located 

within the State of New York that hold 

valid CLEP permits are CLIA-exempt for 

all specialties and subspecialties until 

March 27, 2021. 

Dated: March 10, 2015. 

Andrew M. Slavitt, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2015–07113 Filed 3–26–15; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3318–N] 

Medicare Program; Renewal of the 

Medicare Evidence Development & 

Coverage Advisory Committee 

(MEDCAC) 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

renewal of the Medicare Evidence 

Development & Coverage Advisory 

Committee (MEDCAC). 

FOR FURTHER INFORMATION CONTACT: 

Maria Ellis, (410) 786–0309. Additional 

information on the MEDCAC, including 

a copy of the Charter, is available at 

http://www.cms.gov/Regulations-andGuidance/Guidance/FACA/

MEDCAC.html. A copy of the charter 

may also be obtained by submitting a 

request to Maria Ellis via phone or via 

email 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 the establishment of 

the Medicare Coverage Advisory 

Committee (MCAC). The Secretary 

signed the initial charter for the MCAC 

on November 24, 1998. The MCAC was 

originally established to provide 

independent guidance and expert 

advice to CMS on specific clinical 

topics. In 2007, the Charter was 

renewed and the name MCAC was 

modified to Medicare Evidence 

Development and Coverage Advisory 

Committee (MEDCAC) to more 

accurately reflect the Committee’s role. 

The MEDCAC is advisory, with the final 

decision on all issues resting with CMS. 

Under the current charter, the MEDCAC 

advises the Secretary of the Department 

of Health and Human Services (DHHS) 

(the Secretary) and the Administrator of 

the Centers for Medicare & Medicaid 

Services (CMS) on the quality of 

evidence on clinical topics under 

review by CMS. 

The MEDCAC consists of a pool of 

100 appointed members who serve 

overlapping 2-year terms. Members 

shall be invited to serve for two terms 

(up to 4 years total). Members are 

selected from among authorities in 

clinical and administrative medicine, 

biologic and physical sciences, public 

health administration, health care data 

and information management and 

analysis, the economics of health care, 

medical ethics, and other related 

professions, as well as advocates for 

patients. Of the pool of 100 members, a 

maximum of 94 members shall be atlarge standing members (this includes 6 

members who shall be patient 

advocates) and 6 shall be members 

representing industry interests. The 

Secretary or designee appoints a Chair 

and Vice-Chair from among the pool of 

at-large members. 

II. Provisions of This Notice 

This notice announces the renewal of 

the MEDCAC charter by the Secretary, 

effective November 24, 2014. The 

MEDCAC charter is effective for 2 years. 

Among other things, the new charter 

states that the committee will hold four 

to eight meetings over the life of the 

committee. Formerly, the charter 

allowed up to 16 meetings over the life 

of the committee. 

The MEDCAC functions on a 

committee basis. The MEDCAC hears 

public testimony; reviews medical 

literature, technology assessments and 

other relevant evidence; and advises 

CMS on the strength and weaknesses of 

that evidence. The MEDCAC also 

advises CMS of any evidence gaps that 

may exist and recommends the types of 

evidence that should be developed to 

fill those evidentiary gaps. The 

Committee may be asked to develop 

recommendations about specific issues 

related to Medicare coverage, and/or to 

review and comment upon proposed or 

existing Medicare coverage policies. The 

Committee may also be asked to 

comment on pertinent aspects of 

coverage proposals being considered 

and other policies. The Committee 

works from an agenda provided by a 

designated Federal official, which lists 

specific issues to be reviewed. 

Authority: 5 U.S.C. App. 2, section 10(a)(1) 

and (a)(2). 

Dated: March 20, 2015. 

Patrick Conway, 

Deputy Administrator for Innovation and 

Quality and CMS Chief Medical Officer, 

Centers for Medicare & Medicaid Services. 

[FR Doc. 2015–07105 Filed 3–26–15; 8:45 am] 

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