### 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 athttp://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, amaximum 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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