80 FR 16412 - Medicare Program; Renewal of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 80, Issue 59 (March 27, 2015)
Centers for Medicare & Medicaid Services
Federal Register Volume 80, Issue 59 (March 27, 2015)
| Page Range | 16412-16412 | |
| FR Document | 2015-07105 |
[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)] [Notices] [Page 16412] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-07105] ----------------------------------------------------------------------- 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-and-Guidance/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 [email protected]. 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 at-large 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] BILLING CODE 4120-01-P
![16412 Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices
• Costs of federal inspections of Dated: March 10, 2015. overlapping 2-year terms. Members
laboratories in the state to verify that Andrew M. Slavitt, shall be invited to serve for two terms
New York State’s laboratory licensure Acting Administrator, Centers for Medicare (up to 4 years total). Members are
program requirements are equivalent to & Medicaid Services. selected from among authorities in
or more stringent than those in the CLIA [FR Doc. 2015–07113 Filed 3–26–15; 8:45 am] clinical and administrative medicine,
program, and that they are enforced in BILLING CODE 4120–01–P biologic and physical sciences, public
an appropriate manner. The average health administration, health care data
federal hourly rate is multiplied by the and information management and
total hours required to perform federal DEPARTMENT OF HEALTH AND analysis, the economics of health care,
validation surveys within the state. HUMAN SERVICES medical ethics, and other related
• Costs incurred for federal surveys, Centers for Medicare & Medicaid professions, as well as advocates for
including investigations of complaints Services patients. Of the pool of 100 members, a
that are substantiated. We will bill the maximum of 94 members shall be at-
[CMS–3318–N] large standing members (this includes 6
State of New York on a semiannual
basis. Medicare Program; Renewal of the members who shall be patient
• The State of New York’s Medicare Evidence Development & advocates) and 6 shall be members
proportionate share of the costs Coverage Advisory Committee representing industry interests. The
associated with establishing, (MEDCAC) Secretary or designee appoints a Chair
maintaining, and improving the CLIA and Vice-Chair from among the pool of
AGENCY: Centers for Medicare & at-large members.
computer system, based on the portion Medicaid Services (CMS), HHS.
of those services from which the State ACTION: Notice. II. Provisions of This Notice
of New York received direct benefit or
which contributed to the CLIA program SUMMARY: This notice announces the This notice announces the renewal of
in the state. Thus, the State of New York renewal of the Medicare Evidence the MEDCAC charter by the Secretary,
is being charged for a portion of our Development & Coverage Advisory effective November 24, 2014. The
direct and indirect costs of Committee (MEDCAC). MEDCAC charter is effective for 2 years.
administering the CLIA program. Such FOR FURTHER INFORMATION CONTACT: Among other things, the new charter
costs will be incurred by CMS, the Maria Ellis, (410) 786–0309. Additional states that the committee will hold four
Centers for Disease Control and information on the MEDCAC, including to eight meetings over the life of the
Prevention (CDC), the Food and Drug a copy of the Charter, is available at committee. Formerly, the charter
Administration (FDA) and contractors http://www.cms.gov/Regulations-and- allowed up to 16 meetings over the life
working on behalf of these respective Guidance/Guidance/FACA/ of the committee.
agencies. MEDCAC.html. A copy of the charter The MEDCAC functions on a
may also be obtained by submitting a committee basis. The MEDCAC hears
To estimate the State of New York’s
request to Maria Ellis via phone or via
proportionate share of the general public testimony; reviews medical
email at Maria.Ellis@cms.hhs.gov.
overhead costs to develop and literature, technology assessments and
SUPPLEMENTARY INFORMATION:
implement CLIA, we determined the other relevant evidence; and advises
ratio of laboratories in the state to the I. Background CMS on the strength and weaknesses of
total number of laboratories nationally. On December 14, 1998, we published that evidence. The MEDCAC also
Approximately 1.5 percent of the a notice in the Federal Register (63 FR advises CMS of any evidence gaps that
registered laboratories are in the State of 68780) announcing the establishment of may exist and recommends the types of
New York. We determined that a the Medicare Coverage Advisory evidence that should be developed to
corresponding percentage of the Committee (MCAC). The Secretary fill those evidentiary gaps. The
applicable CMS, CDC, FDA, and their signed the initial charter for the MCAC Committee may be asked to develop
respective contractor costs should be on November 24, 1998. The MCAC was recommendations about specific issues
borne by the State of New York. originally established to provide related to Medicare coverage, and/or to
The State of New York has agreed to independent guidance and expert review and comment upon proposed or
pay the state’s pro rata share of the advice to CMS on specific clinical existing Medicare coverage policies. The
anticipated overhead costs and costs of topics. In 2007, the Charter was Committee may also be asked to
actual validation (including complaint renewed and the name MCAC was comment on pertinent aspects of
investigation surveys). A final modified to Medicare Evidence coverage proposals being considered
reconciliation for all laboratories and all Development and Coverage Advisory and other policies. The Committee
expenses will be made. We will Committee (MEDCAC) to more works from an agenda provided by a
reimburse the state for any overpayment accurately reflect the Committee’s role. designated Federal official, which lists
The MEDCAC is advisory, with the final specific issues to be reviewed.
or bill it for any balance.
decision on all issues resting with CMS.
II. Approval Under the current charter, the MEDCAC Authority: 5 U.S.C. App. 2, section 10(a)(1)
advises the Secretary of the Department and (a)(2).
In light of the foregoing, we grant
mstockstill on DSK4VPTVN1PROD with NOTICES
of Health and Human Services (DHHS) Dated: March 20, 2015.
approval of the State of New York’s (the Secretary) and the Administrator of Patrick Conway,
laboratory licensure program, CLEP, the Centers for Medicare & Medicaid
under subpart E. All laboratories located Deputy Administrator for Innovation and
Services (CMS) on the quality of Quality and CMS Chief Medical Officer,
within the State of New York that hold evidence on clinical topics under Centers for Medicare & Medicaid Services.
valid CLEP permits are CLIA-exempt for review by CMS. [FR Doc. 2015–07105 Filed 3–26–15; 8:45 am]
all specialties and subspecialties until The MEDCAC consists of a pool of
March 27, 2021. BILLING CODE 4120–01–P
100 appointed members who serve
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Document Created: 2015-12-18 11:37:03
Document Modified: 2015-12-18 11:37:03
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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-and-Guidance/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 [email protected] | |
| FR Citation | 80 FR 16412 |
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