Weekly Legislative & Regulatory Round-up

Medicaid Payments Made for Nonemergency Services Provided to Undocumented Aliens and Legal Aliens Restricted to Emergency Services in Texas (A-06-07-00108)

Review of Connecticut’s Community Based Medicaid Administrative Claims for State Fiscal Years 2005 and 2006 (A-01-08-00003)

September 14

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Draft Guidance for Industry and Food and Drug Administration

Staff; Clinical Study Designs for Surgical Ablation Devices for

Treatment of Atrial Fibrillation; Availability

ACTION:  Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing the

availability of the draft guidance entitled ``Clinical Study Designs

for Surgical Ablation Devices for Treatment of Atrial Fibrillation.''

This draft guidance provides FDA's proposed recommendations on clinical

trial designs for surgical ablation devices intended for the treatment

of atrial fibrillation. This draft guidance is not final nor is it in

effect at this time.

DATES:  Although you can comment on any guidance at any time (see 21

CFR 10.115(g)(5)), to ensure that the agency considers your comment on

this draft guidance before it begins work on the final version of the

guidance, submit written or electronic comments on the draft guidance

by December 14, 2009.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

 Food and Drug Administration

Memorandum of Understanding With Duke University

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is providing notice of

a memorandum of understanding (MOU) between the Food and Drug

Administration and Duke University. The purpose of this MOU is to

establish a framework for collaboration between the Parties and for

pursuing specific collaborative projects. This collaboration between

the Parties shall be known as the Cardiac Safety Research Consortium.

DATES: The agreement became effective August 4, 2009.

Food and Drug Administration

Pediatric Clinical Trials Workshop: Unmet Needs, Trial Designs

and Clinically Meaningful Safety and Effectiveness Outcomes

ACTION: Notice of public workshop; request for comments.

Dates and Times: The public workshop will be held on October 29,

2009, from 8 a.m. to 5:30 p.m. and October 30, 2009, from 8 a.m. to 12

noon.

Location: The public workshop will be held at the Holiday Inn

College Park located off I-95 at 10000 Baltimore Ave., College Park, MD

20740.

September 15

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the National Coordinator for Health Information

Technology; HIT Standards Committee

ACTION: Notice of committee recommendations and invitation for public

input.

SUMMARY: This notice publishes recommendations made by the HIT

Standards Committee (Committee) at its public meeting on August 20,

2009, and invites public input on the recommendations at the

Committee's next meeting on September 15, 2009. The Committee is a

Federal advisory committee to the Office of the National Coordinator

for Health Information Technology (ONC).

September 16

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

Medicare Program; Limitation on Recoupment of Provider and

Supplier Overpayments

ACTION: Final rule.

SUMMARY: This final rule implements a provision of the Medicare

Prescription Drug, Improvement, and Modernization Act of 2003 (MMA)

which prohibits recouping Medicare overpayments from a provider or

supplier that seeks a reconsideration from a Qualified Independent

Contractor (QIC). This provision changes how interest is to be paid to

a provider or supplier whose overpayment is reversed at subsequent

administrative or judicial levels of appeal. This final rule defines

the overpayments to which the limitation applies, how the limitation

works in concert with the appeals process, and the change in our

obligation to pay interest to a provider or supplier whose appeal is

successful at levels above the QIC.

DATES: Effective Date: These regulations are effective on November 16,

2009.

Centers for Medicare & Medicaid Services

Children's Health Insurance Program (CHIP); Allotment Methodology

and States' Fiscal Year 2009 CHIP Allotments

ACTION: Proposed rule.

SUMMARY: This proposed rule describes the implementation of certain

funding provisions under title XXI of the Social Security Act (the

Act), the Children's Health Insurance Program (CHIP), as amended by the

Children's Health Insurance Program Reauthorization Act of 2009

(CHIPRA), by the Medicare, Medicaid, and SCHIP Extension Act of 2007

(MMSEA), and by other related CHIP legislation. Specifically, this

proposed rule addresses methodologies and procedures for determining

States' FY 2009 through FY 2013 allotments and payments in accordance

with sections 2104 and 2105 of the Act, as amended by CHIPRA.

DATES: To be assured consideration, comments must be received at one of

the addresses provided below, no later than 5 p.m. eastern standard

time (e.s.t.) on November 16, 2009.

September 17 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Food and Drug Administration

Draft Guidance for Industry on Microbiological Data for Systemic

Antibacterial Drug Products--Development, Analysis, and Presentation;

Availability

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing the

availability of a draft guidance for industry entitled

``Microbiological Data for Systemic Antibacterial Drug Products--

Development, Analysis, and Presentation.''

DATES: Although you can comment on any guidance at any time (see 21 CFR

10.115(g)(5)), to ensure that the agency considers your comment on this

draft guidance before it begins work on the final version of the

guidance, submit written or electronic comments on the draft guidance

by December 16, 2009.

Food and Drug Administration

Guidance for Industry: Considerations for Allogeneic Pancreatic

Islet Cell Products; Availability

ACTION:  Notice.

Food and Drug Administration

Submission of Quality Information for Biotechnology Products in

the Office of Biotechnology Products; Notice of Extension of Deadlines

to Request Participation in Pilot Program and to Submit Applications;

and Notice of Increase in the Number of Original Applications in Pilot

Program

ACTION: Notice.

September 18

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Centers for Medicare & Medicaid Services

Agency Information Collection Activities: Proposed Collection;

Comment Request

1. Type of Information Collection Request: Extension of a currently

approved collection; Title of Information Collection: Electronic Funds

Transfer Authorization Agreement

Food and Drug Administration

Draft Guidance for Industry: Clinical Considerations for

Therapeutic Cancer Vaccines; Availability

ACTION:  Notice.

SUMMARY:  The Food and Drug Administration (FDA) is announcing the

availability of a draft document entitled ``Guidance for Industry:

Clinical Considerations for Therapeutic Cancer Vaccines'' dated

September 2009. The draft guidance document provides recommendations to

sponsors who wish to submit an Investigational New Drug application

(IND) for a therapeutic cancer vaccine on critical clinical

considerations for investigational studies of these products. The draft

guidance applies to therapeutic cancer vaccines that are intended to be

administered to patients with an existing cancer for the purpose of

treatment. The draft guidance does not apply to products intended to be

administered to patients to prevent or decrease the incidence of cancer

and does not apply to adoptive immunotherapeutic products such as T

cell or NK cell products.

Food and Drug Administration

Preparation for International Conference on Hamonization: Public

Meeting

ACTION: Notice of public meeting.

SUMMARY:  The Food and Drug Administration (FDA) is announcing a public

meeting entitled ``Preparation for ICH meetings in St. Louis,

Missouri'' to provide information and receive comments on the

International Conference on Harmonization (ICH) as well as the upcoming

meetings in St. Louis, MO. The topics to be discussed are the topics

for discussion at the forthcoming ICH Steering Committee Meeting. The

purpose of the public meeting is to solicit public input prior to the

next Steering Committee and Expert Working Groups meetings in St.

Louis, MO, October 24 to 29, 2009, at which discussion of the topics

underway and the future of ICH will continue.

Date and Time: The public meeting will be held on Wednesday,

October 14, 2009, from 2:30 p.m. to 4:30 p.m.

Health Resources and Services Administration

Notice of Availability of Draft Policy Documents for Comment

ACTION: This is a Notice of Availability and request for comments on a

draft Agency Guidance (``Policy Information Notices'' (PINs)) to convey

and clarify statutory and regulatory governance requirements for

federally-funded health centers and Federally Qualified Health Center

(FQHC) Look-Alikes. The PIN, ``Health Center Governance Requirements

and Expectations'' is available on the Internet at http://

bphc.hrsa.gov/draftsforcomment/governance/draftgovernancepin.htm.

DATES: Comments must be received by October 26, 2009.