Weekly Legislative & Regulatory Round-up

Exclusions and Reinstatements Occurring in the Month of February 2009

Review of Medicare Payments to Managed Care Plans on Behalf of Deceased Enrollees (A-07-07-01046) 

Hospital Compliance With Medicare’s Postacute Care Transfer Policy During Fiscal Years 2003 Through 2005 (A-04-07-03035)

Updated Corporate Integrity Agreements (CIAs), Certification of Compliance Agreements (CCAs) and Integrity Agreements (IAs)

Civil Monetary Penalty Enforcement Actions

Criminal and Civil Enforcement Actions: February

March 9, 2009

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

Advisory Council on Blood Stem Cell Transplantation; Request for

Nominations for Voting Members

ACTION: Notice

SUMMARY: The Health Resources and Services Administration (HRSA) is

requesting nominations to fill expected vacancies on the Advisory

Council on Blood Stem Cell Transplantation.

    The Advisory Council on Blood Stem Cell Transplantation was

established pursuant to Public Law 109-129, 42 U.S.C. 274k (section 379

of the Public Health Service Act, as amended). In accordance with

Public Law 92-463, the Council was chartered on December 19, 2006.

Office of the Secretary, Office of Public Health and Science

Meeting of the Presidential Advisory Council on HIV/AIDS

ACTION: Notice.

SUMMARY: As stipulated by the Federal Advisory Committee Act, the U.S.

Department of Health and Human Services (DHHS) is hereby giving notice

that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a

meeting. The meeting will be open to the public.

DATES: The meeting will be held on Tuesday, March 24, 2009 and

Wednesday, March 25, 2009. The meeting will be held from 9 a.m. to

approximately 5 p.m. on both days.

March 10, 2009

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

Rescission of the Regulation Entitled ``Ensuring That Department

of Health and Human Services Funds Do Not Support Coercive or

Discriminatory Policies or Practices in Violation of Federal Law'';

Proposal

ACTION: Proposed rule

SUMMARY: The Department of Health and Human Services proposes to

rescind the December 19, 2008 final rule entitled ``Ensuring That

Department of Health and Human Services Funds Do Not Support Coercive

or Discriminatory Policies or Practices in Violation of Federal Law.''

The Department believes it is important to have an opportunity to

review this regulation to ensure its consistency with current

Administration policy and to reevaluate the necessity for regulations

implementing the Church Amendments, Section 245 of the Public Health

Service Act, and the Weldon Amendment.

March 11, 2009

No relevant notices

March 12, 2009

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the National Coordinator for Health Information

Technology

HIT Standards Committee and HIT Policy Committee Nomination

Letters

ACTION: Notice on letters of nomination

SUMMARY: The American Recovery and Reinvestment Act of 2009 (Act),

Public Law 111-5 amends the Public Health Service Act (PHSA) to add new

sections 3002 and 3003. The new section 3003 of the PHSA establishes

the HIT Standards Committee to make recommendations to the National

Coordinator for Health Information Technology on standards,

implementation specifications, and certification criteria for the

electronic exchange and use of health information for purposes of

health information technology adoption. The HIT Standards Committee

members are to be appointed by the Secretary of the Department of

Health and Human Services with the National Coordinator taking a

leading role. Membership of the HIT Standards Committee should at least

reflect the following categories of stakeholders and will include other

individuals: providers, ancillary healthcare workers, consumers,

purchasers, health plans, technology vendors, researchers, relevant

Federal agencies, and individuals with technical expertise on health

care quality, privacy and security, and on the electronic exchange and

use of health information.

    In addition, we also seek nominations to the HIT Policy Committee

(established by the new section 3002 of the PHSA), which makes

recommendations to the National Coordinator on the implementation of a

nationwide health information technology infrastructure.

March 13, 2009

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

Medicare Program; Meeting of the Medicare Evidence Development

and Coverage Advisory Committee--May 6, 2009

ACTION: Notice of meeting.

SUMMARY: This notice announces that a public meeting of the Medicare

Evidence Development and Coverage Advisory Committee (MEDCAC)

(``Committee'') will be held on Wednesday, May 6, 2009. The Committee

generally provides advice and recommendations concerning the adequacy

of scientific evidence needed to determine whether certain medical

items and services are reasonable and necessary under the Medicare

statute. The Committee may also review and evaluate medical literature

and make recommendations concerning items and services that may be

eligible for Medicare coverage. This meeting will focus on the

requirements for evidence to determine if the use of screening genetic

testing of beneficiaries without signs or symptoms of disease improves

health outcomes in Medicare beneficiaries. The meeting will discuss the

various kinds of evidence that are useful to support requests for

Medicare coverage in this field. This meeting is open to the public in

accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2,

section 10(a)).

DATES: Meeting Date: The public meeting will be held 7:30 a.m. until

4:30 p.m., daylight saving time (d.s.t.) on Wednesday, May 6, 2009.

Food and Drug Administration

Memorandum of Understanding With Baylor College of Medicine, The

University of Texas M.D. Anderson Cancer Center, Rice University,

University of Houston, The University of Texas Health Science Center at

Houston, Texas A&M Health Science Center, The University of Texas

Medical Branch at Galveston, and The Methodist Hospital Research

Institute for the FDA-ANH Nanotechnology Initiative

ACTION: Notice

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

a memorandum of understanding (MOU) with The Alliance for NanoHealth

(ANH), a collaboration among: Baylor College of Medicine, The

University of Texas M.D. Anderson Cancer Center, Rice University,

University of Houston, The University of Texas Health Science Center at

Houston, Texas A&M Health Science Center, The University of Texas

Medical Branch at Galveston, and The Methodist Hospital Research

Institute. This MOU identifies the terms of collaboration between FDA

and ANH in the area of nanotechnology. Specifically, this MOU

establishes the FDA-ANH Nanotechnology Initiative (FANTI), a public-

private partnership dedicated to the identification of scientific and

translational gaps in moving nanoengineered medical products from the

preclinical stages of development through clinical stages and then to

commercialization, all with immediate benefit to public health.

Food and Drug Administration

Clinical Trials Endpoints for Acute Graft-Versus-Host Disease

After Allogeneic Hematopoietic Stem Cell Transplantation; Public

Workshop

ACTION: Notice of public workshop

This is a 1-day workshop for academics, government researchers, clinical trial experts, government regulators, and industry representatives. The purpose of the public workshop is to

review the data that will serve as the foundation for protocol design

and clinical trial evidence-based endpoints intended to support the

approval of new drugs or biologics to prevent or treat acute GVHD. The

public workshop also will inform FDA and assist investigators in

facilitating clinical development programs for products to prevent or

treat acute GVHD indications.