Weekly Legislative & Regulatory Round-up
Week of October 31 - November 6
| GAO reports |
No relevant reports.
| OIG reports |
Follow-up Review of the Medicaid Drug Rebate Program in Indiana (A-04-08-07006)
Renal Dialysis Facilities’ Dosage Protocols for Administering Erythropoiesis-Stimulating Agents (OEI-03-09-00010)
Medicare Drug Integrity Contractors’ Identification of Potential Part D Fraud and Abuse (OEI-03-08-00420)
Reassignment of Medicare Benefits (OEI-07-08-00180)
Implementation of the Core Medical Services Requirement in the Ryan White Program (OEI-07-08-00240)
| Bills introduced |
|
Number/ Title |
Date Introduced | Sponsor | Description |
| H. Res. 883 | 10/2/09 | WALLY HERGER (R-CA) | A resolution expressing the sense of the House of Representatives that Members of the House receive the necessary cost information regarding health care reform legislation at least 72 hours before any vote on such legislation; Referred to the Committee on Rules. |
| H.R. 3987 | 10/2/09 | ROY BLUNT (R-MO) | A bill to amend titles XI and XVIII of the Social Security Act to promote the use of health information technology to better coordinate health care; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means. |
| H.R. 4007 | 10/2/09 | CHRISTOPHER LEE (R-NY) | A bill to authorize the Secretary of Health and Human Services to make grants to 5 States to establish medical malpractice tribunal pilot programs, and for other purposes; Referred to the Committee on the Judiciary. |
| S. 2730 | 10/4/09 | SHERROD BROWN (D-OH) | A bill to extend and enhance the COBRA subsidy program under the American Recovery and Reinvestment Act of 2009; Referred to the Committee on Health, Education, Labor, and Pensions. |
| H.R. 4018 | 10/4/09 | NATHAN DEAL (R-GA) | A bill to amend the Public Health Service Act to provide additional health insurance options for unemployed individuals; Referred to the Committee on Energy and Commerce. |
| H.R. 4019 | 10/4/09 | NATHAN DEAL (R-GA) | A bill to amend the Public Health Service Act to limit preexisting condition exclusions in the individual health insurance market to those permitted in the group health insurance market; Referred to the Committee on Energy and Commerce. |
| H.R. 4024 | 10/4/09 | MAZIE HIRONO (D-HI) | A bill to amend the Native Hawaiian Health Care Improvement Act to revise and extend that Act; Referred to the Committee on Energy and Commerce. |
| S. 2734 | 10/5/09 | AL FRANKEN (D-MN) | A bill to amend the Public Health Service Act with respect to the prevention of diabetes, and for other purposes; Referred to the Committee on Health, Education, Labor, and Pensions. |
| S. 2741 | 10/5/09 | TOM UDALL (D-NM) | A bill to establish telehealth pilot projects, expand access to stroke telehealth services under the Medicare program, improve access to ``store-and-forward'' telehealth services in facilities of the Indian Health Service and Federally qualified health centers, reimburse facilities of the Indian Health Service as originating sites, establish regulations to consider credentialing and privileging standards for originating sites with respect to receiving telehealth services, and for other purposes; Referred to the Committee on Finance. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Medical Examination of Aliens--Removal of Human Immunodeficiency
Virus (HIV) Infection From Definition of Communicable Disease of Public
Health Significance
ACTION: Final rule.
SUMMARY: Through this final rule, the Centers for Disease Control and
Prevention (CDC), within the U.S. Department of Health and Human
Services (HHS), is amending its regulations to remove ``Human
Immunodeficiency Virus (HIV) infection'' from the definition of
communicable disease of public health significance and remove
references to ``HIV'' from the scope of examinations for aliens.
DATES: This final rule is effective January 4, 2010.
HHS Office of the Secretary
Determination and Declaration Regarding Emergency Use of the
Antiviral Product Peramivir Accompanied by Emergency Use Information
ACTION: Notice.
SUMMARY: The Secretary of Health and Human Services (HHS) is issuing
this notice pursuant to section 564(b) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 360bbb-3(b)(4). On April 26, 2009, the
then Acting Secretary of HHS determined that a public health emergency
exists nationwide involving Swine Influenza A (now known as 2009-H1N1
Influenza A, or 2009-H1N1 influenza) that affects or has significant
potential to affect national security. On July 24 and October 1, 2009
the Secretary renewed that determination of a public health emergency. On the basis of this
determination, on October 20, 2009 the Secretary declared an emergency
justifying the authorization of emergency use of the antiviral product
peramivir accompanied by emergency use information subject to the terms
of any authorization issued by the Commissioner of Food and Drugs
(Commissioner) under 21 U.S.C. 360bbb-3(a). The Secretary also
specified that this declaration is a declaration of emergency as
defined in the Declaration under the Public Readiness and Emergency
Preparedness (PREP) Act for Influenza Antiviral peramivir.
DATES: The declaration of an emergency justifying the authorization of
emergency use of the antiviral product peramivir is effective October
20, 2009.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Draft Guideline for the Prevention of Intravascular Catheter-
Related Infections
ACTION: Notice of availability and request for public comment.
SUMMARY: This notice is a request for review of and comment on the
Draft Guideline for the Prevention of Intravascular Catheter-Related
Infections, available on the following Web site: http://wwwn.cdc.gov/publiccomments/.
This document is for use by infection prevention staff, healthcare
epidemiologists, healthcare administrators, nurses, other healthcare
providers, and persons responsible for developing, implementing, and
evaluating infection prevention and control programs for healthcare
settings across the continuum of care. The guideline updates and
expands the Guideline for the Prevention of Intravascular Device-
Related Infections published in 2002. These guidelines provide
evidence-based recommendations for preventing intravascular catheter-
related infections.
DATES: Comments must be received on or before December 3, 2009.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
HHS Public Health Emergency Medical Countermeasures Enterprise
(PHEMCE) Stakeholders Workshop 2009 and BARDA Industry Day
ACTION: Notice.
SUMMARY: The Department of Health and Human Services (HHS) is pleased
to announce the upcoming HHS Public Health Emergency Medical
Countermeasures Enterprise (PHEMCE) Stakeholders Workshop 2009 and
BARDA Industry Day to be held December 2-4, 2009, at the Marriott
Wardman Park Hotel in Washington, DC. This annual PHEMCE event will
bring together private- and public-sector stakeholders including:
Federal Officials, International Governments, Industry, Healthcare
Providers, First Responders, Community-Based Organizations, and other
interested audiences.
DATES: The Stakeholders Workshop 2009 & BARDA Industry Day will be held
December 2-4, 2009. Each day will begin at 9 a.m.
ADDRESSES: The Workshop will be held at the Marriott Wardman Park
Hotel, 2660 Woodley Road, NW., Washington, DC 20008.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Medicare Programs; End-Stage Renal Disease Prospective Payment
System; Extension of Comment Period
ACTION: Notice of extension of comment period for proposed rule.
SUMMARY: This notice extends the comment period for a proposed rule
published in the Federal Register on September 29, 2009, (74 FR 49922).
The proposed rule would implement a case-mix adjusted bundled
prospective payment system (PPS) for Medicare outpatient end-stage
renal disease (ESRD) dialysis facilities. The proposed ESRD PPS would
also replace the current basic case-mix adjusted composite payment
system and the methodologies for the reimbursement of separately
billable outpatient ESRD services. The comment period for the proposed
rule, which would have ended on November 16, 2009, is extended for 30
days.
DATES: Effective Date: The comment period is extended to 5 p.m. on
December 16, 2009.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Amendment to Memorandum of Understanding Between the Food and
Drug Administration and WebMD, LLC
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is providing notice of
an amendment to a memorandum of understanding (MOU) between FDA's
Office of External Relations and WebMD, LLC.
DATES: The amendment became effective October 14, 2009.
Food and Drug Administration
Draft Guidance for Industry on Dosage Delivery Devices for Over-
The-Counter Liquid Drug Products; Availability
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry titled ``Dosage Delivery
Devices for OTC Liquid Drug Products.'' FDA is issuing this guidance
because of ongoing concerns about potentially serious accidental drug
overdoses that can result from the use of dosage delivery devices with
markings inconsistent or incompatible with the labeled dosage
directions for over-the-counter (OTC) liquid drug products.
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 February 3, 2010.
Food and Drug Administration
Food and Drug Administration's Safe Use Initiative; Availability
of Information
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
launch of its Safe Use Initiative with the release of a report titled
``FDA's Safe Use Initiative--Collaborating to Reduce Preventable Harm
from Medicines.'' FDA is opening a docket to enable the public to
comment on the report and the initiative. In addition, a safe use Web
site has been created to facilitate transparency as the initiative
moves forward. The initiative proposes a series of next steps,
including working with interested partners--patients, consumers,
caretakers, healthcare practitioners, pharmacists, healthcare systems,
health insurers, drug manufacturers, and other Federal agencies--to
select specific candidate cases of preventable, drug-related harm for
analysis, intervention proposals, and evaluation metrics. The report
identifies some specific areas of concern that could benefit from Safe
Use Initiative partnerships.
DATES: Submit electronic or written comments at any time.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
ACTION: Notice.
SUMMARY: This notice announces the intention of the Agency for
Healthcare Research and Quality (AHRQ) to request that the Office of
Management and Budget (OMB) approve the proposed information collection
project: ``Collection of Information for Agency for Healthcare Research
and Quality's (AHRQ) Hospital Survey on Patient Safety Culture
Comparative Database.'' In accordance with the Paperwork Reduction Act
of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on
this proposed information collection.
This proposed information collection was previously published in
the Federal Register on September 2nd, 2009 and allowed 60 days for
public comment. One comment was received. The purpose of this notice is
to allow an additional 30 days for public comment.
DATES: Comments on this notice must be received by December 7, 2009.
Centers for Medicare & Medicaid Services
Agency Information Collection Activities: Proposed Collection;
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid
Services (CMS) is publishing the following summary of proposed
collections for public comment.
1. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Medicare
Advantage Appeals and Grievance Data Disclosure Requirements (42 CFR
422.111).
Centers for Medicare & Medicaid Services
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid
Services (CMS), Department of Health and Human Services, is publishing
the following summary of proposed collections for public comment.
1. Type of Information Collection Request: Extension without change
of a currently approved collection; Title of Information Collection:
Creditable Coverage Disclosure to CMS On-Line Form and Instructions.
2. Type of Information Collection Request: New collection; Title of
Information Collection: Electronic Health Records (EHR) Testing.
Food and Drug Administration
Guidance for Industry and Food and Drug Administration Staff; In
Vitro Diagnostic 2009 H1N1 Tests for Use in the 2009 H1N1 Emergency;
Availability
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``In Vitro Diagnostic 2009 H1N1
Tests for Use in the 2009 H1N1 Emergency.'' FDA is issuing this
guidance to inform industry and agency staff of its recommendations for
the type of information and data FDA believes needs to be included in
an Emergency Use Authorization Request (EUA) for in vitro diagnostic
(IVD) devices intended for use in diagnosing 2009 H1N1 Influenza virus
infections during the emergency involving Swine Influenza A\1\. The
Secretary of the Department of Health and Human Services (HHS) declared
the emergency on April 26, 2009, in accordance with the Federal Food,
Drug, and Cosmetics Act (the Act).
Office for Human Research Protections, Office of Public Health
and Science, Office of the Secretary
Draft Guidance on Institutional Review Board Approval of Research
With Conditions
ACTION: Notice.
SUMMARY: The Office for Human Research Protections (OHRP), Office of
Public Health and Science, is announcing the availability of a draft
guidance document entitled ``Guidance on IRB Approval of Research with
Conditions,'' and is seeking comment on the draft guidance. The draft
guidance document, when finalized, would provide OHRP's first formal
guidance on this topic. The draft document, which is available on the
OHRP Web site at http://www.hhs.gov/ohrp/requests/, is intended
primarily for institutional review boards (IRBs), investigators,
Department of Health and Human Services (HHS) funding agencies, and
others that may be responsible for the review, conduct, or oversight of
human subject research conducted or supported by HHS. OHRP will
consider comments received before issuing the final guidance document.
DATES: Submit written comments by January 5, 2010.
Office for Human Research Protections, Office of Public Health
and Science, Office of the Secretary
Draft Guidance on Institutional Review Board Continuing Review of
Research
ACTION: Notice.
SUMMARY: The Office for Human Research Protections (OHRP), Office of
Public Health and Science, is announcing the availability of a draft
guidance document entitled, ``Guidance on IRB Continuing Review of
Research,'' and is seeking comment on the draft guidance. The draft
guidance document, when finalized, will represent OHRP's current
thinking on this topic and will supersede OHRP's January 15, 2007
guidance document entitled ``Guidance on Continuing Review,'' available
at http://www.hhs.gov/ohrp/humansubjects/guidance/contrev0107.htm. The
draft document, which is available on the OHRP Web site at http://
www.hhs.gov/ohrp/requests/, is intended primarily for institutional
review boards (IRBs), investigators, Department of Health and Human
Services (HHS) funding agencies, and others that may be responsible for
the review, conduct, or oversight of human subject research conducted
or supported by HHS. OHRP will consider comments received before
issuing the final guidance document.
DATES: Submit written comments by January 5, 2010.