Weekly Legislative & Regulatory Round-up
Week of August 22 - 28
| GAO reports |
No relevant notices.
| OIG reports |
Audit of the Indian Health Service Headquarters Cost Statement for Fiscal Year 2005 (A-09-07-00054)
MSIS Data Usefulness for Detecting Fraud, Waste, and Abuse (OEI-04-07-00240) (pdf)
| Bills introduced |
Congress in recess.
| Federal Register notices |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Breach Notification for Unsecured Protected Health Information
AGENCY: Office for Civil Rights, Department of Health and Human
Services.
ACTION: Interim final rule with request for comments.
SUMMARY: The Department of Health and Human Services (HHS) is issuing
this interim final rule with a request for comments to require
notification of breaches of unsecured protected health information.
DATES: Effective Date: This interim final rule is effective September
23, 2009. Comment Date: Comments on the provisions of this interim final rule
are due on or before October 23, 2009. Comments on the information
collection requirements associated with this rule are due on or before
September 8, 2009.
Office of the Secretary
Request for Information Relevant to the Regionalization of
Emergency Medical Care Delivery Systems and Demonstration Model
Development
ACTION: Notice.
SUMMARY: This is a time-sensitive Request for Information (RFI) issued
by the Emergency Care Coordination Center in the Office of the
Assistant Secretary for Preparedness and Response on behalf of the
Council on Emergency Medical Care (CEMC) and the Federal Interagency
Committee on Emergency Medical Services (FICEMS)--collectively known as
the Emergency Care Enterprise (ECE). The information requested is meant
to ascertain key concepts, best practices, and operational approaches
to support regionalized, comprehensive and accountable emergency care
and trauma systems. The information will be analyzed by the ECCC to
help guide the development of demonstration programs that design and
evaluate innovative models of regionalized, coordinated and accountable
emergency care and trauma systems.
ADDRESSES: Responses to this RFI may be submitted electronically to
eccc@hhs.gov by COB September 30th 2009.
Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Proposed Project: HRSA/Bureau of Primary Health Care Capital
Improvement Program Application Electronic Health Records (EHR)
Readiness Checklist (OMB No. 0915-0325)--Extension
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Healthcare Infection Control Practices Advisory Committee
(HICPAC)
ACTION: Meeting Notice
DATE: 2 p.m.-3 p.m., September 9, 2009.
Food and Drug Administration
Oncologic Drugs Advisory Committee
ACTION: Notice of Meeting.
DATE: The meeting will be held on October 6, 2009, from
8 a.m. to 4 p.m.
ADDRESS: Hilton Washington DC North/Gaithersburg, The
Ballrooms, 620 Perry Pkwy., Gaithersburg, MD. The hotel phone number
is 301-977-8900.
Food and Drug Administration
Peripheral and Central Nervous System Drugs Advisory Committee
ACTION: Notice of Meeting.
DATE: The meeting will be held on October 14, 2009,
from 8 a.m. to 5 p.m.
ADDRESS: The Inn and Conference Center, University of Maryland
University College (UMUC), Marriott Conference Centers, 3501
University Blvd. East, Adelphi, MD. The hotel telephone number is
301-985-7300.
Office of the Secretary
Patient Safety and Quality Improvement: Civil Money Penalty
Inflation Adjustment
ACTION: Direct final rule.
SUMMARY: The Department of Health and Human Services amends the Patient
Safety and Quality Improvement Rule by adjusting for inflation the
maximum civil money penalty amount for violations of the
confidentiality provisions of the Rule. We are amending the penalty
amount to comply with the Federal Civil Penalties Inflation Adjustment
Act of 1990. We are using direct final rulemaking for this action
because we expect that there will be no significant adverse comment on
the rule.
Office of the Secretary
Patient Safety and Quality Improvement: Civil Money Penalty
Inflation Adjustment
ACTION: Proposed rule.
SUMMARY: The Department of Health and Human Services is publishing this
companion proposed rule to the direct final rule, published elsewhere
in this issue of the Federal Register, which amends the Patient Safety
and Quality Improvement Rule by adjusting for inflation the maximum
civil money penalty amount for violations of the confidentiality
provisions of the Rule. We are proposing to amend the penalty amount to
comply with the Federal Civil Penalties Inflation Adjustment Act of
1990.
Health Resources and Services Administration
National Advisory Committee on Rural Health and Human Services
ACTION: Notice of Meeting.
DATE: September 9, 2009, 9 a.m.-4:45 p.m.; September 10,
2009, 8:30 a.m.-4 p.m.; September 11, 2009, 8:45 a.m.-11 a.m.
ADDRESS: Sheraton Grand Hotel, 1230 J Street, Sacramento, California
95814, Phone: 916-341-3605.
National Institutes of Health
National Institute of Allergy and Infectious Diseases
ACTION: Notice of Meeting
Name of Committee: AIDS Research Advisory Committee, NIAID, AIDS
Vaccine Research Subcommittee.
DATE: September 15-16, 2009, 8:30 a.m. to 5 p.m.
ADDRESS: Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD
20814.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Electronic Public Comment Transmission Error for Two Medicare
Program Rules
ACTION: Request for resubmission of comments.
SUMMARY: This document requests that the public resubmit their comments
on the CY 2010 Physician Fee Schedule or CY 2010 Hospital Outpatient
Prospective Payment System/Ambulatory Surgical Center Payment System
proposed rule before the close of the comment period for these rules
(that is, August 31, 2009) if their comments were originally submitted
via www.regulations.gov during the period from July 26, 2009 through
July 30, 2009.
National Institutes of Health
National Center for Complementary and Alternative Medicine
Announcement of Wellness Workshop
ACTION: Notice.
SUMMARY: The National Center for Complementary and Alternative Medicine
(NCCAM) invites the research community to participate in a workshop
focused on wellness. The purpose of this workshop is to review several measures of
wellness, identify their strengths and weaknesses, and make
recommendations on how best to capture the construct. This information
will help NCCAM guide development of questions for the 2012 National
Health Interview Survey.
DATE: September 25, 2009.
Food and Drug Administration
Industry Exchange Workshop on Food and Drug Administration Drug
and Device Requirements; Public Workshop
ACTION: Notice of public workshop.
SUMMARY: The Food and Drug Administration (FDA) Philadelphia District,
in cosponsorship with the Society of Clinical Research Associates
(SoCRA) is announcing a public workshop entitled: ``FDA Clinical Trial
Requirements, Regulations, Compliance and GCP.'' This 2-day public
workshop is intended to provide information about FDA clinical trial
requirements to the regulated industry.
Date and Time: The public workshop will be held on October 21,
2009, from 8:30 a.m. to 5 p.m. and October 22, 2009, from 8:30 a.m. to
5 p.m.
Location: The public workshop will be held at the Hyatt Regency
Pittsburgh International Airport, 1111 Airport Blvd., Pittsburgh, PA
15231, 724-899-1234 or 1-800-233-1234.
Office of the Secretary, Office of Public Health and Science
Solicitation of Nominations for Membership on the Presidential
Advisory Council on HIV/AIDS
ACTION: Notice.
Office of the Secretary, Office of Public Health and Science
Solicitation of Nomination for Appointment to the Chronic Fatigue
Syndrome Advisory Committee
ACTION: Notice.
Health Resources and Services Administration
Office of Health Information Technology, Office for the
Advancement of Telehealth
ACTION: Notice of non-competitive supplemental funding to Center for
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Medicare Program; Changes to the Hospital Inpatient Prospective
Payment Systems for Acute Care Hospitals and Fiscal Year 2010 Rates;
and Changes to the Long-Term Care Hospital Prospective Payment System
and Rate Years 2010 and 2009 Rates
ACTION: Final rules and interim final rule with comment period.
SUMMARY: We are revising the Medicare hospital inpatient prospective
payment systems (IPPS) for operating and capital-related costs of acute
care hospitals to implement changes arising from our continuing
experience with these systems, and to implement certain provisions made
by the TMA, Abstinence Education, and QI Program Extension Act of 2007,
the Medicare Improvements for Patients and Providers Act of 2008, and
the American Recovery and Reinvestment Act of 2009. In addition, in the
Addendum to this final rule, we describe the changes to the amounts and
factors used to determine the rates for Medicare acute care hospital
inpatient services for operating costs and capital-related costs.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Medicare and Medicaid Programs; Application of the American
Osteopathic Association for Continued Deeming Authority for Hospitals
ACTION: Final notice.
SUMMARY: This notice announces our decision to approve the American
Osteopathic Association (AOA) for continued recognition as a national
accreditation program for hospitals seeking to participate in the
Medicare or Medicaid programs.
Centers for Medicare & Medicaid Services
Medicare Program; Request for Nominations for the Advisory Panel
on Medicare Education
ACTION: Notice.
SUMMARY: This notice requests nominations for individuals to serve on
the Advisory Panel on Medicare Education (the Panel) to fill current
vacancies and vacancies that will become available in 2009. The Panel
advises and makes recommendations to the Secretary of Health and Human
Services and the Administrator of the Centers for Medicare & Medicaid
Services on the effectiveness of consumer education strategies
concerning the Medicare program.
Centers for Medicare & Medicaid Services
Medicare Program; Meeting of the Medicare Evidence Development
and Coverage Advisory Committee--October 21, 2009
ACTION: Notice of meeting.
DATES: Wednesday, October 21, 2009 from 7:30 a.m. until 4:30 p.m., d.s.t.
ADDRESSES: Meeting Location: The meeting will be held in the main
auditorium of the Centers for Medicare & Medicaid Services, 7500
Security Boulevard, Baltimore, MD 21244.
Food and Drug Administration
Blood Establishment Computer Software: Understanding What to
Include in a 510(k) Submission; Public Workshop
ACTION: Notice of public workshop.
DATE: The public workshop will be held on November 4,
2009, from 8:30 a.m. to 5 p.m. and November 5, 2009, from 8:30 a.m. to
12 noon.
ADDRESS: The public workshop will be held at The Universities at
Shady Grove Conference Center, Bldg. II, multipurpose room, 9630
Gudelsky Dr., Rockville, MD 20850.
Office of the Secretary
Agency Emergency Information Collection Clearance Request for
Proposed Project: Rapid Assessment of Critical Illness Due to 2009-
H1N1 Influenza OMB No. 0990-New--Office of the Assistant Secretary for
Preparedness and Response (ASPR), Office of Preparedness and Emergency
Operations (OPEO).
Health Resources and Services Administration
Notice of Availability of Draft Policy Document for Comment
ACTION: This Policy Information Notice (PIN) describes the
documentation that will be considered by the Health Resources and
Services Administration (HRSA) to establish whether an organization can
qualify as a ``public agency'' (also referred to in previous PINs as
``public entities'' or ``public applicants'') for the purpose of
determining eligibility for a Health Center Program grant under Section
330 of the Public Health Service (PHS) Act (``Section 330'') and/or
Federally Qualified Health Center (FQHC) Look-Alike designation. This
draft PIN is available on the Internet at http://bphc.hrsa.gov/
draftsforcomment/publiccenter.
DATES: Comments must be received by October 13, 2009.