Weekly Legislative & Regulatory Round-up
Week of April 24 - 30, 2010
| GAO reports |
Centers for Medicare and Medicaid Services: Pervasive Internal Control Weaknesses Hindered Effective Contract Management GAO-10-637T
Medicare Contracting Reform: Agency Has Made Progress with Implementation, but Contractors Have Not Met All Performance Standards GAO-10-71
| OIG reports |
Summary of IG Compliance Keynote Address to the Health Care Compliance Association (PDF)
Comparison of Third-Quarter 2009 Average Sales Prices and Average Manufacturer Prices: Impact on Medicare Reimbursement for First Quarter 2010 (PDF) (OEI-03-10-00150)
| Bills introduced |
|
Number/ Title |
Date Introduced | Sponsor | Description |
H.R. 5145 |
4/27/10 |
JERRY MCNERNEY (D-CA) |
A bill to amend title 38, United States Code, to improve the continuing professional education reimbursement provided to health professionals employed by the Department of Veterans Affairs; Referred to the Committee on Veterans' Affairs. |
H.R. 5185 |
4/28/10 |
PETER DEFAZIO (D-OR) |
A bill to amend titles 10 and 38, United States Code, to increase the maximum age for children eligible for medical care under the TRICARE program and the CHAMPVA program; Referred to the Committee on Armed Services, and in addition to the Committee on Veterans' Affairs. |
H.R. 5187 |
4/28/10 |
ALCEE HASTINGS (D-FL) |
A bill to require the Secretary to establish a commission that is designed to construct a comprehensive national strategy on how to increase the affordability, accessibility, and effectiveness of long-term care and community services; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means. |
H. Res. 1311 |
4/18/10 |
STEVE COHEN (D-TN) |
A resolution expressing support for the charitable collection and good samaritan distribution to uninsured, low-income Americans of Food and Drug Administration-approved, medically-appropriate, non-expired, non-narcotic prescription medications by non-profit organizations licensed to dispense such medications; Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary. |
| Federal Register notices |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Draft Guidance for Industry and Food and Drug Administration
Staff; Total Product Life Cycle: Infusion Pump--Premarket Notification
[510(k)] Submissions; Availability
ACTION: Notice.
Office of the Secretary
Regulatory Agenda
ACTION: Semiannual regulatory agenda
SUMMARY: The following Agenda presents the results of the statutorily
required semi-annual inventory of rulemaking actions currently under
development within the U.S. Department of Health and Human Services
(HHS). We hope that this information will enable interested members of
the public to more effectively participate in the Department's
regulatory activity.
Office of the National Coordinator for Health Information
Technology
HIT Policy Committee Advisory Meeting; Notice of Meeting
ACTION: Notice of meeting.
Date and Time: The meeting will be held on May 19, 2010, from 10
a.m. to 4 p.m./Eastern Time.
Location: TBD. Please check ONC Web site for information on
location.
Office of the National Coordinator for Health Information
Technology
HIT Policy Committee's Workgroup Meetings; Notice of
Meetings
ACTION: Notice of meetings.
Date and Time: The HIT Policy Committee Workgroups will hold the
following public meetings during May 2010: May 4th Meaningful Use
Workgroup, 10 a.m. to 12 p.m./ET; May 7th Privacy & Security Policy
Workgroup, 2 p.m. to 4 p.m./ET; May 10th NHIN Workgroup, 10 a.m. to
1 p.m./ET; and May 11th Strategic Plan Workgroup, 9 a.m. to 11 a.m./
ET.
Office of the National Coordinator for Health Information
Technology
HIT Standards Committee Advisory Meeting; Notice of Meeting
ACTION: Notice of meeting.
Date and Time: The meeting will be held on May 26, 2010, from 9
a.m. to 1 p.m./Eastern Time.
Location: The May 26th meeting will be conducted virtually only.
Dial into the meeting: 1-877-705-6006; webcast: http://
altarum.adobeconnect.com/HITstandards.
Office of the National Coordinator for Health Information
Technology;
HIT Standards Committee's Workgroup Meetings; Notice of Meetings
ACTION: Notice of meetings.
Date and Time: The HIT Standards Committee Workgroups will hold
the following public meetings during May 2010: May 4th Clinical
Operations Workgroup/Vocabulary Task Force, 1 p.m. to 4 p.m./ET; May
12th Clinical Operations Workgroup/Vocabulary Task Force, 10 a.m. to
11 a.m./ET; May 14th Privacy & Security Workgroup, 10 a.m. to 12
p.m./ET (dial in only); May 21st Clinical Quality Workgroup, 10 a.m.
to 12 p.m./ET; and May 25th Clinical Operations Workgroup/Vocabulary
Task Force, 9 a.m. to 11 a.m./ET.
Health Resources and Services Administration
Secretary's Advisory Committee on Heritable Disorders in Newborns
and Children
ACTION: Request for public comment on a Secretary's Advisory Committee
on Heritable Disorders in Newborns and Children's commissioned report:
Considerations and Recommendations for National Guidance Regarding the
Retention and Use of Residual Dried Blood Spot Specimens after Newborn Screening.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service
Office of Clinical and Preventive Services; Division of Oral
Health; Dental Preventive and Clinical Support Centers Program
Announcement Type: New and Continuing Competitive.
Funding Announcement Number: HHS-2010-IHS-TDCP-0001.
No relevant notices.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Bar Code Label
Requirement for Human Drug and Biological Products
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by June 1,
2010.
Food and Drug Administration
Draft Guidance for Industry and Food and Drug Administration
Staff; User Fees for 513(g); Requests for Information; Availability
ACTION: Notice.
Health Resources and Services Administration
Part D Comprehensive Services and Access to Research for Women,
Infants, Children and Youth Grant Under the Ryan White HIV/AIDS Program
ACTION: Fhttp://edocket.access.gpo.gov/2010/pdf/2010-9968.pdf for the
Mecklenburg County Health Department and Duke University.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Medicaid Program; State Flexibility for Medicaid Benefit Packages
ACTION: Final rule.
SUMMARY: This rule revises the final rule published on December 3, 2008
to implement provisions of section 6044 of the Deficit Reduction Act of
2005, which amends the Social Security Act by adding a new section 1937
related to the coverage of medical assistance under approved State
plans. That rule provides States increased flexibility under an
approved State plan to define the scope of covered medical assistance
by offering coverage of benchmark or benchmark-equivalent benefit
packages to certain Medicaid-eligible individuals. In addition, this
final rule responds to public comments on the February 22, 2008
proposed rule and comments received in response to rules published
subsequently that delayed the effective date of the December 3, 2008
final rule until July 1, 2010.
DATES: Effective Date: These regulations are effective on July 1, 2010.
Centers for Medicare & Medicaid Services
Agency Information Collection Activities: Proposed Collection;
1. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Electronic Health
Records Demonstration System (EHRDS)--practice application and profile
update system.
2. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Detailed
Explanation of Non-Coverage (42 CFR 422.626(e)(1)), and Notice of
Medicare Non-Coverage (42 CFR 422.624(b)(1))
3. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Notice of Denial
of Medical Coverage (NDMC) and Notice of Denial of Payment (NDP)--42
CFR 422.568.
Centers for Medicare & Medicaid Services
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
1. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Hospital and
Health Care Complexes Cost Report and supporting Regulations in 42 CFR
413.20 and 413.24.
Centers for Medicare & Medicaid Services
Medicare Program; Inpatient Psychiatric Facilities Prospective
Payment System Payment--Update for Rate Year Beginning July 1, 2010 (RY
2011)
ACTION: Notice
SUMMARY: This notice updates the payment rates for the Medicare
prospective payment system (PPS) for inpatient psychiatric hospital
services provided by inpatient psychiatric facilities (IPFs). These
changes are applicable to IPF discharges occurring during the rate year
beginning July 1, 2010 through June 30, 2011. We are also responding to
comments on the IPF PPS teaching adjustment and the market basket,
which we received in response to our May 2009 IPF PPS notice with
request for comments.
DATES: Effective Date: The updated IPF prospective payment rates are
effective for discharges occurring on or after July 1, 2010 through
June 30, 2011.
Food and Drug Administration
Emerging Infectious Diseases: Evaluation to Implementation for
Transfusion and Transplantation Safety and Quantitative Risk
Assessment: Blood Safety and Availability; Public Workshops
ACTION: Notice of public workshops.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Implementation of Section 5001 of the American Recovery and
Reinvestment Act of 2009 (Pub. L. 111-5) for Adjustments to the Second
Quarter of Fiscal Year 2010 Federal Medical Assistance Percentage Rates
for Federal Matching Shares for Medicaid and Title IV-E Foster Care,
Adoption Assistance and Guardianship Assistance Programs
ACTION: Notice.
SUMMARY: This notice provides the adjusted Federal Medical Assistance
Percentage (FMAP) rates for the second quarter of Fiscal Year 2010
(FY10) as required under Section 5001 of the American Recovery and
Reinvestment Act of 2009 (ARRA). Section 5001 of the ARRA provides for
temporary increases in the FMAP rates to provide fiscal relief to
States and to protect and maintain State Medicaid and certain other
assistance programs in a period of economic downturn. The increased
FMAP rates apply during a recession adjustment period that is defined
in ARRA as the period beginning October 1, 2008 and ending December 31,
2010.
DATES: Effective Date: These percentages are effective for the quarter
beginning January 1, 2010 through March 31, 2010.