Weekly Legislative & Regulatory Round-up
Week of August 8 - 14
| GAO reports |
No relevant notices.
| OIG reports |
No relevant notices.
| Bills introduced |
No bills introduced.
| Federal Register notices |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of grant funds for the support of Office of Critical Path
Programs (OCPP). The goal of OCPP is to develop an administrative and
scientific infrastructure to support the creation and execution of a
series of projects under the FDA's Critical Path Initiative.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Medicare Program; Prospective Payment System and Consolidated
Billing for Skilled Nursing Facilities for FY 2010; Minimum Data Set,
Version 3.0 for Skilled Nursing Facilities and Medicaid Nursing
Facilities
ACTION: Final rule.
SUMMARY: This final rule updates the payment rates used under the
prospective payment system (PPS) for skilled nursing facilities (SNFs),
for fiscal year (FY) 2010.
DATES: This final rule becomes effective on October 1,
2009.
Food and Drug Administration
Joint Meeting of the Anesthetic and Life Support Drugs Advisory
Committee and the Drug Safety and Risk Management Advisory Committee;
ACTION: Notice of public meeting.
Name of Committees: Anesthetic and Life Support Drugs Advisory
Committee and the Drug Safety and Risk Management Advisory Committee.
DATE: The meeting will be held on September 23, 2009, from
8 a.m. to 4:30 p.m.
ADDRESSES: Holiday Inn, The Ballrooms, Two Montgomery Village Ave.,
Gaithersburg, MD. The hotel phone number is 301-948-8900.
Food and Drug Administration
Oncologic Drugs Advisory Committee; Notice of Meeting
ACTION: Notice of public meeting.
Name of Committee: Oncologic Drugs Advisory Committee.
DATE: The meeting will be held on September 2, 2009, from
8 a.m. to 5 p.m.
ADDRESSES: Hilton Washington DC/Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. The hotel phone number is 301-589-
5200.
No relevant notices
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Medicare Program; Home Health Prospective Payment System Rate
Update for Calendar Year 2010
ACTION: Proposed rule.
SUMMARY: This proposed rule sets forth an update to the Home Health
Prospective Payment System (HH PPS) rates; the national standardized
60-day episode rates, the national per-visit rates, the non-routine
medical supply (NRS) conversion factor, and the low utilization payment
amount (LUPA) add-on payment amount, under the Medicare prospective
payment system for home health agencies effective January 1, 2010.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on September 28,
2009.
Food and Drug Administration
Charging for Investigational Drugs Under an Investigational New
Drug Application
ACTION: Final rule.
SUMMARY: The Food and Drug Administration (FDA) is amending its
investigational new drug application (IND) regulation concerning
charging patients for investigational new drugs.
DATES: This rule is effective October 13, 2009.
Food and Drug Administration
Expanded Access to Investigational Drugs for Treatment Use
ACTION: Final rule.
SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations on access to investigational new drugs for the treatment of
patients. The final rule clarifies existing regulations and adds new
types of expanded access for treatment use.
DATES: This rule is effective October 13, 2009.
No relevant notices.