Weekly Legislative & Regulatory Round-up
Week of April 17 - 23, 2010
| GAO reports |
Poorly Performing Nursing Homes: Special Focus Facilities Are Often Improving, but CMS's Program Could Be Strengthened GAO-10-197
| OIG reports |
Review of American Recovery and Reinvestment Act of 2009 Medicaid Eligibility Requirements in Louisiana (A-06-09-00100)
Review of Medicaid Compound Drug Expenditures in California for Fiscal Years 2004 and 2005 (A-09-08-00034)
| Bills introduced |
|
Number/ Title |
Date Introduced | Sponsor | Description |
S. 3223 |
4/19/10 |
OLYMPIA SNOWE (R-ME) |
A bill to amend the Employee Retirement Income Security Act of 1974 and the Public Health Service Act to provide parity under group health plans and group health insurance coverage for the provision of benefits for prosthetics and custom orthotics and benefits for other medical and surgical services; Referred to the Committee on Health, Education, Labor, and Pensions. |
H.R. 5066 |
4/20/10 |
JOHN FLEMING (R-LA) |
A bill to prohibit the hiring of additional employees by the Internal Revenue Service to implement, administer, or enforce health insurance reform; Referred to the Committee on Ways and Means. |
H.R. 5073 |
4/20/10 |
PAUL BROUN (R-GA) |
A bill to repeal the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 and enact the OPTION Act of 2009; Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Education and Labor, Appropriations, the Judiciary, Natural Resources, House Administration, and Rules. |
S. 3239 |
4/21/10 |
RUSS FEINGOLD (D-WI) |
A bill to repeal unwarranted provisions from the Patient Protection and Affordable Care Act and to more efficiently use taxpayer dollars in health care spending; Referred to the Committee on Finance. |
H.R. 5095 |
4/21/10 |
ERIK PAULSEN (R-MN) |
A bill to amend the Internal Revenue Code of 1986 to repeal the excise tax on medical devices; Referred to the Committee on Ways and Means |
S. 3255 |
4/22/10 |
BLANCHE LINCOLN (D-AK)
|
A bill to amend title XVIII of the Social Security Act to provide coverage for custom fabricated breast prostheses following a mastectomy; Referred to the Committee on Finance. |
H.R. 5126 |
4/22/10 |
JOHN FLEMING (R-LA) |
A bill to repeal provisions of the Patient Protection and Affordable Care Act relating to health savings accounts, and for other purposes; Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce. |
H. Res. 1291 |
4/22/10 |
MICHAEL ARCURI (D-NY) |
A resolution expressing support for designation of the week beginning May 9, 2010, as National Nursing Home Week; Referred to the Committee on Energy and Commerce. |
| Federal Register notices |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
1. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Recovery Act--
Reporting Requirements for States Under FMAP Increase and TMA
Provisions; Use
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: State Plan Pre-
print implementing Section 6087 of the Deficit Reduction Act: Optional
Self-Direction Personal Assistance Services (PAS) Program (Cash and
Counseling)
3. Type of Information Collection Request: New collection; Title of
Information Collection: Medicare Gainsharing Demonstration Evaluation:
Physician Focus Groups
4. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Detailed Notice
of Discharge (DND)
5. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Important Message
from Medicare (IM)
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: Annual Early and
Periodic Screening, Diagnostic and Treatment (EPSDT) Services
Participation Report
2. 1. Type of Information Collection Request: Extension of a
currently approved collection; Title of Information Collection: Request
for Employment Information.
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: Medicare
Prescription Drug Benefit Plan
2. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Consumer
Assessment of Health Care Providers and Systems (CAHPS)
3. Type of Information Collection Request: New collection; Title of
Information Collection: Medicare Part C and Part D Data Validation (42
CFR 422.516g and 423.514g)
4. Type of Information Collection Request: New collection; Title of
Information Collection: New Quality Measures for Medicare Advantage
Organizations.
Food and Drug Administration
Amended Authorization of Emergency Use of the Antiviral Product
Peramivir Accompanied by Emergency Use Information; Availability
ACTION: Notice.
Food and Drug Administration
Amended Authorizations of Emergency Use of Certain Antiviral
Drugs Zanamivir and Oseltamivir Phosphate; Availability
ACTION: Notice.
Food and Drug Administration
Authorization of Emergency Use of Certain In Vitro Diagnostic
Devices; Availability
ACTION: Notice.
Indian Health Service
Request for Public Comment: 30-Day Proposed Information
Collection: Application for Participation in the IHS Scholarship
Program
ACTION: Notice.
Food and Drug Administration
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Postmarket
Surveillance
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 (the PRA).
DATES: Fax written comments on the collection of information by May 20,
2010.
Food and Drug Administration
Agency Information Collection Activities; Proposed Collection;
Comment Request; Tobacco Health Document Submission
ACTION: Notice.
Food and Drug Administration
Guidance for Industry on Tobacco Health Document Submission;
Availability
ACTION: Notice.
Centers for Disease Control and Prevention
Total Inward Leakage Requirements for Respirators
ACTION: Notice of proposed rulemaking; reopening of comment period.
SUMMARY: The Centers for Disease Control and Prevention (CDC) is
reopening the comment period for the notice of proposed rulemaking by
the National Institute for Occupational Safety and Health (NIOSH) of
CDC, entitled ``Total Inward Leakage Requirements for Respirators,''
published in the Federal Register on October 30, 2009 (74 FR 56141).
The comment period on this proposed regulation closed on March 29, 2010
(74 FR 66935) and is being reopened until September 30, 2010.
DATES: All written comments must be received on or before September 30,
2010.
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Comment Request
Proposed Project: The Stem Cell Therapeutic Outcomes Database (OMB No.
0915-0310)—Extension
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Medical Device Use in the Home Environment: Implications for the
Safe and Effective Use of Medical Device Technology Migrating Into the
Home; Public Workshop; Request for Comments
ACTION: Notice of public workshop; request for comments.
Dates and Times: The public workshop will be held on May 24, 2010,
from 7:30 a.m. to 5 p.m. Persons interested in attending and/or
participating in the workshop must register by 5 p.m. on May 17, 2010.
Submit written or electronic comments by June 30, 2010.
Location: The public workshop will be held at the Hilton Hotel,
8727 Colesville Rd., Silver Spring, MD 20910. The hotel's front desk
telephone number is 301-589-5200.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Center for Devices and Radiological Health; New Address
Information
ACTION: Final rule; technical amendments.
Food and Drug Administration
Town Hall Discussion With the Director of the Center for Devices
and Radiological Health and Other Senior Center Management
ACTION: Notice of public meeting; request for comments.
The Food and Drug Administration (FDA) is announcing a public
meeting entitled: ``Town Hall Discussion With the Director of the
Center for Devices and Radiological Health and Other Senior Center
Management.'' The purpose of this meeting is to present the Center for
Devices and Radiological Health (CDRH) fiscal year (FY) 2010
priorities. In addition, FDA is interested in engaging in discussions
about issues that are of importance to the medical device industry.
Dates and Time: The public meeting will be held on May 18, 2010,
from 9 a.m. to 4 p.m.
Location: The public meeting will be held at the Hilton
Minneapolis, Saint Paul Airport, 3800 American Blvd. East, Bloomington,
MN, 55425-1658. The meeting will not be videotaped or webcast.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Medicare and Medicaid Programs; Waiver of Disapproval of Nurse
Aide Training Program in Certain Cases
ACTION: Final rule.
SUMMARY: This final rule will permit a waiver of a nurse aide training
disapproval as it applies to skilled nursing facilities, in the
Medicare program, and nursing facilities, in the Medicaid program, that
are assessed a civil money penalty of at least $5,000 for noncompliance
that is not related to quality of care. This is a statutory provision
enacted by section 932 of the Medicare Prescription Drug, Improvement,
and Modernization Act of 2003 (MMA) (Pub. L. 108-173, enacted December
8, 2003).
DATES: Effective Date: These regulations are effective on May 24, 2010.
Centers for Medicare & Medicaid Service
Medicare Program; Ambulatory Surgical Centers, Conditions for
Coverage
ACTION: Proposed rule.
SUMMARY: This proposed rule would revise one of the existing conditions
for coverage (CfC) that ambulatory surgical centers (ASCs) must meet in
order to participate in the Medicare program. The proposed revision
would modify the current CfC for patient rights to include an exception
that would allow an ASC to provide patients or the patients'
representative or surrogate with required patient rights information on
the day of the procedure when the procedure must, to safeguard the
health of the patient, be performed on the same day as the physician's
referral. In addition, we are proposing some other minor changes to the
CfC for patient right requirements.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. EST on June 22,
2010.
Centers for Medicare & Medicaid Services
Agency Information Collection Activities: Proposed Collection;
1. Type of Information Collection Request: New collection; Title of
Information Collection: Medicare Prescription Drug Plan (PDP) and
Medicare Advantage Prescription Drug Plan (MA-PD) Disenrollment Reasons
Survey.
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Chronic Care
Improvement Program and Medicare Advantage Quality Improvement Project.
Centers for Medicare & Medicaid Services
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
1. Type of Information Collection Request: New Collection; Title of
Information Collection: Developing Outpatient Therapy Payment
Alternatives.
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Examination and
Treatment for Emergency Medical Conditions and Women Labor (EMTALA), 42
CFR 482.12, 488.18, 489.20, and 489.24.
Centers for Medicare & Medicaid Services
Medicaid Program; Final FY 2008, Revised Preliminary FY 2009, and
Preliminary FY 2010 Disproportionate Share Hospital Allotments and
Final FY 2008, Revised Preliminary FY 2009, and Preliminary FY 2010
Disproportionate Share Hospital Institutions for Mental Disease Limits
ACTION: Notice.
SUMMARY: This notice announces the final Federal share disproportionate
share hospital (DSH) allotments for Federal FY (FY) 2008 and the
preliminary Federal share DSH allotments for FY 2010. This notice also
announces the final FY 2008 and the preliminary FY 2010 limitations on
aggregate DSH payments that States may make to institutions for mental
disease and other mental health facilities. This notice also announces
the revised preliminary Federal share DSH allotments for FY 2009 and
the revised preliminary FY limitations on aggregate DSH payments that
States may make to institutions for mental disease and other mental
health facilities to reflect the provisions of the American
Reinvestment and Recovery Act of 2009 (the Recovery Act), enacted on
February
DATES: Effective Date: This notice is effective June 22, 2010. The
final allotments and limitations set forth in this notice are effective
for the fiscal year's specified.
Centers for Medicare & Medicaid Services
Medicaid Program; State Allotments for Payment of Medicare Part B
Premiums for Qualifying Individuals: Federal Fiscal Year 2009 and
Federal Fiscal Year 2010
ACTION: Notice.
SUMMARY: This notice sets forth final allotments available to States to
pay the Medicare Part B premiums for Qualifying Individuals (QIs) for
the Federal fiscal year (FY) 2009 and the preliminary QI allotments for
FY 2010. The amounts of these QI allotments were determined in
accordance with the methodology set forth in regulations, as amended in
the Federal Register published on November 24, 2008, and reflect
funding for the QI program made available under recent legislation.
DATES: Effective dates: The final QI allotments for payment of Medicare
Part B premiums for FY 2009 are effective October 1, 2008. The
preliminary QI allotments for FY 2010 are effective October 1, 2009.
Centers for Medicare & Medicaid Services
Medicare and Medicaid Programs; Announcement of an Application
From a Hospital Requesting Waiver for Organ Procurement Service Area
ACTION: Notice with comment period.
SUMMARY: A hospital has requested a waiver of statutory requirements
that would otherwise require the hospital to enter into an agreement
with its designated Organ Procurement Organization (OPO). The request
was made in accordance with section 1138(a)(2) of the Social Security
Act (the Act). This notice requests comments from OPOs and the general
public for our consideration in determining whether we should grant the
requested waiver.
DATES: Comment Date: To be assured consideration, comments must be
received at one of the addresses provided below, no later than 5 p.m.
on June 22, 2010.
Office of the Secretary
Agency Information Collection Request; 30-Day Public Comment
Proposed Project: HavBED Assessment to Prepare for Public Health
Emergencies--OMB No. 0990-0344--Revision--Office of the Assistant
Secretary for Preparedness and Response (ASPR), Office of Preparedness
and Emergency Operations (OPEO).