Weekly Legislative & Regulatory Round-up
Week of February 27 - March 5, 2010
| GAO reports |
Group Purchasing Organizations: Research on Their Pricing Impact on Health Care Providers GAO-10-323R
Medicare Part D: Spending, Beneficiary Cost Sharing, and Cost-Containment Efforts for High-Cost Drugs Eligible for a Specialty Tier GAO-10-242
Emergency Communications: Establishment of the Emergency Communications Preparedness Center and Related Interagency Coordination Challenges GAO-10-463R
Medicare Part D: CMS Oversight of Part D Sponsors' Fraud and Abuse Programs Has Been Limited, but CMS Plans Oversight Expansion GAO-10-481T
The Federal Government's Long-Term Fiscal Outlook: January 2010 Update GAO-10-468SP
| OIG reports |
Adverse Events In Hospitals: Methods For Identifying Events (PDF) (OEI-06-08-00221)
Beneficiaries Remain Vulnerable to Sales Agents' Marketing of Medicare Advantage Plans (PDF) (OEI-05-09-00070)
| Bills introduced |
|
Number/ Title |
Date Introduced | Sponsor | Description |
S. 3058 |
3/2/10 |
BYRON DORGAN (D-ND) |
A bill to amend the Public Health Service Act to reauthorize the special diabetes programs for Type I diabetes and Indians under that Act; Referred to the Committee on Health, Education, Labor, and Pensions. |
H.R. 4732 |
3/2/10 |
DIANE WATSON (D-CA) |
A bill to amend the Federal Food, Drug, and Cosmetic Act to create a new conditional approval system for drugs, biological products, and devices that is responsive to the needs of seriously ill patients, and for other purposes; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means. |
H. Con. Res. 245 |
3/2/10 |
LEONARD LANCE (R-NJ) |
Concurrent resolution recognizing the life-saving role of ostomy care and prosthetics in the daily lives of hundreds of thousands of people in the United States; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means. |
H.R. 4752 |
3/3/10 |
PETER WELCH (D-VT) |
A bill to amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means. |
H. Con. Res. 246 |
3/3/10 |
TAMMY BALDWIN (D-WI) |
Concurrent resolution supporting the goals and ideals of World Glaucoma Day; Referred to the Committee on Energy and Commerce. |
S. 3078 |
3/4/10 |
DIANE FEINSTEIN (D-CA) |
A bill to provide for the establishment of a Health Insurance Rate Authority to establish limits on premium rating, and for other purposes; Referred to the Committee on Health, Education, Labor, and Pensions. |
H.R. 4757 |
3/4/10 |
JANICE SCHAKOWSKY (D-IL) |
A bill to provide for the establishment of a Health Insurance Rate Authority to establish limits on premium rating, and for other purposes; 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: Organ Procurement
Organization's (OPO's) Health Insurance Benefits Agreement and
Supporting Regulations at 42 CFR 486.301-486.348
Food and Drug Administration
Agency Information Collection Activities; Proposed Collection;
Comment Request; Human Tissue Intended for Transplantation
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
requirements relating to FDA regulations for human tissue intended for
transplantation.
DATES: Submit written or electronic comments on the collection of
information by April 30, 2010.
Food and Drug Administration
Agency Information Collection Activities; Proposed Collection;
Comment Request; Pretesting of Tobacco Communications
ACTION: Notice.
Food and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent
Extension; FIRMAGON
ACTION: Notice.
Food and Drug Administration
Draft Guidance for Industry on Non-Inferiority Clinical Trials;
Availability
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Non-
Inferiority Clinical Trials.'' This draft guidance provides sponsors
and review staff in the Center for Drug Evaluation and Research (CDER)
and the Center for Biologics Evaluation and Research (CBER) with the
agency's interpretation of the underlying principles involved in the
use of non-inferiority (NI) study designs to provide evidence of the
effectiveness of a drug or therapeutic biologic product. The draft
guidance offers advice on when NI studies can be interpretable, how to
choose the NI margin, and how to analyze the results.
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 June 1, 2010.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; Reinstatement of OMB
No. 0925-0601/exp. 02/28/2010, Request for Human Embryonic Stem Cell
Line To Be Approved for Use in NIH Funded Research
No relevant notices
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Request for Measures of Patient Experiences of Cancer Care
ACTION: Notice of request.
SUMMARY: The Agency for Healthcare Research and Quality (AHRQ), in
collaboration with the National Cancer Institute (Nd), is soliciting
voluntary submission of survey instruments and items, which ask adult
survey respondents to assess the care delivered by cancer care
providers. AHRQ is seeking these items and measures from researchers,
survey firms, cancer care providers, patient advocacy groups,
individual cancer patients, and other stakeholders who are interested
in the development of survey measures of patient experiences of cancer
care. To be as inclusive as possible, AHRQ is requesting such
instruments and individual items, along with any available
documentation of their validity and reliability and descriptions of
survey methods for using them.
Food and Drug Administration
Guidance for Industry: Characterization and Qualification of Cell
Substrates and Other Biological Materials Used in the Production of
Viral Vaccines for Infectious Disease Indications; Availability
ACTION: Notice.
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 ofInformation Collection: Intermediate Care Facility (ICF)
for the Mentally Retarded (MR) or Persons with Related Conditions Survey Report
Form and Supporting Regulations at 42 CFR 442.30, 483.410, 483.420,
483.440, 483.450 and 483.460
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Annual Early and
Periodic Screening, Diagnostic and Treatment (EPSDT) Services
Participation Report
Centers for Medicare & Medicaid Services
Notice of Opportunity for a Hearing on Compliance of Missouri
State Plan Provisions Concerning Payments for Home Health Services With
Title XIX (Medicaid) of the Social Security Act
ACTION: Notice of Opportunity for a Hearing; Compliance of Missouri
Medicaid State Plan Home Health Benefit.
Food and Drug Administration
Strengthening the Center for Devices and Radiological Health's
510(k) Review Process; Public Meeting; Extension of Comment Period
ACTION: Notice; extension of comment period.
SUMMARY: The Food and Drug Administration (FDA) is extending to March
19, 2010, the comment period for the notice that appeared in the
Federal Register of Wednesday, January 27, 2010 (75 FR 4402). In the
notice, FDA requested comments on a number of identified challenges
associated with the 510(k) process. The agency is taking this action to
allow interested persons additional time to submit comments.
DATES: Submit written or electronic comments and information by March
19, 2010.
Health Resources and Services Administration
Notice Regarding 340B Drug Pricing Program--Contract Pharmacy
Services
ACTION: Final notice.
SUMMARY: Section 602 of Public Law 102-585, the ``Veterans Health Care
Act of 1992'' enacted Section 340B of the Public Health Service Act
(PHS). Section 340B implements a drug pricing program by which
manufacturers who sell covered outpatient drugs to particular covered
entities listed in the statute must agree to charge a price that will
not exceed the amount determined under a statutory formula. The purpose
of this Final Notice is to inform interested parties of final
guidelines regarding the utilization of multiple contract pharmacies
and suggested contract pharmacy provisions, which had been previously
limited to the Alternative Methods Demonstration Project program.