Weekly Legislative & Regulatory Round-up
Week of October 17 - 23
| GAO reports |
Oversight of Clinical Investigators: Action Needed to Improve Timeliness and Enhance Scope of FDA's Debarment and Disqualification Processes for Medical Product Investigators GAO-09-807
| OIG reports |
Review of Texas Department of State Health Services’ Bioterrorism and Emergency Preparedness Program (A-06-09-00038)
Adverse Event Reporting for Medical Devices (OEI-01-08-00110)
| Bills introduced |
|
Number/ Title |
Date Introduced | Sponsor | Description |
| S. 1796 | 10/19/09 | MAX BAUCUS (D-MT) | An original bill to provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes; from the Committee on Finance; placed on the calendar. |
| S. 1810 | 10/20/09 | TOM HARKIN (D-IA) | A bill to direct the Secretary of Health and Human Services to publish physical activity guidelines for the general public, and for other purposes; Referred to the Committee on Health, Education, Labor, and Pensions. |
| H.R. 3851 | 10/20/09 | BART GORDON (D-TN) | A bill to direct the Secretary of Health and Human Services to publish physical activity guidelines for the general public, and for other purposes; Referred to the Committee on Energy and Commerce. |
| H.R. 3856 | 10/20/09 | SHELLY BERKLEY (D-NV) | A bill to amend the Public Health Service Act to provide for osteoporosis and related bone disease education, research, and surveillance, and for other purposes; Referred to the Committee on Energy and Commerce. |
| H. Res. 847 | 10/20/09 | VERN BUCHANAN (R-FL) | A resolution expressing the sense of the House of Representatives that any conference committee or other meetings held to determine the content of national health care legislation be conducted in public under the watchful eye of the people of the United States; Referred to the Committee on Rules. |
| H.R. 3887 | 10/21/09 | ROY BLUNT (R-MO) | A bill to amend the Employee Retirement Income Security Act of 1974, the Public Health Service Act, and the Internal Revenue Code of 1986 to improve health insurance coverage of dependents; Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Education and Labor. |
| H.R. 3889 | 10/21/09 | PAUL BROUN (R-GA) | A bill to amend the Internal Revenue Code of 1986 to repeal the percentage floor on medical expense deductions, expand the use of tax-preferred health care accounts, and establish a charity care credit, to amend the Social Security Act to create a Medicare voucher program and reform EMTALA requirements, and to amend Public Health Service Act to provide for cooperative governing of individual health insurance coverage offered in interstate commerce; Referred to the Committee on Energy and Commerce, and in addition to the Committees on Education and Labor, and Ways and Means. |
| H.R. 3891 | 10/21/09 | ROBERT BRADY (D-PA) | A bill to improve research on health hazards in housing, to enhance the capacity of programs to reduce such hazards, to require outreach, and for other purposes; Referred to the Committee on Energy and Commerce, and in addition to the Committees on Financial Services, and Agriculture. |
| H.R. 3894 | 10/21/09 | KATHY DAHLKEMPER (D-PA) | A bill to amend the Public Health Service Act to authorize a community-based overweight and obesity prevention program; Referred to the Committee on Energy and Commerce. |
| H.R. 3895 | 10/21/09 | KATHY DAHLKEMPER (D-PA) | A bill to authorize the Secretary of Health and Human Services to conduct or support research and demonstration projects on the use of financial and in-kind subsidies and rewards to encourage individuals and communities to promote wellness, adopt healthy behaviors, and use evidence-based preventive health services, and for other purposes; Referred to the Committee on Energy and Commerce. |
| H.R. 3896 | 10/21/09 | JO ANN EMERSON (R-MO) | A bill to amend title XVIII of the Social Security Act to improve access to health care for individuals residing in underserved rural areas, and for other purposes; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means. |
| S. 1837 | 10/22/09 | SHERRO BROWN (D-OH) | A bill to amend title XVIII of the Social Security Act to cover hearing aids and auditory rehabilitation services under the Medicare Program; Referred to the Committee on Finance. |
| S. 1843 | 10/22/09 | SPECTER (D-PA) | A bill to provide increased penalties for health care fraud; Referred to the Committee on the Judiciary. |
| S. 1857 | 10/22/09 | DEBBIE STABENOW (D-MI) | A bill to establish national centers of excellence for the treatment of depressive and bipolar disorders; Referred to the Committee on Health, Education, Labor, and Pensions. |
| H.R. 3911 | 10/22/09 | CAROLYN MALONEY (D-NY) | A bill to amend the Public Health Service Act and Employee Retirement Income Security Act of 1974 to require that group and individual health insurance coverage and group health plans provide coverage for qualified individuals for bone mass measurement (bone density testing) to prevent fractures associated with osteoporosis; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Education and Labor. |
| H.R. 3917 | 10/22/09 | BART STUPAK (D-MI) | A bill to amend title XVIII of the Social Security Act to modernize and improve the Medicare payment methodology for radiopharmaceuticals under the hospital outpatient prospective payment system and to ensure equitable payment and patient access to certain low volume, high cost radiopharmaceuticals; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Guidance for Industry and Review Staff on Labeling for Human
Prescription Drug and Biological Products--Determining Established
Pharmacologic Class for Use in the Highlights of Prescribing
Information; Availability
ACTION: Notice.
Office of the National Coordinator for Health Information
Technology
HIT Standards Committee's Implementation Workgroup Meeting;
Notice of Meeting
ACTION: Notice of meeting.
Date and Time: The meeting will be held on October 29, 2009, from 9
a.m. to 3 p.m./Eastern Time.
Location: The Omni Shoreham Hotel, 2500 Calvert Street, NW.,
Washington, DC. The hotel telephone number is 202-234-0700.
Office of the Secretary, Office of Public Health and Science
Solicitation for Members of the National Vaccine Advisory
Committee
ACTION: Notice.
SUMMARY: The National Vaccine Program Office (NVPO), a program office
within the Office of Public Health and Science, DHHS, is soliciting
nominations of qualified candidates to be considered for appointment as
public members to the National Vaccine Advisory Committee (NVAC). The
activities of this Committee are governed by the Federal Advisory
Committee Act (FACA). Management support for the activities of this
Committee is the responsibility of the NVPO.
DATES: Nominations for membership on the Committee must be received no
later than 5 p.m. EDT on November 16, 2009, at the address below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Draft Guidance for Industry and Food and Drug Administration
Staff: Investigational New Drug Applications for Minimally Manipulated,
Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for
Hematopoietic Reconstitution for Specified Indications; Availability
ACTION: Notice.
Food and Drug Administration
Guidance for Industry: Minimally Manipulated, Unrelated
Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic
Reconstitution for Specified Indications; Availability
ACTION: Notice.
Food and Drug Administration
Medical Device User Fee and Modernization Act; Notice to Public
of Web Location of 2010 Proposed Guidance Development
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the Web
location where it will post a list of guidance documents the Center for
Devices and Radiological Health (CDRH) is considering for development.
In addition, FDA has established a docket where stakeholders may
provide comments and/or draft language for those topics as well as
suggestions for new or different guidances.
DATES: Submit written or electronic comments at any time.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Medical Devices; Clinical Chemistry and Clinical Toxicology
Devices; Classification of the Cardiac Allograft Gene Expression
Profiling Test Systems
ACTION: Final rule.
Food and Drug Administration
Draft Guidances for Industry and Food and Drug Administration
Staff; Computer-Assisted Detection Devices Applied to Radiology Images
and Radiology Device Data--Premarket Notification [510(k)] Submissions
and Clinical Performance Assessment: Considerations for Computer-
Assisted Detection Devices Applied to Radiology Images and Radiology
Device Data--Premarket Approval (PMA) and Premarket Notification
[510(k)] Submissions; Availability
ACTION: Notice.
Food and Drug Administration
Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document: Cardiac Allograft Gene
Expression Profiling Test Systems; Availability
ACTION: Notice.
Office of the Secretary, Office of Public Health and Science
Meeting of the National Vaccine Advisory Committee
ACTION: Notice.
SUMMARY: As stipulated by the Federal Advisory Committee Act, the
Department of Health and Human Services (HHS) is hereby giving notice
that the National Vaccine Advisory Committee (NVAC) will hold a meeting
via teleconference. The meeting is open to the public. Pre-registration
is not required, however, individuals who wish to participate in the
public comment session should either e-mail nvpo@hhs.gov or call 202-
690-5566 to register and RSVP.
DATES: The meeting will be held on Friday, November 6, 2009, from 3
p.m. to 5 p.m. EST.
ADDRESSES: The meetings will occur by teleconference.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Medicare Program; Policy and Technical Changes to the Medicare
Advantage and the Medicare Prescription Drug Benefit Programs
ACTION: Proposed rule.
SUMMARY: We are proposing revisions to the Medicare Advantage (MA)
program (Part C) and prescription drug benefit program (Part D) based
on our continued experience in the administration of the Part C and D
programs. The proposed revisions clarify various program participation
requirements; specify changes to strengthen beneficiary protections;
ensure that plan offerings to beneficiaries include meaningful
differences; improve plan payment rules and processes; and implement
new policy such as a Part D formulary policy.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. Eastern Standard
Time (EST) on December 8, 2009.
Centers for Medicare & Medicaid Services
Medicare Program; Inpatient Hospital Deductible and Hospital and
Extended Care Services Coinsurance Amounts for Calendar Year 2010
ACTION: Notice.
SUMMARY: This notice announces the inpatient hospital deductible and
the hospital and extended care services coinsurance amounts for
services furnished in calendar year (CY) 2010 under Medicare's Hospital
Insurance Program (Medicare Part A). The Medicare statute specifies the
formulae used to determine these amounts. For CY 2010, the inpatient
hospital deductible will be $1,100. The daily coinsurance amounts for
CY 2010 will be--(a) $275 for the 61st through 90th day of
hospitalization in a benefit period; (b) $550 for lifetime reserve
days; and (c) $137.50 for the 21st through 100th day of extended care
services in a skilled nursing facility in a benefit period.
DATES: Effective Date: This notice is effective on January 1, 2010.
Centers for Medicare & Medicaid Services
Medicare Program; Medicare Part B Monthly Actuarial Rates,
Premium Rate, and Annual Deductible Beginning January 1, 2010
ACTION: Notice.
SUMMARY: This notice announces the monthly actuarial rates for aged
(age 65 and over) and disabled (under age 65) beneficiaries enrolled in
Part B of the Medicare Supplementary Medical Insurance (SMI) program
beginning January 1, 2010. In addition, this notice announces the
monthly premium for aged and disabled beneficiaries as well as the
income-related monthly adjustment amounts to be paid by beneficiaries
with modified adjusted gross income above certain threshold amounts.
The monthly actuarial rates for 2010 are $221.00 for aged enrollees and
$270.40 for disabled enrollees. The standard monthly Part B premium
rate for 2010 is $110.50, which is equal to 50 percent of the monthly
actuarial rate for aged enrollees or roughly 25 percent of the expected
average total cost of Part B coverage for aged enrollees. (The 2009
standard premium rate was $96.40.) The Part B deductible for 2010 is
$155.00 for all Part B beneficiaries. A beneficiary who has to pay an
income-related monthly adjustment may have to pay a total monthly
premium of roughly 35, 50, 65 or 80 percent of the total cost of Part B
coverage.
DATES: Effective Date: January 1, 2010.
Centers for Medicare & Medicaid Services
Medicare Program; Part A Premium for Calendar Year 2010 for the
Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted
Other Entitlement
ACTION: Notice.
SUMMARY: This annual notice announces Medicare's Hospital Insurance
(Part A) premium for uninsured enrollees in calendar year (CY) 2010.
This premium is paid by enrollees age 65 and over who are not otherwise
eligible for benefits under Medicare Part A (hereafter known as the
``uninsured aged'') and by certain disabled individuals who have
exhausted other entitlement. The monthly Part A premium for the 12
months beginning January 1, 2010 for these individuals will be $461.
The reduced premium for certain other individuals as described in this
notice will be $254.
DATES: Effective Date: This notice is effective on January 1, 2010.
Food and Drug Administration
Request for Notification From Industry Organizations Interested
in Participating in Selection Process for Nonvoting Industry
Representatives on Public Advisory Committees and Request for
Nominations for Nonvoting Industry Representatives on Public Advisory
Committees
ACTION: Notice.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Type of Information Collection Request: Extension of the
currently approved collection; Title of Information Collection:
Indirect Medical Education (IME) and Supporting Regulations
Centers for Medicare & Medicaid Services
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
1. Type of Information Collection Request: Extension without change
of a currently approved collection; Title of Information Collection:
Medicaid Statistical Information System
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: State Plan
Preprints to Implement Sections 6083, 6036, 6041, 6042, 6043 and 6044
of the Deficit Reduction Act (DRA) of 1995.
Centers for Medicare & Medicaid Services
Medicare and Medicaid Programs; Conditional Approval of the
Community Health Accreditation Program for Continued Deeming Authority
for Hospices
ACTION: Final notice.
SUMMARY: This notice announces our decision to conditionally approve,
with a 180-day probationary period, the Community Health Accreditation
Program's (CHAP's) request for continued recognition as a national
accreditation program for hospices seeking to participate in the
Medicare or Medicaid programs.
DATES: Effective Date: This final notice is effective November 20, 2009
through November 20, 2012, with a 180-day probationary period beginning
November 20, 2009 through May 19, 2010.
Centers for Medicare & Medicaid Services
Medicare Program; Criteria for Medicare Coverage of Inpatient
Hospital Rehabilitation Services
ACTION: Rescission of Ruling.
SUMMARY: This notice rescinds HCFA Ruling 85-2, ``Medicare Criteria for
Coverage of Inpatient Hospital Rehabilitation Services,'' 50 FR 31040
(July 31, 1985), as corrected at 50 FR 32643 (Aug. 13, 1985) which
established the criteria for Medicare coverage of inpatient hospital
rehabilitation services.
DATES: Effective Date: This notice is effective on January 1, 2010.