Weekly Legislative & Regulatory Round-up
Week of January 10 - 16
| GAO reports |
| OIG reports |
No relevant reports.
| Bills introduced |
|
Number/ Title |
Date Introduced | Sponsor | Description |
H.R. 362 |
1/9/09 |
LEONARD BOSWELL (D-IA) |
A bill to amend title XVIII of the Social Security Act to provide for temporary improvements to the Medicare inpatient hospital payment adjustment for low-volume hospitals and to provide for the use of the non-wage adjusted PPS rate under the Medicare-dependent hospital (MDH) program, and for other purposes; Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce. |
H.R. 398 |
1/9/09 |
JOSPEH CROWLEY (D-NY) |
A bill to amend title XIX of the Social Security Act to restore and protect access to Medicaid discount drug prices for university-based and safety-net clinics; Referred to the Committee on Energy and Commerce |
H.R. 439 |
1/9/09 |
DENNIS REHBERG (R-MT) |
A bill to amend the Public Health Service Act regarding residential treatment programs for pregnant and parenting women, a program to reduce substance abuse among nonviolent offenders, and for other purposes; Referred to the Committee on Energy and Commerce. |
H.R. 444 |
1/9/09 |
BOBBY RUSH (D-IL) |
A bill to amend section 340B of the Public Health Service Act to revise and expand the drug discount program under that section to improve the provision of discounts on drug purchases for certain safety net providers; Referred to the Committee on Energy and Commerce. |
H.R. 449 |
1/9/09 |
JOE SESTAK (D-PA) |
A bill to amend title 38, United States Code, to expand the availability of health care provided by the Secretary of Veterans Affairs by adjusting the income level for certain priority veterans; to the Committee on Veterans' Affairs. |
S. 207 |
1/12/09 |
BARBARA BOXER (D-CA) |
A bill to amend the Internal Revenue Code of 1986 to allow a deduction for health insurance premiums; Referred to the Committee on Finance. |
S. 211 |
1/12/09 |
HILARY CLINTON (D-NY) |
A bill to facilitate nationwide availability of 2-1-1 telephone service for information and referral on human services and volunteer services, and for other purposes; Referred to the Committee on Health, Education, Labor, and Pensions. |
S. 214 |
1/12/09 |
JEFF BINGAMAN (D-NM) |
A bill to amend title XXI of the Social Security Act to permit qualifying States to use their allotments under the State Children's Health Insurance Program for any fiscal year for certain Medicaid expenditures; Referred to the Committee on Finance |
S. 225 |
1/13/09 |
EVAN BAYH (D-IN) |
A bill to amend title XIX of the Social Security Act to establish programs to improve the quality, performance, and delivery of pediatric care; Referred to the Committee on Finance. |
S. 228 |
1/13/09 |
JEFF BINGAMAN (D-NM) |
A bill to amend title XIX of the Social Security Act to permit States, at their option, to require certain individuals to present satisfactory documentary evidence of proof of citizenship or nationality for purposes of eligibility for Medicaid, and for other purposes; to the Committee on Finance. |
H.R. 2 |
1/13/09 |
FRANK PALLONE (D-NJ) |
A bill to amend title XXI of the Social Security Act to extend and improve the Children's Health Insurance Program, and for other purposes; Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Education and Labor. |
H.R. 462 |
1/13/09 |
ELIJAH CUMMINGS (D-MD) |
A bill to amend titles XIX and XXI of the Social Security Act to improve dental benefits under Medicaid and the State Children's Health Insurance Program (SCHIP), and for other purposes; Referred to the Committee on Energy and Commerce |
H.R. 463 |
1/13/09 |
LOUISE MCINTOSH SLAUGHTER (D-28TH NY) |
A bill to expand access to preventive health care services that help reduce unintended pregnancy, reduce abortions, and improve access to women's health care; Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Education and Labor. |
H.R. 464 |
1/13/09 |
TOM PRICE (R-GA) |
A bill to provide for a 5-year SCHIP reauthorization for coverage of low-income children, an expansion of child health care insurance coverage through tax fairness, and a health care Federalism initiative, and for other purposes; Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Rules. |
H.R. 465 |
1/13/09 |
GENE GREEN (D-TX) |
A bill to amend titles XIX and XXI of the Social Security Act to permit States to ensure coverage without a 5-year delay of certain children and pregnant women under the Medicaid program and SCHIP; Referred to the Committee on Energy and Commerce |
H.R. 468. |
1/13/09 |
JANICE SCHAKOWSKY (D-IL) |
A bill to expand, train, and support all sectors of the health care workforce to care for the growing population of older individuals in the United States; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Education and Labor. |
H.R. 479 |
1/13/09 |
JIM MATHESON (D-UT) |
A bill to amend the Public Health Service Act to provide a means for continued improvement in emergency medical services for children; Referred to the Committee on Energy and Commerce. |
H.R. 484 |
1/13/09 |
MICHAEL ROGERS (R-MI) |
A bill to require the Secretary of Defense to develop and implement a plan to provide chiropractic health care services and benefits for certain new beneficiaries as part of the TRICARE program; Referred to the Committee on Armed Services. |
H.R. 487 |
1/13/09 |
IKE SKELTON (D-MO) |
A bill to waive the 35-mile requirement for designation of a critical access hospital under the Medicare program; Referred to the Committee on Ways and Means. |
S. 239 |
1/14/09 |
JEANNE SHAHEEN (D-NH) |
A bill to amend title 38, United States Code, to ensure that veterans in each of the 48 contiguous States are able to receive services in at least one full-service hospital of the Veterans Health Administration in the State or receive comparable services provided by contract in the State; Referred to the Committee on Veterans' Affairs. |
S. 245 |
1/14/09 |
HERBERT H. KOHL (D-WI) |
A bill to expand, train, and support all sectors of the health care workforce to care for the growing population of older individuals in the United States; to the Committee on Health, Education, Labor, and Pensions |
S. 246 |
1/14/09 |
RICHARD DURBIN (D-IL) |
A bill to amend title 38, United States Code, to improve the quality of care provided to veterans in Department of Veterans Affairs medical facilities, to encourage highly qualified doctors to serve in hard-to-fill positions in such medical facilities, and for other purposes; to the Committee on Veterans' Affairs. |
H.R. 502 |
1/14/09 |
MICHELLE BACHMANN (R- MN) |
A bill to amend the Internal Revenue Code of 1986 to improve health care choice by providing for the tax deductibility of medical expenses by individuals; Referred to the Committee on Ways and Means |
H.R. 521 |
1/14/09 |
PETER KING (R-NY) |
A bill to amend the Public Health Service Act to provide for the national collection of data on stillbirths in a standardized manner, and for other purposes; Referred to the Committee on Energy and Commerce. |
H.R. 542 |
1/14/09 |
ADAM PUTNAM (R-FL) |
A bill to amend titles XIX and XXI of the Social Security Act to permit States to rely on findings from an express plan agency to conduct simplified eligibility determinations under Medicaid and the State Children's Health Insurance Program; to the Committee on Energy and Commerce. |
H.R. 544 |
1/14/09 |
ED ROYCE (R-CA) |
A bill to amend the Internal Revenue Code of 1986 to allow amounts in a health flexible spending arrangement that are unused during a plan year to be carried over to subsequent plan years or deposited into certain health or retirement plans; Referred to the Committee on Ways and Means. |
S. 252 |
1/15/09 |
DANIEL K. AKAKA (D-HI) |
A bill to amend title 38, United States Code, to enhance the capacity of the Department of Veterans Affairs to recruit and retain nurses and other critical health-care professionals, to improve the provision of health care veterans, and for other purposes; Referred to the Committee on Veterans' Affairs |
S. 254 |
1/15/09 |
BLANCHE L. LINCOLN (D-AR) |
A bill to amend title XVIII of the Social Security Act to provide for the coverage of home infusion therapy under the Medicare Program; to the Committee on Finance |
S. 259 |
1/15/09 |
CHRISTOPHER S. BOND (R-MO) |
A bill to establish a grant program to provide vision care to children, and for other purposes; to the Committee on Health, Education, Labor, and Pensions |
S. 264 |
1/15/09 |
DEBBIE A. STABENOW (D-MI) |
A bill to amend title XIX of the Social Security Act to encourage the use of certified health information technology by providers in the Medicaid program and the Children's Health Insurance Program, and for other purposes; Referred to the Committee on Finance. |
S. 266 |
1/15/09 |
BILL NELSON (D-FL) |
A bill to amend title XVIII of the Social Security Act to reduce the coverage gap in prescription drug coverage under part D of such title based on savings to the Medicare program resulting from the negotiation of prescription drug prices; to the Committee on Finance |
H.R. 563 |
1/15/09 |
JUDY BIGGERT (R-IL) |
A bill to amend title XXI of the Social Security Act to require States to provide priority under the State Children's Health Insurance Program (SCHIP) to children in families with gross income below 200 percent of the Federal poverty level; Referred to the Committee on Energy and Commerce. |
H.R. 568 |
1/15/09 |
JERRY COSTELLO (D-IL) |
A bill to amend title 38, United States Code, to improve the quality of care provided to veterans in Department of Veterans Affairs medical facilities, to encourage highly qualified doctors to serve in hard-to-fill positions in such medical facilities, and for other purposes; Referred to the Committee on Veterans' Affairs, and in addition to the Committee on Oversight and Government Reform. |
H.R. 574 |
1/15/09 |
ELIOT ENGEL (D-NY) |
A bill to amend title XVIII of the Social Security Act to provide for the coverage of home infusion therapy under the Medicare Program; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means. |
H.R. 577 |
1/15/09 |
GENE GREEN (D-TX) |
A bill to establish a grant program to provide vision care to children, and for other purposes; Referred to the Committee on Energy and Commerce |
H.R. 584 |
1/15/09 |
BARBARA LEE (D-CA) |
A bill to provide for coverage of hormone replacement therapy for treatment of menopausal symptoms, and for coverage of an alternative therapy for hormone replacement therapy for such symptoms, under the Medicare and Medicaid Programs, group health plans and individual health insurance coverage, and other Federal health insurance programs; Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Education and Labor, Oversight and Government Reform, and Veterans' Affairs. |
H.R. 585 |
1/15/09 |
BARBARA LEE (D-CA) |
A bill to direct the President to enter into an arrangement with the National Academy of Sciences to evaluate certain Federal rules and regulations for potentially harmful impacts on public health, air quality, water quality, plant and animal wildlife, global climate, or the environment; and to direct Federal departments and agencies to create plans to reverse those impacts that are determined to be harmful by the National Academy of Sciences; Referred to the Committee on Science and Technology, and in addition to the Committees on Transportation and Infrastructure, Natural Resources, Agriculture, and Energy and Commerce. |
H.R. 592 |
1/15/09 |
ALLYSON SCHWARTZ (D- PA) |
A bill to amend title XIX of the Social Security Act to encourage the use of certified health information technology by providers in the Medicaid Program and the Children's Health Insurance Program, 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
Medicare Program; Medicare Advantage and Prescription Drug
Benefit Programs: Negotiated Pricing and Remaining Revisions
ACTION: Final rule with comment period.
SUMMARY:
This rule contains final regulations governing the Medicare Advantage (MA) program (Part C) and prescription drug benefit program (Part D), and interim final regulations governing certain aspects of the Retiree Drug Subsidy (RDS) Program, and reflecting new statutory definitions relating to Special Needs Plans under Part C. The final regulations revising the Part C and Part D regulations include provisions regarding medical savings account (MSA) plans, cost-sharing for dual eligible enrollees in the MA program, the prescription drug payment and novation processes in the Part D program, and the enrollment and appeals processes for both programs. This final rule with comment period also responds to public comments on the May 16, 2008 proposed rule and takes into account statutory revisions contained in the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA).
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Federal Financial Participation in State Assistance Expenditures;
Federal Matching Shares for Medicaid, the State Children's Health Insurance Program, and Aid to Needy Aged, Blind, or Disabled Persons for October 1, 2009 through September 30, 2010; Correction
ACTION: Notice; correction.
SUMMARY: This document corrects a technical error that appeared in the notice published in the November 26, 2008 Federal Register entitled “Federal Financial Participation in State Assistance Expenditures; Federal Matching Shares for Medicaid, the State Children's Health
Insurance Program, and Aid to Needy Aged, Blind, or Disabled Persons for October 1, 2009 through September 30, 2010.''
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Meeting To Discuss Women's Health
ACTION: Notice of meeting.
The Food and Drug Administration (FDA), Office of Women's Health is
announcing the following meeting: ``Women's Health Dialogue.'' The
meeting is intended for directors of national organizations interested
in discussing women's health research and educational out reach.
Date and Time: The meeting will be held on February 9, 2009, from
8:30 a.m. to 11:30 a.m.
Location: The meeting will be held at HMA Associates, Inc., 1101
17th St., NW., suite 1102, Washington, DC 20036.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Guidance for Industry on Good Reprint Practices for the
Distribution of Medical Journal Articles and Medical or Scientific
Reference Publications on Unapproved New Uses of Approved Drugs and
Approved or Cleared Medical Devices; Availability
ACTION: Notice.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Solicitation of Written Comments on Draft Strategic National
Vaccine Plan
ACTION: Notice.
SUMMARY: On behalf of the National Vaccine Advisory Committee (NVAC),
the National Vaccine Program Office (NVPO) is soliciting public comment
on the draft strategic National Vaccine Plan.
DATES: All comments on the draft strategic National Vaccine Plan should
be received no later than 5 p.m. on January 30, 2009.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
ACTION: Notice.
SUMMARY: This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Improving Patient Flow and Reducing Emergency Department Crowding.''
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Assistant Secretary for Planning and Evaluation, Department of Health and Human Services
Notice of Availability of Request for Information (RFI) Regarding the Potential Roles for HHS in Developing a Dynamic Environment To
Encourage the Innovation and Diffusion of Medical Technologies That
Enhance Health System Value
ACTION: Request for information.
SUMMARY: The Department of Health and Human Services (HHS) is soliciting ideas and information relating to ways in which HHS could continue to improve its use of resources and authorities in encouraging the development and use of new medical technologies, consistent with the goals of (a) maintaining and improving the quality of care, (b) controlling overall healthcare costs, and (c) using timely and practical administrative procedures.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Guidance for Clinical Investigators, Sponsors, and Institutional
Review Boards on Adverse Event Reporting--Improving Human Subject
Protection; Availability
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Adverse Event
Reporting--Improving Human Subject Protection.'' This guidance is
intended to assist the research community in interpreting requirements
for submitting reports of unanticipated problems, including certain
adverse events reports, to institutional review boards (IRBs).
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Unique Device Identification System; Public Workshop; Request for
Comments
ACTION: Notice of public workshop; request for comments.
The Food and Drug Administration (FDA) is announcing a public
workshop entitled: ``Unique Device Identification System.'' The purpose
of the public workshop is to obtain information to help us better
understand the issues involved in the establishment of a unique device
identification system (UDI system) and request comments on this topic.
Dates and Time: The public workshop will be held on, February 12,
2009, from 9 a.m. to 5 p.m. See section V of this document for
additional dates associated with registration and participation in the
workshop.
Location: The public workshop will be held at the Marriott
Gaithersburg Washingtonian Center, 9751 Washingtonian Blvd.,
Gaithersburg, MD 20878, 301-590-0044.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Secure Supply Chain Pilot Program; Notice of Pilot Program
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for sponsors and foreign manufacturers of finished drug
products and active pharmaceutical ingredients (APIs) intended for
human use imported by a secure supply chain to apply to participate in
a voluntary Secure Supply Chain (SSC) pilot program to be conducted by
FDA's Center for Drug Evaluation and Research (CDER) and Office of
Regulatory Affairs (ORA). The goal of the pilot program is to allow FDA
to determine the practicality of developing a secure supply chain
program.
DATES: Submit written or electronic comments on this pilot program by
March 16, 2009. Submit written or electronic comments on the collection
of information by March 16, 2009.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Health Insurance Reform; Modifications to the Health Insurance
Portability and Accountability Act (HIPAA) Electronic Transaction
Standards
ACTION: Final rule.
SUMMARY: This final rule adopts updated versions of the standards for
electronic transactions originally adopted under the Administrative
Simplification subtitle of the Health Insurance Portability and
Accountability Act of 1996 (HIPAA). This final rule also adopts a
transaction standard for Medicaid pharmacy subrogation. In addition,
this final rule adopts two standards for billing retail pharmacy
supplies and professional services, and clarifies who the ``senders''
and ``receivers'' are in the descriptions of certain transactions.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
HIPAA Administrative Simplification: Modifications to Medical
Data Code Set Standards To Adopt ICD-10-CM and ICD-10-PCS
ACTION: Final rule.
SUMMARY: This final rule adopts modifications to two of the code set
standards adopted in the Transactions and Code Sets final rule
published in the Federal Register pursuant to certain provisions of the
Administrative Simplification subtitle of the Health Insurance
Portability and Accountability Act of 1996 (HIPAA). Specifically, this
final rule modifies the standard medical data code sets (hereinafter
``code sets'') for coding diagnoses and inpatient hospital procedures
by concurrently adopting the International Classification of Diseases,
10th Revision, Clinical Modification (ICD-10-CM) for diagnosis coding,
including the Official ICD-10-CM Guidelines for Coding and Reporting,
as maintained and distributed by the U.S. Department of Health and
Human Services (HHS), hereinafter referred to as ICD-10-CM, and the
International Classification of Diseases, 10th Revision, Procedure
Coding System (ICD-10-PCS) for inpatient hospital procedure coding,
including the Official ICD-10-PCS Guidelines for Coding and Reporting,
as maintained and distributed by the HHS, hereinafter referred to as
ICD-10-PCS.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Medicare Program; Changes to the Competitive Acquisition of
Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies
(DMEPOS) by Certain Provisions of the Medicare Improvements for
Patients and Providers Act of 2008 (MIPPA)
ACTION: Interim final rule with comment period.
SUMMARY: This interim final rule with comment period implements certain
provisions of section 154 of the Medicare Improvements for Patients and
Providers Act of 2008 (MIPPA) related to the durable medical equipment,
prosthetics, orthotics, and supplies (DMEPOS) Competitive Acquisition
Program. Specifically, this rule: Implements certain MIPPA provisions
that delay implementation of Round 1 of the program; requires CMS to
conduct a second Round 1 competition (the ``Round 1 rebid'') in 2009;
and mandates certain changes for both the Round 1 rebid and subsequent
rounds of the program, including a process for providing feedback to
suppliers regarding missing financial documentation and requiring
contractors to disclose to CMS information regarding subcontracting
relationships.
DATES: Effective date: These regulations are effective on February 17,
2009.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Medicare Program: Medicare Advantage and Prescription Drug
Programs MIPPA Drug Formulary & Protected Classes Policies
ACTION: Interim final rule with comment period.
SUMMARY: This interim final rule with comment period revises the
regulations governing the Medicare prescription drug benefit program
(Part D). This regulation makes conforming changes to reflect revisions
to the rules governing Part D that were made as a result of provisions
in the Medicare Improvements for Patients and Providers Act (MIPPA),
which became law on July 15, 2008. These MIPPA provisions change the
definition of a covered Part D drug, and add new requirements that
apply to Part D formularies.
DATES: Effective date: These regulations are effective January 16,
2009.
Comment date: To be assured consideration, comments must be
received at one of the addresses provided below, no later than 5 p.m.
on March 17, 2009.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Medicare, Medicaid, and Clinical Laboratory Improvement
Amendments of 1988 (CLIA) Program; Cytology Proficiency Testing (PT)
ACTION: Proposed rule.
SUMMARY: This proposed rule would amend the Clinical Laboratory
Improvement Amendments of 1988 (CLIA) regulations for cytology
proficiency testing (PT), to reflect changes in cytology laboratory
operations and practices. The proposed changes are based on
recommendations received from the Clinical Laboratory Improvement
Advisory Committee (CLIAC), input from the professional community, and
government experience with the implementation of cytology PT.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Medicare Program; Meeting of the Medicare Evidence Development &
Coverage Advisory Committee--March 18, 2009
ACTION: Notice of meeting.
DATES: Meeting Date: The public meeting will be held on Wednesday,
March 18, 2009 from 7:30 a.m. until 4:30 p.m., daylight savings time
(d.s.t).
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Draft Guidance for Industry on Standards for Securing the Drug
Supply Chain--Standardized Numerical Identification for Prescription
Drug Packages; Availability
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Standards for
Securing the Drug Supply Chain--Standardized Numerical Identification
for Prescription Drug Packages.'' This draft guidance is being issued
under the Federal Food, Drug, and Cosmetic Act (the act), which
requires FDA to develop standardized numerical identifiers for
prescription drugs. We are also requesting responses from interested
stakeholders to questions posed in this Federal Register notice related
to the draft guidance.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Draft Guidance for Industry: Current Good Tissue Practice (CGTP)
and Additional Requirements for Manufacturers of Human Cells, Tissues,
and Cellular and Tissue-Based Products (HCT[sol]Ps); Availability
ACTION: Notice.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Draft Guidance for Industry: Submission of Laboratory Packages by
Accredited Laboratories; Availability
ACTION: Notice.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Guidance for Industry: Evidence-Based Review System for the
Scientific Evaluation of Health Claims
ACTION: Notice.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Release of Task Force Report; Guidance for Industry and FDA:
Interim Evidence-Based Ranking System for Scientific Data; Withdrawal
of Guidance
ACTION: Notice; withdrawal.