Weekly Legislative & Regulatory Round-up

Week of July 24 - 30, 2010

GAO reports

No relevant reports.

OIG reports

No relevant reports.

Bills introduced

Number/ Title	Date Introduced	Sponsor	Description
S. 3647	07/26/2010	Tester, Jon (D-MT)	A bill to amend the Public Health Service Act to provide for the participation of particular specialists determined by the Secretary of Health and Human Services to be directly related to the health needs stemming from environmental health hazards that have led to its declaration as a Public Health Emergency to be eligible under the National Health Service Corps in the National Health Service Corps Loan Repayment Program, and for other purposes; Referred to the Committee on Health, Education, Labor, and Pensions.
H.R. 5853	07/26/2010	Boustany, Charles (R-LA)	A bill to amend title XXXII of the Public Health Service Act to require review and approval by law prior to collection of premiums under the CLASS program, to require notice to individuals prior to enrollment, and to require termination of the program in the event of actuarial unsoundness, and for other purposes; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Rules.
H.R. 5861	07/26/2010	Kilroy, Mary Jo (D-OH)	A bill to amend title XVIII of the Social Security Act to establish a cancer center construction loan program; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means.
S. 3653	07/27/2010	Cornyn, John (R-TX)	A bill to remove unelected, unaccountable bureaucrats from seniors' personal health decisions by repealing the Independent Payment Advisory Board; Referred to the Committee on Finance.
H.R. 5882	07/27/2010	Graves, Sam (R-GA)	A bill to deauthorize appropriation of funds to carry out the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010; Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Education and Labor, the Judiciary, Natural Resources, and House Administration.
H.R. 5888	07/27/2010	Michaud, Mike (D-ME)	A bill to establish an America Rx program to establish fairer pricing for prescription drugs for individuals without access to prescription drugs at discounted prices; Referred to the Committee on Energy and Commerce.
H.R. 5889	07/27/2010	Young, Don (R-AK)	A bill to amend the Public Health Service Act and title XVIII of the Social Security Act to increase the number of primary care physicians and medical residents serving health professional shortage areas, 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. 305	07/27/2010	Lowey, Nita (D-NY)	Concurrent resolution expressing the sense of the Congress concerning contraceptives for women; Referred to the Committee on Energy and Commerce.
H. Res. 1561	07/27/2010	Burgess, Michael (R-TX)	A resolution directing the Secretary of Health and Human Services to transmit to the House of Representatives copies of each portion of any document, record, or communication in her possession consisting of or relating to documents prepared by or for the Centers for Medicare & Medicaid Services regarding the Patient Protection and Affordable Care Act, and for other purposes; Referred to the Committee on Energy and Commerce.
H.R. 5890	07/28/2010	Doggett, Lloyd (D-TX)	A bill to amend the Internal Revenue Code of 1986 and title XIX of the Social Security Act to reform the provision of long-term care insurance; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means.

Federal Register notices

July 26

ARCHITECTURAL AND TRANSPORTATION BARRIERS COMPLIANCE BOARD

Americans With Disabilities Act (ADA) Accessibility Guidelines

for Transportation Vehicles

ACTION: Notice of proposed rulemaking.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

Medicare and Medicaid Programs; Application by Det Norske Veritas

Healthcare for Deeming Authority for Critical Access Hospitals (CAHs)

ACTION: Proposed notice.

Centers for Medicare & Medicaid Services

Medicare Program; Meeting of the Medicare Evidence Development

and Coverage Advisory Committee--September 22, 2010

ACTION: Notice of meeting.

DATES: Meeting Date: The public meeting will be held on Wednesday,

September 22, 2010 from 7:30 a.m. until 4:30 p.m., Eastern Daylight

Time (EDT).

ADDRESSES: Meeting Location: The meeting will be held in the main

auditorium of the Centers for Medicare & Medicaid Services, 7500

Security Boulevard, Baltimore, MD 21244.

Office of the Secretary

Seeking Public Comment on Draft National Health Security Strategy

Biennial Implementation Plan

ACTION: Notice.

SUMMARY: To help the Nation achieve national health security and to

implement the first quadrennial National Health Security Strategy

(NHSS) of the United States of America (2009) and build upon the NHSS

Interim Implementation Guide for the National Health Security Strategy

of the United States of America (2009) the U.S. Government has drafted

a NHSS Biennial Implementation Plan (BIP).

Health Resources and Services Administration

Agency Information Collection Activities: Submission for OMB

Review; Comment Request

Proposed Project: Children's Hospital Graduate Medical Education

(CHGME) Payment Program Annual Report (OMB No. 0915-0313)—Extension

July 27

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Advisory Committee on Immunization Practices (ACIP)

Meeting announcement

Time and Date: 10 a.m.-12 p.m., August 5, 2010.

Place: The conference call will originate at the National Center

for Immunization and Respiratory Diseases in Atlanta, Georgia. Please

see SUPPLEMENTARY INFORMATION for details on accessing the conference

call.

Status: Open to the public, limited only by the availability of

telephone ports.

Health Resources and Service Administration

Advisory Committee on Interdisciplinary, Community-Based

Linkages; Notice of Meeting

Name: Advisory Committee on Interdisciplinary, Community-Based

Linkages (ACICBL).

Dates and Times:

August 19, 2010, 8:30 a.m. to 5 p.m., EST.

August 20, 2010, 8:30 a.m. to 3 p.m., EST.

Place: Hilton Washington DC/Rockville Hotel & Executive Meeting

Ctr, 1750 Rockville Pike, Rockville, Maryland 20852.

Status: The meeting will be open to the public.

July 28

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

Medicare and Medicaid Programs; Electronic Health Record

Incentive Program

ACTION: Final rule.

SUMMARY: This final rule implements the provisions of the American

Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5) that

provide incentive payments to eligible professionals (EPs), eligible

hospitals and critical access hospitals (CAHs) participating in

Medicare and Medicaid programs that adopt and successfully demonstrate

meaningful use of certified electronic health record (EHR) technology.

This final rule specifies--the initial criteria EPs, eligible

hospitals, and CAHs must meet in order to qualify for an incentive

payment; calculation of the incentive payment amounts; payment

adjustments under Medicare for covered professional services and

inpatient hospital services provided by EPs, eligible hospitals and

CAHs failing to demonstrate meaningful use of certified EHR technology;

and other program participation requirements. Also, the Office of the

National Coordinator for Health Information Technology (ONC) will be

issuing a closely related final rule that specifies the Secretary's

adoption of an initial set of standards, implementation,

specifications, and certification criteria for electronic health

records. ONC has also issued a separate final rule on the establishment

of certification programs for health information technology.

DATES: Effective Date: These regulations are effective on September 27,

2010.

Food and Drug Administration

Neurological and Physical Medicine Devices; Designation of

Special Controls for Certain Class II Devices and Exemption From

Premarket Notification; Reopening of the Comment Period

ACTION: Proposed rule; reopening of the comment period.

Food and Drug Administration

Draft Guidance for Industry and Food and Drug Administration

Staff; Medical Devices; Neurological and Physical Medicine Device

Guidance Document; Reopening of Comment Period

ACTION: Notice; reopening of comment period.

Office of the National Coordinator for Health Information

Technology Health Information Technology: Initial Set of Standards,

Implementation Specifications, and Certification Criteria for

Electronic Health Record Technology

ACTION: Final rule.

SUMMARY: The Department of Health and Human Services (HHS) is issuing

this final rule to complete the adoption of an initial set of

standards, implementation specifications, and certification criteria,

and to more closely align such standards, implementation

specifications, and certification criteria with final meaningful use

Stage 1 objectives and measures. Adopted certification criteria

establish the required capabilities and specify the related standards

and implementation specifications that certified electronic health

record (EHR) technology will need to include to, at a minimum, support

the achievement of meaningful use Stage 1 by eligible professionals,

eligible hospitals, and/or critical access hospitals (hereafter,

references to ``eligible hospitals'' in this final rule shall mean

``eligible hospitals and/or critical access hospitals'') under the

Medicare and Medicaid EHR Incentive Programs. Complete EHRs and EHR

Modules will be tested and certified according to adopted certification

criteria to ensure that they have properly implemented adopted

standards and implementation specifications and otherwise comply with

the adopted certification criteria.

DATES: Effective Date: This final rule is effective August 27, 2010.

The incorporation by reference of certain publications listed in the

rule is approved by the Director of the Federal Register as of August

27, 2010.

July 29

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality

Agency Information Collection Activities: Proposed Collection;

Comment Request

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: ``Eisenberg Center Voluntary Customer Survey Generic Clearance

for the Agency for Health Care Research and Quality.'' In accordance

with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the

public to comment on this proposed information collection.

This proposed information collection was previously published in

the Federal Register on May 20th, 2010 and allowed 60 days for public

comment. One comment was received. The purpose of this notice is to

allow an additional 30 days for public comment.

DATES: Comments on this notice must be received by August 30, 2010.

July 30

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: Revision of a currently

approved collection; Title of Information Collection: Coordination of

Benefits between Part D Plans and Other Prescription Coverage

Providers.

2. Type of Information Collection Request: Extension of a currently

approved collection; Title of Information Collection: Medicare

Participating Physician or SupplierAgreement; Form No.: CMS-460 (OMB 0938-0373).

3. Type of Information Collection Request: New collection; Title of

Information Collection: Survey to Inform the Children's Health

Insurance Program (CHIP) National Outreach & Education Campaign; Form

No.: CMS-10318 (OMB 0938-New).

Centers for Medicare & Medicaid Services

Agency Information Collection Activities: Proposed Collection;

Comment Request

1. Type of Information Collection Request: Extension of a currently

approved collection; Title of Information Collection: Medicare and

Medicaid Programs: Programs of All-Inclusive Care for the Elderly

(PACE).

Centers for Medicare & Medicaid Services

Medicaid Program; Request for Comments on Legislative Changes To

Provide Quality of Care to Children

ACTION: Notice with Comments.

SUMMARY: This notice requests comments from the public for our

consideration in developing the Secretary's recommendations for

legislative changes to improve the quality of care provided to children

under Medicaid and the Children's Health Insurance Program, including

recommendations for quality reporting by the States. The Children's

Health Insurance Program Reauthorization Act of 2009 (CHIPRA) requires

the Secretary of Health and Human Services to provide to Congress

recommendations for legislative changes to improve the quality of care

provided to children under Medicaid and the Children's Health Insurance

Program.

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 August 30, 2010.

Centers for Medicare & Medicaid Services

Medicare and Medicaid Programs; Announcement of an Application

From a Hospital Seeking To Enter Into an Agreement With a Different

Organ Procurement Organization

ACTION: Notice with comment period.

Office of Consumer Information and Insurance Oversight

Pre-Existing Condition Insurance Plan Program

ACTION: Interim final rule with comment period.

SUMMARY: Section 1101 of Title I of the Patient Protection and

Affordable Care Act of 2010 (Affordable Care Act) requires that the

Secretary establish, either directly or through contracts with States

or nonprofit private entities, a temporary high risk health insurance

pool program to provide affordable health insurance coverage to

uninsured individuals with pre-existing conditions. This program will

continue until January 1, 2014, when Exchanges established under

sections 1311 and 1321 of the Affordable Care Act will be available for

individuals to obtain health insurance coverage. This interim final

rule implements requirements in section 1101 of the Affordable Care

Act. Key issues addressed in this interim final rule include

administration of the program, eligibility and enrollment, benefits,

premiums, funding, and appeals and oversight rules.

DATES: Effective date: This regulation is effective on July 30, 2010.

Comment date: To be assured consideration, comments must be

received at one of the addresses provided below, no later than 5 p.m.

on September 28, 2010.

Office of the Secretary, Office of the Assistant Secretary for

Planning and Evaluation

ACTION: Notice of Reestablishment of the Technical Review Panel on the

Medicare Trustees Reports.