Weekly Legislative & Regulatory Round-up

Week of July 17 - 23, 2010

GAO reports

Older Americans: Continuing Care Retirement Communities Can Provide Benefits, but Not Without Some Risk GAO-10-611

Older Americans: Continuing Care Retirement Communities Can Provide Benefits, but Not Without Some Risk GAO-10-904T

Recovery Act: Contracting Approaches and Oversight Used by Selected Federal Agencies and States GAO-10-809

OIG reports

Review of American Recovery and Reinvestment Act of 2009 Medicaid Eligibility Requirements in Texas (A-06-09-00099)

Review of Medicare Contractor Information Security Program Evaluations for Fiscal Year 2007 (A-18-07-30291)

Monthly Recovery Act Report: June

Bills introduced

Number/ Title	Date Introduced	Sponsor	Description
S. 3609	07/19/2010	Akaka, Daniel (D-HI)	A bill to extend the temporary authority for performance of medical disability examinations by contract physicians for the Department of Veterans Affairs; Referred to the Committee on Veterans' Affairs.
H.R. 5795	07/20/2010	Blumenauer, Earl (D-OR)	A bill to amend the Social Security Act to provide for coverage of voluntary advance care planning consultation under Medicare and Medicaid, and for other purposes; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means.
H.R. 5802.	07/20/2010	Upton, Fred (R-MI)	A bill to repeal a provision of the Patient Protection and Affordable Care Act providing for funds to a health care facility and rescind funds made available under such section; Referred to the Committee on Energy and Commerce.
H.R. 5803	07/21/2010	McGovern, James (D-MA)	A bill to amend title XVIII of the Social Security Act to protect Medicare beneficiaries' access to home health services under the Medicare Program; Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce.
H.R. 5807	07/21/2010	Roybal-Allard Lucile (D-CA)	A bill to promote optimal maternity outcomes by making evidence-based maternity care a national priority, and for other purposes; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means.
H.R. 5808	07/21/2010	Woolsey, Lynn (D-CA)	A bill to amend the Patient Protection and Affordable Care Act to establish a public health insurance option; Referred to the Committee on Energy and Commerce.
H. Res. 1547	07/21/2010	Waters, Maxine (D-CA)	A resolution supporting the goals and ideals of National Clinicians HIV/AIDS Testing and Awareness Day, and for other purposes; Referred to the Committee on Energy and Commerce.
S. 3632	07/22/2010	Gillibrand, Kristen (D-NY)	A bill to provide for enhanced penalties to combat Medicare and Medicaid fraud, a Medicare data-mining system, and a Beneficiary Verification Pilot Program, and for other purposes; Referred to the Committee on Finance.
H.R. 5844	07/22/2010	Rothman, Steve (D-NJ)	A bill to amend title XVIII of the Social Security Act to provide all Medicare beneficiaries with the right to guaranteed issue of a Medicare supplemental policy and annual open change-in-enrollment periods, and for other purposes; Referred to the Committee on Ways and Means.

Federal Register notices

July 19

DEPARTMENT OF THE TREASURY

Internal Revenue Service

DEPARTMENT OF LABOR

Employee Benefits Security Administration

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Interim Final Rules for Group Health Plans and Health Insurance

Issuers Relating to Coverage of Preventive Services Under the Patient

Protection and Affordable Care Act

ACTION: Interim final rules with request for comments.

SUMMARY: This document contains interim final regulations implementing

the rules for group health plans and health insurance coverage in the

group and individual markets under provisions of the Patient Protection

and Affordable Care Act regarding preventive health services.

DATES: Effective date. These interim final regulations are effective on

September 17, 2010.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

International Conference on Harmonisation; Draft Guidance on Q4B

Evaluation and Recommendation of Pharmacopoeial Texts for Use in the

International Conference on Harmonisation Regions; Annex 14 on

Bacterial Endotoxins Test General Chapter; Availability

ACTION: Notice.

Office of the Assistant Secretary for Planning and Evaluation

Request for Information on Development of an Inventory of

Comparative Effectiveness Research

ACTION: Request for Information.

SUMMARY: The Office of the Assistant Secretary for Planning Evaluation

(ASPE) is developing a national inventory of comparative effectiveness

research (CER) and CER-related information. This initiative is driven

by the American Recovery and Reinvestment Act of 2009 (ARRA) which

provided $1.1 billion for research and development in the area of CER.

ARRA allocated $400 million to the Office of the Secretary (OS) in the

U.S. Department of Health and Human Services (HHS), $400 million to the

National Institutes of Health (NIH), and $300 million to the Agency for

Healthcare Research and Quality. ARRA also established the Federal

Coordinating Council for CER, which, after significant public input,

developed a strategic framework and recommended high-level priorities

for OS funds. While the FCC's Report to Congress drew on an initial CER

inventory focused on federal investments, the process of cataloguing

CER activities and infrastructure will be critical to tracking ongoing

and future investments in CER. An important component of this effort is

creating an inventory of CER to ensure that patients, clinicians, and

other decision makers can identify and locate relevant CER in a timely

manner.

DATES: Submit comments by 11:59 p.m. Eastern Time on August 9, 2010.

Health Resources and Services Administration

Agency Information Collection Activities: Proposed Collection:

Comment Request

Proposed Project: Black Lung Clinics Program Database (OMB No. 0915-

0292)—Extension

July 20

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Medical Devices; Pediatric Uses of Devices; Requirements for

Submission of Information on Pediatric Subpopulations That Suffer From

a Disease or Condition That a Device Is Intended to Treat, Diagnose, or

Cure; Withdrawal

ACTION: Direct final rule; withdrawal.

Food and Drug Administration

International Conference on Harmonisation; Draft Recommendation

for the Revision of the Permitted Daily Exposure for the Solvent Cumene

According to the Maintenance Procedures for the Guidance Q3C

Impurities: Residual Solvents; Availability

ACTION: Notice.

Office of the National Coordinator for Health Information

Technology

Office of the National Coordinator for Health Information

Technology; HIT Policy Committee Advisory Meeting; Notice of Meeting

ACTION: Notice of meeting.

Date and Time: The meeting will be held on July 21, 2010, from 9:30

a.m. to 4 p.m. e.t.

Location: The Renaissance Washington, DC, Dupont Circle Hotel, 1143

New Hampshire Avenue, NW., Washington, DC, phone: 202-775-0800.

Office of the National Coordinator for Health Information

Technology

Office of the National Coordinator for Health Information

Technology; HIT Standards Committee Advisory Meeting; Notice of Meeting

ACTION: Notice of meeting.

Date and Time: The meeting will be held on July 28, 2010, 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.

National Institutes of Health

Office of Biotechnology Activities; Recombinant DNA Research:

Proposed Action Under the NIH Guidelines for Research Involving

Recombinant DNA Molecules (NIH Guidelines)

ACTION: Notice of proposed action under the NIH Guidelines.

July 21

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Public Health Security and Bioterrorism Preparedness and Response

Act of 2002; Biennial Review and Republication of the Select Agent and

Toxin List

ACTION: Advance notice of proposed rulemaking and request for comments.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Responsibility of Applicants for Promoting Objectivity in

Research for Which Public Health Service Funding Is Sought and

Responsible Prospective Contractors

ACTION: Proposed rule; extension of comment period; request for

comments.

SUMMARY: The Department of Health and Human Services (HHS or the

Department), including the HHS Public Health Service (PHS), is

extending the comment period for a proposed rule that would amend the

regulations on the Responsibility of Applicants for Promoting

Objectivity in Research for which PHS Funding is Sought and Responsible

Prospective Contractors, and is clarifying certain elements of the

proposed rule for which we are seeking additional comment. The proposed

rule was published in the Federal Register on May 21, 2010 (75 FR

28688). The comment period is extended by 30 days and thus will end on

August 19, 2010.

DATES: Comments must be received on or before August 19, 2010 in order

to ensure we will be able to consider the comments when preparing the

final rule.

July 22

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

Medicare Program; Hospice Wage Index for Fiscal Year 2011

ACTION: Notice with comment period.

SUMMARY: This notice with comment period announces the annual update to

the hospice wage index for fiscal year 2011 and continues the phase out

of the wage index budget neutrality adjustment factor (BNAF), with an

additional 15 percent BNAF reduction, for a total BNAF reduction in FY

2011 of 25 percent. The BNAF phase-out will continue with successive 15

percent reductions from FY 2012 through FY 2016.

DATES: Effective Date: These regulations are effective on October 1,

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 20, 2010.

Centers for Medicare & Medicaid Services

Medicare Program; Inpatient Rehabilitation Facility Prospective

Payment System for Federal Fiscal Year 2011

ACTION: Notice.

SUMMARY: This notice updates the payment rates for inpatient

rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2011 (for

discharges occurring on or after October 1, 2010 and on or before

September 30, 2011) as required under section 1886(j)(3)(C) of the

Social Security Act (the Act). Section 1886(j)(5) of the Act requires

the Secretary to publish in the Federal Register on or before the

August 1 that precedes the start of each fiscal year, the

classification and weighting factors for the IRF prospective payment

system's (PPS) case-mix groups and a description of the methodology and

data used in computing the prospective payment rates for that fiscal

year.

DATES: Effective Date: The updated IRF prospective payment rates are

effective for IRF discharges occurring on or after October 1, 2010 and

on or before September 30, 2011 (FY 2011).

Centers for Medicare & Medicaid Services

Medicare Program; Prospective Payment System and Consolidated

Billing for Skilled Nursing Facilities for FY 2011

ACTION: Notice with comment period.

SUMMARY: This notice with comment period sets forth an update to the

payment rates used under the prospective payment system for skilled

nursing facilities for fiscal year 2011, and implements section 10325

of the Patient Protection and Affordable Care Act.

DATES: Effective Date: The rate updates in this notice with comment

period are effective on October 1, 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 20, 2010.

Office of Minority Health, Office of Public Health and Science

Solicitation of Nomination for Appointment to the Advisory

Committee on Minority Health

ACTION: Notice.

SUMMARY: The Department of Health and Human Service (HHS), Office of

Public Health and Science (OPHS), is seeking nominations of qualified

candidates to be considered for appointment as a member of the Advisory

Committee on Minority Health (ACMH). In accordance with Public Law 105-

392, the Committee provides advice to the Deputy Assistant Secretary

for Minority Health, on the development of goals and specific program

activities of the Office of Minority Health (OMH) designed to improve

the health of racial and ethnic minority groups. Nominations of

qualified candidates are being sought to fill current and impending

vacant positions on the Committee.

DATES: Nominations for membership on the Committee must be received no

later than 5 p.m. EST on October 20, 2010, at the address listed below.

Health Resources and Services Administration

The Negotiated Rulemaking Committee on the Designation of

Medically Underserved Populations and Health Professions Shortage Areas

ACTION: Notice of establishment.

SUMMARY: Pursuant to Section 5602 of the ACA, HRSA plans to establish a

comprehensive methodology and criteria for Designation of MUPs and

Primary Care HPSAs [under Sections 330(b)(3) and 332 of the Public

Health Service (PHS) Act, respectively], using a Negotiated Rulemaking

process. To do this, HRSA announces the establishment of the Negotiated

Rulemaking Committee on the Designation of Medically Underserved

Populations and Health Professions Shortage Areas.

FOR FURTHER INFORMATION CONTACT: Andy Jordan, Senior Analyst, Office of

Shortage Designation, Bureau of Health Professions; e-mail

ajordan@hrsa.gov; telephone (301) 594-0197.

July 23

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: ``Reduction of Clostridium difficile Infections in a Regional

Collaborative of Inpatient Healthcare Settings through Implementation

of Antimicrobial Stewardship.'' In accordance with the Paperwork

Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment

on this proposed information collection.

DATES: Comments on this notice must be received by September 21, 2010.

Centers for Medicare & Medicaid Services

Medicare Program; Home Health Prospective Payment System Rate

Update for Calendar Year 2011; Changes in Certification Requirements

for Home Health Agencies and Hospices

ACTION: Proposed rule.

SUMMARY: This proposed rule would set forth an update to the Home

Health Prospective Payment System (HH PPS) rates, including: The

national standardized 60-day episode rates, the national per-visit

rates, the non-routine medical supply (NRS) conversion factors, and the

low utilization payment amount (LUPA) add-on payment amounts, under the

Medicare prospective payment system for HHAs effective January 1, 2011.

This rule also proposes to update the wage index used under the HH PPS

and, in accordance with The Affordable Care Act of 2010 (The Affordable

Care Act), Public Law 111-148, to update the HH PPS outlier policy. In

addition, this rule proposes changes to the home health agency (HHA)

capitalization requirements. This rule further proposes to add

clarifying language to the ``skilled services'' section. Finally, this

rule incorporates new legislative requirements regarding face-to-face

encounters with providers related to home health and hospice care.

DATES: To be assured consideration, comments must be received at one of

the addresses provided below, no later than 5 p.m. on September 14,

2010.

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: 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: Revision of a currently

approved collection; Title of Information Collection: Notice of Denial

of Medicare Prescription Drug Coverage.

4. Type of Information Collection Request: Revision of a currently

approved collection; Title of Information Collection: Detailed

Explanation of Non-Coverage (42 CFR 422.626(e)(1)), and Notice of

Medicare Non-Coverage (42 CFR 422.624(b)(1)).

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: Hospice Cost and

Data Report and supporting regulations 42 CFR 413.20 and 42 CFR 413.24;

Use.

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

approved collection; Title of Information Collection: Health Insurance

Benefit Agreement.

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

approved collection; Title of Information Collection: Children's Health

Insurance Program.

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.

Centers for Medicare & Medicaid Services

Medicare Program; Solicitation for Proposals for the Medicare

Imaging Demonstration

ACTION: Notice.

SUMMARY: This notice informs interested parties (here in there after

referred to as conveners) of an opportunity to apply to participate in

the Medicare Imaging Demonstration (MID) that was authorized by section

135(b) of the Medicare Improvements for Patients and Providers Act of

2008 (MIPPA). The goal of the MID is to collect data regarding

physician compliance with appropriateness criteria selected by the

Secretary under the terms of the statute in order to determine the

appropriateness of advanced diagnostic imaging services furnished to

Medicare beneficiaries.

DATES: Proposals will be considered timely if they are received on or

before 5 p.m., Eastern Standard Time (E.S.T.) on September 21, 2010.

Food and Drug Administration

International Conference on Harmonisation; Draft Guidance on Q4B

Evaluation and Recommendation of Pharmacopoeial Texts for Use in the

International Conference on Harmonisation Regions; Annex 13 on Bulk

Density and Tapped Density of Powders General Chapter; Availability;

Correction

ACTION: Notice; correction.

Food and Drug Administration

Voluntary Registration by Authorized Officials of Non-Covered

Retail Food Establishments and Vending Machine Operators Electing To Be

Subject to the Menu and Vending Machine Labeling Requirements

Established by the Patient Protection and Affordable Care Act of 2010

ACTION: Notice.

DEPARTMENT OF THE TREASURY

Internal Revenue Service

DEPARTMENT OF LABOR

Employee Benefits Security Administration

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Interim Final Rules for Group Health Plans and Health Insurance

Issuers Relating to Internal Claims and Appeals and External Review

Processes Under the Patient Protection and Affordable Care Act

ACTION: Interim final rules with request for comments.

SUMMARY: This document contains interim final regulations implementing

the requirements regarding internal claims and appeals and external

review processes for group health plans and health insurance coverage

in the group and individual markets under the Patient Protection and

Affordable Care Act. The regulations will generally affect health

insurance issuers; group health plans; and participants, beneficiaries,

and enrollees in health insurance coverage and in group health plans.

The regulations provide plans and issuers with guidance necessary to

comply with the law.

DATES: Effective date. These interim final regulations are effective on

September 21, 2010.

Health Resources and Services Administration

Administration for Children and Families

Maternal, Infant, and Early Childhood Home Visiting Program

ACTION: Request for public comment on criteria for evidence of

effectiveness of home visiting program models for pregnant women,

expectant fathers, and caregivers of children birth through

kindergarten entry.

SUMMARY: The Health Resources and Services Administration and

Administration for Children and Families, HHS, solicit comments by

August 17, 2010 on proposed criteria for evidence of effectiveness of

home visiting program models for pregnant women, expectant fathers, and

primary caregivers of children birth through kindergarten entry. Final

criteria for evidence of effectiveness will be included in the program

announcement inviting eligible entities to apply for funding under the

Affordable Care Act Maternal, Infant, and Early Childhood Home Visiting

Program.