Weekly Legislative & Regulatory Round-up

Formal Statement of Lewis Morris, Chief Counsel to the Inspector General (PDF), before the U.S. Senate Committee on Finance’s April 21, 2009, "Roundtable Discussion on Health Care Reform." 

Comparison of Third-Quarter 2008 Average Sales Prices and Average Manufacturer Prices: Impact on Medicare Reimbursement for First Quarter 2009 (PDF) (OEI-03-09-00150) 

Payments to Medicare Suppliers and Home Health Agencies Associated With Currently Not Collectible' Overpayments (PDF) (OEI-06-07-00080): Re-post

Testimony of Lewis Morris, Chief Counsel to the Inspector General (PDF), before the U.S. Senate Homeland Security and Governmental Affairs Subcommittee on Federal Financial Management, Government Information, Federal Services, and International Security on Eliminating Waste and Fraud in Medicare and Medicaid

Congress in recess

April 20, 2009

No relevant notices.

April 21, 2009

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Department of Health and Human Services

Notice of Availability of Federal Matching Shares for Medicaid

and Foster Care and Adoption Assistance

ACTION: Notice.

SUMMARY: The Federal Medical Assistance Percentages (FMAPs) for the

first two quarters of Fiscal Year 2009 have been recalculated pursuant

to the American Recovery and Reinvestment Act (ARRA). These percentages

will be effective from October 1, 2008 through March 31, 2009. This

notice announces the calculated FMAPs that the U.S. Department of

Health and Human Services (HHS) will use in determining the amount of

Federal matching for State medical assistance under Title XIX and Title

IV-E.

Food and Drug Administration

Guidance for Industry on Integrated Summaries of Effectiveness

and Safety: Location Within the Common Technical Document; Availability

ACTION:  Notice.

SUMMARY:  The Food and Drug Administration (FDA) is announcing the

availability of a guidance for industry entitled ``Integrated Summaries

of Effectiveness and Safety: Location Within the Common Technical

Document.'' Since FDA began accepting new drug application (NDA) and

biologics license application (BLA) submissions in the common technical

document (CTD) format, there has been confusion regarding where within

the CTD to include an integrated summary of effectiveness (ISE) and

integrated summary of safety (ISS), both of which are required

components of an NDA submission and recommended components of a BLA

submission. This guidance informs applicants where to place the ISE and

ISS in the CTD, addresses specific FDA requirements not discussed in

the ICH guidance for industry ``M4E: The CTD--Efficacy,'' and is

intended to improve application quality and consistency. This guidance

finalizes the draft guidance of the same title published in the Federal

Register of July 3, 2007 (72 FR 36471).

Office of the Secretary

 Office of Resources and Technology; Statement of Organization,

Functions, and Delegations of Authority

This reorganization will establish an Office of Recovery Act

Coordination (AMV) within the Office of Resources and Technology (ORT)

to coordinate within HHS the American Recovery and Reinvestment Act of

2009 and the Office of Management and Budget (OMB) implementing

guidelines.

 The Office of Recovery Act Coordination (ORAC) is responsible for

coordinating the implementation of the American Recovery and

Reinvestment Act of 2009 (ARRA or Recovery Act) within the Department

of Health and Human Services (FIRS).

Office of the Secretary, Office of Public Health and Science, Office of Minority Health

Meeting of the Advisory Committee on Minority Health

ACTION: Notice of meeting.

SUMMARY: As stipulated by the Federal Advisory Committee Act, the

Department of Health and Human Services (DHHS) is hereby giving notice

that the Advisory Committee on Minority Health (ACMH) will hold a

meeting. This meeting is open to the public. Preregistration is

required for both public attendance and comment. Any individual who

wishes to attend the meeting and/or participate in the public comment

session should e-mail acmh@osophs.dhhs.gov.

DATES: The meeting will be held on Tuesday, May 12, 2009 from 9 a.m. to

5 p.m. and Wednesday, May 13, 2009 from 9 a.m. to 1 p.m.

ADDRESSES: The meeting will be held at the Doubletree Hotel, 1515 Rhode

Island Ave., NW., Washington, DC 20005.

April 22, 2009

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Committee on Vital and Health Statistics: Meeting

Name: National Committee on Vital and Health Statistics (NCVHS),

Executive Subcommittee.

Time and Date:

April 28, 2009, 9 a.m.--5:30 p.m.

April 29, 2009, 9 a.m.--5:30 p.m.

Place: Marriott Wardman Park, 2660 Woodley Road, NW.,

Washington, DC 20008

Status: Open.

Purpose: The NCVHS Executive Subcommittee will hold a public

meeting on April 28-29, 2009 to help define and clarify the term

``Meaningful Use,'' a term used in the HITECH Act (part of the

American Recovery and Re-invention Act [ARRA]). This hearing will

obtain stakeholders' perspectives on the appropriate functional

criteria for ``meaningful use'' of health information technology,

both for the initial year of the ARRA Health IT incentive programs

and the out years. The broader prospective for the inquiry is how

the meaningful use of health information technology will support

improvements in the quality, efficiency and safety of health care.

Written testimony (no more than 1-2 pages in length) can be submitted to Marietta Squire at marietta.squire@cdc.hhs.gov, phone: 301-458-4524.

In order for written testimony to be included in the meeting

summary, it must be submitted by April 30, 2009.

April 23, 2009

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Request for Nominations of Candidates To Serve on the Board of

Scientific Counselors, Coordinating Office for Terrorism Preparedness

and Emergency Response (BSC, COTPER)

    CDC is soliciting nominations for possible membership on the BSC,

COTPER. This board provides advice and guidance to the Secretary,

Department of Health and Human Services (HHS), the Director, CDC, and

the Director, COTPER, concerning strategies and goals for the programs

and research within the divisions; conducts peer-review of scientific

programs; and monitors the overall strategic direction and focus of the

divisions.

    Nominations are being sought for individuals who have the expertise

and qualifications necessary to contribute to the accomplishment of the

board's objectives. Nominees will be selected by the Secretary, HHS, or

designee, from authorities knowledgeable in the fields relevant to the

issues addressed by the offices and divisions within the coordinating

office and related disciplines, including: Medicine, epidemiology,

laboratory science, informatics, behavioral science, social science,

engineering, business, and crisis leadership. Members may be invited to

serve for terms of up to four years. Consideration is given to

representation from diverse geographic areas, both genders, ethnic and

minority groups, and the disabled. Nominees must be U.S. citizens.

National Institutes of Health

Draft National Institutes of Health Guidelines for Human Stem

Cell Research Notice

SUMMARY: The National Institutes of Health (NIH) is requesting public

comment on draft guidelines entitled ``National Institutes of Health

Guidelines for Human Stem Cell Research'' (Guidelines).

    The purpose of these draft Guidelines is to implement Executive

Order 13505, issued on March 9, 2009, as it pertains to extramural NIH-

funded research, to establish policy and procedures under which NIH

will fund research in this area, and to help ensure that NIH-funded

research in this area is ethically responsible, scientifically worthy,

and conducted in accordance with applicable law. Internal NIH

procedures, consistent with Executive Order 13505 and these Guidelines,

will govern the conduct of intramural NIH research involving human stem

cells.

April 24

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality

Agency Information Collection Activities: Proposed Collection;

Comment Request

ACTION: Notice.

SUMMARY:

Proposed Project:``Evaluation of AHRQ's Effective Health Care Program''

AHRQ proposes to perform an evaluation of the Effective Health Care

(EHC) program's governance structure, methods for engaging stakeholders

and approaches to setting national research priorities. Pursuant to

Section 1013 of the Medicare Prescription Drug, Improvement, and

Modernization Act of 2003, Pub. L. 108-173, the EHC program was

established by AHRQ to conduct research, demonstrations, and

evaluations designed to improve the quality, effectiveness, and

efficiency of Medicare, Medicaid, and the State Children's Health

Insurance Program. AHRQ invites the public to

comment on this proposed information collection.

Agency for Healthcare Research and Quality

Agency Information Collection Activities: Proposed Collection;

Comment Request

ACTION: Notice.

SUMMARY:

Proposed Project:``Building an Implementation Toolset for E-Prescribing''    AHRQ proposes to develop and test an electronic prescribing (e-prescribing) toolset to provide information and tools of sufficient detail to act as a ``how-to guide'' for implementing e-prescribing across various organizational settings.

AHRQ invites the public to comment on this proposed information collection.

DATES: Comments on this notice must be received by June 23, 2009.

Agency for Healthcare Research and Quality

Agency Information Collection Activities: Proposed Collection;

Comment Request

ACTION: Notice.

SUMMARY: ``Evaluation of Phase I Demonstrations of the Pharmacy Quality

Alliance.'' AHRQ proposes to conduct an independent evaluation of five Phase I demonstrations undertaken by the Pharmacy Quality Alliance (PQA). The PQA launched the five demonstration projects to test the feasibility of implementing a pharmacy provider report card system, which will be used to provide feedback to pharmacies on their performance. AHRQ invites the public to comment on this proposed information collection.

DATES: Comments on this notice must be received by May 26, 2009.

Centers for Medicare & Medicaid Services

Medicaid Program; Disproportionate Share Hospital Payments;

Correcting Amendment

ACTION: Final rule; correcting amendment.

SUMMARY: This correcting amendment corrects a technical error in the

regulations text in the final rule published in the Federal Register on

December 19, 2008 (73 FR 77904) entitled, ``Disproportionate Share

Hospital Payments.'' In that final rule, we set forth data elements

necessary to comply with the requirements of section 1923(j) of the Social Security Act (the Act) related to auditing and reporting of disproportionate share hospital payments under State Medicaid programs. The effective date was January 19, 2009.

Centers for Medicare & Medicaid Services

Medicare Program; Proposed Hospice Wage Index for Fiscal Year

2010

ACTION: Proposed rule; request for comments.

SUMMARY: This proposed rule would set forth the hospice wage index for

fiscal year 2010. The proposed rule would adopt a MedPAC recommendation

regarding a process for certification and recertification of terminal

illness. This proposed rule would also continue the phase-out of the

wage index budget neutrality adjustment factor (BNAF), which will

conclude in 2011. In addition, we are requesting comments on a

suggestion to require recertification visits by physicians or advanced

practice nurses, and on issues of payment reform for use in possible

future policy development. Finally, the proposed rule would make

several technical and clarifying changes to the regulatory text.

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

the addresses provided below, no later than 5 p.m. on June 22, 2009.

Centers for Medicare & Medicaid Services

Medicare and Medicaid Programs; Application of the American

Osteopathic Association for Continued Deeming Authority for Hospitals

ACTION: Proposed notice.

SUMMARY: This proposed notice with comment period acknowledges the

receipt of a deeming application from the American Osteopathic

Association for continued recognition as a national accrediting

organization for hospitals that wish to participate in the Medicare or

Medicaid programs.

Section 1865(a)(3)(A) of the Social Security Act requires that

within 60 days of receipt of an organization's complete application, we

publish a notice that identifies the national accrediting body making

the request, describes the nature of the request, and provides at least

a 30-day public comment period.

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

the addresses provided below, no later than 5 p.m. May 26, 2009.

Centers for Medicare & Medicaid Services

Medicare Program; Recognition of NAIC Model Standards for

Regulation of Medicare Supplemental Insurance

ACTION: Notice.

SUMMARY: This notice announces changes made by the Genetic Information

Nondiscrimination Act of 2008 (GINA) and the Medicare Improvements for

Patients and Providers Act of 2008 (MIPPA) to section 1882 of the

Social Security Act (the Act), which governs Medicare supplemental

insurance. This notice also recognizes that the Model Regulation

adopted by the National Association of Insurance Commissioners (NAIC)

on September 24, 2008, is considered to be the applicable NAIC Model

Regulation for purposes of section 1882 of the Act, subject to our

clarifications that are set forth in this notice.

DATES: Amendments made by GINA apply to issuers of Medigap policies for

policy years beginning on or after May 21, 2009. Each State shall have

up to July 1, 2009 to conform its regulatory program to the statutory

changes made by GINA, and the revisions to the NAIC Model Regulation

that reflect GINA. Amendments made by MIPPA apply to Medigap policies

with an effective date on or after June 1, 2010. Each State shall have

up to September 24, 2009 to conform its regulatory program to the

statutory changes made by MIPPA and the revisions to the NAIC model law

and regulations that reflect MIPPA.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

Medicare Program; Meeting of the Practicing Physicians Advisory

Council, June 1, 2009

ACTION: Notice.

SUMMARY: This notice announces a quarterly meeting of the Practicing

Physicians Advisory Council (the Council). The Council will meet to

discuss certain proposed changes in regulations and manual instructions

related to physicians' services, as identified by the Secretary of

Health and Human Services. This meeting is open to the public.

DATES: Meeting Date: Monday, June 1, 2009, from 8:30 a.m. to 5 p.m.

e.d.t.

ADDRESSES: Meeting Location: The meeting will be held in Room 505A, in

the Hubert H. Humphrey Building, 200 Independence Avenue, SW.,

Washington, DC 20201.

Health Resources and Services Administration

``Low Income Levels'' Used for Various Health Professions and

Nursing Programs Included in Titles III, VII and VIII of the Public

Health Service Act

ACTION: Notice.

SUMMARY: The Health Resources and Services Administration (HRSA) is

updating income levels used to identify a ``low income family'' for the

purpose of determining eligibility for programs that provide health

professions and nursing training for individuals from disadvantaged

backgrounds. These various programs are included in Titles III, VII and

VIII of the Public Health Service Act.

Health Resources and Services Administration

Part C Early Intervention Services Grant

ACTION: Notice of Noncompetitive Replacement Award.

SUMMARY: The Health Resources and Services Administration (HRSA) is

issuing a non-competitive replacement award of Part C Early

Intervention Services funds under Title XXVI of the Public Health

Service Act, as amended by the Ryan White HIV/AIDS Treatment

Modernization Act of 2006, to the Reading Hospital for services

previously provided by the St. Joseph Medical Center in order to ensure

continuity of critical HIV medical care and treatment services and to

avoid a disruption of HIV clinical care to clients in the city of

Reading, Pennsylvania, and all of Berks and Schuylkill Counties.