Weekly Legislative & Regulatory Round-up

OIG FY 2010 Budget: Justifications of Estimates for Appropriations Committees

Testimony of Daniel R. Levinson, Inspector General (PDF), before the Senate Special Committee on Aging on fraud in the Medicare and Medicaid programs and recommendations for reducing this fraud while maintaining a high level of services for providers and patients participating in the Medicare and Medicaid programs

Inappropriate Medicare Payments for Chiropractic Services

May 4, 2009

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Pediatric Device Consortia Grant Program

ACTION: Notice.

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

availability of grant funds for the support of the Office of Orphan

Products Development (OOPD) Pediatric Device Consortia Grant Program

(PDCGP). The goal of the PDCGP is to promote pediatric device

development by providing grants to nonprofit consortia whose business

model and approach to device development will either result in, or

substantially contribute to, market approval of medical devices

designed specifically for use in children. Although administered by the

OOPD, this grant program is intended to encompass devices that could be

used in all pediatric conditions or diseases, not just rare diseases.

The pediatric population (neonates, infants, children, and adolescents)

includes patients who are 21 years of age or younger at the time of

diagnosis or treatment.

Office of the Secretary

Agency Information Collection Request; 60-Day Public Comment

Request

In compliance with the requirement of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the Office of the Secretary (OS),

Department of Health and Human Services, is publishing the following

summary of a proposed information collection request for public

comment.

Proposed Project: Standards for Privacy of Individually

Identifiable Health Information and Supporting Regulations at 45 CFR

Parts 160 and 164 (Extension)- OMB No. 0990-0294 Office of Civil

Rights.

Abstract: The Privacy Rule implements the privacy requirements of

the Administrative Simplification subtitle of the Health Insurance

Portability and Accountability Act of 1996. The final regulation

requires covered entities (as defined in the regulation) to maintain

strong protections for the privacy of individually identifiable health

information; to use or disclose this information only as required or

permitted by the Rule or with the express written authorization of the

individual; to provide a notice of the entity's privacy practices; and

to document compliance with the Rule. Respondents are health care

providers with health plans, and health care clearinghouses. The

affected public includes individuals, public and private businesses,

state and local governments.

Health Resources and Services Administration

Agency Information Collection Activities Under Emergency Review

for the Office of Management and Budget (OMB)

The Health Resources and Services Administration (HRSA) has

submitted the following request (see below) for emergency OMB review

under the Paperwork Reduction Act (44 U.S.C. Chapter 35).

The American Recovery and Reinvestment Act (ARRA) provides $1.5

billion in grants to support construction, renovation and equipment,

and the acquisition of health information technology systems, for

health centers, including health center controlled networks receiving

operating grants under section 330 of the Public Health Service (PHS)

Act, as amended (42 U.S.C. 254b). HRSA is requesting emergency

processing procedures for the Environmental Information and

Documentation portion of the application because this information is

needed before the expiration of the normal time limits under

regulations at 5 CFR part 1320 to ensure the timely availability of

data to make award determinations for receipt of funds under ARRA. Of

the $1.5 billion, HRSA will award approximately $850 million, through

limited competition grants, for one-time Capital Improvement Program

(CIP) grant funding in fiscal year (FY) 2009 to support existing

section 330 funded health centers. Funding under this opportunity will

address pressing capital improvement needs in health centers, such as

construction, repair, renovation, and equipment purchases, including

health information technology systems. Applicants must provide

information and assurance of compliance with the National Environmental

Policy Act of 1969 (NEPA) on the Environmental Information and

Documentation (EID) checklist.

Health Resources and Services Administration

Agency Information Collection Activities Under Emergency Review

for the Office of Management and Budget (OMB)

    The Health Resources and Services Administration (HRSA) has

submitted the following request (see below) for emergency OMB review

under the Paperwork Reduction Act (44 U.S.C. Chapter 35). OMB approval

has been requested upon publication of this notice for 120 days and the

approval foregoes the routine comment period. During the emergency

approval period, HRSA will publish a Federal Register notice announcing

the initiation of a broad 60-day public comment period and begin the

process for a routine information collection request. To request more

information on the proposed project or to obtain a copy of the data

collection plans and draft instruments, e-mail paperwork@hrsa.gov or

call the HRSA Reports Clearance Officer on (301) 443-1129.

Proposed Project: HRSA/Bureau of Primary Health Care Capital

Improvement Program Application Electronic Health Records (EHR)

Readiness Checklist (NEW)

The American Recovery and Reinvestment Act (ARRA) provides $1.5

billion in grants to support construction, renovation and equipment,

and the acquisition of health information technology systems, for

health centers, including health center controlled networks receiving

operating grants under section 330 of the Public Health Service (PHS)

Act, as amended (42 U.S.C. 254b). HRSA is requesting emergency

processing procedures for the Electronic Health Records (EHR) Readiness

Checklist portion of the application because this information is needed

before the expiration of the normal time limits under regulations at 5

CFR part 1320 to ensure the timely availability of data to make award

determinations for receipt of funds under ARRA. Of the $1.5 billion,

HRSA will award approximately $850 million, through limited competition

grants, for one-time Capital Improvement Program (CIP) grant funding in

fiscal year (FY) 2009 to support existing section 330 funded health

centers. Funding under this opportunity will address pressing capital

improvement needs in health centers, such as construction, repair,

renovation, and equipment purchases, including health information

technology systems. Applicants must provide information using the EHR

Readiness Checklist that demonstrates comprehensive planning and

readiness for implementing EHRs.

May 5, 2009

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Revision of the Requirements for Publication of License

Revocation; Companion Document to Direct Final Rule

ACTION: Proposed rule.

SUMMARY: The Food and Drug Administration (FDA) is proposing to amend

the biologics regulations to clarify the regulatory procedures for

notifying the public about the revocation of a biologics license to be

consistent with current practices. This proposed rule is a companion

document to the direct final rule published elsewhere in this issue of

the Federal Register.

Office of the Secretary

Agency Information Collection Request; 60-Day Public Comment

Request

Proposed Project: ``Evaluate the Advancing Systems Improvements to

Support Targets for Healthy People 2010 (ASIST2010) Program''--OMB No.

0990-NEW--Office on Women's Health.

Health Resources and Services Administration

National Vaccine Injury Compensation Program; List of Petitions

Received

ACTION: Notice.

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

publishing this notice of petitions received under the National Vaccine

Injury Compensation Program (``the Program''), as required by Section

2112(b)(2) of the Public Health Service (PHS) Act, as amended. While

the Secretary of Health and Human Services is named as the respondent

in all proceedings brought by the filing of petitions for compensation

under the Program, the United States Court of Federal Claims is charged

by statute with responsibility for considering and acting upon the

petitions.

National Institutes of Health

Government-Owned Inventions; Availability for Licensing

ACTION: Notice.

SUMMARY: The inventions listed below are owned by an agency of the U.S.

Government and are available for licensing in the U.S. in accordance

with 35 U.S.C. 207 to achieve expeditious commercialization of results

of Federally-funded research and development. Foreign patent

applications are filed on selected inventions to extend market coverage

for companies and may also be available for licensing.

May 6, 2009

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: ``Medical Expenditure Panel Survey (MEPS) Household Component and the MEPS  Medical Provider Component Through 2012.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C.

3506(c)(2)(A)), 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: 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: ``Understanding Patients' Knowledge and Use of

Acetaminophen.'' In accordance with the Paperwork Reduction Act of

1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on

this proposed information collection.

This proposed information collection was previously published in

the Federal Register on February 26th, 2009 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.

Centers for Medicare & Medicaid Services

Medicaid Program; Health Care-Related Taxes

ACTION: Proposed rule; delay of enforcement.

SUMMARY: This proposed rule would delay enforcement of certain portions

of the final rule entitled ``Medicaid Program; Health Care-Related

Taxes'' from the expiration of a Congressional moratorium on

enforcement on July 1, 2009 until June 30, 2010. That final rule

revised the threshold levels under the regulatory indirect guarantee

hold harmless arrangement test to reflect the provisions of the Tax

Relief and Health Care Act of 2006, amended the definition of the

``class of managed care organization services,'' and removed obsolete

transition period regulatory language. These changes would not be

affected by this delay of enforcement. The final rule also clarified

the standard for determining the existence of a hold harmless

arrangement under the positive correlation test, Medicaid payment test,

and the guarantee test. This proposed rule would delay enforcement of

these latter provisions, concerning hold harmless arrangements, for 1

year.

Centers for Medicare & Medicaid Services

Medicaid Program: Rescission of School-Based Services Final Rule,

Outpatient Services Definition Final Rule, and Partial Rescission of

Case Management Services Interim Final Rule

ACTION: Proposed rule.

SUMMARY: This rule proposes to rescind the December 28, 2007 final rule

entitled ``Elimination of Reimbursement Under Medicaid for School

Administration Expenditures and Costs Related to Transportation of

School-Age Children Between Home and School''; the November 7, 2008

final rule entitled ``Clarification of Outpatient Hospital Facility

(Including Outpatient Hospital Clinic) Services Definition''; and

certain provisions of the December 4, 2007 interim final rule with

comment period entitled ``Optional State Plan Case Management

Services.'' These regulations have been the subject of Congressional

moratoria and have not yet been implemented (or, with respect to case

management interim final rule, have only been partially implemented) by

CMS. In light of concerns raised about the adverse effects that could

result from these regulations, in particular the potential restrictions

on services available to beneficiaries, potential deleterious effect on

state partners in the economic downturn, and the lack of clear evidence

demonstrating that the approaches taken in the regulations are

warranted, CMS is proposing to rescind the two final rules in full, and

to partially rescind the interim final rule. Rescinding these

provisions will permit further opportunity to determine the best

approach to further the objectives of the Medicaid program in providing

necessary health benefits coverage to needy individuals.

Centers for Medicare & Medicaid Services

Medicare Program; Inpatient Rehabilitation Facility Prospective

Payment System for Federal Fiscal Year 2010

ACTION: Proposed rule.

SUMMARY: This proposed rule would update the payment rates for

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

2010 (for discharges occurring on or after October 1, 2009 and on or

before September 30, 2010) 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.

    We are proposing to revise existing policies regarding the IRF PPS

within the authority granted under section 1886(j) of the Act.

Office of the National Coordinator for Health Information

Technology

ACTION: Announcement of meeting.

SUMMARY: This notice announces the first meeting of the HIT Policy

Committee in accordance with the Federal Advisory Committee Act (Pub.

L. No. 92-463, 5 U.S.C., App.).

DATES: May 11, 2009, from 8:30 a.m. to 11:30 a.m. [Eastern]

Office of the National Coordinator for Health Information

Technology

ACTION: Announcement of meeting.

SUMMARY: This notice announces the first meeting of the HIT Standards

Committee in accordance with the Federal Advisory Committee Act (Pub.

L. No. 92-463, 5 U.S.C., App.).

DATES: May 15, 2009, from 9 a.m. to 12 p.m. [Eastern]

National Institutes of Health

Office of Biotechnology Activities; Recombinant DNA Research:

Notice of Extension for Public Comment Period for the Consideration of

a Proposed Action Under the NIH Guidelines for Research Involving

Recombinant DNA Molecules (NIH Guidelines); Notice

National Institutes of Health

Prospective Grant of Exclusive License: Development of

Therapeutics for Use in Humans To Induce Tolerance for Transplantation

and To Treat T cell Lymphoma and Leukemia, Autoimmune Diseases Such as

Lupus, and Graft-Versus-Host Disease

ACTION: Notice.

May 7, 2009

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Proposed Collection; Comment Request; NHLBI Health Information

Center's Revolving Customer Satisfaction Survey

SUMMARY: In compliance with the requirement of section 3506(c)(2)(A) of

the Paperwork Reduction Act of 1995, for opportunity for public comment

on proposed data collection projects, the National Heart, Lung and

Blood Institute (NHLBI), the National Institutes of Health (NIH) will

publish periodic summaries of proposed projects to be submitted to the

Office of Management and Budget (OMB) for review and approval.

Proposed Collection: Title: NHLBI Health Information Center's

Revolving Customer Satisfaction Survey.

May 8, 2009

DEPARTMENT OF DEFENSE

Office of the Secretary

TRICARE; Hospital Outpatient Prospective Payment System (OPPS):

Statement Concerning Additional Public Comments Following Final Rule

Issuance

ACTION: Response to comments.

SUMMARY: This document is to inform the public of DoD's views regarding

the additional public comments that were invited by the document

published February 6, 2009 (74 FR 6228), on the final rule issued

December 10, 2008 (73 FR 74945). DoD is making no changes to the final

rule as implementation of the Temporary Military Contingency Payment

Adjustment (TMCPA) included in the final rule will accommodate the

major concerns expressed in the additional public comments.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Agency Information Collection Activities; Submission for Office

of Management and Budget Review; Comment Request; Emergency Shortages

Data Collection System (formerly ``Emergency Medical Device Shortages

Program Survey'')

ACTION:  Notice.

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

proposed collection of information has been submitted to the Office of

Management and Budget (OMB) for review and clearance under the

Paperwork Reduction Act of 1995.

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; Request for Comments

ACTION: Advance notice of proposed rulemaking.

SUMMARY: On behalf of the Department of Health and Human Services (HHS)

and the Public Health Service (PHS), a component of the HHS, the

National Institutes of Health (NIH) seeks comments from the public on

whether the HHS should amend its regulations on the responsibility of

applicants for promoting objectivity in research for which phs funding

is sought and on responsible prospective. We are interested

particularly in receiving comments on the issues presented below from

the general public, individual Investigators, scientific societies and

associations, Members of Congress, other Federal agencies that support

or conduct research, and institutions that receive PHS funds to conduct

or support biomedical or behavioral research.