Weekly Legislative & Regulatory Round-up

Week of August 7 - 13, 2010

GAO reports

Electronic Waste: Considerations for Promoting Environmentally Sound Reuse and Recycling GAO-10-626

OIG reports

Review of Medicare Part D Drug Payments to Virginia for Service Dates January 1 Through March 8, 2006 (A-03-09-00021).

Bills introduced

Number/ Title	Date Introduced	Sponsor	Description
H.R. 6081	08/09/10	C.W. BILL YOUNG (R-FL)	A bill to amend the Stem Cell Therapeutic and Research Act of 2005; Referred to the Committee on Energy and Commerce.
H.R. 6083	08/10/10	MARY BONO MACK (R-CA)	A bill to amend the Stem Cell Therapeutic and Research Act of 2005; Referred to the Committee on Energy and Commerce.
H.R. 6095	08/10/10	JOHN DINGELL (D-MI)	A bill to amend title XVIII of the Social Security Act to preserve integrated care for durable medical equipment under the competitive bidding program for qualified hospital-related DME entities; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

Federal Register notices

August 9

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Comprehensive List of Guidance Documents at the Food and Drug

Administration

ACTION: Notice.

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

comprehensive list of all guidance documents currently in use at the

agency. This list is being published under FDA's Good Guidance

Practices (GGPs). It is intended to inform the public of the existence

and availability of all of our current guidance documents. It also

provides information on guidance documents that have been added or

withdrawn in the past 5 years.

DATES: We welcome general comments on this list and on agency guidance

documents at any time.

Health Resources and Services Administration

Agency Information Collection Activities: Submission for OMB

Review; Comment Request

The following request has been submitted to the Office of

Management and Budget for review under the Paperwork Reduction Act of

1995:

Proposed Project: Title: ``Health Care and Other Facilities''

Project Status Update Form (OMB No. 0915-0309)--[Extension].

August 10

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Determination That DECA-DURABOLIN (Nandrolone Decanoate)

Injection, 200 Milligrams/Milliliter, 1 Milliliter, Was Not Withdrawn

From Sale for Reasons of Safety or Effectiveness

ACTION: Notice.

Food and Drug Administration

Determination That MOTRIN (Ibuprofen) Tablets and Four Other Drug

Products Were Not Withdrawn From Sale for Reasons of Safety or

Effectiveness

ACTION: Notice.

Food and Drug Administration

Advancing the Development of Medical Products Used In the

Prevention, Diagnosis, and Treatment of Neglected Tropical Diseases;

Public Hearing; Change of Hearing Date and Location

ACTION: Notice.

August 11

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

Medicaid Program and Children's Health Insurance Program (CHIP);

Revisions to the Medicaid Eligibility Quality Control and Payment Error

Rate Measurement Programs

ACTION: Final rule.

SUMMARY: This final rule implements provisions from the Children's

Health Insurance Program Reauthorization Act of 2009 (CHIPRA) (Pub. L.

111-3) with regard to the Medicaid Eligibility Quality Control (MEQC)

and Payment Error Rate Measurement (PERM) programs. This final rule

also codifies several procedural aspects of the process for estimating

improper payments in Medicaid and the Children's Health Insurance

Program (CHIP).

DATES: Effective Date: These regulations are effective on September 10,

2010.

Centers for Medicare & Medicaid Services

Medicare, Medicaid and CLIA Programs; COLA (Formerly the

Commission on Office Laboratory Accreditation) Voluntary Withdrawal

From the Specialty of Pathology

ACTION: Notice.

SUMMARY: This notice announces COLA's voluntary withdrawal from the

specialty of Pathology. COLA is an accreditation organization for

clinical laboratories under the Clinical Laboratory Improvement

Amendments (CLIA) program.

DATES: Effective Date: This notice is effective on August 27, 2010.

Assistant Secretary for Preparedness and Response, Biomedical Advanced Research Development

Authority

Single Source Cooperative Agreement Award for the World Health

Organization (WHO) To Continue Development of Sustainable Influenza

Vaccine Production

ACTION: Notice.

SUMMARY: Notification of Single Source Cooperative Agreement Award for

the World Health Organization (WHO) To Continue Development of

Sustainable Influenza Vaccine Production Capacity in Under-Resourced

Nations CFDA: 93.360.

August 12

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

Medicare Program; End-Stage Renal Disease Prospective Payment

System

ACTION: Final rule.

SUMMARY: This final rule implements a case-mix adjusted bundled

prospective payment system (PPS) for Medicare outpatient end-stage

renal disease (ESRD) dialysis facilities beginning January 1, 2011

(ESRD PPS), in compliance with the statutory requirement of the

Medicare Improvements for Patients and Providers Act (MIPPA), enacted

July 15, 2008. This ESRD PPS also replaces the current basic case-mix

adjusted composite payment system and the methodologies for the

reimbursement of separately billable outpatient ESRD services.

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

2011, except for Sec. 413.174(f)(6), which will be effective on

January 1, 2014 and Sec. 413.232(f) and Sec. 413.239(b), which will

be effective November 1, 2010.

Centers for Medicare & Medicaid Services

Medicare Program; End-Stage Renal Disease Quality Incentive

Program

ACTION: Proposed rule.

SUMMARY: This proposed rule proposes to implement a quality incentive

program (QIP) for Medicare outpatient end-stage renal disease (ESRD)

dialysis providers and facilities with payment consequences beginning

January 1, 2012, in accordance with section 1881(h) of the Act (added

on July 15, 2008 by section 153(c) of the Medicare Improvements for

Patients and Providers Act (MIPPA)). The proposed ESRD QIP would reduce

ESRD payments by up to 2.0 percent for dialysis providers and

facilities that fail to meet or exceed a total performance score for

performance standards established with respect to certain specified

measures.

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

the addresses provided below, no later than 5 p.m. eastern standard

time (EST) on September 24, 2010.

August 13

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: Independent Renal

Dialysis Facility Cost Report.

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

approved collection; Title of Information Collection: Home Health

Agency Cost Report.

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

approved collection; Title of Information Collection: Data Collection

for the Nursing Home Value-Based Purchasing (NHVBP) Demonstration.

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

approved collection; Title of Information Collection: Medicare Current

Beneficiary Survey.

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

approved collection; Title of Information Collection: Medicare Health

Outcomes Survey (HOS).

Office of the Secretary

Statement of Organization, Functions, and Delegations of

Authority; Office of the National Coordinator for Health and

Information Technology; Correction

ACTION: Notice, correction.

SUMMARY: This Notice was previously published in the Federal Register

on December 1, 2009, but it contained an error with respect to one of

the office names.