Weekly Legislative & Regulatory Round-up

Week of July 10 - 16, 2010

GAO reports

Medicare Recovery Audit Contracting: Lessons Learned to Address Improper Payments and Improve Contractor Coordination and Oversight GAO-10-864T

Health Care Quality Measurement: The National Quality Forum Has Begun a 4-Year Contract with HHS GAO-10-737

OIG reports

Guidance And Standards On Language Access Services: Medicare Providers (PDF) (OEI-05-10-00050)

Guidance And Standards On Language Access Services: Medicare Plans (PDF) (OEI-05-10-00051)

Health Resources and Services Administration’s Bureau of Primary Health Care Facility Investment Program Grants – Internal Control Review of the Process for Awarding American Recovery and Reinvestment Act Funds (A-03-09-00364)

Bills introduced

Number/ Title	Date Introduced	Sponsor	Description
S. 3574	07/13/2010	Brown, Sherrod (D-OH)	A bill to amend title II of the Social Security Act to prohibit the inclusion of Social Security account numbers on Medicare cards; Referred to the Committee on Finance.
S. 3575	07/13/2010	Durbin, Richard (D-IL)	A bill to amend and reauthorize the controlled substance monitoring program under section 399O of the Public Health Service Act and to authorize the Secretary of Veterans Affairs to share information about the use of controlled substances by veterans with State prescription monitoring programs to prevent misuse and diversion of prescription medicines; Referred to the Committee on Health, Education, Labor, and Pensions.
H.R. 5712	07/13/2010	Levin, Sander (D-MI)	A bill to provide for certain clarifications and extensions under Medicare, Medicaid, and the Children's Health Insurance Program; Referred to the Committee on Energy and Commerce, and in addition to the Committees on the Budget, and Ways and Means.
H.R. 5714	07/13/2010	Doggett, Lloyd (D-TX)	A bill to amend title II of the Social Security Act to prohibit the inclusion of Social Security account numbers on Medicare cards; Referred to the Committee on Ways and Means.
H.R. 5719	07/13/2010	Cardoza, Dennis (D-CA)	A bill to amend title 10, United States Code, to require the Secretary of Veterans Affairs to develop, and the Secretary of Defense to distribute to members of the Armed Forces upon their discharge or release from active duty, information in a compact disk read-only memory format or other appropriate digital format that lists and explains the health, education, and other benefits for which veterans are eligible under the laws administered by the Secretary of Veterans Affairs; Referred to the Committee on Armed Services, and in addition to the Committee on Veterans' Affairs..
H.R. 5731	07/14/2010	Kirkpatrick, Ann (D-AZ)	A bill to amend title 38, United States Code, to provide for annual reviews of mental health professionals treating veterans, and for other purposes; Referred to the Committee on Veterans' Affairs.
H.R. 5732	07/14/2010	Kilroy, Mary Jo (D-OH)	A bill to amend title XVIII of the Social Security Act to permit coverage of certain covered part D drugs for uses that are determined to be for medically accepted indications based upon clinical evidence in peer reviewed medical literature; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means.
H.R. 5733	07/14/2010	Braley, Bruce (D-IA)	A bill to permit health care providers to disclose certain protected health information to law enforcement officials; Referred to the Committee on Energy and Commerce.
S. 3596.	07/15/2010	Hagan, Kay (D-NC)	A bill to establish the Culture of Safety Hospital Accountability Study and Demonstration Program; Referred to the Committee on Finance.
H.R. 5756	07/15/2010	Doyle, Mike (D-PA)	A bill to amend title I of the Developmental Disabilities Assistance and Bill of Rights Act of 2000 to provide for grants and technical assistance to improve services rendered to children and adults with autism, and their families, and to expand the number of University Centers for Excellence in Developmental Disabilities Education, Research, and Service; Referred to the Committee on Energy and Commerce.
H.R. 5761	07/15/2010	Melancon, Charles (D-LA)	A bill to amend the Patient Protection and Affordable Care Act to expedite the application of the provision prohibiting rescissions of health insurance coverage; Referred to the Committee on Energy and Commerce.
H.R. 5768	07/15/2010	Welch, Peter (D-VT)	A bill to amend title 38, United States Code, to authorize the waiver of the collection of copayments for telehealth and telemedicine visits of veterans, and for other purposes; Referred to the Committee on Veterans' Affairs.

Federal Register notices

July 12

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

Medicare and Medicaid Programs; Civil Money Penalties for Nursing

Homes

ACTION: Proposed rule.

SUMMARY: This proposed rule would revise and expand current Medicare

and Medicaid regulations regarding the imposition and collection of

civil money penalties by CMS when nursing homes are not in compliance

with Federal participation requirements in accordance with the Patient

Protection and Affordable Care Act of 2010.

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

the addresses provided below, no later than 5 p.m. EST on August 11,

2010.

Centers for Medicare & Medicaid Services

Agency Information Collection Activities: Proposed Collection;

Comment Request

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

Information Collection: Current State Practices Related to Payments to

Providers for Health Care-Acquired Conditions

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

approved collection; Title of Information Collection: Prospective

Payments for Hospital Outpatient Service and Supporting Regulations is

42 CFR 413.65

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

approved collection; Title of Information Collection: QualityNet

Identity Management System (QIMS) Account Form.

Office of the Secretary, HHS

60-Day Notice; Agency Information Collection Request; 60-Day

Public Comment Request

Proposed Project: Evaluation of Pregnancy Prevention Approaches:

First Follow-Up Data Collection--OMB No. 0970-0360--Office of

Adolescent Health in collaboration with the Administration for Children

and Families.

Office of the Secretary, HHS

Agency Information Collection Request. 60-Day Public Comment

Request

Proposed Project: Prevention and Wellness-Leveraging National

Organizations OMB No. 0990-New--Office of Public Health and Science

Office of the Secretary, HHS

Agency Information Collection Request; 60-Day Public Comment

Request

Proposed Project: An Assessment of the Sustainability and Impact of

Community Coalitions Once Federal Funding Has Expired--OMB No. 0990-

NEW--Assistant Secretary Planning Evaluation (ASPE).

Office of the Secretary, HHS

60-Day Notice; Agency Information Collection Request; 60-Day

Public Comment Request

Proposed Project: Uniform Data Set (UDS)--Revision--OMB No. 0990-

0275--Office of Public Health Science (OPHS)--Office of Minority

Health.

Office of the Secretary, HHS

Agency Information Collection Request. 60-Day Public Comment

Request

Proposed Project: Evaluation of Pregnancy Prevention Approaches:

Implementation Study Data Collection--OMB No. 0970-0360--Office of

Adolescent Health in collaboration with the Administration for Children

and Families.

July 13

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Proposed Data Collections Submitted for Public Comment and

Recommendations

Proposed Project: National Ambulatory Medical Care Survey (NAMCS), (OMB No. 0920-0234

exp. 7/31/2012)--Revision--National Center for Health Statistics

(NCHS), Centers for Disease Control and Prevention (CDC).

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

Medicare Program; Payment Policies Under the Physician Fee

Schedule and Other Revisions to Part B for CY 2011

ACTION: Proposed rule.

SUMMARY: This proposed rule addresses proposed changes to the physician

fee schedule and other Medicare Part B payment policies to ensure that

our payment systems are updated to reflect changes in medical practice

and the relative value of services. It also addresses, implements or

discusses certain provisions of both the Affordable Care Act and the

Medicare Improvements for Patients and Providers Act of 2008. In

addition, this proposed rule discusses payments under the Ambulance Fee

Schedule, Clinical Laboratory Fee Schedule, payments to ESRD

facilities, and payments for Part B drugs. Finally, the proposed rule

includes a discussion regarding the Chiropractic Services Demonstration

program, the Competitive Bidding Program for Durable Medical Equipment

and Provider and Supplier Enrollment Issues associated with Air

Ambulances. (See the Table of Contents for a listing of the specific

issues addressed in this proposed rule.)

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

the addresses provided below, no later than 5 p.m. on August 24, 2010.

Food and Drug Administration

Agency Information Collection Activities; Proposed Collection;

Comment Request; ``Antiparasitic Drug Survey''

ACTION: Notice.

Food and Drug Administration

Agency Information Collection Activities; Proposed Collection;

Comment Request; Guidance for Industry on Special Protocol Assessment

ACTION: Notice.

Food and Drug Administration

Agency Information Collection Activities; Proposed Collection;

Comment Request; Testing Communications on Medical Devices and

Radiation-Emitting Products

ACTION: Notice.

National Institutes of Health

Proposed Collection; Comment Request; Cancer Trials Support Unit

(CTSU) Public Use Forms and Customer Satisfaction Surveys (NCI)

July 14

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

ACTION: Notice.

Food and Drug Administration

Town Hall Discussion With the Director of the Center for Devices

and Radiological Health and Other Senior Center Management

ACTION: Notice of public meeting; request for comments.

The Food and Drug Administration (FDA) is announcing a public

meeting entitled: ``Town Hall Discussion With the Director of the

Center for Devices and Radiological Health and Other Senior Center

Management.'' The purpose of this meeting is to present the Center for

Devices and Radiological Health (CDRH) Fiscal Year (FY) 2010

Priorities. In addition, FDA is interested in engaging in discussions

about issues that are of importance to the medical device industry.

Date and Time: The public meeting will be held on October 7, 2010,

from 8 a.m. to 12 noon.

Location: The public meeting will be held at the Hilton Irvine/

Orange County Airport Hotel, 18800 MacArthur Blvd., Irvine, CA 92612.

The meeting will not be videotaped or webcast.

Office for Civil Rights, Department of Health and Human

Services Modifications to the HIPAA Privacy, Security, and Enforcement

Rules Under the Health Information Technology for Economic and Clinical

Health Act

ACTION: Notice of proposed rulemaking.

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

Department'') is issuing this notice of proposed rulemaking to modify

the Standards for Privacy of Individually Identifiable Health

Information (Privacy Rule), the Security Standards for the Protection

of Electronic Protected Health Information (Security Rule), and the

rules pertaining to Compliance and Investigations, Imposition of Civil

Money Penalties, and Procedures for Hearings (Enforcement Rule) issued

under the Health Insurance Portability and Accountability Act of 1996

(HIPAA). The purpose of these modifications is to implement recent

statutory amendments under the Health Information Technology for

Economic and Clinical Health Act (``the HITECH Act'' or ``the Act''),

to strengthen the privacy and security protection of health

information, and to improve the workability and effectiveness of these

HIPAA Rules.

DATES: Submit comments on or before September 13, 2010.

July 15

No relevant notices

July 16

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: Electronic Health

Records Demonstration System (EHRDS)--practice application and profile

update system.

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

approved collection; Title of Information Collection: Notice of Denial

of Medical Coverage (NDMC) and Notice of Denial of Payment (NDP)--42

CFR 422.568.

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

approved collection; Title of Information Collection: Federal

Qualification Application (42 CFR 417.140) and Medicare Health Care

Prepayment Plan Application (42 CFR 417.800).

Centers for Medicare & Medicaid Services

Medicare and Medicaid Programs; Approval of the Community Health

Accreditation Program for Continued Deeming Authority for Hospices

ACTION: Final notice of Removal of Conditional Probationary Status.

SUMMARY: Based on our review and observations, we have determined that

the standards and processes used by the Community Health Accreditation

Program (CHAP) hospice accreditation program meet or exceed our

requirements. This final notice announces our decision to approve

without condition CHAP's request for continued recognition as a

national accreditation program for hospices seeking to participate in

the Medicare or Medicaid programs.

DATES: Effective Date: This final notice is effective November 20, 2009

through November 20, 2012..