Weekly Legislative & Regulatory Round-up

Week of August 21 - 27, 2010

GAO reports

No relevant reports.

OIG reports

No relevant reports.

Bills introduced

No bills introduced.

Federal Register notices

August 23

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality

Request for Measures of Health Plan Efforts To Address Health

Plan Members' Health Literacy Needs

ACTION: Notice of request for measures.

SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is

soliciting the submission of instruments or items that measure how well

health plans and health providers address health plan enrollees' health

literacy needs and how well they communicate with health plan

enrollees. This initiative is in response to the need identified by

AHRQ to develop a new supplemental item set (the ``new instrument'')

for addressing health literacy for the CAHPS[supreg] Health Plan

Survey. The intent of the planned survey is to gain patients'

perspective on how well health and health plan information is

communicated to them by healthcare professionals and health plans. The

results of the planned survey may become an important source of

information for health plans, clinicians, group practices, and other

interested parties assessing quality of health information or planning

changes in how health plan information is delivered to health plan

enrollees.

Food and Drug Administration

Food and Drug Administration Clinical Trial Requirements,

Regulations, Compliance, and Good Clinical Practice; Public Workshop

ACTION: Notice of public workshop.

Food and Drug Administration

Public Workshop on Medical Devices and Nanotechnology:

Manufacturing, Characterization, and Biocompatibility Considerations

ACTION: Notice of public workshop; request for comments.

Food and Drug Administration

Quality and Compliance in Merging and Emerging Cultures; Public

Conference

ACTION: Notice of public conference.

Office of the National Coordinator for Health Information

Technology

ACTION: Notice of HIT Policy Committee Advisory Meeting.

Name of Committee: HIT Policy Committee

Date and Time: The meeting will be held on September 14, 2010, from

10 a.m. to 4 p.m./Eastern Time.

Location: To be determined. For up-to-date information, go to the

ONC Web site, http://healthit.hhs.gov.

Office of the National Coordinator for Health Information

Technology

ACTION: Notice of HIT Policy Committee Advisory Meeting.

Name of Committee: HIT Policy Committee.

Date and Time: The meeting will be held on September 14, 2010, from

10 a.m. to 4 p.m./Eastern Time.

Location: To be determined. For up-to-date information, go to the

ONC Web site, http://healthit.hhs.gov.

Office of the National Coordinator for Health Information

Technology

ACTION: Notice of HIT Policy Committee's Workgroup Meetings.

Name of Committees: HIT Policy Committee's Workgroups: Meaningful

Use, Privacy & Security Tiger Team, Enrollment, Governance, Adoption/

Certification, and Information Exchange workgroups.

Date and Time: The HIT Policy Committee Workgroups will hold the

following public meetings during September 2010: September 3rd

Governance Workgroup, 1 p.m. to 3:30 p.m./ET; September 10th Enrollment

Workgroup, 11 a.m. to 2 p.m./ET; September 22nd Meaningful Use

Workgroup, 9 a.m. to 3:30 p.m./ET; September 24th Enrollment Workgroup,

10 a.m. to 3 p.m./ET; and September 28th Governance Workgroup, 10 a.m.

to 4 p.m./ET.

Location: All workgroup meetings will be available via Webcast; for

instructions on how to listen via telephone or Web visit http://

healthit.hhs.gov. Please check the ONC Web site for additional

information or revised schedules as it becomes available.

Office of the National Coordinator for Health Information

Technology

ACTION: Notice of HIT Standards Committee's Workgroup Meetings.

Name of Committees: HIT Standards Committee's Workgroups: Clinical

Operations Vocabulary, Clinical Quality, Implementation, and Privacy &

Security workgroups.

Date and Time: The HIT Standards Committee Workgroups will hold the

following public meetings during September 2010: September 1 and 2,

Vocabulary Task Force hearing; and September 15, Implementation

Workgroup, 12 p.m. to 2 p.m./ET.

Location: All workgroup meetings will be available via webcast;

visit http://healthit.hhs.gov for instructions on how to listen via

telephone or Web. Please check the ONC Web site for additional

information as it becomes available.

Health Resources and Services Administration

Agency Information Collection Activities: Submission for OMB

Review; Comment Request

Proposed Project: The National Health Service Corps Loan Repayment

Program (OMB No. 0915-0127)--Extension

August 24

No relevant notices.

August 25

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: ``Eisenberg Center Voluntary Customer Survey Generic Clearance

for the Agency for Healthcare Research and Quality.'' In accordance

with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the

public to comment on this proposed information collection.

National Institutes of Health

Submission for OMB Review; Comment Request; Resource for the

Collection and Evaluation of Human Tissues and Cells From Donors With

an Epidemiology Profile (NCI)

August 26

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; Corrections

ACTION: Correction of proposed rule.

SUMMARY: This document corrects technical and typographical errors in

the proposed rule entitled ``Medicare Program; Payment Policies Under

the Physician Fee Schedule and Other Revisions to Part B for CY 2011''

that appeared in the July 13, 2010 Federal Register. The proposed rule

that appeared in the July 13, 2010 Federal Register addressed 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.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Implementation of Section 5001 of the American Recovery and

Reinvestment Act of 2009 (Pub. L. 111-5) for Adjustments to the Third

Quarter of Fiscal Year 2010 Federal Medical Assistance Percentage Rates

for Federal Matching Shares for Medicaid and Title IV-E Foster Care,

Adoption Assistance and Guardianship Assistance Programs

ACTION: Notice.

SUMMARY: This notice provides the adjusted Federal Medical Assistance

Percentage (FMAP) rate for the third quarter of Fiscal Year 2010 (FY10)

as required under Section 5001 of the American Recovery and

Reinvestment Act of 2009 (ARRA). Section 5001 of the ARRA provides for

temporary increases in the FMAP rates to provide fiscal relief to

States and to protect and maintain State Medicaid and certain other

assistance programs in a period of economic downturn. The increased

FMAP rates apply during a recession adjustment period that is defined

in ARRA as the period beginning October 1, 2008 and ending December 31,

2010. This notice does not account for changes as a result of Public

Law 111-226. However, future FMAP notices will account for these

changes.

DATES: Effective Date: The percentages listed are for the third quarter

of FY10 beginning April 1, 2010 through June 30, 2010.

Health Resources and Services Administration

Agency Information Collection Activities: Proposed Collection:

Comment Request

Proposed Project: Sickle Cell Disease and Other Hemoglobinopathies

Program Evaluation--[NEW]

DEPARTMENT OF THE TREASURY

Internal Revenue Service

DEPARTMENT OF LABOR

Employee Benefits Security Administration

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Availability of Interim Procedures for Federal External Review

and Model Notices Relating to Internal Claims and Appeals and External

Review Under the Patient Protection and Affordable Care Act; Notice

AGENCY: Internal Revenue Service, Department of the Treasury; Employee

Benefits Security Administration, Department of Labor; Office of

Consumer Information and Insurance Oversight, Department of Health and

Human Services.

ACTION: Notice.

August 27

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

Medicare Program; Establishing Additional Medicare Durable

Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS)

Supplier Enrollment Safeguards

ACTION: Final rule.

SUMMARY: This final rule will clarify, expand, and add to the existing

enrollment requirements that Durable Medical Equipment and Prosthetics,

Orthotics, and Supplies (DMEPOS) suppliers must meet to establish and

maintain billing privileges in the Medicare program.

DATES: These regulations are effective on September 27, 2010.

Centers for Medicare & Medicaid Services

Medicare Program; Listening Session Regarding the Implementation

of Section 10332 of the Patient Protection and Affordable Care Act,

Availability of Medicare Data for Performance Measurement

DATE: September 20, 2010.

ACTION: Notice of meeting.

SUMMARY: This notice announces a listening session to receive comments

regarding implementation of section 10332 of the Patient Protection and

Affordable Care Act (the Affordable Care Act), which amended section

1874 of the Social Security Act: Availability of Medicare Data for

Performance Measurement. The purpose of the listening session is to

solicit input from potential stakeholders on key components of the

design of the program. We are soliciting input on the types of

organizations that may be interested in receiving data as qualified

entities under this provision; the criteria such organizations will

have to meet for participation; procedures for CMS to approve

interested organizations for participation; provider communities and

geographic areas that might be served by these entities; data elements

required, and the sources and types of other data that these

organizations might match to Medicare claims; challenges in calculating

performance measures from the data, and issues related to the

identification, selection, and reporting of the performance measures.

DATES: Meeting Date: The listening session will be held on Monday,

September 20, 2010 from 9 a.m. until 1 p.m. Eastern Daylight Time

(e.d.t.).

Food and Drug Administration

Draft Guidance for Industry on Acute Bacterial Skin and Skin

Structure Infections: Developing Drugs for Treatment; Availability

ACTION: Notice.

Food and Drug Administration

Development and Distribution of Patient Medication Information

for Prescription Drugs; Public Hearing

ACTION: Notice of public hearing; request for comment.

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

President's Council on Fitness, Sports and Nutrition

ACTION: Notice of meeting.

SUMMARY: As stipulated by the Federal Advisory Committee Act, the U.S.

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

that the President's Council on Fitness, Sports and Nutrition (PCFSN)

will hold a meeting. The meeting will be open to the public.

DATES: The meeting will be held on September 14, 2010, from 1:30 p.m.

to 5 p.m.

ADDRESSES: The George Washington University, 1957 E Street, NW., 7th

Floor, Washington, DC.

Office of Global Health Affairs; Trans-Atlantic Task Force on

Antimicrobial Resistance (TATFAR)

ACTION: Notice of public meeting and request for comments.

SUMMARY: The Office of Global Health Affairs is seeking comments and

suggestions from the public on the activities of the Trans-Atlantic

Taskforce on Antimicrobial Resistance (TATFAR).