Weekly Legislative & Regulatory Round-up

Review of Medicaid Administrative Costs Claimed for the Massachusetts Department of Transitional Assistance (A-01-08-00014)

Advisory Opinion 10-01 (PDF)
Advisory Opinion 10-02 (PDF)
Advisory Opinion 10-03 (PDF)
(concerning the use of a "preferred hospital" network as part of a Medicare Supplemental Health Insurance ["Medigap"] policy)

February 22

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Safety and Efficacy Review for Additional Ingredients in Over-

the-Counter Drug Products for Human Use; Request for Environmental

Impact Data and Information

ACTION:  Request for data and information.

Office of Disease Prevention and Health Promotion, Office of Public

Announcement of Meeting of the Secretary's Advisory Committee on

National Health Promotion and Disease Prevention Objectives for 2020

ACTION: Notice of meeting.

DATES: The Committee will meet on April 1, 2010 from 2 p.m. to 4 p.m.

Eastern Time (ET).

ADDRESSES: The meeting will be held online, via WebEx software. For

detailed instructions about how to make sure that your windows computer

and browser is set up for WebEx, please visit the ``Secretary's

Advisory Committee'' Web page of the Healthy People Web site at: http:/

/www.healthypeople.gov/hp2020/advisory/default.asp.

February 23

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the National Coordinator for Health Information

Technology

ACTION: Notice of meetings. 

HIT Policy Committee's Workgroup Meeting

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

following public meetings during March 2010: March 4th Meaningful Use

Workgroup, 10 a.m. to 12 p.m./Eastern Time; March 9th Strategic Plan

Workgroup, 9 a.m. to 12 p.m./Eastern Time; March 16th NHIN Workgroup,

2:30 p.m. to 5 p.m./Eastern Time; March 25th Privacy & Security Policy

Workgroup, 2 to 4 p.m./Eastern Time; and March 29th Adoption/

Certification Workgroup, 10 a.m. to 12 p.m./Eastern Time.

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 as it becomes available.

HIT Standards Committee's Workgroup Meetings; Notice of

Meeting

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

following public meetings during March 2010: March 8th Implementation

Workgroup, 9 a.m. to 4 p.m./Eastern Time; March 22nd Implementation

Workgroup, 3 to 4 p.m./Eastern Time; March 23rd Clinical Operations

Vocabulary, 9 a.m. to 4 p.m./Eastern Time; March 26th Privacy &

Security Workgroup, 2 to 4 p.m./Eastern Time; March 30th Implementation

Workgroup, 9 to 11 a.m./Eastern Time; March 31st Clinical Quality

Workgroup, 10 a.m. to 12 p.m./Eastern Time.

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.

President's Advisory Council on Faith-Based and Neighborhood

Partnerships

Action: Meeting announcement

Time and Date: Tuesday, March 9th 9 a.m.-3 p.m. (EST).

Place: Meeting will be held at a location to be determined in

the White House complex, 1600 Pennsylvania Ave., NW., Washington,

DC. Space is extremely limited.

February 24

Centers for Medicare & Medicaid Services

Medicare Program; Meeting of the Practicing Physicians Advisory

Council, March 8, 2010; Correction

ACTION: Correction of notice.

Food and Drug Administration

Device Improvements to Reduce Unnecessary Radiation Exposure From

Medical Imaging; Public Meeting; Request for Comments

ACTION: Notice of public meeting; request for comments.

Dates and Time: The public meeting will be held on March 30 and 31,

2010, from 8 a.m. to 5 p.m. Persons interested in attending and/or

participating in the meeting must register by 5 p.m. on March 15, 2010.

Submit written or electronic comments by April 15, 2010.

Location: The public meeting will be held at the Holiday Inn

Gaithersburg, 2 Montgomery Village Ave., Gaithersburg, MD 20879. The

meeting will not be videotaped or webcast.

Office for Civil Rights

Workshop on the HIPAA Privacy Rule's De-

Identification Standard; Notice of Meeting

ACTION: Notice of meeting.

SUMMARY: This notice announces a forthcoming workshop organized by the

Office for Civil Rights (OCR). The meeting will be open to the public.

General Purpose of the Meeting: Section 13424 (c) of the Health

Information Technology for Clinical and Economic Health (HITECH) Act,

part of the American Recovery and Reinvestment Act of 2009 (ARRA),\1\

requires HHS to issue guidance on methods for de-identification of

protected health information as designated in the Health Insurance

Portability and Accountability Act (HIPAA) Privacy Rule. In response to

this mandate, OCR is soliciting stakeholder input from experts with

practical technical and policy experience to inform the creation of

guidance materials. OCR is collecting views regarding de-identification

approaches, best practices for implementation and management of the current

de-identification standard and potential changes to address policy concerns.

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: Part C and D Complaints Resolution Performance

Measures.

Health Resources and Services Administration

Agency Information Collection Activities: Proposed Collection:

Comment Request

Proposed Project: HRSA AIDS Education and Training Centers Evaluation

Activities (OMB No. 0915-0281)—Revision

Health Resources and Services Administration

Advisory Commission on Childhood Vaccines; Notice of Meeting

Date and Time: March 4, 2010, 1 p.m. to 5:30 p.m. EST. March 5,

2010, 9 a.m. to 12:30 p.m. EST.

Place: Parklawn Building (and via audio conference call),

Conference Rooms G & H, 5600 Fishers Lane, Rockville, MD 20857.

February 26

DEPARTMENT OF HEALTH AND HUMAN SERVICES

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: Eligibility Error

Rate Measurement in Medicaid and the Children's Health Insurance

Program.

Centers for Medicare & Medicaid Services

Medicare Program; Public Meetings in Calendar Year 2010 for All

New Public Requests for Revisions to the Healthcare Common Procedure

Coding System (HCPCS) Coding and Payment Determinations

ACTION: Notice.

SUMMARY: This notice announces the dates, time, and location of the

Healthcare Common Procedure Coding System (HCPCS) public meetings to be

held in calendar year 2010 to discuss our preliminary coding and

payment determinations for all new public requests for revisions to the

HCPCS. These meetings provide a forum for interested parties to make

oral presentations or to submit written comments in response to

preliminary coding and payment determinations. Discussion will be

directed toward responses to our specific preliminary recommendations

and will include all items on the public meeting agenda.

Centers for Medicare & Medicaid Services

Medicare Program; Meeting of the Medicare Evidence Development

and Coverage Advisory Committee--April 21, 2010

ACTION: Notice of meeting.

SUMMARY: This notice announces that a public meeting of the Medicare

Evidence Development & Coverage Advisory Committee (MEDCAC)

(``Committee'') will be held on Wednesday, April 21, 2010. The

Committee generally provides advice and recommendations concerning the

adequacy of scientific evidence needed to determine whether certain

medical items and services should be covered under the Medicare

statute. This meeting will focus on the currently available evidence

regarding the risks, benefits, and outcomes of radiation therapy,

inclusive of external beam radiotherapy (EBRT) and brachytherapy, for

the treatment of localized prostate cancer. This meeting is open to the

public in accordance with the Federal Advisory Committee Act (5 U.S.C.

App. 2, section 10(a)).

Centers for Medicare & Medicaid Services

Medicare Program; Request for Nominations for Members for the

Medicare Evidence Development & Coverage Advisory Committee

ACTION: Notice.

SUMMARY: This notice announces the request for nominations for

consideration for membership on the Medicare Evidence Development &

Coverage Advisory Committee (MEDCAC). Among other things, the MEDCAC

advises the Secretary of the Department of Health and Human Services

(the Secretary) and the Administrator of the Centers for Medicare &

Medicaid Services, as requested by the Secretary, whether medical items

and services are ``reasonable and necessary'' and therefore eligible

for coverage under Title XVIII of the Social Security Act.

DATES: Nominations will be considered if postmarked by Monday, March

29, 2010 and mailed to the address specified in the ADDRESSES section

of this notice.

Food and Drug Administration

Agency Information Collection Activities; Submission for Office

of Management and Budget Review; Comment Request; Mental Models Study

of Recruitment and Retention of Pregnant Women Into An Asthma Pregnancy

Registry

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.

DATES: Fax written comments on the collection of information by March

29, 2010.

Food and Drug Administration

Agency Information Collection Activities; Proposed Collection;

Comment Request; Reporting and Recordkeeping Requirements and

Availability of Sample Electronic Products for Manufacturers and

Distributors of Electronic Products

ACTION:  Notice.

Food and Drug Administration

Draft Guidance for Industry on Adaptive Design Clinical Trials

for Drugs and Biologics; Availability

ACTION: Notice.

Office of the National Coordinator for Health Information

ACTION: Notice of meeting.

Technology HIT Policy Committee Advisory Meeting

Date and Time: The meeting will be held on March 17, 2010, from 10

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

Location: The Omni Shoreham Hotel, 2500 Calvert Street, NW.,

Washington, DC. The hotel telephone number is 202-234-0700.

HIT Standards Committee Advisory Meeting

Date and Time: The meeting will be held on March 24, 2010, from 9

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

Location: The Omni Shoreham Hotel, 2500 Calvert Street, NW.,

Washington, DC. The hotel telephone number is 202-234-0700.

Health Resources and Services Administration

Discretionary Grant Program

ACTION: Notice of Noncompetitive Program Extension Supplemental Awards.

SUMMARY: HRSA will be providing extensions with funds ranging from 5 to

10 months to program grantees for the following programs in order to

bring these programs into alignment with changes resulting from HRSA's

Maternal and Child Health Bureau's developing strategic plan and the

Early Learning and Development Initiative of the HHS and Department of

Education.