Weekly Legislative & Regulatory Round-up

Updated Special Fraud Alert: Telemarketing by Durable Medical Equipment Suppliers (PDF)

Review of the Reconciliation and Reporting of Medicaid Non-Risk Contract Payments by the Utah Department of Health (A-07-09-02754)

Review of Maryland’s Claims Associated With the Increased Federal Medical Assistance Percentage Under the American Recovery and Reinvestment Act of 2009 (A-03-09-00203)

January 11 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

The General Hospital and Personal Use Devices Panel of the

Medical Devices Advisory Committee; Notice of Meeting

ACTION:  Notice.

Date and Time: The meeting will be held on March 5, 2010, from 8

a.m. to 5 p.m.

Location: Hilton Washington DC North/Gaithersburg, Salons C, D and

E, 620 Perry Pkwy., Gaithersburg, MD.

Health Resources and Services Administration

National Advisory Council on Migrant Health; Notice of Meeting

Dates and Times: February 10, 2010, 8:30 a.m. to 5 p.m.,

February 11, 2010, 8:30 a.m. to 5 p.m.

Place: Red Lion Hotel on Fifth Avenue, 1415 Fifth Avenue,

Seattle, Washington 98101, Telephone: 206-971-8000, Fax: 206-971-

8100.

Status: The meeting will be open to the public.

Indian Health Service

Indian Health Professions Preparatory, Indian Health Professions

Pregraduate and Indian Health Professions Scholarship Programs

Announcement of funding opportunity

Indian Health Service

FY 2010 Special Diabetes Program for Indians Community-Directed

Grant Program

Announcement of funding opportunity

January 12

No relevant notices.

January 13

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

Medicare and Medicaid Programs; Electronic Health Record

Incentive Program

ACTION: Proposed rule.

SUMMARY: This proposed rule would implement the provisions of the

American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5)

that provide incentive payments to eligible professionals (EPs) and

eligible hospitals participating in Medicare and Medicaid programs that

adopt and meaningfully use certified electronic health record (EHR)

technology. The proposed rule would specify the--initial criteria an EP

and eligible hospital must meet in order to qualify for the incentive

payment; calculation of the incentive payment amounts; payment

adjustments under Medicare for covered professional services and

inpatient hospital services provided by EPs and eligible hospitals

failing to meaningfully use certified EHR technology; and other program

participation requirements. Also, as required by ARRA the Office of the

National Coordinator for Health Information Technology (ONC) will be

issuing a closely related interim final rule that specifies the

Secretary's adoption of an initial set of standards, implementation,

specifications, and certification criteria for electronic health

records. ONC will also be issuing a notice of proposed rulemaking on

the process for organizations to conduct the certification of EHR

technology.

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

the addresses provided below, no later than 5 p.m. on March 15, 2010.

Food and Drug Administration

Draft Guidance for Institutional Review Boards, Clinical

Investigators, and Sponsors: IRB Continuing Review After Clinical

Investigation Approval; Availability

ACTION:  Notice.

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

availability of a draft guidance entitled, ``Guidance for IRBs,

Clinical Investigators, and Sponsors: IRB Continuing Review After

Clinical Investigation Approval.'' The draft guidance announced in this

notice is intended to assist institutional review boards (IRBs) in

carrying out their continuing review responsibility by providing

recommendations regarding the criteria, process, and frequency of

continuing review to assure the protection of the rights and welfare of

subjects in clinical investigations.

DATES: Although comments on any guidance can be submitted at any time

(see 21 CFR 10.115(g)(5)), to ensure that the agency considers a

comment on this draft guidance before it begins work on the final

version of the guidance, written or electronic comments on the draft

guidance should be submitted by March 15, 2010.

Office of the National Coordinator for Health Information

Technology

Health Information Technology: Initial Set of Standards,

Implementation Specifications, and Certification Criteria for

Electronic Health Record Technology

ACTION: Interim final rule.

SUMMARY: The Department of Health and Human Services (HHS) is issuing

this interim final rule with a request for comments to adopt an initial

set of standards, implementation specifications, and certification

criteria, as required by section 3004(b)(1) of the Public Health

Service Act. This interim final rule represents the first step in an

incremental approach to adopting standards, implementation

specifications, and certification criteria to enhance the

interoperability, functionality, utility, and security of health

information technology and to support its meaningful use. The

certification criteria adopted in this initial set establish the

capabilities and related standards that certified electronic health

record (EHR) technology will need to include in order to, at a minimum,

support the achievement of the proposed meaningful use Stage 1

(beginning in 2011) by eligible professionals and eligible hospitals

under the Medicare and Medicaid EHR Incentive Programs.

DATES: Effective Date: This interim final rule is effective February

12, 2010. The incorporation by reference of certain publications listed

in the rule is approved by the Director of the Federal Register as of

February 12, 2010.

Comment Date: To be assured consideration, written or electronic

comments must be received at one of the addresses provided below, no

later than 5 p.m. on March 15, 2010.

Health Resources and Services Administration

Maternal and Child Health Bureau

ACTION: Notice of Non-competitive Supplemental Funding to Georgetown

University.

January 14

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of Inspector General

Publication of OIG Updated Special Fraud Alert on Telemarketing

by Durable Medical Equipment Suppliers

ACTION: Notice.

SUMMARY: This Federal Register notice sets forth the recently issued

OIG Updated Special Fraud Alert addressing telemarketing by durable

medical equipment (DME) suppliers. For the most part, OIG Special Fraud

Alerts address national trends in health care fraud, including

potential violations of the anti-kickback statute for Federal health

care programs. This Updated Special Fraud Alert updates the Special

Fraud Alert on Telemarketing by Durable Medical Equipment Suppliers

originally issued in March 2003 and continues to highlight the

statutory provision prohibiting DME suppliers from making unsolicited

telephone calls to Medicare beneficiaries regarding the furnishing of a

covered item.

January 15

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: Reinstatement without

change of a previously approved collection; Title of Information

Collection: Electronic Funds Transfer Authorization Agreement.

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

approved collection; Title of Information Collection: Hospital Wage

Index Occupational Mix Survey and Supporting Regulations in 42 CFR,

Section 412.64.

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

Information Collection: Medicare Program/Home Health Prospective

Payment System Rate Update for Calendar Year 2010: Physician Narrative

Requirement and Supporting Regulation in 42 CFR 424.22.

Centers for Medicare & Medicaid Services

Agency Information Collection Activities: Proposed Collection;

Comment Request

1. Type of Information Collection Request: Reinstatement with

change of a previously approved collection; Title of Information

Collection: Business Proposal Forms for Quality Improvement

Organizations (QIOs).

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

Information Collection: Medicare Gainsharing Demonstration Evaluation:

Physician Focus Groups.

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

approved collection; Title of Information Collection: End Stage Renal

Disease (ESRD) Network Semi-Annual Cost Report Forms and Supporting

Regulations in 42 CFR section 405.2110 and 42 CFR 405.2112.

Food and Drug Administration

Clinical Accuracy Requirements for Point of Care Blood Glucose

Meters; Public Meeting; Request for Comments

ACTION: Notice of public meeting; request for comments.

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

Office on Women's Health

Call for Collaborating Partners for National Women's Health Week

ACTION: Notice.

SUMMARY: The U.S. Department of Health and Human Services (HHS), Office

on Women's Health (OWH)invites public and private sector women's health-related organizations

to participate in National Women's Health Week as collaborating

partners to help create awareness of women's health issues and educate

women about improving their health and preventing disease.

DATES: Representatives of women's health organizations should submit

expressions of interest by February 28, 2010.

Office of the Secretary, Office of Public Health and Science

Meeting of the Presidential Advisory Council on HIV/AIDS

ACTION: Notice.

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

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

that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a

meeting. The meeting will be open to the public.

DATES: The meeting will be held on February 2, 2010 from 9 a.m. to

approximately 5 p.m.

ADDRESSES: South Court Auditorium, Eisenhower Executive Office

Building, Pennsylvania Avenue and 17th Street, NW., Washington, DC

20501.

President's Council on Physical Fitness and Sports

Opportunity for Co-Sponsorship of the President's Challenge

Physical Activity and Fitness Awards Program; Correction

ACTION: Notice; correction.

SUMMARY: The President's Council on Physical Fitness and Sports

published a document in the Federal Register of December 28, 2009,

concerning the opportunity for non-Federal entities to co-sponsor and

administer a series of financially self-sustaining activities related

to the President's Challenge Physical Activity and Fitness Awards

Program. The document contained incorrect addresses and contact

information.

Health Resources and Services Administration

National Vaccine Injury Compensation Program: Revised Amount of

the Average Cost of a Health Insurance Policy

The Health Resources and Services Administration (HRSA) is

publishing an updated monetary amount of the average cost of a health

insurance policy as it relates to the National Vaccine Injury

Compensation Program (VICP).

Health Resources and Services Administration

Advisory Committee on Heritable Disorders in Newborns and

Children

ACTION: Notice of Request for Nominations.

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

requesting nominations to fill three (3) vacancies on the Secretary's

Advisory Committee on Heritable Disorders in Newborns and Children.

DATES: The agency must receive nominations on or before May 1, 2010.

National Institutes of Health

Moving Into the Future--New Dimensions and Strategies for Women's

Health Research for the National Institutes of Health; Notice.

Notice is hereby given that the Office of Research on Women's

Health (ORWH), Office of the Director, National Institutes of Health,

Department of Health and Human Services, in collaboration with the

Emory University School of Medicine will convene a public hearing and

scientific workshop February 16-17, 2010, at Emory University School of

Medicine, James B. Williams Medical Education Building, Atlanta,

Georgia.