Weekly Legislative & Regulatory Round-up

Notice of Modification of OIG Advisory Opinion 08-11 (PDF)
(concerning Advisory Opinion No. 08-11 (PDF), which was issued on 09-04-2008, regarding the waiving of cost sharing obligations for protocol-required clinical services and oxygen therapy provided to Medicare beneficiaries who participate in the Long-term Oxygen Treatment Trial sponsored by the National Heart, Lung, and Blood Institute and the Centers for Medicare and Medicaid Services)

Review of the Calculations of Temporary Increases in Federal Medical Assistance Percentages Under the American Recovery and Reinvestment Act (A-09-09-00075)

OIG's First Audit of Recovery Act Funding Finds No Discrepancies: Press Release (PDF) 

Medicaid Managed Care Encounter Data: Collection and Use (OEI-07-06-00540) (PDF)

Congress in recess this week

May 26, 2009

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

Medicare and Medicaid Programs; Application by the American

Osteopathic Association for Continued Deeming Authority for Ambulatory

Surgical Centers

ACTION: Proposed notice.

SUMMARY: This proposed notice acknowledges the receipt of a deeming

application from the American Osteopathic Association (AOA) for

continued recognition as a national accrediting organization for

ambulatory surgical centers (ASCs) that wish to participate in the

Medicare or Medicaid programs. The statute requires that we publish,

within 60 days of receipt of an organization's complete application, a

notice identifying the national accrediting body making the request,

describing the nature of the request, and providing at least a 30-day

public comment period.

Office of the National Coordinator for Health Information

Technology (ONC)

HIT Standards Committee Schedule for the Assessment of HIT Policy

Committee Recommendations

ACTION: Notice.

SUMMARY: Section 3003(b)(3) of the American Recovery and Reinvestment

Act of 2009 mandates that the HIT Standards Committee develop a

schedule for the assessment of policy recommendations developed by the

HIT Policy Committee and publish it in the Federal Register. This

notice fulfills the requirements of Section 3003(b)(3) and shall be

updated at least annually.  In anticipation of receiving recommendations originally developed  by the HIT Policy Committee, the Standards Committee has created three

workgroups or subcommittees to analyze the areas of clinical

quality, clinical operations, and privacy and security.  HIT Standards Committee Schedule for the Assessment of HIT Policy Committee Recommendations:

The National Coordinator will establish priority areas based in

part of recommendations received from the HIT Policy Committee

regarding health information technology standards, implementation

specifications, and/or certification criteria.

May 27, 2009

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Draft Guidance for Industry on Presenting Risk Information in

Prescription Drug and Medical Device Promotion; Availability

ACTION:  Notice.

SUMMARY:  This guidance responds to stakeholder requests for specific guidance on how FDA evaluates prescription drug and device promotional pieces to determine whether they adequately present risk information. The guidance describes and discusses the factors FDA considers when

evaluating prescription drug advertisements (ads), restricted device

ads, and prescription drug and device promotional labeling for their

compliance with the Federal Food, Drug, and Cosmetic Act (the act) and

relevant regulations. The guidance gives examples to illustrate FDA's

thinking on these factors and is intended to help regulated industry

gain a better understanding of what they should consider as they

develop the content and format of their promotional communications.

May 28, 2009

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the National Coordinator for Health Information

Technology

Health Information Technology Extension Program

ACTION: Notice and request for comments.

SUMMARY: This notice announces the draft description of the program for

establishing regional centers to assist providers seeking to adopt and

become meaningful users of health information technology, as required

under Section 3012(c) of the Public Health Service Act, as added by the

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

May 29, 2009

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of Public Health and Science, The President's Council on Bioethics Public Meeting of the President's Council on Bioethics

ACTION: Notice.

SUMMARY: The President's Council on Bioethics (Edmund D. Pellegrino,

MD, Chairman) will hold its thirty-seventh and final meeting. The full

agenda will be posted on the Council's Web site at http://

www.bioethics.gov prior to the meeting.

DATES: The meeting will take place Thursday, June 25, 2009, from 9 a.m.

to 3 p.m., ET; and Friday, June 26, 2009, from 9 a.m. to 11:45 a.m.,

ET.

ADDRESSES: The Ritz-Carlton, Washington, DC, 1150 22nd Street, NW.,

Washington, DC 20037. Phone 202-835-0500.