[Federal Register: September 8, 2006 (Volume 71, Number 174)]
[Notices]
[Page 53095-53096]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08se06-51]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Meeting on Patient and Physician Concerns in Access to
Intravenous Immunoglobulin (IVIG)
AGENCY: Department of Health and Human Services, Office of the
Assistant Secretary for Planning and Evaluation (HHS/ASPE).
ACTION: Notice of Meeting.
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SUMMARY: This notice announces the date and location of a Town Hall
meeting to be held on September 28, 2006 to obtain public comment on
patient and physician concerns with access to IVIG. The Department of
Health and Human Services, Office of the Assistant Secretary for
Planning and Evaluation has contracted with Eastern Research Group,
Inc. (ERG) to develop an analysis of supply, distribution, demand, and
access issues associate with IVIG. This public meeting provides a forum
for interested parties to make oral comments and to submit written
comments about IVIG access for use in the analysis. In particular,
comments are invited that will aid in the analysis of any physician or
patient problems with access to IVIG, including the nature, size, and
scope of any problems, as well as estimation of changes in health
outcomes that may result from access problems.
DATES: The Town Hall meeting will be held on September 28, 2006 from 10
a.m. to 5 p.m.
ADDRESSES: Sheraton Crystal City Hotel, 1800 Jefferson Davis Highway,
Arlington, VA.
FOR FURTHER INFORMATION CONTACT: Amber Jessup. Office of the Assistant
Secretary for Planning and Evaluation, 200 Independence Ave., SW.,
Washington, DC 20201. Telephone: 202-690-6621.
Web site: Additional details regarding the Town Hall meeting
process for public comments, along with information on how to register
and guidelines for an effective presentation and/or electronic comment
submission, can be found on the project Web site at https://www2.ergweb.com/projects/conferences/hhs
.
SUPPLEMENTARY INFORMATION:
I. Background
The Department of Health and Human Services, Office of the
Assistant Secretary for Planning and Evaluation has contracted with
Eastern Research Group, Inc. (ERG) to develop an analysis of supply,
distribution, demand, and access issues associated with IVIG. As part
of this analysis, a Town Hall meeting is being scheduled to obtain
public comment on access issues to be used in the analysis.
Intravenous Immune Globulin (IVIG) is a plasma product that is used
to treat patients with immune system disorders. Immune globulins are
antibodies. IVIG has a number of on-label uses including treatment of
humoral immunodeficiency, acute and chronic idiopathic thrombocytopenia
purpura, B cell chronic lymphocytic leukemia (to prevent recurrent
bacterial infections), Kawasaki disease, pediatric HIV, and bone marrow
transplantation. It is also used for off-label treatments including
autoimmune, neurological, and systemic inflammatory conditions.
According to the Department of Health and Human Services Advisory
Committee on Blood Safety and Availability, more than half of IVIG use
may be for off-label indications. Due at least in part to the increase
in off-label uses, demand for IVIG has increased in recent years. The
number of infusion days in hospitals increased to 70,000 days in 2004
from 40,000 days in 2002 and the number of grams infused in physician
offices increased by 1.7 million grams, between 2003 and 2004, from 2.3
to 4.0 million grams.
IVIG is covered under Medicare Part B. In 2005, Medicare shifted
from Average Wholesale Price (AWP) as the basis for reimbursement to
Average
[[Page 53096]]
Sales Price (ASP) as required by the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (MMA). This shift reduced
the reimbursement amount to physicians by 35 percent for the powder
form of IVIG and by 15 percent for the liquid form of IVIG. Since
January 2005, some patient advocacy groups and physicians have reported
difficulty acquiring IVIG. The FDA Center for Biologics Evaluation and
Research, however, has not identified a shortage of IVIG. There have
also been reports of IVIG being diverted to secondary markets with
increases in prices.
The focus of the Town Hall meeting is on receiving information from
stakeholders that will be helpful in the analysis. The Town Hall
meeting will accept comments from all stakeholders, but is focused on
patient and physician concerns with access to IVIG including:
(1) Patients switching IVIG products due to access problems,
(2) Changes in the administration location,
(3) Patients receiving fewer treatments,
(4) Patients receiving reduced dosages, and
(5) Reimbursement problems with IVIG products,
(6) Patients receiving reduced dosages, and
(7) Health consequences for patients of any access issues.
II. Registration
Registration procedures: Registration can be completed online at
https://www2.ergweb.com/projects/conferences/hhs/. To register by
telephone, contact ERG's Conference Registration Line at 781-674-7374.
The following information must be provided when registering: Name,
organization name and address (if applicable), and consent to publish
contact information on a participants list and other reports to
document the Town Hall meeting. An ERG staff member will confirm your
registration by mail, e-mail, or fax. Attendees may participate in
person or by phone. If you wish to participate by phone, please
indicate this in your registration and a call-in conference number will
be provided in your registration confirmation. Attendees must register
by September 21.
III. Comment Format
a. ``5-Minute'' Public Comment
Meeting attendees can sign up on a first-come, first-served basis
to present their comments (maximum of 5 minutes) via the meeting Web
site when you register. Comments may be made in person or by phone.
Commenters should focus on issues related to access to IVIG and
quantify these impacts when possible. Commenters must provide their
name, title, and organization (if applicable) on their registration and
identify the topic area they will address. Presenters that can not
attend in person can participate via phone. If you are unable to attend
in person, you should indicate at registration that you wish to
participate via phone. A call-in conference number will be provided to
you in your registration confirmation.
b. Written Comments From Meeting Attendees
Written comments are welcome from the public regardless of whether
you attend the Town Hall Meeting or whether you make an oral
presentation at the Town Hall Meeting. Written comments can be
submitted either at the meeting, or before or after the meeting via e-
mail to meetings@erg.com (subject: IVIG Meeting Comments). Or via
regular mail to Attn: IVIG Meeting, ERG, 110 Hartwell Avenue,
Lexington, MA 02421. Please note that electronic submissions are
preferred due to delays in receiving US Postal Mail. We are able to
consider only those comments received in writing and/or via e-mail by 5
p.m. EST on October 15, 2006.
IV. Special Accommodations
Individuals attending the meeting who are hearing- or visually-
impaired and have special requirements, or a condition that requires
special assistance or accommodations, must provide this information
when registering for the meeting and accommodations will be made.
Dated: August 31, 2006.
Jerry Regier,
Principal Deputy Assistant Secretary for Planning and Evaluation,
Office of the Assistant Secretary for Planning and Evaluation.
[FR Doc. 06-7510 Filed 9-7-06; 8:45 am]
BILLING CODE 4151-06-M