[Federal Register Volume 75, Number 250 (Thursday, December 30, 2010)]
[Notices]
[Pages 82400-82402]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-32963]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Development of Health Risk Assessment Guidance; Public Forum

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice of Public Meeting.

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SUMMARY: On November 16, 2010, the Centers for Disease Control and 
Prevention (CDC), located within the Department of Health and Human 
Services (HHS), published a notice in the Federal Register (75 FR 
70009) requesting public comment to assist development of guidance for 
Health Risk Assessments (HRAs). Section 4103 of the Affordable Care Act 
(ACA) (Pub. L. 111-148) requires that a Health Risk Assessment be 
included in the annual wellness visit benefit authorized for Medicare 
beneficiaries under the ACA. CDC is collaborating with the Centers for 
Medicare and Medicaid Services (CMS), also located within HHS, in the 
development of guidance for this type of assessment. This guidance is 
also intended to be useful for HRAs

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conducted in other patient populations, including those persons covered 
by employer healthcare plans. In the November 16, 2010 notice, CDC also 
announced that it would hold a public forum in early February 2011 to 
obtain additional public comment. Today's notice announces the public 
forum.

DATES: The public forum will be held on:
    Tuesday, February 1, 2011, from 9 a.m. to 5 p.m. EST and Wednesday, 
February 2, 2011, from 9 a.m. to 5 p.m. EST.

ADDRESSES: The Public Forum will be held at the Centers for Disease 
Control and Prevention, Roybal Campus, Tom Harkin Global Communications 
Center, Building 19, Auditorium A, 1600 Clifton Road, NE., Atlanta, 
Georgia 30333.
    Upon entering the campus visitors must stop at the CDC Visitor's 
Center parking guard station. Visitors will be asked for identification 
and the purpose of the visit. Please be aware that your vehicle is 
subject to search before being allowed to enter the facility. A 
government-issued photo ID is required for entry for all adults over 
the age of 16. Acceptable forms of identification include a valid 
driver's license, a passport or a state-issued photo identification 
card. Parking spaces for visitors are available in the parking lot 
adjacent to the CDC Visitor's Center (Building 19). Once inside the CDC 
Visitor's Center, visitors will be asked to show their picture ID again 
and a visitor's badge will be issued. Those who have registered in 
advance will have a visitor's badge waiting and entry will be 
expedited. Non-U.S. citizens (including permanent residents) must 
register in advance. Please note, this is a working Federal Facility. 
Please follow the guards' directions. Backpacks, suitcases or large 
containers are prohibited and photography is restricted.
    Please visit our Web site for additional information on security 
and for directions to the facility (http://www.cdc.gov/museum/security.htm).
    CDC will make every effort to accommodate persons with physical 
disabilities or special needs. If you require special accommodations 
due to a disability, please contact Paula Staley at (404) 639-0210 at 
least 7 days in advance of the meeting.
    Registration: Participants are encouraged to pre-register for the 
Public Forum. On-line registration and a draft agenda is available at: 
http://www.cdc.gov/policy. As space is limited, registration by January 
7, 2011 is strongly encouraged.

FOR FURTHER INFORMATION CONTACT: Paula Staley, Office of Prevention 
through Healthcare, Office of the Associate Director for Policy, 
Centers for Disease Control and Prevention, 1600 Clifton Road, NE., 
Atlanta, Georgia 30333; phone: (404) 639-0210.

SUPPLEMENTARY INFORMATION: Section 4103 of the Affordable Care Act 
(ACA) requires that a Health Risk Assessment (HRA) be included in the 
annual wellness visit benefit authorized for Medicare beneficiaries 
under the ACA. CDC is collaborating with the Centers for Medicare and 
Medicaid Services (CMS) in the development of guidance for this type of 
assessment. This guidance is also intended to be useful for HRAs 
conducted in other patient populations such as privately insured 
populations, including those persons covered by employer healthcare 
plans. Currently there is considerable variation in available HRAs, 
with the majority created to support employer-based health and wellness 
programs. Several instruments have been created for use in research and 
are not available in the marketplace; and the scientific rigor of HRA 
tools is not always evident. Therefore, the development of HRA guidance 
is essential for effective implementation of this part of the Medicare 
wellness visit and to support broader HRA use within primary care.
    Agenda: The meeting will open with presentations related to 
background information on the elderly population, HRAs and the HRA 
guidance development. The meeting will consist of panel presentations 
for each of the areas of emphasis which are listed in this notice as 
well as in the November 16, 2010 Federal Register notice. Participants 
attending the public forum will be invited to provide comment at the 
end of each half day of the meeting. The final agenda and panelists' 
presentations will be made available to the public no later than two 
business days before the meeting. If CDC is unable to post the 
presentations on its Web site prior to the meeting, the material will 
be made publicly available at the location of the meeting. The final 
agenda and panelists' presentations will be available at http://www.cdc.gov/policy. The agenda is subject to change without notice.
    Areas of Emphasis:

Content and Design

     Risk assessment domains--What are generic elements of any 
HRA and what elements must be tailored to specific populations, 
particularly those stratified by age?
     How should literacy and other cultural appropriateness 
factors be factored into the design?
     Should the HRA instrument support shared decision-making 
by provider and patient? If so, how?

Mode of Administration

     How will individuals access the HRA (e.g., via kiosk or 
some other means in the physician's office, internet, mail-in paper 
form, other non-traditional healthcare locations, such as, kiosk in a 
pharmacy)?
     What are the cultural appropriateness factors in patient 
HRA access?

Primary Care Office Capacity

     What primary care office capacity (personnel, Information 
Technology (IT), etc.) is required to utilize HRA data effectively in 
support of personalized prevention planning?
     Is training and technical assistance necessary for 
effective practice utilization of an HRA? What entity should provide 
this technical assistance?
     What are potential or demonstrated community care 
transition linkages--follow-up outside the office by other providers--
that help patients and providers manage priority risks identified by 
the HRA?
     What is the current practice of HRA in medical practices 
of various sizes, particularly those with five or fewer physicians?

Consumer/Patient Perspective

     How could HRA data be shared with the patients for their 
feedback and follow up in the primary care practice?
     What role, if any, do incentives play in motivating 
patients to take the HRA and/or participate in follow-up interventions?

Data

     With respect to IT, how could HRA data entered in any form 
populate electronic health records, and what special challenges and 
solutions occur if the data are entered in a non-electronic form?
     Are there standardized and certified tools available to 
support this data migration from multiple data entry sources?

Certification

     What certification tools and processes should complement 
the HRA standards and how should they be made available to support 
primary care office selection of an HRA instrument?

[[Page 82402]]

Evaluation and Quality Assurance

     How should the HRA standards be evaluated and updated with 
respect to individual and population-level (practice-based panel 
management) health outcomes?
    Procedure: Interested persons may present data, information, or 
views orally or in writing, on topics listed in this Federal Register 
notice. Written submissions for the public comment period may be made 
to the contact person on or before January 18, 2011. Oral presentations 
from the public will be scheduled during 30-minute public comment 
periods at the end of each half day of proceedings, i.e., from 11:30 
a.m. to 12 noon and 4:30 p.m. to 5 p.m. on Tuesday, February 1, 2011 
and Wednesday, February 2, 2011. Those individuals interested in making 
formal oral comments should notify the contact person and submit a 
brief statement of the general nature of the comments they wish to 
present and the names and addresses of proposed participants on or 
before January 11, 2011. Each commenter will be limited to 3-5 minutes. 
The CDC is not responsible for providing access to electrical outlets.
    Individuals who have not submitted comments ahead of time will have 
the opportunity to sign up to comment during registration on the day of 
the forum. However, if time does not allow for all interested parties 
to comment, individuals who have submitted their comments ahead of time 
will be given preference. If the number of participants requesting to 
comment is greater than can be reasonably accommodated, the CDC may 
conduct a lottery to determine the speakers for the scheduled open 
public comment sessions. The contact person will notify interested 
persons regarding their request to comment by January 18, 2011.
    Public forum participants not receiving an opportunity to comment 
during the open public comment period may submit their comments to OPTH 
mailbox at: http://www.cdc.gov/policy. CDC will make all comments it 
receives available to the public without change, including personal 
information you may provide, which includes the name of the person 
submitting the comment or signing the comment on behalf of an 
organization, business, or any such entity. If anyone does not wish to 
have this information published, then that information should not be 
included when submitting the comment.

    Dated: December 21, 2010.
Tanja Popovic,
Deputy Associate Director for Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2010-32963 Filed 12-29-10; 8:45 am]
BILLING CODE 4163-18-P