[Federal Register Volume 75, Number 220 (Tuesday, November 16, 2010)]
[Notices]
[Pages 70009-70010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-28788]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Development of Health Risk Assessment Guidance

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

ACTION: Request for Information.

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SUMMARY: The Centers for Disease Control and Prevention (CDC) located 
within the Department of Health and Human Services (HHS) is seeking 
public comment on the development of guidance concerning Health Risk 
Assessment (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 conducted in other patient populations such as 
privately insured populations, including those persons covered by 
employer healthcare plans. Comments received from this request for 
information will be used to inform the HRA guidance development 
process.

DATES: Written comments must be received on or before January 3, 2011. 
Comments received after January 3, 2011 will be considered to the 
extent possible.

ADDRESSES: You may submit written comments to the following address: 
Office of Prevention through Healthcare, Office of the Associate 
Director for Policy, Centers for Disease Control and Prevention, 1600 
Clifton Road, NE., Mailstop D-28, Atlanta, Georgia, 30333, ATTN: Health 
Risk Assessment Guidance.
    You may also submit written comments via e-mail to: <a href="/cdn-cgi/l/email-protection#317e616579715255521f565e47"><span class="__cf_email__" data-cfemail="ce819e9a868eadaaade0a9a1b8">[email protected]</span></a>. 
Please use ``Health Risk Assessment Guidance'' for the subject line.
    Submitted comments will be available for public review from Monday 
through Friday, except for legal holidays, from 9 a.m. until 5 p.m. 
Eastern Standard Time, at 1600 Clifton Road NE., Atlanta, Georgia 
30333. Please call ahead to 1-404-639-0210 and ask for a representative 
in the Office of Prevention through Healthcare to schedule your visit. 
Comments will also be available for viewing at the following Internet 
address: http://www.cdc.gov/policy/opth/.
    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.

FOR FURTHER INFORMATION CONTACT: Paula Staley, Office of Prevention 
through Healthcare, Associate Director for Policy, Centers for Disease 
Control and Prevention, 1600 Clifton Road, NE., Mailstop D-28, Atlanta, 
Georgia, 30333, telephone: (404) 639-0210.

SUPPLEMENTARY INFORMATION: 
    Section 4103 of the Affordable Care Act (ACA) 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 CMS to develop 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 of assessments 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.
    Although comments on any aspect of the guidance development process 
will be accepted, comments are especially solicited about these areas 
of emphasis:

Content and Design

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

Mode of Administration

    <bullet> 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)?
    <bullet> What are the cultural appropriateness factors in patient 
HRA access?

Primary Care Office Capacity

    <bullet> What primary care office capacity (personnel, Information 
Technology (IT), etc) is required to utilize HRA data effectively in 
support of personalized prevention planning?
    <bullet> Are training and technical assistance necessary for 
effective practice utilization of an HRA? What entity should provide 
this technical assistance?
    <bullet> 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?
    <bullet> What is the current practice of HRA in medical practices 
of various sizes, particularly those with five or fewer physicians?

[[Page 70010]]

Consumer/Patient Perspective

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

Data

    <bullet> With respect to Information Technology (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?
    <bullet> Are there standardized and certified tools available to 
support this data migration from multiple data entry sources?

Certification

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

Evaluation and Quality Assurance

    <bullet> How should the HRA guidance be evaluated and updated with 
respect to individual and population-level (practice-based panel 
management) health outcomes?
    Public Forum: CDC plans to convene a public forum in early February 
2011 to highlight some of the key challenges, barriers, opportunities 
and innovations related to HRA standardization. The public forum will 
consist of panel presentations followed by public comment. CDC will 
publish a separate notice in the Federal Register announcing additional 
information for the Public Forum.

    Dated: November 8, 2010.
Tanja Popovic,
Deputy Associate Director for Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2010-28788 Filed 11-15-10; 8:45 am]
BILLING CODE 4163-18-P


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