Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Centers for Disease Control and Prevention

# AGENCY:

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

# ACTION:

Request for Information.

# 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:                         *OPTH@cdc.gov.*                         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

    - 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?
    - How should the HRA instrument support shared decision-making by provider and patient?

## 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?
    - Are 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?       ( print page 70010)      

## 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 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?
    - 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 guidance and how should they be made available to support primary care office selection of an HRA instrument?

## Evaluation and Quality Assurance

    - 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