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Notice

Development of Health Risk Assessment Guidance; Public Forum

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

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

ACTION:

Notice of Public Meeting.

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 Start Printed Page 82401conducted 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.

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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.

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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?Start Printed 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.

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Dated: December 21, 2010.

Tanja Popovic,

Deputy Associate Director for Science, Centers for Disease Control and Prevention.

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[FR Doc. 2010-32963 Filed 12-29-10; 8:45 am]

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