0920-0976 Mh Ss B_9 12 16

0920-0976 MH SS B_9 12 16.docx

Million Hearts Hypertension Control Challenge

OMB: 0920-0976

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SUPPORTING STATEMENT FOR THE

MILLION HEARTS® HYPERTENSION CONTROL CHALLENGE



OMB No. 0920-0976


Expiration 07/31/2016


Part B


Reinstatement with Change










September 14, 2016













Contact: Mary G. George

Telephone: (770) 488-8092

E-mail: [email protected]

National Center for Chronic Disease

Prevention and Health Promotion

Centers for Disease Prevention and Control

Atlanta, Georgia





TABLE OF CONTENTS




  1. Statistical Methods

  1. Respondent Universe and Sampling Methods

  2. Procedures for the Collection of Information

  3. Methods to Maximize Response Rates and Deal with Nonresponse

  4. Test of Procedures or Methods to be Undertaken

  5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data







List of Attachments

  1. Authorizing Legislation: Public Health Service Act

1b. Authorizing Legislation: COMPETES Act

1c. Authorizing Legislation: Office of Management and Budget Guidance on the Use of Challenges and Prizes to Promote Open Government (March 8, 2010)

  1. 60-Day Federal Register Notice

2a. Summary of Public Comments

3a. Nomination Form 2015 Challenge

3b. Revised Nomination Form 2016 Challenge

3c. Crosswalk of changes to the Nomination Form

3d. Confirmation email

4a. Verification Form 2013 Challenge

4b. Revised Data Verification Form 2016 Challenge

4c. Cross walk of change to Data Verification Form

  1. Interview Guide 2013 (unchanged)

  2. Screenshots 2016 Challenge

  3. Eligibility and Rules for Participation

  4. IRB Determination form



B. STATISTICAL METHODS



  1. Respondent Universe and Sampling Methods


Statistical sampling methods are not applicable and cannot be used to accomplish the purpose of the Million Hearts Hypertension Control Challenge. The Million Hearts ® Hypertension Control Challenge aims to recognize medical practices and healthcare systems that have achieved exemplary rates of hypertension control in adult patients ages 18-85. Respondents are single practice providers, group practice providers or healthcare systems that include clinicians and administrators providing direct services to adult patients. Information collection is based on a convenience sample of respondents who voluntarily self-nominate or agree to be considered.

The Challenge will be open to:

  • Licensed clinicians or medical practices providing primary care, family practice, internal medicine, osteopathic, obstetrics/gynecology, or cardiovascular care, primarily for adults.

    • An individual clinical practice represents one to two licensed clinicians practicing in any setting who provide continuing care for patients with hypertension.

    • A medical practice includes any practice with three or more licensed clinicians who, by formal arrangement, share responsibility for a common panel of patients and practice at the same site, defined as a physical location or street address.

  • Licensed healthcare systems providing direct services to a patient population within a geographic area in an effort to provide more efficient care.

    • A healthcare system provides medical care for participants and/or their dependents. It is a complete network of agencies, facilities, and all providers of health care in a specified geographic area. In a healthcare system, medical centers and clinics may work together to more efficiently offer a range of services. Healthcare systems managed on a regional basis should submit a nomination for the region as a whole.


Detailed eligibility and exclusion criteria for respondents are provided in Attachment 7, Advisement of Eligibility and Rules for Participation. Nominees are deemed ineligible if the clinician’s license is not current or is questionable, if there are actions pending against the clinician, such as actions for inappropriate billing, as documented on the Office of the Inspector General Exclusions website at http://exclusions.oig.hhs.gov , criminal activities, patient abuse or neglect, healthcare fraud offenses; or if the provider does not respond to requests for data validation. Nominees must be free from convictions or pending investigations of criminal and health care fraud offenses such as felony health care fraud, patient abuse or neglect; felony convictions for other health care-related fraud, theft, or other financial misconduct; and felony convictions relating to unlawful manufacture, distribution, prescription, or dispensing of controlled substances as verified through the Office of the Inspector General List of Excluded Individuals and Entities. Individual nominees must be free from serious sanctions, such as those for misuse or mis-prescribing of prescription medications. Such serious sanctions will be determined at the discretion of the agency consistent with CDC’s public health mission. CDC’s contractor may perform background checks on individual clinicians or medical practices.


To estimate the number of respondents to the Challenge, CDC investigated the number of providers recognized by the NCQA Heart/Stroke Recognition (over 4000 since 2003) and the number of providers recognized by the Bridges to Excellence Hypertension Control Program (285). As there are no reimbursement incentives attached to Million Hearts® recognition such as with other programs, and based on the number of nominations received for previous Million Hearts® Challenges, CDC estimates a maximum number of respondents to be 13% of the NCQA recognized Heart/Stroke providers, or 500 nominees.


CDC plans to recognize up to 40 Million Hearts® Hypertension Control Champions each year. From the pool of 500 nominees, up to 40 finalists may be selected for further consideration. Because finalists may voluntarily decide to discontinue their participation, or may be deemed ineligible, the number of finalists may exceed the number of selected Champions.


  1. Procedures for the Collection of Information


The Million Hearts® Hypertension Control Challenge will be hosted through a unique URL: www.MHhypertensionchallenge.com. The Million Hearts® Hypertension Control Challenge platform will have no content directed at children less than 13 years of age.


Nomination information will be collected electronically once per year through a web-based online portal (Attachment 6), while verification information will be collected by phone and/or site visit and through electronic medical review or paper review once per year


Nominees will enter the Challenge by completing the nomination form that includes information about the population served by the practice or healthcare system and sustainability. Estimated time required to complete the form is less than 30 minutes or less (see Attachment 3b).

  • Nominees will create a free account on an external web platform

  • On this external web platform, the nominee will find the Million Hearts® Hypertension Control Challenge Nomination Form.

  • After submitting a nomination on the challenge web platform, a confirmation email will be sent to the email address provided (Attachment 3d).

  • Applicants will submit the Nomination Form during the submission period, (anticipated to begin February 2017, and end March 2017).


.

When submitting a nomination, the nominee agrees to be recognized if selected, and to participate in data verification which includes a phone interview and/or site visit to assure accuracy and reasonableness of the information, e.g., that newly diagnosed patients are added to control rate calculations (Attachment 4b) and verification of blood pressure control rate through electronic medical record review or paper review. CDC intends that verification will be planned and conducted by an independent organization with expertise in data verification as well as practices to protect privacy, such as the National Committee on Quality Assurance.


Nominees also agree to participate in an interview regarding their blood pressure control strategies and how they are implemented. The interview will be conducted in person or by phone, whichever is agreeable to both participants and expedient for the Government (see Attachment 5).


  1. Methods to Maximize Response Rates and Deal with Nonresponse


Maximizing response rate will rely heavily on promotion of the Challenge. Promotion will be through the Million Hearts® website, the Challenge.gov website, and Million Hearts® partners, meetings, and promotions.


Because response is voluntary and based on a convenience sample, CDC does not perform non-response analysis.


  1. Test of Procedures or Methods to be Undertaken


Prior to the initial Challenge, the nomination form and interview guide were reviewed and pilot tested by a small group of CDC staff. The nomination form and data verification form have been updated, based on CDC’s experience, the data verification contractor’s experience, and feedback from applicants.


Prior to release of the web portal, testing of the nomination form will be undertaken to ensure that there are no flaws in the nomination form, form submission, or access to submitted information.


  1. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Information


The individuals that participated in the design of the information collection include:


Judy Hannan, MPH, RN, Senior Advisor to Director on Million Hearts

Division for Heart Disease and Stroke Prevention, CDC

Telephone (770) 488-4572, [email protected]


Hilary Wall, MS, Million Hearts Science Lead

Division for Heart Disease and Stroke Prevention, CDC

Telephone (770) 488-8172, [email protected]


Janet Wright, MD

Million Hearts Executive Director

Division for Heart Disease and Stroke Prevention, CDC

Telephone (410) 786-6503, [email protected]


The individual responsible for overseeing information analysis is:


Matthew Ritchey, PT, DPT, OCS, MPH, Epidemiologist

Division for Heart Disease and Stroke Prevention, CDC

Telephone (770) 488-7232, [email protected]


The individual responsible for overseeing information collection is:


Mary G. George, MD, MSPH, FACS, Deputy Assoc. Director for Science & Sr. Medical Officer

Division of Heart Disease and Stroke Prevention, CDC

Telephone (770)488-8092, [email protected]

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