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Notice

Announcement of Requirements and Registration for the 2019 Million Hearts® Hypertension Control Challenge

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Start Preamble Start Authority

Authority: 15 U.S.C. 3719.

End Authority

AGENCY:

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

Award Approving Official: Robert R. Redfield, MD, Director, Centers for Disease Control and Prevention, and Administrator, Agency for Toxic Substances and Disease Registry

ACTION:

Notice.

SUMMARY:

The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) announces the launch of the 2019 Million Hearts® Hypertension Control Challenge.

Million Hearts® is a national initiative to prevent one million heart attacks and strokes by 2022. In order to prevent one million events, we need to decrease smoking, sodium consumption and physical inactivity by 20%; improve performance on appropriate aspirin use, blood pressure control, cholesterol management, and smoking cessation to 80%; and improve outcomes for priority populations. Over the last five years, we have seen tremendous progress by providers and health care systems that focus on improving their performance in controlling patients' blood pressure. Getting to 80% control would mean that 10 million more Americans with hypertension would have their blood pressure under control, and be at substantially lower risk for strokes, heart attacks and other events. For more information about the initiative, visit https://millionhearts.hhs.gov/​ .

The challenge is an important way to call attention to the need for improved control, provides a powerful motivation and target for clinicians, and will improve understanding of successful implementation strategies at the health system level. It will identify clinicians, clinical practices, and health systems that have exceptional rates of hypertension control and recognize them as 2019 Million Hearts® Hypertension Control Champions. To support improved quality of care delivered to patients with hypertension, Million Hearts® will document the systems, strategies, processes, and staffing that contribute to the exceptional blood pressure control rates achieved by Champions.

DATES:

The Challenge will accept applications from February 14, 2019 through April 1, 2019.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Mary George, Division for Heart Disease and Stroke Prevention, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, 4770 Buford Hwy. NE, Mailstop F-73, Chamblee, GA 30341, Telephone: 770-488-2424, Email: millionhearts@cdc.gov; subject line of email: Million Hearts Hypertension Control Challenge; Attention: Mary George.

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SUPPLEMENTARY INFORMATION:

Subject of Challenge Competition

The challenge is authorized by Public Law 111-358, the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education and Science Reauthorization Act of 2010 (COMPETES Act).

Applicants for the 2019 Million Hearts® Hypertension Control Challenge will be asked to provide two hypertension control rates for the practice's or health system's hypertensive population: a current rate for the most recent 12-month reporting period (e.g., 1/1/2018-12/31/2018) and a previous rate for a 12-month period 1 year before the most recent reporting period (e.g., 1/1/2017-12/31/2017). Applicants will also be asked to provide the prevalence of hypertension in their population (more details provided below), describe some population characteristics (such as urban/rural location, percent minority, percent enrolled in Medicaid, percent with no health insurance, and percent whose primary language is not English) and strategies used by the practice or health system that support continued improvements in blood pressure control. A copy of the application form will be available on the Challenge website for the duration of the Challenge.

Eligibility Rules for Participating in the Competition

To be eligible to be recognized as a Million Hearts® Hypertension Control Start Printed Page 3448Champion under this challenge, an individual or entity—

(1) Shall have completed the application form in its entirety to participate in the competition under the rules developed by HHS/CDC;

(2) Shall have complied with all the requirements in this section and satisfy the requirements in one of the following subparts:

a. Be a U.S. licensed clinician, practicing in any U.S. setting, who provides continuing care for adult patients with hypertension. The individual must be a citizen or permanent resident of the U.S.;

b. Be a U.S. incorporated clinical practice, defined as any practice with two or more U.S. licensed clinicians who by formal arrangement share responsibility for a common panel of patients, practice at the same physical location or street address, and provide continuing medical care for adult patients with hypertension;

c. Be a health system, incorporated in and maintaining a primary place of business in the U.S., that provides continuing medical care for adult patients with hypertension. We encourage large health systems (those that are comprised of a large number of geographically dispersed clinics and/or have multiple hospital locations) to consider having one or a few of the highest performing clinics or regional affiliates apply individually instead of the health system applying as a whole;

(3) Must treat all adult patients with hypertension in the practice seeking care, not a selected subgroup of patients;

(4) Must have a data management system (electronic or paper) that allows HHS/CDC or their contractor to verify data submitted;

(5) Must treat a minimum of 500 adult patients annually and have a hypertension control rate of at least 80%;

(6) May not be a Federal entity or Federal employee acting within the scope of their employment;

(7) An HHS employee must not work on their application(s) during assigned duty hours;

(8) Shall not be an employee of or contractor at CDC;

(9) Must agree to participate in a data validation process to be conducted by a reputable independent contractor. Data will be kept confidential by the contractor to the extent applicable law allows and will be shared with the CDC, in aggregate form only (e.g., the hypertension control rate for the practice not individual patients' hypertension values);

(10) Must agree to sign, without revisions, a Business Associate Agreement with the contractor conducting the data validation.

(11) Must have a written policy in place about conducting periodic background checks on all providers and taking appropriate action based on the results of the check. CDC's contractor may also request to review the policy and any supporting information deemed necessary. In addition, a health system background check will be conducted by CDC or a CDC contractor that includes a search for The Joint Commission sanctions and current investigations for serious institutional misconduct (e.g., attorney general investigation). Eligibility status, based upon the above-referenced written policy, appropriate action, and background check, will be determined at the discretion of the CDC consistent with CDC's public health mission.

(12) Must agree to be recognized if selected and agree to participate in an interview to develop a success story that describes the systems and processes that support hypertension control among patients. Champions will be recognized on the Million Hearts® website. Strategies used by Champions that support hypertension control may be written into a success story, placed on the Million Hearts® website, and attributed to Champions.

In addition to meeting the requirements listed in parts 1-12 above, to be eligible to be recognized in the challenge, an individual or entity also must comply with the conditions or requirements set forth in each of the following paragraphs in this section.

Federal funds may not be used to develop COMPETES Act challenge applications or to fund efforts in support of a COMPETES Act challenge.

Individual applicants and individuals in a group practice must be free from convictions for 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, prescribing, or dispensing of controlled substances as verified through the Office of the Inspector General List of Excluded Individuals and Organizations. http://oig.hhs.gov/​exclusions/​background.asp.

Individual applicants must be free from serious sanctions, such as those for misuse or mis-prescribing of prescription medications. Eligibility status of individual applicants with serious sanctions will be determined at the discretion of CDC. CDC or CDC's contractor may perform background checks on individual clinicians and medical practices.

Champions previously recognized through the 2013, 2014, 2015, 2017, and 2018 Million Hearts® Hypertension Control Challenges retain their designation as a “Champion” and are not eligible to be named a Champion in the 2019 challenge.

An individual or organization shall not be disqualified from the 2019 Million Hearts Hypertension Control Challenge for utilizing Federal facilities or consulting with Federal employees during a competition so long as the facilities and Federal employees are made available to all individuals and organizations participating in the competition on an equal basis.

By participating in this challenge, an individual or organization agrees to assume any and all risks related to participating in the challenge. Individuals or organizations also agree to waive claims against the Federal Government and its related entities, except in the case of willful misconduct, when participating in the challenge, including claims for injury; death; damage; or loss of property, money, or profits, and including those risks caused by negligence or other causes.

By participating in this challenge, individuals and organizations agree to protect the Federal Government against third party claims for damages arising from or related to challenge activities.

Individuals or organizations are not required to hold liability insurance related to participation in this challenge.

No cash prize will be awarded. Champions will receive national recognition.

Registration Process for Participants

To participate and submit an application, interested parties should go to https://millionhearts.hhs.gov or https://www.challenge.gov. On this site, applicants will find the application form and the rules and guidelines for participating. Information required of the applicants on the application form includes:

  • The size of the applicant's adult primary care patient population, a summary of known patient demographics (e.g., age distribution), and any noteworthy patient population characteristics (such as urban/rural location, percent minority, percent enrolled in Medicaid, percent with no health insurance, and percent whose primary language is not English).
  • The number of the applicant's adult primary care patients, ages 18-85, who were seen during the measurement year Start Printed Page 3449and had a hypertension diagnosis (i.e. hypertension prevalence).
  • The applicant's current hypertension control rate for their hypertensive population ages 18-85 during the measurement year is required. In determining the hypertension control rate, CDC defines “hypertension control” as a blood pressure reading <140 mmHg systolic and <90 mmHg diastolic among patients ages 18-85 with a diagnosis of hypertension.
  • The hypertension control rate should be for the provider's or health system's entire adult hypertensive patient population ages 18-85, and not limited to a sample. The provider's or health system's hypertensive population ages 18-85 should include only patients in primary care or in cardiology care in the case of a cardiology clinic. Patients seen only in dental care or behavioral health care should not be included. Examples of ineligible data submissions include hypertension control rates that are limited to treatment cohorts from research studies or pilot studies, patients limited to a specific age range (such as 18-35 only), or patients enrolled in limited scale quality improvement projects.
  • Completion of a checklist of sustainable clinic systems or processes that support hypertension control. These may include provider or patient incentives, dashboards, staffing characteristics, electronic record keeping systems, reminder or alert systems, clinician reporting, service modifications, etc. The estimated burden for completing the application form is 30 minutes.

Amount of the Prize

Up to 35 of the highest scoring clinical practices or health systems will be recognized as Million Hearts® Hypertension Control Champions. No cash prize will be awarded. Champions will receive national recognition.

Basis Upon Which Winner Will Be Selected

The application will be scored based on two hypertension control rates: one for your most recent 12-month reporting period ending not earlier than December 31, 2017, and consistency with a previous rate for a 12-month period 1 year before the current rate.

Phase 1 includes verification of the hypertension prevalence and blood pressure control rate data submitted and a background check. For applicants whose Phase 1 data is verified as accurate and who pass the background check without concerns, phase 2 consists of a medical chart review. The medical chart review will verify the diagnosis of hypertension during the reporting year as well as blood pressure being controlled to <140 mmHg systolic and <90 mmHg diastolic.

A CDC-sponsored panel of three to five experts consisting of HHS/CDC staff will review the applications that pass phase 2 to select Champions. Final selection of Champions will take into account all the information from the application form, the background check, and data verification and validation. In the event of tied scores based on the hypertension control rate at any point in the selection process, geographic location may be taken into account to ensure a broad distribution of champions.

Some Champions will participate in a post-challenge telephone interview. The interview will include questions about the strategies employed by the individual practice or organization to achieve high rates of hypertension control, including barriers and facilitators for those strategies. The interview will focus on systems and processes and should not require preparation time by the Champion. The estimated time for the interview is two hours, which includes time to review the interview protocol with the interviewer, respond to the interview questions, and review a summary about the Champion's practices. The summary may be written as a success story and will be posted on the Million Hearts® website.

Additional Information

Information received from applicants will be stored in a password protected file on a secure server. The challenge website will not include confidential or proprietary information about individual applicants, as described further below. The database of information submitted by applicants will not be posted on the website. Information collected from applicants will include general details, such as the business name, address, and contact information of the applicant. This type of information is generally publicly available. The application will collect and store only aggregate clinical data through the application process; no individually identifiable patient data will be collected or stored. Confidential or propriety data, clearly marked as such, will be secured to the full extent allowable by law.

Information for selected Champions, such as the provider, practice, or health system's name, location, hypertension control rate, and clinic practices that support hypertension control will be shared through press releases, the challenge website, and Million Hearts® and HHS/CDC resources.

Summary data on the types of systems and processes that all applicants use to control hypertension may be shared in documents or other communication products that describe generally used practices for successful hypertension control. HHS/CDC will use the summary data only as described.

Compliance With Rules and Contacting Contest Winners

Finalists and the Champions must comply with all terms and conditions of these Official Rules, and winning is contingent upon fulfilling all requirements herein. The initial finalists will be notified by email, telephone, or mail after the date of the judging.

Privacy

If Contestants choose to provide HHS/CDC with personal information by registering or filling out the submission form through the Challenge.gov website, that information is used to respond to Contestants in matters regarding their submission, announcements of applicants, finalists, and winners of the Contest.

General Conditions

HHS/CDC reserves the right to cancel, suspend, and/or modify the Contest, or any part of it, for any reason, at HHS/CDC's sole discretion.

Participation in this Contest constitutes a contestants' full and unconditional agreement to abide by the Contest's Official Rules found at https://www.Challenge.gov and https://millionhearts.hhs.gov/​.

Start Authority

Authority: 15 U.S.C. 3719.

End Authority Start Signature

Dated: February 6, 2019.

Sandra Cashman,

Executive Secretary, Centers for Disease Control and Prevention.

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[FR Doc. 2019-01914 Filed 2-11-19; 8:45 am]

BILLING CODE 4163-18-P