[Federal Register Volume 84, Number 29 (Tuesday, February 12, 2019)]
[Notices]
[Pages 3447-3449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01914]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Announcement of Requirements and Registration for the 2019 
Million Hearts[supreg] Hypertension Control Challenge

    Authority: 15 U.S.C. 3719.

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.

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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[supreg] Hypertension Control 
Challenge.
    Million Hearts[supreg] 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[supreg] 
Hypertension Control Champions. To support improved quality of care 
delivered to patients with hypertension, Million Hearts[supreg] 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.

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: [email protected]; subject line of 
email: Million Hearts Hypertension Control Challenge; Attention: Mary 
George.

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[supreg] 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[supreg] 
Hypertension Control

[[Page 3448]]

Champion 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[supreg] 
website. Strategies used by Champions that support hypertension control 
may be written into a success story, placed on the Million 
Hearts[supreg] 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[supreg] 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

[[Page 3449]]

and 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[supreg] 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[supreg] 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[supreg] 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/.

    Authority: 15 U.S.C. 3719.

    Dated: February 6, 2019.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2019-01914 Filed 2-11-19; 8:45 am]
 BILLING CODE 4163-18-P