[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)]
[Notices]
[Pages 48863-48866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20076]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Announcement of Requirements and Registration for 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: Thomas R. Frieden, MD, MPH, 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 Million Hearts[supreg] Hypertension Control Challenge on 
August 18, 2015. The challenge will be open until October 31, 2015.
    Million Hearts[supreg] is a national initiative to prevent one 
million heart attacks and strokes by 2017. Achieving this goal means 10 
million more Americans must have their blood pressure under control. 
Million Hearts[supreg] is working to control high blood pressure 
through clinical approaches, such as using health information 
technology to its fullest potential and integrating team-based 
approaches to health care, and community approaches, such as 
strengthening tobacco control and lowering sodium consumption. For more 
information about the initiative, visit www.millionhearts.hhs.gov.
    To support improved blood pressure control, HHS/CDC is announcing 
the 2015 Million Hearts[supreg] Hypertension Control Challenge. The 
challenge will improve understanding of successful implementation 
strategies at the health system level by motivating clinical practices 
and health systems to strengthen their hypertension control efforts. It 
will identify clinicians, clinical practices, and health systems that 
have exceptional rates of hypertension control and recognize them as 
Million Hearts[supreg] Hypertension Control Champions. To support 
improved quality of care delivered to patients with hypertension, 
Million Hearts[supreg] will document the systems, processes, and 
staffing that contribute to the exceptional blood pressure control 
rates achieved by Champions.
    Champions will receive local and national recognition.

DATES: Effective August 18, 2015. Office of Management and Budget 
control number 0920-0976 expires 7/31/2016.

FOR FURTHER INFORMATION CONTACT: 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-77, Chamblee, GA 30341, Telephone: 770-488-2424, Email: 
[email protected]; Attention: Hypertension Control Challenge.

SUPPLEMENTARY INFORMATION: 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).

Subject of Challenge Competition

    Entrants to the 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 a 12-
month period and a previous rate for a 12 month period a year or more 
before. Entrants will also be asked to provide the prevalence of 
hypertension in their population, and describe some population 
characteristics and the sustainable systems used by the practice or 
health system that support continued improvements in blood pressure 
control.

Eligibility Rules for Participating in the Competition

    To be eligible to be recognized as a Hypertension Champion under 
this challenge, an individual or entity --
    (1) Shall have completed the nomination 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;
    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. Or 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. Or 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 check data submitted;
    (5) Must treat a minimum of 500 adult patients annually and have a 
hypertension control rate of at least 70%;
    (6) May not be a Federal entity or Federal employee acting within 
the scope of their employment;
    (7) Shall not be an HHS employee working on their applications or 
submissions during assigned duty hours;
    (8) Shall not be an employee 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 and will be shared with the CDC to the 
extent applicable law allows, in aggregate form only (i.e., the 
hypertension control rate for the practice not individual hypertension 
values);
    (10) Must have a written policy in place that conducts periodic 
background checks on all providers and takes appropriate action 
accordingly, if individual or entity is a health system. 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). CDC's contractor may also request the 
policy and any supporting information deemed necessary.
    (11) 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] 
Web site. Strategies used by Champions that support hypertension 
control may be written into a success story, placed on the Million 
Hearts[supreg] Web site, and attributed to Champions.
    Federal grantees may not use Federal funds to develop COMPETES Act 
challenge applications unless consistent with the purpose of their 
grant award and specifically requested to do so due to competition 
design.
    Federal contractors may not use Federal funds from a contract to 
develop COMPETES Act challenge applications or to fund efforts in 
support of a COMPETES Act challenge.
    Individual nominees and individuals in a group practice 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

[[Page 48865]]

Inspector General List of Excluded Individuals and Entities. http://oig.hhs.gov/exclusions/background.asp.
    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.
    Champions previously recognized through the 2013 and 2014 Million 
Hearts Hypertension Control Challenge retain their designation as a 
``Champion'' and are not eligible to be named a Champion in the 2015 
challenge.
    An individual or entity shall not be deemed ineligible because the 
individual or entity used Federal facilities or consulted with Federal 
employees during a competition if the facilities and employees are made 
available to all individuals and entities 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 or 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.

Registration Process for Participants

    To participate, interested parties should go to 
www.millionhearts.hhs.gov. On this site, nominees will find the entry 
form and the rules and guidelines for participating. Information 
required of the nominees on the nomination form includes:
     The size of the nominee's adult patient population, a 
summary of known patient demographics (e.g., age distribution), and any 
noteworthy patient population characteristics.
     The number of the nominee's adult patients who were seen 
during the past year and had a hypertension diagnosis (i.e., 
hypertension prevalence).
     The nominee's current hypertension control rate for their 
hypertensive population. In addition, the hypertension control rate 
during the previous 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 with a 
diagnosis of hypertension.
    The hypertension control rate should be for the provider's or 
health system's entire adult hypertensive patient population, not 
limited to a sample. 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), or patients enrolled in limited scale quality 
improvement projects.
     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 nomination form is 30 
minutes.

Recognition

    Up to a total of 35 of the highest scoring clinical practices or 
health systems will be recognized as Million Hearts[supreg] 
Hypertension Control Champions.

Basis Upon Which Winner Will Be Selected

    The nomination will be scored based on hypertension control rate 
(95% of score); and sustainable systems in the practice that support 
hypertension control (5% of score).
    Nominees with the highest score will be required to participate in 
a two-phase process to verify their data. Nominees who are non-
compliant or non-responsive with the data requests or timelines will be 
removed from further consideration. Phase 1 includes verification of 
the hypertension prevalence and blood pressure control rate data 
submitted and a background check. For nominees whose Phase 1 data is 
verified as accurate, phase 2 consists of a medical chart review.
    A CDC-sponsored panel of three to five experts consisting of HHS/
CDC staff will review the nominations that pass phase 2 to select 
Champions. Final selection of Champions will take into account all the 
information from the nomination form, the background check, and data 
verification. In the event of tie scores at any point in the selection 
process, geographic location may be taken into account to ensure a 
broad distribution of champions across rural or more populated areas.
    Some Champions will participate in a post-challenge telephone 
interview. The interview will include questions about the strategies 
employed by the individual 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 data about the Champion's practices. 
The summary will be written as a success story and will be posted on 
the Million Hearts[supreg] Web site.

Additional Information

    Information received from nominees will be stored in a password 
protected file on a secure server. The challenge Web site may post the 
number of nominations received but will not include information about 
individual nominees. The database of information submitted by nominees 
will not be posted on the Web site. Information collected from nominees 
will include general details, such as the business name, address, and 
contact information of the nominee. This type of information is 
generally publicly available. The nomination will collect and store 
only aggregate clinical data through the nomination process; no 
individual 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 Web site, and Million 
Hearts[supreg] and HHS/CDC resources.
    Summary data on the types of systems and processes that all 
nominees 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.

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Compliance With Rules and Contacting Contest Winners

    Finalists and 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

    Personal information provided by entrants on the nomination form 
through the challenge Web site will be used to contact selected 
finalists. Information is not collected for commercial marketing. 
Winners are permitted to cite that they won this challenge.
    The names, cities, and states of selected Champions will be made 
available in promotional materials and at recognition events.

General Conditions

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

    Authority: 15 U.S.C. 3719

    Dated: August 3, 2015.
Pamela J. Cox,
Director, Division of the Executive Secretariat, Office of the Chief of 
Staff, Centers for Disease Control and Prevention.
[FR Doc. 2015-20076 Filed 8-13-15; 8:45 am]
 BILLING CODE 4163-18-P