Announcement of Requirements and Registration for Million Hearts® Hypertension Control Challenge, 16595-16597 [2017-06670]
Download as PDF
Federal Register / Vol. 82, No. 64 / Wednesday, April 5, 2017 / Notices
Prevention and the Agency for Toxic
Substances and Disease Registry.
Claudette Grant,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2017–06673 Filed 4–4–17; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention (CDC)
SUPPLEMENTARY INFORMATION:
Announcement of Requirements and
Registration for Million Hearts®
Hypertension Control Challenge
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
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®
Hypertension Control Challenge.
Million Hearts® is a national initiative
to prevent one million heart attacks and
strokes by 2022. Achieving this goal
means 10 million more Americans must
have their blood pressure under control.
Million Hearts® 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
promoting physical activity. For more
information about the initiative, visit
https://millionhearts.hhs.gov/.
To support improved blood pressure
control, HHS/CDC is announcing the
2017 Million Hearts® 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® 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.
jstallworth on DSK7TPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
15:11 Apr 04, 2017
Jkt 241001
The Challenge will run from
April 7, 2017 through June 2, 2017.
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–73, Chamblee, GA 30341,
Telephone: 770–488–2424, Email:
millionhearts@cdc.gov; subject line of
email: Million Hearts Hypertension
Control Challenge; Attention: Mary
George.
DATES:
Award Approving Official: Anne
Schuchat, MD, Acting Director, Centers
for Disease Control and Prevention, and
Administrator, Agency for Toxic
Substances and Disease Registry
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).
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 your most recent 12month reporting period and a previous
rate for a 12 month period 1 to 2 years
before the current rate. Entrants will
also be asked to provide the prevalence
of hypertension in their population,
describe some population
characteristics that might present
significant challenges and barriers in
controlling hypertension. Entrants with
patients presenting with these
challenges, as well entrants with
systems and processes in place that
support hypertension control and are
likely to endure, such as electronic
reminder systems or team based care,
will be taken into consideration in
selection.
Nominations will be scored and
judged separately by size and type of
nominee in the categories listed below.
CDC does not guarantee that a specific
proportion of Champions will be
selected from each category.
• Small individual providers or
practices (500–49,999 covered lives)
• Large providers or practices (50,000
or more covered lives)
• Health Systems
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
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
16595
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 to the extent applicable law
allows and will be shared with the CDC,
in aggregate form only (i.e., the
hypertension control rate for the
practice not individual hypertension
values);
(10) Must agree to sign a Business
Associate Agreement with the
contractor conducting the data
validation.
(11) Must have a written policy in
place regarding conducting periodic
background checks on all providers and
E:\FR\FM\05APN1.SGM
05APN1
jstallworth on DSK7TPTVN1PROD with NOTICES
16596
Federal Register / Vol. 82, No. 64 / Wednesday, April 5, 2017 / Notices
taking appropriate action based on the
results of the check. CDC’s contractor
may also request 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.,
investigations for professional medical
misconduct). 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® Web site.
Strategies used by Champions that
support hypertension control may be
written into a success story, placed on
the Million Hearts® 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, prescribing,
or dispensing of controlled substances
as verified through the Office of the
Inspector General List of Excluded
Individuals and Entities. https://
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. Eligibility
status of individual nominees with
serious sanctions will be determined at
the discretion of CDC. CDC’s contractor
may perform background checks on
individual clinicians or medical
practices.
Champions previously recognized
through the 2013, 2014, and 2015
Million Hearts Hypertension Control
Challenge retain their designation as a
VerDate Sep<11>2014
15:11 Apr 04, 2017
Jkt 241001
‘‘Champion’’ and are not eligible to be
named a Champion in the 2017
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.
Champions will receive local and
national recognition.
Registration Process for Participants:
To participate, interested parties
should go to https://
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
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
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.
• 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 nomination form is 30 minutes.
Amount of the Prize:
Up to a total of 40 of the highest
scoring clinical practices or health
systems will be recognized as Million
Hearts® Hypertension Control
Champions.
Basis upon Which Winner Will Be
Selected:
The nomination will be scored based
on hypertension control rate (at least
90% of score); and sustainable systems
in the practice that support
hypertension control (up to 5% of
score); and patient population that is
high risk (up to 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 nonresponsive 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, representing
potentially underserved populations.
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
E:\FR\FM\05APN1.SGM
05APN1
jstallworth on DSK7TPTVN1PROD with NOTICES
Federal Register / Vol. 82, No. 64 / Wednesday, April 5, 2017 / Notices
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® 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 confidential or proprietary
information about individual nominees,
as described further below. 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®
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.
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 Web
site, that information is used to respond
to Contestants in matters regarding their
submission, announcements of entrants,
VerDate Sep<11>2014
15:11 Apr 04, 2017
Jkt 241001
finalists, and winners of the Contest.
Information is not collected for
commercial marketing. Champions are
permitted to cite that they were selected
as Champions for the 2017 Million
Hearts Hypertension Control Challenge.
General Conditions:
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. If the Challenge is
cancelled, suspended, and/or modified,
HHS/CDC will inform the public
through the publication of a notice in
the Federal Register.
Participation in this Contest
constitutes a contestants’ full and
unconditional agreement to abide by the
Contest’s Official Rules found at
www.Challenge.gov.
Authority: 15 U.S.C. 3719.
Dated: March 30, 2017.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2017–06670 Filed 4–4–17; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0726]
Antibody Mediated Rejection in Kidney
Transplantation; Public Workshop;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing a public workshop
regarding new developments and
scientific issues related to antibody
mediated rejection (AMR) in kidney
transplantation. This public workshop
is intended to provide information for
and gain perspective from individuals,
industry, health care professionals,
researchers, public health organizations,
patients, patient care providers, and
other interested persons on various
aspects of clinical development of
medical products for prophylaxis and/or
treatment of AMR in kidney transplant
recipients, including clinical trial
design and endpoints. The input from
this public workshop will also help in
developing topics for future discussion.
DATES: The public workshop will be
held on April 12, 2017, from 8 a.m. to
6 p.m. and April 13, 2017, from 8:30
a.m. to 1:30 p.m. Submit either
SUMMARY:
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
16597
electronic or written comments on this
public workshop by April 27, 2017.
Late, untimely filed comments will not
be considered. Electronic comments
must be submitted on or before April 27,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of April 27, 2017. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date. See the SUPPLEMENTARY
INFORMATION section for registration date
and information. Workshop updates and
the workshop agenda will be made
available at: https://www.fda.gov/Drugs/
NewsEvents/ucm532070 prior to the
workshop.
The public workshop will
be held at the Tommy Douglas
Conference Center, 10000 New
Hampshire Ave., Silver Spring, MD
20903. The conference center’s phone
number is 240–645–4000.
You may submit comments as
follows:
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
E:\FR\FM\05APN1.SGM
05APN1
Agencies
[Federal Register Volume 82, Number 64 (Wednesday, April 5, 2017)]
[Notices]
[Pages 16595-16597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-06670]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention (CDC)
Announcement of Requirements and Registration for Million
Hearts[supreg] Hypertension Control Challenge
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
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 Million Hearts[supreg] Hypertension Control Challenge.
Million Hearts[supreg] is a national initiative to prevent one
million heart attacks and strokes by 2022. 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 promoting physical activity. For more
information about the initiative, visit https://millionhearts.hhs.gov/.
To support improved blood pressure control, HHS/CDC is announcing
the 2017 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, strategies,
processes, and staffing that contribute to the exceptional blood
pressure control rates achieved by Champions.
DATES: The Challenge will run from April 7, 2017 through June 2, 2017.
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-73, Chamblee, GA 30341, Telephone: 770-488-2424, Email:
millionhearts@cdc.gov; subject line of email: Million Hearts
Hypertension Control Challenge; Attention: Mary George.
SUPPLEMENTARY INFORMATION:
Award Approving Official: Anne Schuchat, MD, Acting Director,
Centers for Disease Control and Prevention, and Administrator, Agency
for Toxic Substances and Disease Registry
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).
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 your
most recent 12-month reporting period and a previous rate for a 12
month period 1 to 2 years before the current rate. Entrants will also
be asked to provide the prevalence of hypertension in their population,
describe some population characteristics that might present significant
challenges and barriers in controlling hypertension. Entrants with
patients presenting with these challenges, as well entrants with
systems and processes in place that support hypertension control and
are likely to endure, such as electronic reminder systems or team based
care, will be taken into consideration in selection.
Nominations will be scored and judged separately by size and type
of nominee in the categories listed below. CDC does not guarantee that
a specific proportion of Champions will be selected from each category.
Small individual providers or practices (500-49,999
covered lives)
Large providers or practices (50,000 or more covered
lives)
Health Systems
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 to the extent applicable law allows and
will be shared with the CDC, in aggregate form only (i.e., the
hypertension control rate for the practice not individual hypertension
values);
(10) Must agree to sign a Business Associate Agreement with the
contractor conducting the data validation.
(11) Must have a written policy in place regarding conducting
periodic background checks on all providers and
[[Page 16596]]
taking appropriate action based on the results of the check. CDC's
contractor may also request 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., investigations for professional medical
misconduct). 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]
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, prescribing, or dispensing of
controlled substances as verified through the Office of the Inspector
General List of Excluded Individuals and Entities. https://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.
Eligibility status of individual nominees with serious sanctions will
be determined at the discretion of CDC. CDC's contractor may perform
background checks on individual clinicians or medical practices.
Champions previously recognized through the 2013, 2014, and 2015
Million Hearts Hypertension Control Challenge retain their designation
as a ``Champion'' and are not eligible to be named a Champion in the
2017 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. Champions will receive local and
national recognition.
Registration Process for Participants:
To participate, interested parties should go to https://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.
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 nomination form is 30
minutes.
Amount of the Prize:
Up to a total of 40 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
(at least 90% of score); and sustainable systems in the practice that
support hypertension control (up to 5% of score); and patient
population that is high risk (up to 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,
representing potentially underserved populations.
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
[[Page 16597]]
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 confidential or
proprietary information about individual nominees, as described further
below. 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.
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 Web site, that information is used to respond to
Contestants in matters regarding their submission, announcements of
entrants, finalists, and winners of the Contest. Information is not
collected for commercial marketing. Champions are permitted to cite
that they were selected as Champions for the 2017 Million Hearts
Hypertension Control Challenge.
General Conditions:
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. If the Challenge is cancelled, suspended, and/or modified,
HHS/CDC will inform the public through the publication of a notice in
the Federal Register.
Participation in this Contest constitutes a contestants' full and
unconditional agreement to abide by the Contest's Official Rules found
at www.Challenge.gov.
Authority: 15 U.S.C. 3719.
Dated: March 30, 2017.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2017-06670 Filed 4-4-17; 8:45 am]
BILLING CODE 4163-18-P