[Federal Register Volume 80, Number 183 (Tuesday, September 22, 2015)]
[Notices]
[Pages 57187-57189]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23990]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Announcement of Requirements and Registration for Healthcare 
Associated Venous Thromboembolism Prevention 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.

-----------------------------------------------------------------------

SUMMARY: The Centers for Disease Control and Prevention (CDC) located 
within the Department of Health and Human Services (HHS) announces the 
launch of the Healthcare Associated Venous Thromboembolism (HA-VTE) 
Prevention Challenge on November 2, 2015. The challenge will be open 
until January 10, 2016.
    Venous thromboembolism (VTE), blood clots occurring as deep vein 
thrombosis (DVT), pulmonary embolism (PE), or both, is an important and 
growing public health issue. Prevention of healthcare associated VTE 
(HA-VTE) is a national hospital safety priority. Many HA-VTEs can be 
prevented, but VTE prevention strategies and are still not being 
applied regularly or effectively across the United States.
    To support and promote HA-VTE prevention, HHS/CDC is announcing the 
2015 HA-VTE Prevention Challenge. The challenge will bring prestige to 
organizations that invest in VTE prevention, improve understanding of 
successful implementation strategies at the health system level, and 
motivate health systems to strengthen their VTE prevention efforts. The 
top-judged organizations found to have implemented innovative and 
effective VTE prevention strategies will be recognized as HA-VTE 
Prevention Champions. HHS/CDC will document these successful strategies 
and highlight the systems, processes, and staffing that contributed to 
exceptional VTE prevention outcomes achieved by Champions. Champions 
will receive a cash prize (if eligible) and other forms of recognition.

DATES: Contest begins on November 2, 2015 and ends on January 10, 2016.

FOR FURTHER INFORMATION CONTACT: Michele Beckman, Division of Blood 
Disorders, National Center on Birth Defects and Developmental 
Disabilities, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE., Mailstop E-64, Atlanta, GA 30329, Telephone: 404-498-6474, 
Fax: 404-498-6799, Attention: HA-VTE Prevention Challenge, Email: 
[email protected].

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 of the HA-VTE Prevention Challenge will be asked to 
describe the VTE prevention strategy and reasons that support the 
strategy choice developed by their organization. In addition, entrants 
will be asked to describe the specific intervention(s) (e.g. 
implementation of VTE protocols and order sets, risk assessment, 
electronic alerts, clinical decision support tools, performance 
monitoring systems and dashboards, patient and/or provider education 
and awareness, post-discharge follow-up, etc.), methods, and systems 
used to implement, support and evaluate the strategy. Entrants will be 
asked to submit at least one quantitative measure showing an increase 
of VTE prevention (e.g. number of patients assessed for VTE risk, 
number of at risk patients receiving appropriate VTE prevention, number 
of patients and/or providers receiving education on VTE prevention, 
etc.) and/or decrease in HA-VTE rates for the organization's population 
of interest. Each measure submitted must include two data points: One 
for the control or pre-intervention period and a second for the post-
intervention period. Control/pre-intervention and post-intervention 
measures must cover a period of at least six months. This information 
collection is approved by the Office of Management and Budget under OMB 
Control Number 0990-0390, expiration April 30, 2018.

Eligibility Rules for Participating in the Competition

    To be eligible to win a monetary prize under this challenge, an 
individual or entity--
    (1) Shall have completed and submitted the nomination form in its 
entirety to participate in the competition under the rules promulgated 
by HHS/CDC;
    (2) Must be a hospital, multi-hospital system, hospital network or 
managed care organization, incorporated in and maintaining a primary 
place of business in the United States that provides inpatient medical 
care for patients.
    (3) May not be a Federal entity or Federal employee acting within 
the scope of their employment (Federal entities or employees are 
eligible to participate in the challenge; however, they are not 
eligible to receive a monetary prize. Federal entities are eligible for 
non-monetary recognition only.);
    (4) Shall not be an HHS employee working on their applications or 
submissions during assigned duty hours;
    (5) Shall not be an employee or contractor at HHS/CDC;
    (6) Federal grantees may not use Federal funds to develop COMPETES 
Act challenge applications unless consistent with the purpose of their 
grant award.
    (7) 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 submission;
    (8) Must agree to participate in a data validation process to be 
conducted by an HHS/CDC-selected contractor. To the extent applicable 
law allows, data will be kept confidential by the contractor and will 
be shared with the CDC in aggregate form only; i.e., the VTE prevention 
coverage rate for the practice not individual data;
    (9) Must have a data management system (electronic or paper) that 
allows HHS/CDC or their contractor to check data submitted;
    (10) 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 healthcare-related 
fraud, theft, or other financial misconduct; and felony convictions 
relating to unlawful manufacture, distribution, prescription, or 
dispensing of controlled substances as verified through the Office of 
the Inspector General List of Excluded Individuals

[[Page 57188]]

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. HHS/CDC's contractor may 
perform background checks on individual clinicians or medical 
practices.
    (11) Health systems must have a written policy in place that 
conducts periodic background checks as described in (10) on all 
providers and takes appropriate action accordingly. In addition, a 
health system background check may be conducted, as deemed necessary, 
by HHS/CDC or an HHS/CDC contractor that includes a search for The 
Joint Commission sanctions and current investigations for serious 
institutional misconduct (e.g., attorney general investigation). HHS/
CDC's contractor may also request the policy and any supporting 
information deemed necessary.
    (12) Must agree to accept the monetary prize and be recognized if 
selected, and agree to participate in an interview to develop a success 
story that describes the systems and processes that support VTE 
prevention. Champions will be recognized on HHS/CDC Web sites. 
Strategies used by Champions that support VTE prevention may be written 
into a success story, placed on HHS/CDC Web sites, and attributed to 
Champions.
    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.
    Entrants who are a U.S. federal hospital, multi-hospital system, 
hospital network or managed care organization that provides inpatient 
medical care for patients may apply for non-monetary recognition. No 
monetary prize will be awarded.
    Entrants who are an international hospital, multi-hospital system, 
hospital network or managed care organization that provides inpatient 
medical care for patients may apply for non-monetary recognition. No 
monetary prize will be awarded.

Registration Process for Participants

    To participate, interested parties will navigate to 
www.challenge.gov. On this site, nominees will have access to the 
nomination form. Information required of the nominees on the nomination 
form includes:
     The organization name, address, and contact information of 
the nominee.
     The size, scope, and general demographic characteristics 
of the nominees' patient population.
     Details regarding the nominee's VTE prevention strategy 
and implementation including the population(s) observed, intervention, 
and methods of implementation. Examples of strategies include 
implementation of sustainable systems or processes that support VTE 
prevention. These may include but are not limited to implementation of 
VTE protocols and order sets, risk assessment, electronic alerts, 
clinical decision support tools, performance monitoring systems and 
dashboards, patient and/or provider education and post-discharge 
follow-up.
     A description of the observed results of the VTE 
prevention strategy including the pre-implementation and post-
implementation measures for the observed VTE prevention activity. 
Examples of outcome measures include but are not limited to the number 
of patients assessed for VTE risk, the number of at risk patients 
receiving appropriate VTE prevention, and the number of patients and/or 
providers receiving education on VTE prevention.
     A brief summary of the barriers and successes to 
implementation.
    The VTE prevention rates achieved should be for the organizations 
entire patient population observed as outlined in their strategy and 
intervention methods, not limited to a sample. Data on subpopulations 
is allowed, but must be inclusive of all patients seen during the 
stated time period of study. Examples of ineligible data submissions 
include VTE prevention interventions limited to treatment cohorts from 
clinical trials of novel anticoagulant drugs.
    The estimated burden for completing the nomination form is 30 
minutes to 1 hour.

Amount of the Monetary Prize

    An estimated 7 of highest scoring U.S. hospitals, multi-hospital 
systems, hospital networks and managed care organizations will be 
recognized as HA-VTE Prevention Champions and will receive a cash award 
of $10,000. A maximum of $70,000 will be awarded in this challenge. 
Additional honorable mention awards, pending availability of funds, may 
be made if the judges identify more than 7 deserving entries. Federal 
and international winners will receive non-monetary recognition but no 
prize.

Payment of the Monetary Prize

    Monetary prizes awarded under this challenge will be paid by 
electronic funds transfer and may be subject to Federal income taxes. 
HHS will comply with the Internal Revenue Service withholding and 
reporting requirements, where applicable.

Basis Upon Which Winner Will Be Selected

    Challenge submissions will be evaluated by a panel of three to five 
judges (CDC, HHS agencies such as the Agency for Healthcare Research 
and Quality and the Centers for Medicare and Medicaid Services, and 
external industry experts) using the information provided on, and in 
accordance with, the nomination form. The judges will score the 
nomination form using a rubric based on the following evaluation 
criteria: methods (30% of score); results (50% of score); and 
feasibility/utility (20% of score) of the strategy and interventions 
associated with the intended outcome of interest. Nominees with the 
highest score will be required to participate in a process to verify 
their data. Final selection will take into account all the information 
form the nomination form, the background check, and data verification. 
Geographic location and population treated may be used to break any 
ties in the event of tie scores at any point in the selection process. 
An estimated 7 organizations will be recognized as prize winners.
    Some Champions will participate in a post-challenge telephone 
interview. The interview will include questions about the strategies 
employed by the organization to achieve high rates of VTE prevention, 
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 one

[[Page 57189]]

hour, which includes time to review the interview protocol with the 
interviewer, respond to the interview questions, and review a summary 
report about the Champion's practices. The summary will be written as a 
success story and will be posted on the CDC 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. Personal information collected and 
stored from nominees will only include general details, such as the 
organization name, address, and contact information of the nominee. 
This type of information is generally publically available. The 
nomination form and submission 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 hospital or health 
system's name, location, VTE prevention outcomes, and practices that 
support HA-VTE prevention will be shared through press releases, the 
challenge Web site, social media, and other HHS/CDC resources. Summary 
data on the types of systems and processes used to increase VTE 
prevention will be shared in documents or other communication products 
that describe generally used practices for successful VTE prevention. 
HHS/CDC will use the summary data only as described.

Compliance With Rules and Contacting Contest Winners

    Finalists must comply with all terms and conditions of these 
official rules, and winning is contingent upon fulfilling all 
requirements herein. The finalists will be notified by email, 
telephone, or mail after the date of 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 HHS/CDC's educational materials on VTE prevention and at 
recognition events.

General Conditions

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

    Dated: September 15, 2015.
Sandra Cashman,
Acting Director, Division of the Executive Secretariat, Office of the 
Chief of Staff, Centers for Disease Control and Prevention.
[FR Doc. 2015-23990 Filed 9-21-15; 8:45 am]
BILLING CODE 4163-18-P