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

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Federal RegisterAug 14, 2015
80 Fed. Reg. 48863 (Aug. 14, 2015)

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 Million Hearts® Hypertension Control Challenge on August 18, 2015. The challenge will be open until October 31, 2015.

Million Hearts® 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® 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® 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, 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: millionhearts@cdc.gov; 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® 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, prescription, or dispensing of controlled substances as verified through the Office of the 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® 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® 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® 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 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