Proposed Data Collection Submitted for Public Comment and Recommendations

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Federal RegisterDec 21, 2021
86 Fed. Reg. 72239 (Dec. 21, 2021)

AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION:

Notice with comment period.

SUMMARY:

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled 2022 Million Hearts® Hypertension Control Champions Challenge. This program will be used to identify clinicians, clinical practices, and health systems that have exceptional rates of hypertension control and recognize them as 2022 Million Hearts® Hypertension Control Champions.

DATES:

CDC must receive written comments on or before February 22, 2022.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2021-0130 by any of the following methods:

Federal eRulemaking Portal: Regulations.gov . Follow the instructions for submitting comments.

Mail: Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H21-8, Atlanta, Georgia 30329.

Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to regulations.gov.

Please note: Submit all comments through the Federal eRulemaking portal (regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT:

To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H21-8, Atlanta, Georgia 30329; phone: 404-639-7118; Email: omb@cdc.gov.

SUPPLEMENTARY INFORMATION:

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Enhance the quality, utility, and clarity of the information to be collected;

4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses; and

5. Assess information collection costs.

Proposed Project

2022 Million Hearts® Hypertension Control Champions Challenge (OMB Control No. 0920-0976, Exp. 11/30/2022)—Revision—National Center for Chronic Disease and Public Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Million Hearts® is a national initiative to prevent one million heart attacks and strokes by 2022. In order to prevent one million cardiovascular events ( e.g., heart attacks and strokes), we need to decrease smoking, sodium consumption and physical inactivity by 20%; improve performance on quality-of-care measures for appropriate aspirin use, blood pressure control, cholesterol management, and smoking cessation to 80%; and improve outcomes for priority populations disproportionately burdened by cardiovascular disease.

Over the last nine 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% blood pressure control (defined as <140/<90 mm Hg) 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, kidney failure, and other related cardiovascular events. For more information about the initiative, visit https://millionhearts.hhs.gov/. Million Hearts® is a registered trademark of the Department of Health and Human Services.

The challenge is an important way to call attention to the need for improved hypertension 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 2022 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.

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 2022 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 the most recent 12-month reporting period ( e.g., 1/1/2021-12/31/2021) and a previous rate for the 12-month period immediately preceding the most recent reporting period ( e.g., 1/1/2020-12/31/2020). 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 improvements in blood pressure control. A copy of the application form will be available on the Challenge website for the duration of the Challenge.

To be eligible for recognition as a Million Hearts® Hypertension Control 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 eligibility requirements and satisfy the requirements in one of the following subparts:

a. Be a U.S. licensed clinician ( i.e., MD, DO, nurse practitioner, or physician assistant), practicing in any U.S. setting, who provides ongoing 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, 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 (blood pressure <140 mm Hg systolic and <90 mm Hg diastolic) 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® website. Strategies used by Champions that support hypertension control may be written into a success story, placed on the Million Hearts® website, used in press releases, publications, and attributed to Champions.

No cash prize will be awarded. Champions will receive national recognition. CDC requests OMB approval for an estimated 215 annual burden hours. There are no costs to respondents other than their time to participate.

Estimated Annualized Burden Hours

Type of respondents Form name Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden (in hours)
Physician, practices and healthcare systems Million Hearts® Hypertension Control Champion Application Form 200 1 30/60 100
Finalists Million Hearts® Hypertension Control Champion Data Verification Form 40 1 2 80
Champions Interview Guide: Million Hearts® Hypertension Control Champion 35 1 1 35
Total 215

Jeffrey M. Zirger,

Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.

[FR Doc. 2021-27600 Filed 12-20-21; 8:45 am]

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