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Comments requested in the Federal Register for the development of guidance for Health Risk Assessments (HRAs) We received this collection of public comments from numerous public sources and in multiple formats. We have attempted to make all of these comments Section 508 compliant, but there are sections within this document that we cannot ensure will be compliant. If you experience issues reading this document, please contact us and identify, if possible, where you encountered problems. [email protected] Office of Prevention through Healthcare Office of the Associate Director for Policy Centers for Disease Control and Prevention American Academy of Family Physicians Recv’d 1/13/2011 Comments on the Development of Health Risk Assessment Guidance- The American Cancer Society Cancer Action Network (ACS CAN), the American Diabetes Association (ADA), and the American Heart Association (AHA) are pleased to submit joint public comments to the Centers for Disease Control and Prevention (CDC) and the Department of Health and Human Services (HHS) regarding the development of guidance for Health Risk Assessments (HRAs) pursuant to Section 4103 of the Affordable Care Act (ACA). I. Integration of the HRA tool into the Personalized Prevention Plan As stipulated in Section 4103 of the Affordable Care Act, we strongly recommend that the Health Risk Assessment (HRA) and the annual wellness visit be integrated into a single entity – the personalized prevention plan service. The HRA is a statutorily mandated component of the personalized prevention plan service and is a critical first step toward helping health care practitioners to create a customized health care plan for patients that optimizes delivery of care. The HRA is not another “element” or component of the annual wellness visit that simply has to be checked off, but rather it is the mechanism that drives the content of the office visit and personalizes the prevention plan service. As part of the process for developing guidelines for the HRA, the office visit’s structure must be revisited in order to more clearly define and establish the interplay between the elements, the HRA, and the prevention plan visit. The final rule on the new annual wellness visit issued by the Centers for Medicare and Medicaid Services (CMS) did not include or make reference to the relationship between the HRA and the office visit. Consequently, CMS is requiring all the possible elements of the prevention plan service provided for in the statute to be a mandatory part of the office visit. Such an overly proscriptive approach to the office visit is unnecessary and fails to optimize this visit’s potential for improving the health and well-being of Medicare beneficiaries. Instead of a one-size-fits all office visit with a long list of required elements, the HRA must play a role in addressing many of those elements prior to the office visit. This approach allows clinicians to spend the bulk of their time during the visit on a personalized and comprehensive conversation about the patients risk profile in addition to identifying the steps the patient is willing to take to modify that risk. We recommend that CDC stipulate that required elements can be addressed, at least to some degree, as part of the HRA. This information will help clarify how the personalized prevention plan visit takes into account the results of the HRA as required by statute, which will in turn provide practitioners flexibility and discretion to determine how best to set up their prevention plan service. The HRA should serve as the primary tool for establishing/updating medical history and screening for certain risks while the office visit should be dedicated primarily to personalized counseling and planning based on the HRA and the practitioner’s own expertise and/or knowledge of the patient. This approach will help avoid services that may be unnecessary for a particular patient while ensuring that appropriate services specific to the patient’s needs are not overlooked. II. General Comments and Guidance on HRAs In general, we recommend that the HRA should be: • The key tool for guiding the visit with the healthcare provider, thus allowing the content of the appointment to be tailored to the needs of that particular patient based on their risk profile. • Available/completed prior to a preventive medicine visit with health care provider. • A robust enough questionnaire to uncover both health risks and disease symptoms, as well as the patient’s demographic profile, that may reveal risks, health factors, and conditions amenable to intervention and modification once identified, such as diabetes, cancer, cardiovascular disease, and stroke. • Coupled with written, personalized information in layman’s terms outlining discovered risks and suggestions for risk modifications. • Available in multiple formats from multiple vendors (i.e., do not require a single, standardized HRA) and available in the community, such as through State Health Insurance Assistance Programs (SHIP) that provide assistance to Medicare beneficiaries. • Adequately reimbursed, taking into account the amount of time practices will need not only to analyze and interpret the HRA results, but also to provide various options for administering the assessment (e.g., some patients will be unable to complete a web-based HRA for various reasons and may need to complete a paper- based form in the office). III. HRA Content and Design We strongly recommend framing the standard HRA requirements in a manner consistent with the elements currently required by CMS for the annual wellness visit so as to maximize the integration of the HRA and annual wellness visit. To that end, we would request that the HRA must be capable of performing and reporting the following: A. Establishing or updating the individual’s medical and family history; at a minimum, this includes the collection and documentation of the following: - Past medical and surgical history, including experiences with illnesses, hospital stays, operations, allergies, injuries, and treatments. - Use or exposure to medications and supplements, including calcium and vitamins. - Medical events experienced by the individual’s parents, and siblings , including diseases that may be hereditary or place the individual at increased risk B. Establishing or updating a list of current providers and suppliers regularly involved in providing medical care to the individual; C. Gathering or updating of key demographic factors (marital status, level of education, socioeconomic status) that may put a person at greater risk, as well as age-, gender-, and risk-appropriate measurements, if known or available in the health record, including weight, height, body mass index (or waist circumference, if appropriate), blood pressure, cholesterol, blood glucose, tobacco use status, and any other routine measurements as deemed appropriate, based on the individual’s medical and family history; D. Screening for risk of any cognitive impairment. E. Generating or updating a written screening schedule for the next 5 to 10 years such as a checklist, that is appropriate for the individual’s age, gender and risk factors, based on the individual’s health status, screening history, and age- appropriate preventive services covered by Medicare; F. Asking questions to assess risk factors for common conditions and chronic diseases, including but not limited to cancer, diabetes, cardiovascular disease, stroke, depression, cognitive impairment, and functional ability and safety. In formulating these questions, experts in chronic disease should be consulted. These questions will enable the HRA to identify urgent priority health needs and generate (or update) a list of risk factors and conditions for which primary, secondary or tertiary interventions are recommended or are underway, and a list of treatment options and their associated risks and benefits. In order to assess risk for diabetes, cancer, heart disease, and stroke, questions should be included that capture information based on risk assessments and clinical guidelines developed by experts in these chronic disease areas. Questions to assess risk for diabetes should capture information on: blood pressure, cholesterol, overweight/obesity, history of prediabetes or being told one has an elevated blood glucose or A1c, family history of diabetes, history of gestational diabetes or past delivery of a baby weighing over 9 pounds, physical inactivity, age and race/ethnicity. Questions to assess risk for heart disease should include family history of heart disease, body weight, age, gender, race/ethnicity, diabetes, physical inactivity, tobacco use, diet quality, cholesterol levels, and blood pressure. Questions to assess risk for cancers should capture information on personal history of cancer, family history of cancer on both the maternal and paternal side (3 generations), smoking history and exposure to tobacco products, history of inflammatory bowel disease, and personal and family history of adenomatous polyps. For women, a history of maternal use of DES, hysterectomy status, history of benign breast biopsy confirmed proliferative lesions or lobular neoplasia, and use of hormone therapy. G. Screening for the individual’s potential (risk factors) for depression, including current or past experiences with depression or other mood disorders, based on the use of an appropriate screening instrument for persons without a current diagnosis of depression, which the health professional may select from various available screening questions or

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