Centers for Medicare and Medicaid Services
Department of Health and Human Services
Attention: CMS-1429 – P
P.O. Box 8012
Baltimore, Maryland 21244-8012

Re: CMS File Code – 1429-P:
Comments on Revision to Payment Policies Under Physician Fee Schedule for 2005
Comments on Section 611 – Initial Preventive Physical Examination

September 24, 2004

Dear Sir or Madam:

The Alzheimer's Association appreciates the opportunity to comment on the Initial Preventive Physical Examination pursuant to Section 611 of the Medicare Prescription, Drug, Improvement and Modernization Act of 2003 (MMA), published in the federal register on August 5, 2004. The Alzheimer's Association is the premier source of information and support for the 4.5 million Americans with Alzheimer's disease. Through its national network of chapters, it offers a broad range of programs and services for people with the disease, their families, and caregivers and represents their interests on Alzheimer-related issues before federal, state, and local government and with health and long term care providers. The largest private funder of Alzheimer research, the Association has committed nearly $150 million toward research into the causes, treatment, prevention, and cure of Alzheimer's disease.

In its proposed regulations, the Centers for Medicare and Medicaid Services (CMS) proposes to interpret the term, “Initial Preventive Physical Examination” to include a “review of the individual’s comprehensive medical and social history” and a “review of the individual’s functional ability and level of safety.” The Alzheimer’s Association believes that both of these assessments should include questions that would identify Medicare beneficiaries with possible Alzheimer’s disease or other dementias. Individuals identified through this process would need a follow-up diagnostic evaluation, which is already covered by Medicare.

We recommend the following revisions to the proposed regulations and implementation of this new benefit:

1. In §410.16(a)(1), the provision should be revised as follows:

“Review of the individual’s comprehensive medical and social history, including memory problems.”

With regard to Section §410.16(a)(1), in the review of the individual’s comprehensive medical and social history, beneficiaries should be asked whether they have memory problems severe enough to interfere with their ability to carry out routine daily activities. This question can be asked in-person. Alternatively, many physicians have a printed questionnaire that lists important medical conditions and is presented to the patient (or family member or other proxy informant) at the time of the first visit or mailed to the patient to be completed ahead of time. The condition “severe memory problems” can be easily added to the list. Since 1998, Kaiser Permanente has used a health status questionnaire for its elderly Medicare enrollees that includes the question, “Do you have any of the following health conditions?” and lists “severe memory problems” as one of 18 conditions. Approximately 5% of Kaiser enrollees (or their proxy informant) give a positive response to this question, and these individuals have been shown to be very likely to have cognitive impairment or dementia.

2. With regard to §410.16(a)(3), in the review of the individual’s functional ability and level of safety,” beneficiaries (or their family member or other proxy informant) should be asked about specific daily activities that are likely to be affected by loss of memory, executive function, and other cognitive abilities and likely to have important safety implications. Two such questions are:

• Do you get lost while walking or driving in familiar places?

• Do you have difficulty (or need help with) taking medications according to instructions?

These questions can be easily added to other questions about functional ability that will be included in the Initial Preventive Physical Examination and will provide important information about cognitive status and safety risks that are highly relevant for physicians and other health care providers.

Reasons for using the approach above rather than screening with a brief mental status questionnaire

Brief mental status tests are frequently used for research and often recommended for use in clinical evaluation of elderly people. These tests generally show acceptable to high accuracy for dementia when they are used in samples that include only people who have previously been determined to have either dementia or normal cognition and exclude people with delirium, mental illness, mental retardation, and other acute and chronic conditions that could affect their cognition. When used in general population samples and general medical settings where these other conditions have not been excluded, mental status test results are much less accurate and result in many false positives, especially for people who are less educated, foreign born, or for whom English is a second language.

For these reasons, the three consensus groups that have considered the use of brief mental status tests to screen for cognitive impairment or dementia in population samples and general medical settings have not recommended their use for this purpose. , , In 2003, the U.S. Preventive Services Task Force concluded that “current evidence does not support routine screening of patients in whom cognitive impairment is not otherwise suspected.”

All three consensus groups and the U.S. Preventive Services Task Force recommend that health care providers learn about and follow up on signs of possible dementia and respond to concerns expressed by the patient, family members, and other knowledgeable informants. The U.S Preventive Services Task Force concluded (some of this is also quoted above):

“Although current evidence does not support routine screening of patients in whom cognitive impairment is not otherwise suspected, clinicians should assess cognitive function whenever cognitive impairment or deterioration is suspected, based on direct observation, patient report, or concerns raised by family members, friends, or caretakers.”

Approximately 2% of people who are 65 years old have Alzheimer’s disease or other dementias. These individuals are much more likely to have vascular dementia than Alzheimer’s disease. The Alzheimer’s Association believes that the approach we propose will provide a more accurate identification of individuals with potential Alzheimer’s disease or other dementias. Beneficiaries identified during the initial preventive physical examination would then require a comprehensive diagnostic evaluation for Alzheimer’s disease or other dementias.

We appreciate the opportunity to comment on the proposed regulations regarding the initial preventive physical examination. The Alzheimer’s Association is ready to work with you, and to assist in identifying appropriate clinical experts, to assure early identification of beneficiaries with possible Alzheimer’s disease or dementia. Please feel free to contact Leslie B. Fried, Director of the Association’s Medicare Advocacy Project, (202) 662-8684 to further discuss these matters.

Sincerely,

Bonnie Hogue
Director, Federal and State Policy

Leslie B. Fried
Director, Medicare Advocacy Project

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