We appreciate the opportunity to comment on the proposed regulations  regarding the initial preventive
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We appreciate the opportunity to comment on the proposed regulations regarding the initial preventive

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www.alz.org Washington 202 393 7737 phonePublic Policy Office 2109 facsimile 1319 F Street, NW, Suite 710 Washington, DC 20004-1106 September 24, 2004 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 ents on Section 611 – Initial Preventive Physical Examination 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, ...

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www.alz.org
Washington
202 393 7737
phone
Public Policy Office
202 393 2109
facsimile
1319 F Street, NW, Suite 710
Washington, DC
20004-1106
September 24, 2004
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
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.
Specific Recommendations
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.
1
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
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
1
Brody KK, Johnson RE, Ried LD, Carder PC, Perrin N. A comparison of two methods for identifying frail Medicare-
aged persons.
J Am Geriatrics Soc
. 2002;50:562-569.
2
2
Crooks VC, Buckwalter JG, Petitti DB. Usefulness of a single question in a self-report questionnaire for identifying
persons with possible dementia: comparisons with other screening measures of cognitive impairment and dementia.
Presentation at the Annual Meeting of the Gerontological Society of America, Nov. 18, 2001; Chicago, IL.
3
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.
3,4,5
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.”
6
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.”
7
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
Leslie B. Fried
Director, Federal and State Policy
Director, Medicare Advocacy Project
3
Brodaty H, Clarke J, Ganguli M, et al. Screening for cognitive impairment in general practice: toward a consensus.
Alzheimer Dis Assoc Disord.
1998;12:1-13.
4
Costa PT, Williams TF, Somerfield M, et al. Recognition and initial assessment of Alzheimer's disease and related
dementias: clinical practice guideline. Rockville, MD: US Dep. of Health and Human Services, Agency for Health Care
Policy and Research: 1996.
5
Patterson JS, Gass DA. Screening for cognitive impairment and dementia in the elderly.
Can J Neurol Sci
. 2001;
28(suppl.):S42-S51.
6
U.S. Preventive Services Task Force.
Screening for Dementia,Recommendations and Rationale,
p. 2, accessed Sept.
14, 2004 at http://www.ahrq.gov/clinic/3rduspstf/dementia/dementrr.htm
.
7
Id.
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