Form CMS-10865 Treatment of Alzheimer's Disease CED Study Registry Form

All fields marked with an asterisk (*) are required.

***SAMPLE FORM: FOR REFERENCE ONLY***

General Information
National Provider Identifier (NPI) *

XXXXXXXXXX

Medicare Beneficiary ID (MBI) *

XXXXXXXXXXX

For more information refer to the NPI Registry:
https://npiregistry.cms.hhs.gov/search

Verified

Reset Form

If you need to re-enter your NPI and MBI to begin again, select the Reset button in order to clear those fields and restart your entry.

CED Study Identifier
NCT*
99999999

Contact Information
Submitter Address List
1234 ANYSTREET, ANY CITY, ST, 55555-5555

Submitter Email Address*
[email protected]

Select an address or manually enter if not listed.

Your email address will be kept confidential and will not be publically shared.

Street Address

State*

1234 ANYSTREET
City*
ANY CITY

State
Zip Code*
55555-5555

Diagnosis
Clinical Diagnosis*
MCI Due to AD

Date of Clinical Diagnosis*

06/19/2023

Mild Cognitive Impairment due to Alzheimer’s Disease (MCI due to AD)

One of the below tests to confirm amyloid pathology is required
Amyloid PET Scan*
Positive
CSF Test*
Not Performed
Other Information

Date of Amyloid PET Scan*

06/15/2023
Other Amyloid Test*
Not Performed

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection
is 0938-XXXX (Expires XX/XX/XXXX). This is a mandatory information collection. The time required to complete this information collection is estimated to average five minutes per response, including the time to review
instructions, search existing data resources, gather the data needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate(s) or suggestions for improving this
form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C4-26-05, Baltimore, Maryland 21244-1850. ****CMS Disclosure**** Please do not send applications, claims, payments,
medical records or any documents containing sensitive information to the PRA Reports Clearance Office. Please note that any correspondence not pertaining to the information collection burden approved under the associated
OMB control number listed on this form will not be reviewed, forwarded, or***SAMPLE
retained. If you have
questions
or concerns
regarding whereONLY***
to submit your documents, please contact Lori Ashby at [email protected].
FORM:
FOR
REFERENCE

***SAMPLE FORM: FOR REFERENCE ONLY***

At least one of the following cognitive tests are required
MoCA Score

Date of MoCA

06/14/2023

26
Other Cognitive Test

At least one of the following functional tests are required
FAQ Score

Date of FAQ

06/14/2023

7
Other Functional Test

The test below is optional
Did you perform a CDR?
Yes

No

Additional Required Information
Is the patient on anticoagulation?*
Yes

No

Monoclonal Antibody Used*

Is the patient on antiplatelets?*
Yes

No

Is there evidence of significant ARIA-E?*

Lecanemab

Yes

Date of ARIA-E test*

No

Is there evidence of significant ARIA-H?*

06/20/2023

Yes

Date of ARIA-H test*

06/20/2023

I’m not a robot
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Submit
***SAMPLE FORM: FOR REFERENCE ONLY***

No

CMS Alzheimer’s Disease Registry/Data Collection Dictionary
(As of June 30, 2023)

Data Element

Description

General Information
National Provider Identifier
(NPI)*

Entry required. The NPI is a unique 10-digit number used to identify
health care providers. All health care providers who are HIPAA-covered
entities, whether individuals or organizations, must obtain an NPI.
Once assigned, an NPI remains the same, even if the provider has a
change of name, address, or other information. An individual clinician
can look up their NPI here: https://npiregistry.cms.hhs.gov/search.
Results will not be made public at the individual clinician or clinician
group level.

Medicare Beneficiary ID (MBID)*

Entry required. CMS uses MBIDs as the unique identifier for all
Medicare transactions like billing, eligibility status, and claim status.
Every person with Medicare has been assigned an MBI. The MBI is
confidential like the Social Security Number and will be protected as
personally identifiable information by the protocol.

CED Study Identifier
NCT*

Entry required. This field will auto-populate with CMS’ anti-beta mAbs
CED Study identification (NCT) number. As additional approved CED
protocols become available, they will be included as options.

Contact Information
Submitter Address List

This field will auto-populate based on the information on file with the
NPI. If needed, the submitter can update the address fields.

Submitter Email Address*

Entry required. CMS requests this to allow for communication with the
submitting provider to resolve any questions to expedite coverage
determination. This information is considered personally identifiable
information and will not be publicly shared.

Street Address

This field records the street number and name associated with the
submitter’s address.

State*

Entry required. This field records the two-letter abbreviation or full
name of the state associated with the submitter’s address.

City*

Entry required. This field records the name of the city associated with
the submitter’s address.

Data Element
Zip Code*

Description
Entry required. This field records the five-digit zip code associated with
the submitter’s address.

Diagnosis
Clinical Diagnosis*

Entry required. Clinical diagnosis includes mild cognitive impairment
(MCI) due to Alzheimer’s disease (AD) or mild AD dementia, both with
confirmed presence of amyloid beta (Aβ) pathology consistent with AD.
The clinical diagnosis will be identified by clinicians using standardpractice, evidence-based guidelines, which involves using cognition and
functional assessments combined with evidence of amyloid on imaging
and/or other clinically appropriate tests.

Date of Clinical Diagnosis*

Entry required. Date of establishing the clinical diagnosis by clinicians
should be entered as mm/dd/yyyy.

Amyloid PET Scan*

Entry required. CMS defers to clinicians’ judgment for determining
whether the results of amyloid positron emission tomography (PET)
scan was positive or negative. If no amyloid PET scan was performed,
the “Not performed” option should be selected.

Date of Amyloid PET Scan*

Entry required if amyloid PET scan was performed. Date of amyloid PET
Scan should be entered as mm/dd/yyyy.

CSF Test Result*

Entry required. CMS defers to clinicians’ judgment for determining
whether the results of cerebral spinal fluid (CSF) test were positive or
negative. If no CSF test was performed, the “Not performed” option
should be selected.

Date of CSF Test Result*

Entry required if CSF test was performed. Date of CSF test should be
entered as mm/dd/yyyy.

Other Amyloid Test*

Entry required. This field records the results of any other amyloid test
that has been performed. If no other amyloid test was performed, the
“Not performed” option should be selected.

Date of Other Amyloid Test*

Entry required if another amyloid test has been performed. Date of
performing any other amyloid test should be entered as mm/dd/yyyy.

Type of Other Amyloid Test*

Entry required if another amyloid test has been performed. Type of any
other amyloid test should be specified in this field.

Description

Data Element
Other Information

Clinicians may feel other diagnostic or clinical information is critical for
their evaluation of patients with MCI due to AD or mild AD dementia.
Therefore, the data submission portal provides an open text field to
enable the person submitting the data to include other relevant
information not required by the CED protocol but potentially valuable
for assessment of anti-Aβ mAb real-world efficacy.

At least one of the cognitive tests below is required.
MoCA© Score

This field records the score of Montreal Cognitive Assessment
(MoCA©) test, which ranges from 0 to 30.

Date of MoCA©

Date of administering MoCA© test (if administered) should be entered
as mm/dd/yyyy.

Other Cognitive Test

This field records the name of any other cognitive test that has been
performed. Example: "Mini-Mental State Exam" with a score of 26.

Other Cognitive Test Score

Entry required if another cognitive test has been performed. Score of
other cognitive test should be entered.

Date of Other Cognitive Test

Entry required if another cognitive test has been performed. Date of
the other cognitive test should be entered as mm/dd/yyyy.

At least one of the functional tests below is required.
FAQ Score

This field records the score of Functional Activities Questionnaire
(FAQ), which ranges from 0 to 30.

Date of FAQ

Date of administering FAQ (if administered) should be entered as
mm/dd/yyyy.

Other Functional Test

This field records the name of any other functional test that has been
performed.

Other Functional Test Score

Entry required if another functional test has been performed. Score of
the other functional test should be entered.

Date of Other Functional Test

Entry required if another functional test has been performed. Date of
the other functional test should be entered as mm/dd/yyyy.

This test is optional.
Did you perform a CDR?

The Clinical Dementia Rating (CDR) is an optional test. This field records
whether a CDR has been performed.

Data Element

Description

Memory*

Entry required if CDR was performed. This field records the score of
“Memory” domain of CDR, ranging from 0 to 3.

Orientation*

Entry required if CDR was performed. This field records the score of
“Orientation” domain of CDR, ranging from 0 to 3.

Judgment and Problem Solving*

Entry required if CDR was performed. This field records the score of
“Judgment and Problem Solving” domain of CDR, ranging from 0 to 3.

Community Affairs*

Entry required if CDR was performed. This field records the score of
“Community Affairs” domain of CDR, ranging from 0 to 3.

Home and Hobbies*

Entry required if CDR was performed. This field records the score of
“Home and Hobbies” domain of CDR, ranging from 0 to 3.

Personal Care*

Entry required if CDR was performed. This field records the score of
“Personal care” domain of CDR, ranging from 0 to 3.

Some of Boxes*

Entry required if CDR was performed. This field will auto-populate
based on the scores in the previous six fields (Memory, Orientation,
Judgment and Problem Solving, Community Affairs, Home and
Hobbies, and Personal Care).

Global *

Entry required if CDR was performed. This field records the CDR global
score, ranging from 0 to 3.

Date for CDR*

Entry required if CDR was performed. Date of administering CDR
should be entered as mm/dd/yyyy.

Additional Required Information
Is the patient on
anticoagulation?*

Entry required. In addition to performing the required cognition and
function assessments, prescribing clinicians need to report on the
patient’s use of anticoagulation therapy. According to patient’s
medication use, “Yes” or “No” should be selected.

Is the patient on antiplatelets?*

Entry required. In addition to performing the required cognition and
function assessments, prescribing clinicians need to report on the
patient’s use of anti-platelet therapy. According to patient’s
medication use, “Yes” or “No” should be selected.

Monoclonal Antibody Used*

Entry required. The generic name of monoclonal antibody (e.g.,
Aducanumab, Lecanemab) should be specified in this field.

Data Element

Description

Is there evidence of significant
ARIA-E?*

Entry required. CMS defers to clinician’s judgment to determine
whether evidence of significant amyloid related imaging abnormalities
with edema (ARIA-E) was observed. Based on clinician’s judgment,
either “Yes” or “No” should be selected.

Is there evidence of significant
ARIA-H?*

Entry required. CMS defers to clinician’s judgment to determine
whether evidence of significant amyloid related imaging abnormalities
with hemorrhage (ARIA-H) was observed. Based on clinician’s
judgment, either “Yes” or “No” should be selected.