Response to Public Comment

Society for Clinical Research Inquiry(s)
1. SCRS Medicaid Question/Comment: The form and its guidance should clearly specify that
the Principal Investigator can also sign as the Health Care Provide, provided it is not the
intent to delay the participant’s enrollment in the study and add cost to the Medicaid
system for them to have to see a second physician.
CMS Response: The attestation form has been revised to include a signatory option for the
principal investigator as well as the Health Care Provider. See the attached attestation form for
details. This update has no impact on the currently approved burden estimates.
2. SCRS Medicaid Question/Comment: The form and its guidance should specify that in the
event the Principal Investigator is not the same person as the Health Care Provider, then the
form can be signed in counterparts and that faxes/scans are OK. This will prevent the
beneficiary from the need to cover transportation resources to carry the form around.
CMS Response: The attestation form contains two signature lines, one for the Health Care
Provider and another for the principal investigator. Since the state will manage the attestation
forms, CMS defers to the state on how they want to handle the signatory obligations in the
event the Principal Investigator is not the same person as the Health Care Provider. See the
revised attestation form for details. This update has no impact on the currently approved
burden estimates.

3. SCRS Medicaid Question/Comment: The form and its guidance should eliminate the need
for gathering “Name/Subject of qualified clinical trial”. First this information is not required
by the law, which only requires the form “includes the option to reference information
regarding the qualifying clinical trial that is publicly available on a website maintained by the
Secretary, such as clinicaltrials.gov (or a successor website)” and the proposed form already
has a blank to link to the trial (e.g., on ClinicalTrials.gov) that meets the requirements of the
law. Second, not only will asking for additional trial identifiers cause extra-regulatory
burden to Medicare beneficiaries and their providers, but it will also facilitate confusion on
uniquely identifying the clinical trial across Medicaid beneficiaries and providers. Clinical
trials almost always have other identifiers, such as Sponsor-assigned protocol identifiers,
IRB approval numbers, internally assigned institution numbers, full titles, abbreviated titles
and the like to which many of these are not even publicly accessible. The single, publicly
accessible and universally accepted unique identifier is the NCT number (which CMS already
recognizes for Medicare coverage) is the NCT number from clinicaltrials.gov. No other trial
identifying information should be gathered other than the NCT number from
clinicaltrials.gov.

CMS Response: The attestation form no longer includes the Name/Subject of the qualified
clinical trial and instead includes the National Clinical Trial Number. See the revised attestation
form for details. This change has no impact on the currently approved burden estimates.
4. SCRS Medicaid Question/Comment: The form and its guidance should replace “link to the
qualified trial” to be the NCT number on clinicaltrials.gov, specifically “NCT# (from
clinicaltrials.gov):_______”. This makes the form unambiguously compliant with the law as
it provides the required reference to the Secretary’s website. Otherwise, the provider may
assume that alternate links are acceptable such as a link to the sponsoring manufacturer’s
website or a social media recruitment advertisement.
CMS Response: The attestation form replaced the link to the qualified trial with “NCT (form
clinicaltrials.gov)”. See the revised attestation form for details. This change has no impact on
the currently approved burden estimates.

5. SCRS Medicaid Question/Comment: The request for NPI number should be eliminated. It is
not required by the law and thus the additional data gathering and quality control costs to
Medicaid beneficiaries and their providers is an unnecessary burden.
CMS Response: The NPI number has been eliminated from the attestation form. See the
revised attestation form for details. This update has no impact on the currently approved
burden estimates.

6. SCRS Medicaid Question/Comment: The name and Medicaid ID of the beneficiary is
gathered twice. This information should only be gathered once at the top of the form to
assure consistency of the information throughout the form.
CMS Response: The attestation form now request the name and Medicaid ID of the beneficiary
once opposed to twice. See the revised attestation form for details. This change has no impact
on the currently approved burden estimates.

7. SCRS Medicaid Question/Comment: It is not clear what the providers and/or Principal
Investigators are supposed to do with this form. The form should specify in the footer if it is
only to be stored in the patient medical record of the billing provider or if it is to also be
submitted to the state Medicaid office and if so, when and how.
CMS Response: CMS defers to the state Medicaid agency on how they will handle the form in
terms of storage/placement since the state Medicaid agencies will manage the attestation
forms. This has no impact on the currently approved burden estimates.
8. SCRS Medicaid Question/Comment: The form should be condensed to one single page. In
this case of this form the second page has the most relevant content and, pragmatically

speaking, the second page of a two-page form has more chance of getting lost and/or not
electronically scanned.
CMS Response: The attestation form has been condensed to one single page. See the revised
attestation for details. This change has no impact on the currently approved burden estimates.
9. SCRS Medicaid Question/Comment: As the requirement and form was supposed to be in
effect January 1, 2022, but the form had and has yet to be finalized by CMS, once the form
is finalized and published it should be stated that the form is not required for patients
enrolled prior to the form’s publication date.
CMS Response: CMS will alert states that the attestation form is not required for patients
enrolled prior to the form’s publication date. This will have no impact on the currently

approved burden estimates.

10. SCRS Medicaid Question/Comment: The form and its instructions should be clearer that
the signatures do not have to be obtained and dated before items and services are
rendered for the patient’s routine care. Specifically, beneficiaries should not be denied
benefits for otherwise billable routine care items and services that are medically necessary
for their serious or life-threatening condition or disease but rendered prior to both or one
signature(s) being obtained and dated on the form.
CMS Response: The attestation form is collected prior to any services rendered to a
beneficiary as the attestation form is attesting to the appropriateness of the clinical trial. This
has no impact on the currently approved burden estimates.

11. SCRS Medicaid Question/Comment: The form and its guidance should make
accommodations for circumstances where one signatory is unavailable to physically sign for
a period of time but verbally agrees. This can be done via documentation that the future
signatory has verbally made the attestation and will sign later.
CMS Response: CMS will defer to the state Medicaid agency to determine signatory
accommodations/requirements since the state Medicaid agency will manage the attestation
forms. This has no impact on the currently approved burden estimates.