Public Comment

January 31, 2022
Submitted Online at http://www.regulations.gov.
RE: CMS-10398/OMB #0938-1148
Dear OMB Reviewers,
We are hereby providing comment on proposed form number CMS-10398/OMB #0938-1148
entitled “APPROPRIATENESS OF THE QUALIFYING CLINICAL TRIAL” (a copy of which
is attached below as Exhibit A).
The Society of Clinical Research Sites has over 9,000 clinical trial site members, many of which
will be the very ones who will have to utilize this form and directly discuss it with the Medicaid
beneficiaries and providers. While we understand that a new form is to be required by CMS as a
result of section 210(a)(3)(c) of the Consolidated Appropriations Act of 2021, we strongly
believe based on our members’ feedback that the form will have the opposite effect of the
intention of the law. It is our expectation that the proposed form will in fact actually decrease
enrollment of the Medicaid population in clinical trials and also have a negative effect on our
increased efforts of diversity and inclusion in clinical trials enrollment by making it more
difficult for this population to enroll than any other socio-economic populations (i.e., those with
private insurance and Medicare). We strongly hope CMS does everything possible to decrease
burden on its Medicaid beneficiaries’ enrolling in qualifying clinical trials while this law is in
effect and are available for further discussion on this issue.
Regarding the proposed form itself we hope that OMB and CMS will respect and accommodate
the feedback from its intended users who directly care for the Medicaid beneficiaries whose lives
this form is intended to improve. While we see that the form seemingly meets the required law
passed by Congress, in its present state there are still a number of outstanding questions and
concerns from the forthcoming end users that we have collected and listed below. [Note that in
the below items we use the term “Principal Investigator” instead of the form’s use of “Principle
Investigator” in an effort for us to remain consistent with the FDA regulatory language
governing clinical trials]. Overall, we hope that the law gets changed to bring both equality to
and equity in the Medicaid population for their enrollment in clinical trials and the advancement
of medical science, however in the interim we hope these items below can either be addressed in
a revision to the form and/or in guidance issued about the form.
1) 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.

2) 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.
3) 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, internallyassigned 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.
4) 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.
5) 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.
6) 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.
7) 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.
8) 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.
9) 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.

10) 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.
11) 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.
As always, we are happy to work with OMB and/or CMS as a liaison to the clinical trial site
community on this and other issues for better access and healthcare equity of the Medicaid
beneficiaries.
Sincerely,

Allyson Small
Chief Operating Officer
cc: Kirsten Jensen, Director, Benefits and Coverage CMS (via email
[email protected])