Supporting Statement A - CMS-10511 OMB 0938-1250

Supporting Statement Part A
Medicare Coverage of Items and Services in FDA Investigational Device Exemption
Clinical Studies--Revision of Medicare Coverage (CMS-1600-F)
(CMS-10511, OMB 0938-1250)

A. Background

Medicare may provide coverage for certain items and services in FDA-approved Investigational
Device Exemption (IDE) studies if certain requirements are met (see section 1862(m) of the
Social Security Act, and 42 CFR Subpart B). Throughout this document, the words “trial” and
“study” are used interchangeably. The FDA and CMS have an interagency agreement (IAA)
whereby for purposes of assisting CMS in determining Medicare coverage of items and services
in IDE studies, the FDA places all FDA-approved IDE devices in one of two categories:
• Category A (Experimental) device, which refers to a device for which “absolute risk” of
the device type has not been established (that is, initial questions of safety and
effectiveness have not been resolved) and the FDA is unsure whether the device type can
be safe and effective; or
• Category B (Non-experimental/investigation) device, which refers to a device for which
the incremental risk is the primary risk in question (that is, initial questions of safety and
effectiveness of that device type have been resolved), or it is known that the device type
can be safe and effective because, for example, other manufacturers have obtained FDA
premarket approval or clearance for that device type.

Section 1862(m) of the Social Security Act (and regulations at 42 CFR Subpart B (sections
405.201-405.215) allows for payment of the routine costs of care furnished to Medicare
beneficiaries in a Category A IDE study and authorizes the Secretary to establish criteria to
ensure that Category A IDE trials conform to appropriate scientific and ethical standards.
Medicare does not cover the Category A device itself because Category A devices do not satisfy
the statutory requirement that Medicare pay for devices determined to be reasonable and
necessary. Medicare may cover Category B devices, and associated routine costs of care, if they
are considered reasonable and necessary and if all other applicable Medicare coverage
requirements are met.
Under the current centralized review process, interested parties (such as study sponsors) that
wish to seek Medicare coverage related to Category A or B IDE studies have a centralized point
of contact for submission, review and determination of Medicare coverage IDE study requests.
Providers no longer need to notify individual contractors regarding IDE studies for which they
plan to submit claims since we will post limited information regarding CMS-approved Category
A and B IDE studies on the CMS coverage website. We are encouraging providers to check the
CMS Coverage Website to see if an IDE study has been approved for purposes of Medicare
coverage before submitting IDE related claims to local Medicare contractors.

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B. Justification
1.

Need and Legal Basis

Section 1862(m) of the Social Security Act (and regulations at 42 CFR Subpart B (sections
405.201-405.215)) allows for payment of the routine costs of care furnished to Medicare
beneficiaries in a Category A IDE trial and authorizes the Secretary to establish criteria to ensure
that Category A IDE trials conform to appropriate scientific and ethical standards. By providing
Medicare coverage of routine costs in Category A trials, the Congress removed a financial
barrier that may have discouraged beneficiaries from participating in these trials. It also gives
Medicare beneficiaries the opportunity to have earlier access to new medical devices.
As part of the CY 2014 Physician Fee Schedule Rule, we modified 42 CFR Subpart B to
establish Medicare Coverage IDE study criteria for Category A and B IDE studies and establish
a centralized review process. We used our general rulemaking authority (Section 1871 of the
Social Security Act) to apply the same Medicare coverage requirements to Category B IDE
studies that would be applicable to Category A IDE studies.
In order for CMS (or its designated entity) to determine if the Medicare coverage criteria are
met, as described in our regulations, CMS (or its designated entity) must review the following
information:
(1) FDA IDE approval letter.
(2) IDE study protocol.
(3) IRB approval letter.
(4) National Clinical Trials (NCT) number.
(5) Supporting materials, as needed.
2.

Information Users

For purposes of Medicare coverage of items and services in Category A and B IDE studies, CMS
scientists and medical officers will use the materials described above to make decisions about
whether a Category A or B IDE study meets the following Medicare Coverage IDE study
criteria.
(1) The principal purpose of the study is to test whether the device improves health
outcomes of appropriately selected patients.
(2) The rationale for the study is well supported by available scientific and medical
information, or it is intended to clarify or establish the health outcomes of interventions
already in common clinical use.
(3) The study results are not anticipated to unjustifiably duplicate existing knowledge.
(4) The study design is methodologically appropriate and the anticipated number of enrolled
subjects is adequate to confidently answer the research question(s) being asked in the
study.
(5) The study is sponsored by an organization or individual capable of successfully
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completing the study.
(6) The study is in compliance with all applicable Federal regulations concerning the
protection of human subjects found at 21 CFR parts 50, 56, 812 and 45 CFR part 46.
(7) Where appropriate, the study is not designed to exclusively test toxicity or disease
pathophysiology in healthy individuals. Studies of all medical technologies measuring
therapeutic outcomes as one of the objectives may be exempt from this criterion only if
the disease or condition being studied is life threatening and the patient has no other
viable treatment options.
(8) The study is registered with the National Institutes of Health’s National Library of
Medicine’s ClinicalTrials.gov.
(9) The study protocol describes the method and timing of release of results on all prespecified outcomes, including release of negative outcomes and that the release should
be hastened if the study is terminated early.
(10) The study protocol must describe how Medicare beneficiaries may be affected by the
device under investigation, and how the study results are or are not expected to be
generalizable to the Medicare beneficiary population. Generalizability to populations
eligible for Medicare due to age, disability, or other eligibility status must be explicitly
described.
3.

Use of Information Technology

All materials should be in electronic form and should be sent to a dedicated CMS electronic
mailbox. The information does not require a signature from the device trial sponsors.
4.

Duplication of Efforts

Medicare coverage is not a requirement for study sponsors to conduct research. Seeking
Medicare coverage related to Category A or B IDE studies is voluntary under existing
regulations and will continue to be voluntary under the provisions of the modified rule. For
parties seeking Medicare coverage of items and services in IDE studies, certain documents
requested by CMS for review, (such as the IDE study protocol, IRB approval letter, and the NCT
number) will be readily available to the study sponsor since this information would have been
previously developed for review by the FDA. The study sponsor may simply include this
material as part of their request. In the course of CMS’ review, we may request documentation
missing from the request that is necessary for our review.
5.

Small Businesses

Some device manufacturers and study sponsors may be small businesses. We believe that by
establishing a centralized review process as of January 2015, we reduced the previous burden by
more than tenfold. Centralizing the submission, review, and determination of Medicare coverage
IDE study requests enhances administrative efficiency for small businesses by eliminating the
previous need for duplicative submission of requests to multiple local Medicare contractors by
providers and/or study sponsors.
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6.

Less Frequent Collection

Seeking Medicare coverage related to Category A or B IDE studies is voluntary and if this
information was collected less frequently, the respondents would have no knowledge of
Medicare coverage of items and services in Category A and B IDE studies.

7.

Special Circumstances

The documents required by CMS may contain proprietary and trade secret information. CMS
will retains the protections in §405.215, Confidential Commercial and Trade Secret
Information. We note that section 502(c) of the Act broadly prohibits the disclosure of trade
secret and confidential commercial or financial information -- information exempt from public
disclosure by the Freedom of Information Act (FOIA) 5 U.S.C. 552(b)(4) outside the
Department. This prohibition is found in the devices and regulatory inspections provisions of
the Social Security Act, and is not limited to device-related information. This disclosure
prohibition also applies to information reported or otherwise obtained by the Department
during inspection activities and other activities. This prohibition is interpreted to allow
information sharing within the U.S. Department of Health and Human Services only.
Upon CMS approval of a Category A or B IDE study, we will post on the CMS Coverage
website and periodically in the Federal Register limited information (study title, sponsor
name, NCT number, and the IDE number) supplied by the interested party as part of their
Medicare coverage IDE study review request, along with the CMS approval date. We note
that the same type of information is currently posted on the CMS Coverage Website for other
clinical study approvals related to Medicare coverage under the coverage with evidence
development paradigm.
8.

Federal Register/Outside Consultation

The 60-Day Federal Register Notice published to the Federal Register 11/20/2018 (83 FR
58572).
No Comments were received.
The 30-Day Federal Register Notice published to the Federal Register TBD.

9.

Payments/Gifts to Respondents

No payments or gifts will be given to respondents to encourage their response, although their
participation does grant the respondents information regarding Medicare coverage of items and
services in Category A and B IDE studies.
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10. Confidentiality
See Section 7.
11. Sensitive Questions
There are no sensitive questions included within the study.
12. Burden Estimates (Hours & Wages)
Estimate of the hour burden and wages of the collection of
information. Number of respondents: 100 studies per year.
Frequency of response: Once for each study
Annual hour burden: 1-2 hours per study (studies typically last 1-3 years, submission of
the documents is only required once)
Since January 1, 2015, when the centralized IDE process was implemented, we have
received approximately 340 IDE studies, averaging 89 per year. We have initially disapproved
approximately 45 studies; and if the sponsor requests a second review, the documents will
have to be sent again. We estimate that this may happen 10-13% of the time. Adding another
13% brings the total estimate of about 100 requests per year.
To derive average costs, we used data from the U.S. Bureau of Labor Statistics for all
salary estimates. The burden associated with the requirements under § 405.211 is the time and
effort it would take a study sponsor that is requesting Medicare coverage of an FDA-approved
IDE to prepare the following electronic documents as described in Section 1.
For the most part, the documents are copies of communications between the study sponsor and
the FDA. Accordingly, we estimate that it will take 1 to 2 hours for an executive administrative
assistant in a medical device company to prepare the require information. We estimate that for
100 requests per year, that the total time to be expended by all potential study sponsors is
estimated to be between 100 to 200 hours.
In deriving costs to the public, we used the Bureau of Labor Statistics May 2017 estimate of
$28.56 + 100% in fringe benefits for estimated hourly wage of $57.12 for an executive
administrative assistant (occupation code 43-6011). We estimate the cost to be between $5,712
$11,424 per study, for 89 potential IDE study sponsors + a potential 11 additional
submissions. If the average time of a study is 2 years, the annualized cost is $2,856 - $11,424
years applications or $28.56 - $57.12 per study.

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13. Capital Costs
We do not anticipate additional capital costs.
14. Cost to Federal Government
There are no cost to the Federal Government.
15. Changes to Burden
The annual costs and associated collection burden has reduced from a 2013 estimated potential
average of 240 annual requests down to a more accurate average of approximately 100 annual
requests. This new estimate is based on the actual number of requests received since January
2015, when the centralized IDE review process was implemented. We expect this burden to
increase in the future as we receive more requests each year than the previous year.
16. Publication/Tabulation Dates
This information is not published or tabulated.
17. Expiration Date
CMS will publish a notice in the Federal Register to inform the public of both the approval and
the expiration date. In addition, the public will be able to access the expiration date on OMB’s
website by performing a search using the OMB control number.
18. Certification Statement
There are no exceptions to the certification statement.

Collections of Information Employing Statistical Methods

CMS does not intend to collect information employing statistical methods.

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